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triamcinolone acetonide

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Description

Triamcinolone Acetonide: An esterified form of TRIAMCINOLONE. It is an anti-inflammatory glucocorticoid used topically in the treatment of various skin disorders. Intralesional, intramuscular, and intra-articular injections are also administered under certain conditions. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

triamcinolone acetonide : A synthetic glucocorticoid that is the 16,17-acetonide of triamcinolone. Used to treat various skin infections. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID6436
CHEMBL ID1504
CHEBI ID71418
SCHEMBL ID4689
MeSH IDM0021897

Synonyms (241)

Synonym
MLS002207192
AC-1239
MLS001148264
AB00383012-11
gtpl2867
aristogel
nsc-21916
wln: t f5 e5 b666 go io rv ahtttt&j a1 bf cq e1 fv1q h1 h1
triaceton
volon a 40
nsc21916
kenalone
pregna-1,20-dione, 9-fluoro-11.beta.,21-dihydroxy-16.alpha.,17-(isopropylidenedioxy)-
omcilon a
aristocort acetonide
solodelf
coupe-a
triamcincolone acetonide
9.alpha.-fluoro-11.beta.,4-pregnadiene,3,20-dione
pregna-1,20-dione, 9-fluoro-11.beta.,16.alpha.,17,21-tetrahydroxy-, cyclic 16,17-acetal with acetone
volon a
flutone
triamcinolone 16,17-acetonide
triam-injekt
pregna-1,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (11.beta.,16.alpha.)-
adcortyl a
pregna-1,20-dione, 9-fluoro-11.beta.,16.alpha.,17,21-tetrahydroxy-,cyclic 16,17-acetal with acetone
tricinolon
aristoderm
9.alpha.-fluoro-16.alpha.-17.alpha.-isopropylidenedioxy-.delta.-1-hydrocortisone
9.alpha.-fluoro-16-hydroxyprednisolone acetonide
rineton
tramacin
(4as,4br,5s,6as,6bs,9ar,10as,10bs)-4b-fluoro-5-hydroxy-6b-(hydroxyacetyl)-4a,6a,8,8-tetramethyl-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2h-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-2-one
vetalog
kenacort-a
9-alpha-fluoro-16-alpha-hydroxyprednisolone 16-alpha,17-alpha-acetonide
tricort-40
kenalog in orabase
triacet
triatex
kenalog-10
pregna-1,4-diene-3,20-dione, 9-fluoro-11-beta,16-alpha,17,21-tetrahydroxy-, cyclic 16,17-acetal with acetone
triamsinolone acetonide
9-alpha-fluoro-11-beta,21-dihydroxy-16-alpha-isopropylidenedioxy-1,4-pregnadiene,3,20-dione
oracort
kenalog-40
kenalog-h
aristocort a
acetospan
flutex
nasacort hfa
triamcinolone acetonide [jan]
pregna-1,4-diene-3,20-dione, 9-fluoro-11beta,16alpha,17,21-tetrahydroxy-, cyclic 16,17-acetal with acetone
9-alpha-fluoro-16-hydroxyprednisolone acetonide
trymex
pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-((1-methylethylidene)bis(oxy))-, (11beta,16alpha)-
azmacort
ccris 5231
nasacort
nsc 21916
panolog ointment (veterinary)
triacort
vetalog (veterinary)
einecs 200-948-7
tri-nasal
triamcinolone acetonide in absorbase
9-fluoro-11beta,16alpha,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone
9-alpha-fluoro-11-beta,21-dihydroxy-16-alpha,17-alpha-isopropylidenedioxypregna-1,4-diene-3,20-dione
triderm
kenalog 40
9alpha-fluoro-16-hydroxyprednisolone acetonide
nasacort aq
9-alpha-fluoro-16-alpha-17-alpha-isopropyledenedioxyprednisolone
9alpha-fluoro-16alpha-17alpha-isopropyledenedioxyprednisolone
9-alpha-fluoro-16-alpha-17-alpha-isopropylidenedioxy-delta-1-hydrocortisone
brn 0060069
oralone
76-25-5
triamcinolone acetonide
C08183
NCGC00023193-04
azmacort (tn)
triamcinolone acetonide (jp17/usp)
nasacort (tn)
D00983
kenalog (tn)
MLS000028538 ,
smr000058335
acetonide, triamcinolone
9alpha-fluoro-11beta,21-dihydroxy-16alpha,17-isopropylidenedioxy-1,4-pregnadiene-3,20-dione
CHEMBL1504
fx006
chebi:71418 ,
BRD-K53790871-001-08-6
extracort
ftorocort
NCGC00023193-05
HMS3259A20
tri-adcortyl
NCGC00256560-01
dtxsid6021371 ,
dtxcid201371
tox21_303014
cas-76-25-5
NCGC00259344-01
tox21_201795
tox21_110885
HMS2232F22
zilretta
trianex
5-19-06-00568 (beilstein handbook reference)
asmacort [common misspelling of azmacort]
nasacort allergy 24 hour
triamcinolone acetonide [usp:inn:ban:jan]
triesence
trivaris
allernaze
unii-f446c597ka
f446c597ka ,
triamcinolone acetonide [who-dd]
triamcinolone acetonide [green book]
triamcinolone acetonide [mart.]
triamcinolone acetonide [mi]
fluocinolone acetonide impurity h
triamcinolone acetonide component of mytrex f
volonimat
triamcinolone acetonide [usp-rs]
triamcinolone hexacetonide impurity a [ep impurity]
triamcinolone acetonide [orange book]
xipere
triamcinolone acetonide component of mytrex a
cls1001
ledercort cream
triamcinolone acetonide [vandf]
cls-1001
triamcinolone acetonide component of mycolog
mykacet component triamcinolone acetonide
triamcinolone acetonide component of mykacet
triamcinolone acetonide [ep monograph]
mytrex a component triamcinolone acetonide
mytrex f component triamcinolone acetonide
triamcinolone acetonide [usp monograph]
mycolog component triamcinolone acetonide
AKOS015894871
9alpha-fluoro-11beta,21-dihydroxy-16alpha,17-isopropylidenedioxy-1,4-pregnadiene,3,20-dione
9alpha-fluoro-11beta,21-dihydroxy-16alpha,17alpha-isopropylidenedioxypregna-1,4-diene-3,20-dione
(11beta,16alpha)-9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]pregna-1,4-diene-3,20-dione
(4as,4br,5s,6as,6bs,9ar,10as,10bs)-4b-fluoro-6b-glycoloyl-5-hydroxy-4a,6a,8,8-tetramethyl-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2h-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-2-one
9alpha-fluoro-16alpha-17alpha-isopropylidenedioxy-delta-1-hydrocortisone
9-fluoro-11beta,16alpha,17,21-tetrahydroxypregna-1,4-diene-3,20-dione-16,17-acetonide
9alpha-fluoro-16alpha-hydroxyprednisolone 16alpha,17alpha-acetonide
HY-B0636
NC00591
SCHEMBL4689
NCGC00023193-06
tox21_110885_1
KS-5330
YNDXUCZADRHECN-JNQJZLCISA-N
Q-201855
AB00383012_12
OPERA_ID_232
triamcinolone (acetonide) ,
triamcinolone acetonide, united states pharmacopeia (usp) reference standard
triamcinolone acetonide, pharmaceutical secondary standard; certified reference material
triamcinolone acetonide, european pharmacopoeia (ep) reference standard
triamcinolone acetonide, analytical standard
triamcinolone acetonide for system suitability, european pharmacopoeia (ep) reference standard
1ta ,
(4as,4br,5s,6as,6bs,9ar,10as,10bs)-4b-fluoro-5-hydroxy-6b-(hydroxyacetyl)-4a,6a,8,8-tetramethyl-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2h,8h-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-2-one
gppe ear oint
remiderm
pevaryl t.c.
audicort
silderm
aureocort
nystadermal
adcortyl in orabase
bdbm50248362
remotic
gppe ear dps cap
dimethyl2-(3-nitro-2-pyridyl)malonate
S1628
Q2211240
triamcinolone-acetonide
CCG-269068
kenalone, solodelf
A856341
triamcinolone acetonide; 76-25-5; azmacort; aristogel; nasacort;
triamcinolone acetonide 100 microg/ml in methanol
HY-B0636R
triamcinolone acetonide (standard)
CS-0695000
dg health nasal allergy
sila iii
medalone cream
foster and thrive 24 hour nasal allergy
triloan ii suik
(4as,4br,5s,6as,6bs,9ar,10as,10bs)-4b-fluoro-6b-glycoloyl-5-hydroxy-4a,6a,8,8-tetramethyl-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2h-naphtho(2',1':4,5)indeno(1,2-d)(1,3)dioxol-2-one
leader nasal allergy
triamcinolone acetonide ointment
triamcinolone acetonide cream .1%
nasal allergy
trivix lite
nasal allergy 24 hour
triamcinolone acetonide (usp:inn:ban:jan)
trianex 0.05%
up and up nasal allergy
triasil
good neighbor pharmacy 24 hour nasal allergy
good sense nasal allergy
pro-c-dure 5 kit
protherix
basic care nasal allergy
pediaderm ta
triamcinolone acetonide suspension
equaline nasal allergy
0.015% triamcinolone acetonide
health mart 24 hour nasal allergy
triamcinolone acetonide (usp monograph)
triamcinolone acetonide (mart.)
tritocin
topcare nasal allergy
triamcinolone acetonide nasal
kirkland signature aller cort
genesis topical spray
signature care nasal allergy
kenalog-80
triamcinolone acetonide (usp-rs)
triamcinolone acetonide ointment usp, 0.05%
vetalog parenteral
oramedy
readysharp triamcinolone
asmacort (common misspelling of azmacort)
24 hour nasal allergy
triamcinolone acetonide (ep monograph)
equate nasal allergy
nasacort allergy 24hr
triloan suik
pro-c-dure 6 kit
triamcinolone acetonide cream

Research Excerpts

Overview

Triamcinolone acetonide (TA) is an effective drug widely (off-label) used in the treatment of several ocular diseases involving inflammation and angiogenic processes. The detailed mechanism of action of TA is not known, part of its action was examined.

ExcerptReferenceRelevance
"Triamcinolone acetonide is a synthetic glucocorticoid used to treat numerous acute and chronic inflammatory conditions. "( Dermal Discoloration Secondary to Triamcinolone Acetonide Injection Observed in Patients with Autoimmune Disorders.
Madrigal, GJ; Wenz, JA; Wright, JA, 2021
)
2.34
"Triamcinolone acetonide (TAA) is a corticosteroid used for treating AR."( Triamcinolone Acetonide in the Treatment of Perennial Allergic Rhinitis: A post hoc Efficacy Analysis of a Phase III Study Performed in Russia.
Ilina, NI; Karaulov, AV; Lucio, L; Maslakov, A; Shartanova, N,
)
2.3
"Triamcinolone acetonide is a glucocorticosteroid used in standard clinical practice for its anti-inflammatory properties. "( Enigma of Intramuscular Triamcinolone Acetonide (Kenalog
Maibach, H; Shahinfar, S, 2023
)
2.66
"Triamcinolone acetonide (TA) is an effective drug widely (off-label) used in the treatment of several ocular diseases involving inflammation and angiogenic processes. "( Triamcinolone acetonide-loaded lipid nanocapsules for ophthalmic applications.
Benoit, JP; Formica, ML; Luna, JD; Palma, SD; Tártara, LI; Ullio Gamboa, GV, 2020
)
3.44
"Triamcinolone acetonide (TA) is a therapeutic agent for DME, but since the detailed mechanism of action of TA is not known, part of its action was examined."( Triamcinolone Acetonide Suppresses Inflammation and Facilitates Vascular Barrier Function in Human Retinal Microvascular Endothelial Cells.
Hara, H; Imai, S; Naito, A; Otsuka, T; Shimazawa, M, 2017
)
2.62
"Triamcinolone acetonide (TA) is an alternative option for diabetic macular edema thanks to its cost-benefit ratio and unique delivery route. "( Comparison of vitrectomized with nonvitrectomized eyes after subtenon injection of triamcinolone acetonide to treat diabetic macular edema: Retrospective comparative Analysis of an interventional case series.
Byon, IS; Choi, BS; Lee, JE; Pak, KY; Park, SW, 2017
)
2.12
"Triamcinolone acetonide is a slowly dissolving crystalline corticosteroid that is often used for this purpose because of its prolonged anti-inflammatory effect."( A Common Procedure With an Uncommon Pathology: Triamcinolone Acetonide Eyelid Injection.
Hatton, MP; Jakobiec, FA; Wolkow, N,
)
1.11
"Triamcinolone acetonide (TAA) is a classical corticosteroid that reduces synovitis and alleviates pain, albeit transiently."( Intra-articular injection of triamcinolone acetonide releasing biomaterial microspheres inhibits pain and inflammation in an acute arthritis model.
Creemers, L; Eijkelkamp, N; Emans, P; Mihov, G; Rudnik-Jansen, I; Schrijver, K; Tellegen, A; Thies, J; Tryfonidou, M; Versteeg, S; Woike, N, 2019
)
1.53
"Triamcinolone acetonide is a nasal corticosteroid preparation indicated for the treatment of seasonal and perennial AR (PAR) in different countries worldwide."( Triamcinolone Acetonide versus Fluticasone Propionate in the Treatment of Perennial Allergic Rhinitis: A Randomized, Parallel-Group Trial.
Chernikova, M; Karaulov, AV; Nenasheva, N; Ovchinnikov, A; Vylegzhanina, T, 2019
)
2.68
"Triamcinolone acetonide (TAA) is an effective and the most commonly used corticosteroid hormone for the treatment of hypertrophic scars (HSs). "( Transdermal permeability of triamcinolone acetonide lipid nanoparticles.
Ban, J; Chen, D; Chen, F; Qin, Z; Tan, Y; Wang, Y, 2019
)
2.25
"Triamcinolone acetonide (TA) is a glucocorticoid (GC) widely used in sports medicine. "( Additional studies on triamcinolone acetonide use and misuse in sports: Elimination profile after intranasal and high-dose intramuscular administrations.
Alechaga, É; Coll, S; Matabosch, X; Monfort, N; Pérez-Mañá, C; Ventura, R, 2019
)
2.27
"Triamcinolone acetonide (Kenacort) is a corticosteroid that can be administrated by subconjunctival injection, with an extended release for up to three months. "( [Safety and efficacy of subconjunctival triamcinolone injections in the management of uveitic macular edema: retrospective study of thirty-one cases].
Bleriot, A; Couret, C; Le Meur, G; Lebranchu, P; Weber, M, 2014
)
1.85
"Triamcinolone acetonide (TA) is a potent, intermediate-acting, steroid that has anti-inflammatory and anti-angiogenic activity. "( Intracellular delivery of dendrimer triamcinolone acetonide conjugates into microglial and human retinal pigment epithelial cells.
Kambhampati, SP; Kannan, RM; Lutty, GA; Mastorakos, P; Mishra, MK; Oh, Y, 2015
)
2.13
"Triamcinolone acetonide (TA) is a corticosteroid drug currently administered by intravitreal injection for a broad spectrum of inflammatory, edematous and angiogenic ocular diseases. "( Nanostructured lipid carriers for triamcinolone acetonide delivery to the posterior segment of the eye.
Araújo, J; Egea, MA; Garcia, ML; Nikolic, S; Souto, EB, 2011
)
2.09
"Triamcinolone acetonide (TA) is a steroidal drug that has been widely administered intravitreally for retinal and choroidal conditions. "( Drug safety evaluation of intravitreal triamcinolone acetonide.
Di Giulio, A; Lanzetta, P; Sarao, V; Veritti, D, 2012
)
2.09
"Triamcinolone acetonide (TA) is a corticosteroid that is used in the systemic and topical treatment of many inflammatory diseases. "( Transdermal delivery system of triamcinolone acetonide from a gel using phonophoresis.
Kim, DK; Kim, TY; Shin, SC; Yang, JH; Yun, MY, 2006
)
2.06
"Triamcinolone acetonide appeared to be an as valuable therapy in minimizing inflammation after cataract surgery as steroid drops on days 7, 14 and 21 postoperatively, a significantly lower intraocular pressure was recorded in the group of patients administered a single injection of triamcinolone acetonide."( [Triamcinolone acetonide in the treatment of inflammation after cataract surgery].
Iveković, R; Lacmanović Loncar, V; Mandić, Z; Musulin, T; Novak-Laus, K; Petric, I; Vatavuk, Z, 2006
)
2.69
"Triamcinolone acetonide mouthrinse is an appropriate treatment for erosive OLP, in view of the high efficacy and low risk of fungal over-infection."( Triamcinolone acetonide mouth rinses for treatment of erosive oral lichen planus: efficacy and risk of fungal over-infection.
Blanco-Carrión, A; Diniz-Freitas, M; Gándara-Rey, J; Gándara-Vila, P; García-García, A; González-García, A, 2006
)
3.22
"Triamcinolone acetonide (TCA) is a corticosteroid that is frequently used in the treatment of asthma. "( Pharmacokinetic and pharmacodynamic evaluation of triamcinolone acetonide after intravenous, oral, and inhaled administration.
Barth, J; Derendorf, H; Erdmann, M; Galia, E; Hochhaus, G; Mollmann, H; Rohatagi, S; Sourgens, H, 1995
)
1.99
"Triamcinolone acetonide is a synthetic glucocorticoid which has been formulated as both an aerosol and an aqueous metered-dose pump spray for nasal inhalation in the treatment of allergic rhinitis. "( Triamcinolone acetonide. A review of its pharmacological properties and therapeutic efficacy in the management of allergic rhinitis.
Faulds, D; Jeal, W, 1997
)
3.18
"Triamcinolone acetonide is a glucocorticoid administered by oral inhalation in the management of asthma. "( A pharmacokinetic study to evaluate the absolute bioavailability of triamcinolone acetonide following inhalation administration.
Argenti, D; Heald, D; Shah, B, 1999
)
1.98
"Triamcinolone acetonide (TACA) is a corticosteroid; it is used in the systemic and topical treatment of a variety of inflammatory conditions, including eczema and psoriasis. "( The influence of hydrocolloid patch composition on the bioavailability of triamcinolone acetonide in humans.
Brown, MB; Hollingsbee, DA; Ladenheim, D; Marriott, C; Martin, GP, 2000
)
1.98
"Triamcinolone acetonide (TAA) is an anti-inflammatory steroid used for topical treatment of allergic rhinitis and asthma. "( Pulmonary distribution and kinetics of inhaled [11C]triamcinolone acetonide.
Berridge, MS; Heald, DL; Lee, Z, 2000
)
2
"Triamcinolone acetonide (TAA) is an effective and safe corticosteroid that is marketed as a metered-dose inhaler (MDI) with an integrated spacer (Azmacort) for the treatment of asthma."( In vitro and in vivo techniques used in drug development for evaluation of dose delivery of inhaled corticosteroids.
Banerji, DD; Chaikin, P; Deluccia, F; Gillen, MS; Rhodes, GR; Rohatagi, S, 2001
)
1.03

Effects

Triamcinolone acetonide (TAA) has been reformulated as an hydrofluoroalkane (HFA) aerosol for intranasal use in patients with seasonal allergic rhinitis (SAR) It has been proposed as an adjuvant to pars plana vitrectomy with silicone oil for the surgical treatment of proliferative vitreoretinopathy.

ExcerptReferenceRelevance
"Triamcinolone acetonide (TAC) has a potent teratogenic effect on various mammalian fetal tissues as well as a steroid effect on the lung. "( Effect of triamcinolone acetonide on the development of the pulmonary airways in the fetal rat.
Massoud, EA; Rotschild, A; Sekhon, HS; Solimano, A; Thurlbeck, WM, 1997
)
2.14
"Triamcinolone acetonide (TA) has been shown to improve morphological and functional outcome in diabetic macular edema (DME) patients. "( Effect of triamcinolone acetonide on retinal inflammation and angiogenesis induced by pericyte depletion in mouse.
Arakawa, R; Masuda, T; Naito, A; Okabe, T; Otsuka, T; Suzuki, A; Takahashi, Y; Uemura, A, 2023
)
2.76
"Triamcinolone acetonide has been used for ITS treatment in various clinical settings."( Intratympanic Triamcinolone Acetonide as a Salvage Treatment for Idiopathic Sudden Sensorineural Hearing Loss.
Andrianakis, A; Graupp, M; Holzmeister, C; Kiss, P; Moser, U; Tomazic, PV; Wolf, A, 2021
)
1.7
"Triamcinolone acetonide (TAA) has been reformulated as an hydrofluoroalkane (HFA) aerosol for intranasal use in patients with seasonal allergic rhinitis (SAR). "( Therapeutic equivalence of triamcinolone acetonide hydrofluoroalkane and chlorofluorocarbon nasal inhalers in patients with seasonal allergic rhinitis.
Newman, KB; Schenkel, E,
)
1.87
"Triamcinolone acetonide (TA) has been proposed as an adjuvant to pars plana vitrectomy with silicone oil for the surgical treatment of proliferative vitreoretinopathy and proliferative diabetic retinopathy. "( The distribution, release kinetics, and biocompatibility of triamcinolone injected and dispersed in silicone oil.
Bartz-Schmidt, KU; Heimann, H; Jaissle, GB; Kaczmarek, RT; Petermeier, K; Spitzer, MS; Szurman, P; Wong, D; Yoeruek, E, 2009
)
1.8
"Triamcinolone acetonide has no inhibitory effect on macrophage infiltration or ICAM-1, Thy-1, or VEGF expression in CNV membranes in the early term. "( Early effects of intravitreal triamcinolone acetonide on inflammation and proliferation in human choroidal neovascularization.
Adam, A; Bartz-Schmidt, KU; Boeyden, V; Claes, C; Eckardt, C; Eckert, T; Grisanti, S; Kaiserling, E; Pertile, G; Scharioth, GB; Shinoda, K; Szurman, P; Tatar, O; Yoeruek, E, 2009
)
2.08
"Triamcinolone acetonide (TA) has applications for the treatment of a large range of intraocular vascular diseases. "( Intravitreal triamcinolone acetonide induced changes in the anterior segment in a pig model of branch retinal vein occlusion.
Cringle, SJ; McAllister, IL; McMenamin, PG; Mendis, KR; Morgan, WH; Vijayasekaran, S; Yu, DY, 2011
)
2.18
"Triamcinolone acetonide (TA) has recently been used to treat diabetic macular edema (DME) but its effectiveness is limited."( Pars plana vitrectomy with removal of posterior hyaloid face in treatment of refractory diabetic macular edema resistant to triamcinolone acetonide.
Higuchi, A; Jo, N; Matsumura, M; Ogata, N; Wada, M,
)
1.78
"Triamcinolone acetonide has been effectively used in ocular therapeutics for over 50 years. "( Triamcinolone acetonide in ocular therapeutics.
Dellacroce, JT; Heffez, J; Jermak, CM; Peyman, GA,
)
3.02
"Triamcinolone acetonide (TAC) has a potent teratogenic effect on various mammalian fetal tissues as well as a steroid effect on the lung. "( Effect of triamcinolone acetonide on the development of the pulmonary airways in the fetal rat.
Massoud, EA; Rotschild, A; Sekhon, HS; Solimano, A; Thurlbeck, WM, 1997
)
2.14

Actions

Triamcinolone acetonide-induced increase in [125I]EGF binding capacity was dose-dependent. maximal binding was observed at 10(-6)M.

ExcerptReferenceRelevance
"Triamcinolone acetonide induced increase in intraocular pressure may not be markedly associated with the dosage used."( Dosage dependency of intravitreal triamcinolone acetonide as treatment for diabetic macular oedema.
Derse, M; Jonas, JB; Papoulis, C; Schmitz-Valckenberg, P; Spandau, UH, 2005
)
1.33
"The triamcinolone acetonide-induced increase in [125I]EGF binding capacity was dose-dependent between 10(-9) and 10(-6)M, and maximal binding was observed at 10(-6)M."( Effect of glucocorticoid on epidermal growth factor receptor in human salivary gland adenocarcinoma cell line HSG.
Kurokawa, R; Kyakumoto, S; Ota, M, 1990
)
0.76

Treatment

Treatment with triamcinolone acetonide is associated with increased tooth movement in rabbits via increased resorptive activity in the alveolar bone. The treatment was associated with a significantly greater increase in fasting serum glucose levels than other preparations (p = 0.006).

ExcerptReferenceRelevance
"Triamcinolone acetonide treatment decreased steroid 5 alpha-reductase activity by 95% and also decreased the activities of steroid 3 alpha- and 3 beta-reductases by more than 90%."( The effect of budesonide and triamcinolone acetonide on hepatic microsomal testosterone metabolism in the rat.
Davies, DS; Edwards, RJ; Freeling, AB; Watson, D, 1992
)
1.3
"Treatment with triamcinolone acetonide delivered by Med-Jet MBX is a safe, minimally painful and effective treatment for nail psoriasis."( Treatment of nail psoriasis with intralesional triamcinolone acetonide using a needle-free jet injector: a prospective trial.
Benohanian, A; Marcil, I; Nantel-Battista, M; Richer, V,
)
0.74
"Treatment with triamcinolone acetonide is associated with increased tooth movement in rabbits via increased resorptive activity in the alveolar bone."( Effect of corticosteroids on orthodontic tooth movement in a rabbit model.
Abtahi, M; Giddon, D; Peel, S; Saghravania, N; Shafaee, H; Sohrabi, K, 2014
)
0.76
"Treatment with triamcinolone acetonide was associated with a significantly greater increase in fasting serum glucose levels than other preparations (p = 0.006)."( Effect of intranasal steroids on glucose and hemoglobin A1c levels in diabetic patients.
Bachar, G; Hadar, T; Mizrachi, A; Vinker, S; Yaniv, E,
)
0.47

Toxicity

Triamcinolone acetonide (TA) has been widely used as a therapeutic method for many ocular diseases. A consensus on an appropriate safe therapeutic window of dosage for intravitreal injection, and whether vehicle of TA should be reduced or eliminated, is not yet reached.

ExcerptReferenceRelevance
" Generally, after application of triamcinolone-acetonide fetal livers accumulated more lipids as toxic response to this glucocorticoid than the maternal organ; the degree of lipid accumulation was clearly dose-dependent in the fetuses."( Analysis of hepatotoxicity in maternal and fetal rats after glucocorticoid administration by lipid histochemistry and thin layer chromatography.
Frank, HG; Gossrau, R; Graf, R, 1989
)
0.28
" The LD50 values of THS-201 both in mice and rats were estimated more than 5000 mg/kg at each route, and these are for above larger than those of TA or MPA."( [Study on toxicity of halopredone acetate. (I) Acute toxicity study in mice and rats].
Ichinohe, M; Kaga, M; Okazaki, S; Shinpo, K; Sudo, J; Takeuchi, M; Tanabe, T; Tsuga, T, 1985
)
0.27
" Mild-to-moderate adverse reactions (sore throat, hoarseness) were reported by six patients during the six-week phase and by ten patients during the 12-month phase."( Efficacy and safety of triamcinolone acetonide aerosol in chronic asthma. Results of a multicenter, short-term controlled and long-term open study.
Bernstein, IL; Chervinsky, P; Falliers, CJ, 1982
)
0.57
" Aerosolized triamcinolone acetonide was therefore considered a safe and effective modality in the management of chronic asthma."( Efficacy and safety of aerosolized triamcinolone acetonide in steroid-dependent and steroid-independent chronic asthmatic patients.
Olivier, N, 1982
)
0.91
" Among patients who reported adverse clinical experiences, most were considered unrelated or remotely related to therapy."( Long-term safety of triamcinolone acetonide nasal aerosol for the treatment of perennial allergic rhinitis.
Bronsky, E; Findlay, S; Pearlman, DS; Southern, DL; Storms, WW; Weakley, S; Welch, MJ,
)
0.45
" There were no differences between the two treatment groups in the incidence of adverse events."( Efficacy and safety of triamcinolone acetonide aqueous nasal spray in patients with seasonal allergic rhinitis.
Feiss, G; Furst, JA; LaForce, C; Munk, ZM; Simpson, B; Smith, JA, 1996
)
0.6
" Adverse events were generally mild or moderate and consistent with long-term use and winter symptoms."( Long-term safety and efficacy of triamcinolone acetonide aqueous nasal spray for the treatment of perennial allergic rhinitis.
Beaucher, WN; Feiss, G; Furst, JA; Kobayashi, RH; Koepke, JW; Ransom, JH; Rosen, JP; Simpson, B; Smith, JA,
)
0.41
" Our findings indicate that TAA-HFA is a safe and effective replacement for the currently marketed CFC-containing product."( Placebo-controlled, comparative study of the efficacy and safety of triamcinolone acetonide inhalation aerosol with the non-CFC propellant HFA-134a in patients with asthma. Azmacort HFA Clinical Study Group.
Banerji, D; Chervinsky, P; Jacobson, K; Kane, RE; Noonan, M; Uryniak, T, 1999
)
0.54
" Seven patients discontinued because of adverse events and two because of ineffective asthma control."( Long-term safety of a non-chlorofluorocarbon-containing triamcinolone acetonide inhalation aerosol in patients with asthma. Azmacort HFA Study Group.
Banerji, D; Kane, RE; Nelson, HS; Petillo, J, 2000
)
0.55
" In the intent-to-treat population (n = 92), there was no difference between treatment groups in the incidence of overall adverse events."( Local safety of intranasal triamcinolone acetonide: clinical and histological aspects of nasal mucosa in the long-term treatment of perennial allergic rhinitis.
Bousquet, J; Klossek, JM; Laliberté, F; Laliberté, MF; Mounedji, N, 2001
)
0.61
" Adverse events, from mild to vision-threatening or life-threatening, were recorded as procedure-related or corticosteroid-related."( Safety of an intravitreal injection of triamcinolone: results from a randomized clinical trial.
Billson, FA; Chua, W; Gillies, MC; Hunyor, AB; Luo, W; Mitchell, P; Penfold, P; Simpson, JM; Zhu, M, 2004
)
0.32
" There were no moderate or severe adverse events related to the surgical procedure in either group."( Safety of an intravitreal injection of triamcinolone: results from a randomized clinical trial.
Billson, FA; Chua, W; Gillies, MC; Hunyor, AB; Luo, W; Mitchell, P; Penfold, P; Simpson, JM; Zhu, M, 2004
)
0.32
"Despite a significant adverse event profile, intravitreal triamcinolone is generally well tolerated by the human eye as long as patients are carefully followed up by their surgeon and treated appropriately, when necessary."( Safety of an intravitreal injection of triamcinolone: results from a randomized clinical trial.
Billson, FA; Chua, W; Gillies, MC; Hunyor, AB; Luo, W; Mitchell, P; Penfold, P; Simpson, JM; Zhu, M, 2004
)
0.32
"The main outcome measures were improvement of best-corrected logarithm of the minimum angle of resolution visual acuity by 5 or more letters and incidence of moderate or severe adverse events."( Intravitreal triamcinolone for diabetic macular edema that persists after laser treatment: three-month efficacy and safety results of a prospective, randomized, double-masked, placebo-controlled clinical trial.
Gillies, MC; Simpson, JM; Sutter, FK, 2004
)
0.32
"In the short term, intravitreal triamcinolone is an effective and relatively safe treatment for eyes with diabetic macular edema that have failed laser treatment."( Intravitreal triamcinolone for diabetic macular edema that persists after laser treatment: three-month efficacy and safety results of a prospective, randomized, double-masked, placebo-controlled clinical trial.
Gillies, MC; Simpson, JM; Sutter, FK, 2004
)
0.32
" Adverse events were uncommon, with no difference between groups."( Cost-effectiveness and safety of epidural steroids in the management of sciatica.
Arden, N; Coglan, L; Price, C; Rogers, P, 2005
)
0.33
"Triamcinolone acetonide is toxic to proliferating cells of retinal origin in vitro at doses normally used in clinical practice."( Toxicity of triamcinolone acetonide on retinal neurosensory and pigment epithelial cells.
Kenney, MC; Kuppermann, BD; Mungcal, JK; Narayanan, R; Seigel, GM, 2006
)
2.16
"Intravitreal triamcinolone acetonide (TA) has been widely used as a therapeutic method for many ocular diseases, but a consensus on an appropriate safe therapeutic window of dosage for intravitreal injection, and whether vehicle of TA should be reduced or eliminated, has not yet been reached."( Vehicle of triamcinolone acetonide is associated with retinal toxicity and transient increase of lens density.
Kai, W; Xiaoxin, L; Yanrong, J, 2006
)
1.09
"To evaluate whether Triamcinolone acetonide (TA)-assisted pars plana vitrectomy for visualisation of posterior hyaloid during macular hole surgery has any adverse effects on macular hole closure rate and intraocular pressure (IOP)."( Safety of Triamcinolone acetonide (TA)-assisted pars plana vitrectomy in macular hole surgery.
Cheema, R; Gorman, C; Kampougeris, G; McPherson, R, 2007
)
1.07
"Case series comparing outcomes and adverse effects in patients who had surgery for macular holes with ILM peel, with and without the use of TA-assisted vitrectomy."( Safety of Triamcinolone acetonide (TA)-assisted pars plana vitrectomy in macular hole surgery.
Cheema, R; Gorman, C; Kampougeris, G; McPherson, R, 2007
)
0.74
"TA is safe and there is no contraindication for its use as an intraoperative aid to facilitate vitreous visualisation in macular hole surgery."( Safety of Triamcinolone acetonide (TA)-assisted pars plana vitrectomy in macular hole surgery.
Cheema, R; Gorman, C; Kampougeris, G; McPherson, R, 2007
)
0.74
"Benzyl alcohol at concentrations modestly higher than what is present in commercial Kenalog is toxic to the rabbit eye."( Intravitreal toxicity of the kenalog vehicle (benzyl alcohol) in rabbits.
Bessho, K; Cheng, L; Davidson, MC; Freeman, WR; Koh, HJ; Morrison, VL, 2006
)
0.33
" While non-adherent TA, if purified, appears to be safe in clinically used concentrations, direct physical contact with crystalline particles might cause a local, rapid-progressive cytotoxicity that involves the induction of the apoptotic cascade."( Differential toxic effect of dissolved triamcinolone and its crystalline deposits on cultured human retinal pigment epithelium (ARPE19) cells.
Aisenbrey, S; Bartz-Schmidt, KU; Decker, P; Grisanti, S; Henke-Fahle, S; Jaissle, GB; Kaczmarek, R; Spitzer, MS; Szurman, P, 2006
)
0.33
" After the treatment, each treatment modality was evaluated by the response rate, relapse rate, and side effect profile."( A comparison of the efficacy, relapse rate and side effects among three modalities of systemic corticosteroid therapy for alopecia areata.
Aiba, S; Kawamura, M; Kurosawa, M; Mizuashi, M; Nakagawa, S; Saito, M; Sasaki, Y, 2006
)
0.33
" However, injections of 4 mg, 8 mg, and 20 mg of TA produced outer retina toxic effects."( Retinal toxicity of intravitreal triamcinolone acetonide: a morphological study.
D'Amico, DJ; Damico, FM; Viola, F; Young, LH; Yu, SY,
)
0.41
" Patients recorded any adverse events (AEs) on daily diary cards."( Safety and clinical relief over 1 year with triamcinolone acetonide hydrofluoroalkane-134a nasal aerosol in patients with perennial allergic rhinitis.
Banerji, D; Faruqi, R; Garcia, J; Georges, G; Weber, R,
)
0.39
" Because 1/10 -vTA appeared to be safe for up to 30 minutes of exposure, use of 1/10 dilutions of vehicle-removed TA is suggested to help surgeons visualize prolapsed vitreous during anterior vitrectomy in complicated cataract surgeries."( Triamcinolone acetonide suspension toxicity to corneal endothelial cells.
Chang, YS; Chen, MF; Tseng, SH; Tseng, SY; Wu, CL, 2006
)
1.78
" Electroretinography tracings were normal, indicating no widespread toxic effect."( Evaluation of the toxicity of subretinal triamcinolone acetonide in the rabbit.
Cheng, L; Davidson, MC; Freeman, WR; Kozak, I; Mendez, T, 2006
)
0.6
"Subretinal injection of TCA crystals can be toxic to the outer retina and retinal pigment epithelium."( Evaluation of the toxicity of subretinal triamcinolone acetonide in the rabbit.
Cheng, L; Davidson, MC; Freeman, WR; Kozak, I; Mendez, T, 2006
)
0.6
" Intravitreal TA up to 30 mg does not seem to have acute toxic effects on the function (ERG) or the structure (LM, EM) of the retina of albino rabbits."( Retinal toxicity of intravitreal triamcinolone acetonide at high doses in the rabbit.
Bayon, A; Montero, JA; Rueda, J; Ruiz-Moreno, JM; Vidal, M, 2007
)
0.62
"To investigate the toxic effects of triamcinolone acetonide (TA) suspensions on human retinal pigment epithelial (RPE) cells."( Cytotoxicity of triamcinolone acetonide on human retinal pigment epithelial cells.
Chang, YS; Kuo, PY; Tseng, SH; Tseng, SY; Wu, CL, 2007
)
0.96
"In the study center, the IVTA is extremely safe in patients without a history of glaucoma."( Safety profile of intravitreal triamcinolone acetonide.
Baath, J; Crichton, A; Ells, AL; Kherani, A; Williams, RG, 2007
)
0.63
"A single intraoperative intravitreal injection of triamcinolone acetonide seemed to be a safe and efficacious route of steroid delivery during phacoemulsification in patients with chronic idiopathic anterior uveitis or intermediate uveitis and is recommended as a substitute for postoperative oral steroid administration."( Safety and efficacy of intraoperative intravitreal injection of triamcinolone acetonide injection after phacoemulsification in cases of uveitic cataract.
Dada, T; Dhawan, M; Garg, S; Mandal, S; Nair, S, 2007
)
0.83
" The mechanism of these toxic events remains, however, poorly understood."( Glucocorticoids induce retinal toxicity through mechanisms mainly associated with paraptosis.
Behar-Cohen, F; BenEzra, D; Gandolphe, C; Jeanny, JC; Savoldelli, M; Torriglia, A; Valamanesh, F, 2007
)
0.34
" These toxic events were not associated with the anti-inflammatory activity of these compounds but depended on the hydro solubility of their formulation."( Glucocorticoids induce retinal toxicity through mechanisms mainly associated with paraptosis.
Behar-Cohen, F; BenEzra, D; Gandolphe, C; Jeanny, JC; Savoldelli, M; Torriglia, A; Valamanesh, F, 2007
)
0.34
" The most common adverse effect was increased intraocular pressure, with an increase of more than 15 mm Hg in 5 eyes (31%)."( Short-term safety and efficacy of intravitreal triamcinolone acetonide for uveitic macular edema in children.
Andrews, R; Chang, JH; Comer, RM; Grigg, JR; Lightman, S; McCluskey, PJ; Sallam, A, 2008
)
0.6
"To evaluate the toxic effects of two triamcinolone acetonide (TA) vehicles on rabbit retina at different volumes."( A moephologic study of retinal toxicity induced by triamcinolone acetonide vehicles in rabbit eyes.
Li, Q; Liu, W; Mo, B; Wang, J; Wang, N; Yang, L; Zeng, H, 2008
)
0.87
" The intensity of the toxic effects of different vehicles may differ."( A moephologic study of retinal toxicity induced by triamcinolone acetonide vehicles in rabbit eyes.
Li, Q; Liu, W; Mo, B; Wang, J; Wang, N; Yang, L; Zeng, H, 2008
)
0.6
"The half-life of commercially available TH in the vitreous is double that of TA, but the former is toxic to the retina in this rabbit model."( Safety and pharmokinetics of triamcinolone hexacetonide in rabbit eyes.
Abd-El-Barr, MM; Albini, TA; Carvounis, PE; Chevez-Barrios, P; He, F; Holz, ER; Manzano, RP; Wensel, TG; Wu, SM, 2008
)
0.35
"0mg/mL, the concentration in commercial TA suspensions, was toxic within 5min on each assay for both human and rabbit RPE cells."( In vitro benzyl alcohol cytotoxicity: implications for intravitreal use of triamcinolone acetonide.
Chang, YS; Kuo, PY; Tseng, SH; Tseng, SY; Wu, CL, 2008
)
0.58
" No evidence of TA toxic effect was noted on histopathology."( Ocular distribution and toxicity of intravitreal injection of triamcinolone acetonide in normal equine eyes.
Davis, JL; Gilger, BC; Salmon, JH; Yi, NY, 2008
)
0.59
" PSTI of TA is an extremely safe procedure and can be repeatedly applied to an eye."( Complications and safety profile of posterior subtenon injection of triamcinolone acetonide.
Byun, YS; Park, YH, 2009
)
0.59
" Safety measures included reports of adverse events, morning serum cortisol levels before and after cosyntropin infusion, and growth as measured using office stadiometry."( Efficacy and safety of triamcinolone acetonide aqueous nasal spray in children aged 2 to 5 years with perennial allergic rhinitis: a randomized, double-blind, placebo-controlled study with an open-label extension.
Georges, G; Nayak, A; Qaqundah, P; Weinstein, S, 2009
)
0.66
" Adverse event rates were comparable between treatment groups."( Efficacy and safety of triamcinolone acetonide aqueous nasal spray in children aged 2 to 5 years with perennial allergic rhinitis: a randomized, double-blind, placebo-controlled study with an open-label extension.
Georges, G; Nayak, A; Qaqundah, P; Weinstein, S, 2009
)
0.66
"Intravitreal drug administration leads to high intraocular concentrations with potentially toxic effects on ocular tissues."( Toxicity assessment of intravitreal triamcinolone and bevacizumab in a retinal explant mouse model using two-photon microscopy.
Euler, T; Jonas, JB; Mittmann, W; Rensch, F; Schlichtenbrede, FC; Vom Hagen, F, 2009
)
0.35
"2P microscopy in combination with SR101 staining allows fast morphologic assessment of living retinal explants and can be used to evaluate adverse effects on retinal viability of test substances."( Toxicity assessment of intravitreal triamcinolone and bevacizumab in a retinal explant mouse model using two-photon microscopy.
Euler, T; Jonas, JB; Mittmann, W; Rensch, F; Schlichtenbrede, FC; Vom Hagen, F, 2009
)
0.35
"There was no difference identified in visual acuity at 12 months for the standard care group compared with the triamcinolone groups; however, rates of adverse events (particularly elevated intraocular pressure and cataract) were highest in the 4-mg group."( A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with standard care to treat vision loss associated with macular Edema secondary to branch retinal vein occlusion: the Standard Care vs Corticosteroid for Retinal Vein Occlu
Blodi, BA; Chan, CK; Fisher, M; Gonzalez, VH; Ip, MS; Oden, NL; Scott, IU; Singerman, LJ; Tolentino, M; VanVeldhuisen, PC, 2009
)
0.35
" However, this treatment is toxic for the retina because it induces a non-apoptotic, caspase-independent cell death related to paraptosis, mostly in the retinal pigmented epithelium cells and the Müller cells."( On the retinal toxicity of intraocular glucocorticoids.
Behar-Cohen, F; Torriglia, A; Valamanesh, F, 2010
)
0.36
"1 mL (4 or 12 mg) intravitreal injection for human eye were found safe in guinea pig eyes."( Further characterization of ocular safety profile of commercially available preserved and preservative-free triamcinolone acetonide.
Chen, H; Cheng, L; Gu, X; Hou, J; Li, G; Li, Y; Luo, L; Qu, J; Shen, H; Zhang, Y, 2012
)
0.59
" There was no evidence of toxic effects on the retina in either group based on ERG or histological analyses."( Vitreous pharmacokinetics and retinal safety of intravitreal preserved versus non-preserved triamcinolone acetonide in rabbit eyes.
Bonini-Filho, MA; Crispim, PT; Cunha, AS; Damico, FM; Haddad, A; Jorge, R; Maia-Filho, A; Messias, A; Oliveira, RC; Ribeiro, JA; Saliba, JB; Scott, IU; Siqueira, RC, 2012
)
0.6
" No toxic reactions in the retina were observed in either group."( Vitreous pharmacokinetics and retinal safety of intravitreal preserved versus non-preserved triamcinolone acetonide in rabbit eyes.
Bonini-Filho, MA; Crispim, PT; Cunha, AS; Damico, FM; Haddad, A; Jorge, R; Maia-Filho, A; Messias, A; Oliveira, RC; Ribeiro, JA; Saliba, JB; Scott, IU; Siqueira, RC, 2012
)
0.6
" Safety of steroidal products for intraocular use is essential because of their risk of ocular adverse events."( Drug safety evaluation of intravitreal triamcinolone acetonide.
Di Giulio, A; Lanzetta, P; Sarao, V; Veritti, D, 2012
)
0.65
" It may imply an off-label use and it may be associated with ocular adverse events."( Drug safety evaluation of intravitreal triamcinolone acetonide.
Di Giulio, A; Lanzetta, P; Sarao, V; Veritti, D, 2012
)
0.65
" In contrast, BBG and TA appear safe after subretinal injection."( Toxicity profiles of subretinal indocyanine green, Brilliant Blue G, and triamcinolone acetonide: a comparative study.
Ejstrup, R; Heegaard, S; Kiilgaard, JF; la Cour, M, 2012
)
0.61
" Recent studies, which evaluated topical and systemic adverse events associated with ciclesonide (CIC), fluticasone furoate (FF), mometasone furoate (MF), triamcinolone acetonide, fluticasone propionate, budesonide, and beclomethasone dipropionate were summarized."( Safety update regarding intranasal corticosteroids for the treatment of allergic rhinitis.
Blaiss, MS,
)
0.33
" TANS was well-tolerated in AR and NAR groups with minor adverse events including headache, nasal burning, and bitter mouth taste."( Efficacy and safety of once daily triamcinolone acetonide aqueous nasal spray in adults with non-allergic and allergic rhinitis.
Baccioglu Kavut, A; Kalpaklıoğlu, F,
)
0.41
" However, because of its long-acting nature, TA can induce long-term local immunosuppression and subsequent adverse events."( Cytomegalovirus-associated gastric ulcer: a side effect of steroid injections for pyloric stenosis.
Fujihara, S; Kato, K; Kobara, H; Masaki, T; Mori, H; Nishiyama, N; Oryu, M; Rafiq, K, 2013
)
0.39
"The consecutive patients using HA attending to our clinic in the past 3 years were divided into 3 categories, according to the time of presentation of the adverse reactions: immediate, early, and late-onset complications."( Undesirable effects after treatment with dermal fillers.
Camacho-Martínez, FM; Rodrigues-Barata, AR, 2013
)
0.39
" Physicians need to be aware of these possible adverse events in order to establish proper treatment and prevent scarring or other sequelae."( Undesirable effects after treatment with dermal fillers.
Camacho-Martínez, FM; Rodrigues-Barata, AR, 2013
)
0.39
"Intravitreal injection of 4 mg and 8 mg TA are safe for the rabbit retina."( Pharmacokinetics and retinal toxicity of various doses of intravitreal triamcinolone acetonide in rabbits.
Gao, YF; Wang, HJ; Xie, HT; Ye, YF, 2014
)
0.64
" Subconjunctival injection of triamcinolone acetonide is a safe and effective treatment of macular edema related to uveitis."( [Safety and efficacy of subconjunctival triamcinolone injections in the management of uveitic macular edema: retrospective study of thirty-one cases].
Bleriot, A; Couret, C; Le Meur, G; Lebranchu, P; Weber, M, 2014
)
0.69
"1 ml intravitreal suspension for rabbit eye is found safe in guinea pig eyes."( [Characteristic of ocular safety profile of triamcinolone made in China].
Cheng, L; Hou, J; Lan, B; Li, J; Sun, S; Zhao, C, 2014
)
0.4
" No serious related adverse events occurred."( One year results of a phase 1 study of the safety and tolerability of combination therapy using sustained release intravitreal triamcinolone acetonide and ranibizumab for subfoveal neovascular AMD.
Lim, JI; Niec, M; Wong, V, 2015
)
0.62
" Safety was assessed from adverse events at all study visits."( Safety and performance of Hydros and Hydros-TA for knee osteoarthritis: a prospective, multicenter, randomized, double-blind feasibility trial.
Alleyne, J; Dellaert, F; Emans, PJ; Gill, DP; Maroney, M; Petrella, RJ, 2015
)
0.42
" Data, including best-corrected Snellen visual acuity, central macular thickness (CMT), intraocular pressure (IOP), and adverse events (AEs), were collected at baseline, week 1, month 1, month 3, and month 6 after initiation of treatment."( Safety and Efficacy of Intravitreal Preservative-Free Triamcinolone Acetonide (Triesence) for Macular Edema.
Broadhead, GK; Chang, AA; Li, H; Luo, K; Zhu, M, 2015
)
0.67
"Subconjunctival injection of triamcinolone acetonide is an effective and safe method for uveitic macular edema."( [The efficacy and safety of subconjunctival triamcinolone acetonide injections in treatment of uveitic macular edema].
Gao, F; Liu, X; Wang, M; Zhang, M; Zhao, C, 2015
)
0.97
"Steroid injection combined with LMS in the treatment of BVFLs was safe and associated with improved voice quality."( Efficacy and Safety of Adjunctive Steroid Injection After Microsurgical Removal of Benign Vocal Fold Lesions.
Cho, JH; Hwang, WS; Joo, YH; Kim, SY; Park, YH; Sun, DI, 2017
)
0.46
" Knee pain (Numeric Rating Scale [NRS]), Oxford Knee Score, overall treatment effect (Global Perceived Effect), analgesic drug use, and adverse events were compared between CRFA and IAS cohorts at 1, 3, and 6 months after intervention."( Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis.
Buvanendran, A; Choi, D; Davis, T; DePalma, M; Desai, M; Gupta, A; Hunter, C; Kapural, L; Lindley, D; Loudermilk, E; Patel, N; Soloman, M, 2018
)
0.48
" There were no procedure-related serious adverse events."( Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis.
Buvanendran, A; Choi, D; Davis, T; DePalma, M; Desai, M; Gupta, A; Hunter, C; Kapural, L; Lindley, D; Loudermilk, E; Patel, N; Soloman, M, 2018
)
0.48
"Intralesional steroid injection appears to be a safe and effective alternative treatment for recurrent AF."( Safety and efficacy of intralesional steroid injection for aggressive fibromatosis.
Arpornchayanon, O; Chaiyawat, P; Klangjorhor, J; Kosachunhanun, N; Lorsomradee, S; Phanphaisarn, A; Pruksakorn, D; Settakorn, J; Teeyakasem, P, 2017
)
0.46
" Adverse effects of these drugs include oral candidiasis with associated burning mouth and hypogeusia, hypersensitive reactions to the drug, and inhibition of the hypothalamic-pituitary-adrenal axis and secondary adrenal insufficiency."( A potential side effect of oral topical steroids: Central serous chorioretinopathy.
Balan, A; George, S,
)
0.13
"Charts of all patients receiving PF-IVTA (2 mg or 4 mg) in a defined time period (2012-2014) at the Cole Eye Institute were examined for patient demographics, time to treatment failure (TTF), use of systemic immunosuppression, use of intraocular pressure-lowering therapies, date of cataract surgery and glaucoma filtration surgery, and adverse events."( Treatment Duration and Side Effect Profile of Long-Term Use of Intravitreal Preservative-Free Triamcinolone Acetonide in Uveitis.
Arepalli, S; Baynes, K; Bena, J; Ganapathy, PS; Li, M; Lowder, CY; Srivastava, SK, 2018
)
0.7
"This retrospective study supports that 2 mg PF-IVTA displayed noninferior treatment duration to 4 mg PF-IVTA, and may carry a significantly lower side-effect profile of cataract development and glaucoma filtering surgery."( Treatment Duration and Side Effect Profile of Long-Term Use of Intravitreal Preservative-Free Triamcinolone Acetonide in Uveitis.
Arepalli, S; Baynes, K; Bena, J; Ganapathy, PS; Li, M; Lowder, CY; Srivastava, SK, 2018
)
0.7
"02% TA cream could significantly reduce postlaser downtime including swelling, redness, crusting, and scaling in 5-7 days, with comparable efficacies in decreasing downtime and adverse reactions, as well as wound healing improvement and lower PIH without statistically significant difference between the two treatments."( Efficacy and safety of moisturizer containing 5% panthenol, madecassoside, and copper-zinc-manganese versus 0.02% triamcinolone acetonide cream in decreasing adverse reaction and downtime after ablative fractional carbon dioxide laser resurfacing: A split
Lueangarun, S; Srituravanit, A; Tempark, T, 2019
)
0.72
"The moisturizer with anti-inflammatory ingredients could be a novel treatment modality for reduction of postablative laser downtime by using nonsteroidal anti-inflammatory agents to avoid adverse effects and improve wound healing process with lower PIH."( Efficacy and safety of moisturizer containing 5% panthenol, madecassoside, and copper-zinc-manganese versus 0.02% triamcinolone acetonide cream in decreasing adverse reaction and downtime after ablative fractional carbon dioxide laser resurfacing: A split
Lueangarun, S; Srituravanit, A; Tempark, T, 2019
)
0.72
" Prolonging corticosteroid presence by controlled release from biomaterials may allow for longer pain relief while circumventing adverse effects such as high bolus dosages."( Safety of intradiscal delivery of triamcinolone acetonide by a poly(esteramide) microsphere platform in a large animal model of intervertebral disc degeneration.
Beukers, M; Creemers, L; Meij, B; Mihov, G; Öner, F; Rudnik-Jansen, I; Tellegen, A; Thies, J; Tryfonidou, M; Woike, N, 2019
)
0.79
" Sustained release of TAA locally in the IVD appeared safe and reduced NGF expression, suggesting its potential applicability for pain relief, although beneficial effects were absent on tissue degeneration."( Safety of intradiscal delivery of triamcinolone acetonide by a poly(esteramide) microsphere platform in a large animal model of intervertebral disc degeneration.
Beukers, M; Creemers, L; Meij, B; Mihov, G; Öner, F; Rudnik-Jansen, I; Tellegen, A; Thies, J; Tryfonidou, M; Woike, N, 2019
)
0.79
" No serious adverse events (AEs) related to treatment were reported."( Efficacy and Safety of Suprachoroidal CLS-TA for Macular Edema Secondary to Noninfectious Uveitis: Phase 3 Randomized Trial.
Ciulla, TA; Henry, CR; Khurana, RN; Kissner, JM; Noronha, G; Shah, M; Wang, RC; Yeh, S, 2020
)
0.56
" However, verapamil has fewer adverse drug reactions than TAC, which allows for a longer treatment period and the possibility that it might be effective for patients who cannot receive TAC."( The Safety and Efficacy of Intralesional Verapamil Versus Intralesional Triamcinolone Acetonide for Keloids and Hypertrophic Scars: A Systematic Review and Meta-analysis.
Fu, ZH; Guo, GH; Jiang, ZY; Liao, XC; Liu, MZ; Min, DH, 2020
)
0.79
" Although triamcinolone acetonide (TAC) is one of the most common and effective treatments for keloids and hypertrophic scars, TAC is not effective in some patients, and some may even experience adverse outcomes."( Efficacy and safety of verapamil vs triamcinolone acetonide for keloids and hypertrophic scars: A systematic review and meta-analysis.
Deng, Z; Liu, L; Liu, R; Yang, B; Zhao, X, 2020
)
1.24
" The three treatment modalities were effective, safe with minimal side effects."( Efficacy and safety of Nd:YAG laser alone compared with combined Nd:YAG laser with intralesional steroid or botulinum toxin A in the treatment of hypertrophic scars.
Hamed, AM; Mohamed, MS; Rahman, SHA, 2021
)
0.62
" RCTs that evaluated treatment effects with the Vancouver Scar Scale or reported adverse effects were included."( Comparing the Efficacy and Safety of Intralesional Verapamil With Intralesional Triamcinolone Acetonide in Treatment of Hypertrophic Scars and Keloids: A Meta-Analysis of Randomized Controlled Trials.
Bi, H; Gu, L; Qin, Z; Wang, P; Wang, Q, 2021
)
0.85
" Although total adverse effects (RR = 0."( Comparing the Efficacy and Safety of Intralesional Verapamil With Intralesional Triamcinolone Acetonide in Treatment of Hypertrophic Scars and Keloids: A Meta-Analysis of Randomized Controlled Trials.
Bi, H; Gu, L; Qin, Z; Wang, P; Wang, Q, 2021
)
0.85
" Although total adverse effects did not change, the incidence of telangiectasia and skin atrophy was lower with verapamil than with TAC."( Comparing the Efficacy and Safety of Intralesional Verapamil With Intralesional Triamcinolone Acetonide in Treatment of Hypertrophic Scars and Keloids: A Meta-Analysis of Randomized Controlled Trials.
Bi, H; Gu, L; Qin, Z; Wang, P; Wang, Q, 2021
)
0.85
" Although total adverse effects did not change, the incidence of telangiectasia and skin atrophy was lower with verapamil than with TAC."( Comparing the Efficacy and Safety of Intralesional Verapamil With Intralesional Triamcinolone Acetonide in Treatment of Hypertrophic Scars and Keloids: A Meta-Analysis of Randomized Controlled Trials.
Bi, H; Gu, L; Qin, Z; Wang, P; Wang, Q, 2021
)
0.85
" Best-corrected visual acuity (BCVA), adverse event (AE) assessment, ophthalmic examinations and optical coherence tomography (OCT) were conducted every 4 weeks for 24 weeks."( Suprachoroidal CLS-TA for non-infectious uveitis: an open-label, safety trial (AZALEA).
Barakat, MR; Ciulla, T; Dayani, P; Hall, C; Henry, CR; Khurana, RN; Rifkin, L; Shah, M; Wang, RC; Yeh, S, 2022
)
0.72
"Suprachoroidally administered CLS-TA was safe and well tolerated over the 24-week, open-label study in NIU subjects with and without MO."( Suprachoroidal CLS-TA for non-infectious uveitis: an open-label, safety trial (AZALEA).
Barakat, MR; Ciulla, T; Dayani, P; Hall, C; Henry, CR; Khurana, RN; Rifkin, L; Shah, M; Wang, RC; Yeh, S, 2022
)
0.72
" No serious adverse events related to study treatment were observed."( Extension study of the safety and efficacy of CLS-TA for treatment of macular oedema associated with non-infectious uveitis (MAGNOLIA).
Barakat, MR; Ciulla, T; Henry, CR; Kapik, B; Khurana, RN; Merrill, P; Shah, M; Suhler, E; Uchiyama, E; Wang, RC; Yeh, S, 2022
)
0.72
" Our results show that the intravitreal injection of corticosteroids is more effective, but is associated with more adverse events, than periocular injection."( Efficacy and safety of intravitreal and periocular injection of corticosteroids in noninfectious uveitis: a systematic review.
Ferreira, A; Figueira, L; José-Vieira, R; Menéres, P; Sousa-Pinto, B,
)
0.13
" Primary outcome for safety was defined as the occurrence of adverse events (AEs) during the follow up period after IAJI."( The efficacy and safety of intra-articular injection of triamcinolone acetonide versus triamcinolone hexacetonide for treatment of juvenile idiopathic arthritis.
Amarilyo, G; Gendler, Y; Goldberg, O; Habot-Wilner, Z; Harel, L; Levinsky, Y; Ohana, O; Peled, O; Rubin, S; Tal, R, 2022
)
0.97
"Suprachoroidal administration of triamcinolone appears to be a safe and effective technique to achieve CD resolution in eyes with RRD."( Safety and efficacy of suprachoroidal triamcinolone acetonide for the management of serous choroidal detachment prior to rhegmatogenous retinal detachment surgery: A Pilot study.
Halim, D; Kohli, GM; Nigam, S; Sen, A; Shenoy, P; Shetty, S; Talwar, D, 2022
)
0.99
" The aim of this study was to describe the occurrence of local and systemic adverse effects after peribulbar injection of triamcinolone in patients with thyroid eye disease."( Adverse effects associated with peribulbar injection of triamcinolone for the treatment of thyroid eye disease: a retrospective case series.
Barlatay, JMG; Basso, TO; Benavente, M; Boza, CP; Hernández-Gauna, GV; Premoli, EJ, 2023
)
0.91
" Verapamil had fewer adverse events than TAC and can be used as a safer alternative for the treatment of keloids and hypertrophic scars."( Efficacy and Safety of Verapamil Versus Triamcinolone Acetonide in Treating Keloids and Hypertrophic Scars: A Systematic Review and Meta-Analysis.
Li, X; Zhang, W, 2023
)
1.18
" Although traditional corticosteroid treatments may demonstrate high levels of efficacy, systemic delivery carries the risk of potentially serious systemic adverse effects (AEs), and standard local modes of delivery may be associated with low bioavailability in posterior ocular tissues and steroid-associated AEs due to anterior ocular tissue exposure."( Suprachoroidal triamcinolone acetonide injectable suspension for macular edema associated with noninfectious uveitis: an in-depth look at efficacy and safety.
Ciulla, T; Yeh, S, 2023
)
1.26
" No serious adverse reactions and good tolerability were reported in the included studies."( Efficacy and safety of needle-free jet injector-assisted intralesional treatments in dermatology-a systematic review.
Bekkers, VZ; Bik, L; Prens, EP; van Doorn, MBA; van Huijstee, JC; Wolkerstorfer, A, 2023
)
0.91
" Enalapril could be a safe alternative to steroids in the treatment of keloid and hypertrophic scars."( Safety and efficacy of intralesional injection of enalapril versus triamcinolone acetonide in the treatment of keloids.
Eltahlawy, S; Hamada Mohamed, B; Marzouk, WA; Mohamad, NE, 2023
)
1.15

Pharmacokinetics

Triamcinolone acetonide was eliminated with a total body clearance of 37 L/h and a half-life of 2. The objectives of this study were to assess the deposition in the lungs and oropharynx of TAA.

ExcerptReferenceRelevance
" Plasma levels of the steroids were measured and pharmacokinetic parameters were calculated."( Pharmacokinetics and pharmacodynamics of glucocorticoid suspensions after intra-articular administration.
Derendorf, H; Grüner, A; Gyselby, G; Haack, D; Möllmann, H, 1986
)
0.27
" Plasma levels of the ester and triamcinolone acetonide were measured and pharmacokinetic parameters were calculated."( Pharmacokinetics of triamcinolone acetonide and its phosphate ester.
Derendorf, H; Möllmann, H; Rohdewald, P; Salomon, V; Schmidt, EW, 1985
)
0.88
" Drug concentration-time data monitored in whole blood showed bi-exponential decay and were analysed by a least-squares regression analysis procedure to obtain pertinent pharmacokinetic parameters."( Effect of liposomal surface charge on the pharmacokinetics of an encapsulated model compound.
Abraham, I; Goundalkar, A; Mezei, M,
)
0.13
" Pharmacodynamic parameters were determined by monitoring lymphocytes, granulocytes, and cortisol."( Pharmacokinetic and pharmacodynamic evaluation of triamcinolone acetonide after intravenous, oral, and inhaled administration.
Barth, J; Derendorf, H; Erdmann, M; Galia, E; Hochhaus, G; Mollmann, H; Rohatagi, S; Sourgens, H, 1995
)
0.54
" Serum samples were obtained and pharmacokinetic parameters estimated from the dose-normalized serum concentrations of doxepin and desmethyldoxepin."( Pharmacokinetics of doxepin in subjects with pruritic atopic dermatitis.
Cohen, L; Drake, LA; Flood, JG; Gillies, R; Phillips, SB; Riordan, AT; Stiller, MJ, 1999
)
0.3
" Serial plasma samples were collected after the first and last dose of test medication for pharmacokinetic analysis."( A study comparing the clinical pharmacokinetics, pharmacodynamics, and tolerability of triamcinolone acetonide HFA-134a metered-dose inhaler and budesonide dry-powder inhaler following inhalation administration.
Argenti, D; Heald, D; Shah, B, 2000
)
0.53
" The half-life of the rapid elimination phase was 83."( Pharmacokinetics and metabolic effects of triamcinolone acetonide and their possible relationships to glucocorticoid-induced laminitis in horses.
French, K; Pass, MA; Pollitt, CC, 2000
)
0.57
" The terminal half-life was significantly longer (82%) at 20:00."( Circadian changes in the pharmacokinetics of triamcinolone acetonide in rabbits.
Burm, JP; Choi, JS; Shin, SC, 2000
)
0.57
" The objectives of this study were to assess the deposition in the lungs and oropharynx of triamcinolone acetonide (TAA; Azmacort, Aventis Pharma, Collegeville, PA) delivered by pMDI formulated with HFA-134a, together with the pharmacokinetic profile of TAA, and to determine the extent to which the Azmacort spacer improves targeting of TAA to the lungs."( Deposition and pharmacokinetics of an HFA formulation of triamcinolone acetonide delivered by pressurized metered dose inhaler.
Gillen, MS; Hirst, PH; Newman, SP; Pitcairn, GR; Richards, JC; Rohatagi, S, 2001
)
0.78
" Available literature data for a suspension-based aqueous triamcinolone acetonide formulation (Nasacort AQ) were used to describe its pharmacokinetic profile after similar single doses of 110, 220, and 440 microg."( A new solution-based intranasal triamcinolone acetonide formulation in patients with perennial allergic rhinitis: how does the pharmacokinetic/pharmacodynamic profile for cortisol suppression compare with an aqueous suspension-based formulation?
Dockhorn, RJ; González, MA; Hochhaus, G; Karafilidis, J; Shilstone, J, 2002
)
0.84
" Concentrations were determined using high performance liquid chromatography; pharmacokinetic analysis was carried out using PK Analyst, an iterative, nonlinear, weighted, least-squares regression program."( Intraocular concentration and pharmacokinetics of triamcinolone acetonide after a single intravitreal injection.
Bakri, SJ; Beer, PM; Liu, W; Miller, M; Peters, GB; Singh, RJ, 2003
)
0.57
"Intraocular concentrations of triamcinolone were measured and population pharmacokinetic parameters were calculated."( Intraocular concentration and pharmacokinetics of triamcinolone acetonide after a single intravitreal injection.
Bakri, SJ; Beer, PM; Liu, W; Miller, M; Peters, GB; Singh, RJ, 2003
)
0.57
" After a single intravitreal injection of triamcinolone, the mean elimination half-life was 18."( Intraocular concentration and pharmacokinetics of triamcinolone acetonide after a single intravitreal injection.
Bakri, SJ; Beer, PM; Liu, W; Miller, M; Peters, GB; Singh, RJ, 2003
)
0.57
" This approach was supported by the pharmacokinetic hypothesis that the intravitreal triamcinolone concentration decreases in accordance with an exponential biphasic equation."( Pharmacokinetic-pharmacodynamic modeling of the effect of triamcinolone acetonide on central macular thickness in patients with diabetic macular edema.
Audren, F; Benosman, R; Bergmann, JF; Caulin, C; Erginay, A; Gaudric, A; Haouchine, B; Massin, P; Tod, M, 2004
)
0.57
"The pharmacodynamic profile of the effect of triamcinolone on CMT was characterized by a curve in three phases: a fast decrease, a steady state, and a relapse."( Pharmacokinetic-pharmacodynamic modeling of the effect of triamcinolone acetonide on central macular thickness in patients with diabetic macular edema.
Audren, F; Benosman, R; Bergmann, JF; Caulin, C; Erginay, A; Gaudric, A; Haouchine, B; Massin, P; Tod, M, 2004
)
0.57
"Pharmacokinetic-pharmacodynamic modeling using CMT constitutes a valid alternative to pharmacokinetic studies."( Pharmacokinetic-pharmacodynamic modeling of the effect of triamcinolone acetonide on central macular thickness in patients with diabetic macular edema.
Audren, F; Benosman, R; Bergmann, JF; Caulin, C; Erginay, A; Gaudric, A; Haouchine, B; Massin, P; Tod, M, 2004
)
0.57
"The half-life of TA in the vitreous after a 4-mg injection of either TA-PF or Kenalog was comparable."( Safety and pharmacokinetics of a preservative-free triamcinolone acetonide formulation for intravitreal administration.
Bungay, PM; Csaky, KG; DE Monasterio, F; Gravlin, L; Grimes, G; Kim, H; Lutz, RJ; Potti, GK; Robinson, MR; Tansey, G; Yuan, P,
)
0.38
"51 nmol/l) of the steroids; indeed, the terminal half-life of TAA-DHP (13."( Comparison of the hypothalamic-pituitary-adrenal axis susceptibility upon single-dose i.m. depot versus long-acting i.v. triamcinolone acetonide therapy: a direct pharmacokinetic correlation.
Abraham, G; Demiraj, F; Ungemach, FR, 2006
)
0.54
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
" The purpose of this study was to compare the pharmacokinetic behavior of this hospital pharmacy preparation of TA (HPP-TA) to that of a commercial preparation of TA (CP-TA) in rats."( Pharmacokinetic behavior of intravitreal triamcinolone acetonide prepared by a hospital pharmacy.
Hashida, N; Kurokawa, N; Maeda, S; Ohguro, N; Oishi, M; Tano, Y,
)
0.4
" The rats were killed between days 1 and 21, and the concentration of TA in the vitreous was measured by high-performance liquid chromatography to determine the pharmacokinetic parameters."( Pharmacokinetic behavior of intravitreal triamcinolone acetonide prepared by a hospital pharmacy.
Hashida, N; Kurokawa, N; Maeda, S; Ohguro, N; Oishi, M; Tano, Y,
)
0.4
"Traditional ocular pharmacokinetic studies are invasive and cannot be easily applied to humans in vivo."( Ocular pharmacokinetic study of a corticosteroid by 19F MR.
Jeong, EK; Li, SK; Liu, X, 2010
)
0.36
"Triamcinolone acetonide concentration in the samples was measured, and pharmacokinetic parameters were calculated."( Intraocular and systemic pharmacokinetics of triamcinolone acetonide after a single 40-mg posterior subtenon application.
Chen, Y; Cheng, L; Qu, J; Shen, L; Sun, S; You, Y, 2010
)
2.06
" The terminal elimination half-life in aqueous, vitreous, and plasma was 11."( Intraocular and systemic pharmacokinetics of triamcinolone acetonide after a single 40-mg posterior subtenon application.
Chen, Y; Cheng, L; Qu, J; Shen, L; Sun, S; You, Y, 2010
)
0.62
" The method was applied to a pharmacokinetic study in rodents using microdialysis to determine protein unbound TA concentrations in blood and muscle."( Simultaneous HPLC analysis of triamcinolone acetonide and budesonide in microdialysate and rat plasma: application to a pharmacokinetic study.
Derendorf, H; Singh, RP; Vieira, Mde L, 2010
)
0.65
" Currently, there is a scant amount of evidence-based literature evaluating the pharmacokinetic profile of TA despite clinical data showing the efficacy of intravitreal TA for multiple forms of macular edema."( Pharmacokinetics of triamcinolone acetonide for the treatment of macular edema.
Cordero-Coma, M; Federici, TJ; Yilmaz, T, 2011
)
0.69
"The pharmacokinetic profile of TA is unpredictable and the agent has a time-limited therapeutic action due to its relatively short half-life."( Pharmacokinetics of triamcinolone acetonide for the treatment of macular edema.
Cordero-Coma, M; Federici, TJ; Yilmaz, T, 2011
)
0.69
"To compare the intravitreal pharmacokinetic profile of a triamcinolone acetonide formulation containing the preservative benzyl alcohol (TA-BA) versus a preservative-free triamcinolone acetonide formulation (TA-PF), and evaluate potential signs of toxicity to the retina."( Vitreous pharmacokinetics and retinal safety of intravitreal preserved versus non-preserved triamcinolone acetonide in rabbit eyes.
Bonini-Filho, MA; Crispim, PT; Cunha, AS; Damico, FM; Haddad, A; Jorge, R; Maia-Filho, A; Messias, A; Oliveira, RC; Ribeiro, JA; Saliba, JB; Scott, IU; Siqueira, RC, 2012
)
0.84
"To compare a theoretical pharmacokinetic model of triamcinolone acetonide after posterior sub-Tenon's injection with experimental serum and undiluted vitreous triamcinolone acetonide concentrations obtained during pars plana vitrectomy."( Pharmacokinetic study of vitreous and serum concentrations of triamcinolone acetonide after posterior sub-tenon's injection.
Arroyo, JG; Ceron, OM; Gukasyan, HJ; Kovacs, K; Quirk, MT; Silva, PA; Singh, RJ; Wagley, S, 2012
)
0.87
" Pharmacokinetic experiment: Rabbits were intravitreally injected with one of four 4-mg triamcinolone acetonide formulations."( Assessment of the differences in pharmacokinetics and pharmacodynamics between four distinct formulations of triamcinolone acetonide.
Burke, J; Feldmann, B; Ghosn, C; Kuppermann, BD; Li, Y; Lin, T; Migon, R; Orilla, W; Ruiz, G; Zacharias, LC, 2013
)
0.82
" The plasma terminal elimination half-life was 11."( Pharmacokinetics of triamcinolone acetonide following intramuscular and intra-articular administration to exercised Thoroughbred horses.
Casbeer, HC; Knych, HK; McKemie, DS; Vidal, MA, 2013
)
0.71
" The terminal half-life of intravitreal TA was 23."( Intravitreal pharmacokinetics after posterior subtenon triamcinolone acetonide injection in vitrectomized rabbit eyes.
Jung, JH; Kim, SI; Lee, JE; Lee, JS; Oum, BS; Pak, KY; Park, HJ, 2014
)
0.65
" Although the terminal half-life of TA was shorter, higher early concentration and similar effective duration were achieved in the vitrectomized eyes."( Intravitreal pharmacokinetics after posterior subtenon triamcinolone acetonide injection in vitrectomized rabbit eyes.
Jung, JH; Kim, SI; Lee, JE; Lee, JS; Oum, BS; Pak, KY; Park, HJ, 2014
)
0.65
"A simple and accurate method including liquid-liquid extraction and protein precipitation procedures from silicone oil and aqueous humor samples followed by high-performance liquid chromatography (HPLC-UV) was developed and validated to determine the pharmacokinetic profile of triamcinolone acetonide in silicone oil and aqueous humor of rabbits' eyes submitted to the pars plana vitrectomy surgery."( Determination of triamcinolone acetonide in silicone oil and aqueous humor of vitrectomized rabbits' eyes: Application for a pharmacokinetic study with intravitreal triamcinolone acetonide injections (Kenalog® 40).
Fernandes-Cunha, GM; Jorge, R; Saliba, JB; Silva-Cunha, A; Siqueira, RC, 2014
)
0.92
"The half-life of intravitreal injection of 4 mg and 8 mg TA was 24 days and 34 days, respectively."( Pharmacokinetics and retinal toxicity of various doses of intravitreal triamcinolone acetonide in rabbits.
Gao, YF; Wang, HJ; Xie, HT; Ye, YF, 2014
)
0.64
" The injection of 8 mg TA produced a longer vitreous half-life and had a prolonged effect on the retina."( Pharmacokinetics and retinal toxicity of various doses of intravitreal triamcinolone acetonide in rabbits.
Gao, YF; Wang, HJ; Xie, HT; Ye, YF, 2014
)
0.64
" The method was successfully applied to a long-term pharmacokinetic study of TAP and TA after 28-day repeated intravenous administration of TAP lipid emulsion injection to beagle dogs."( Simultaneous determination of triamcinolone acetonide palmitate and triamcinolone acetonide in beagle dog plasma by UPLC-MS/MS and its application to a long-term pharmacokinetic study of triamcinolone acetonide palmitate lipid emulsion injection.
Guan, J; Lin, H; Liu, H; Men, L; Tang, X; Wu, P; Yang, M; Yu, Z; Zhao, Y, 2015
)
0.71
"Available corticosteroids for diabetic macular edema exhibit different pharmacokinetic profiles that impact efficacy and adverse events and should be taken into account when developing individualized treatment plans."( INTRAVITREAL CORTICOSTEROIDS IN DIABETIC MACULAR EDEMA: PHARMACOKINETIC CONSIDERATIONS.
Bailey, C; Loewenstein, A; Massin, P; Yang, Y, 2015
)
0.42
" The method was successfully applied to a preclinical pharmacokinetic (PK) study of the six GCs on female nude mice after a single oral dose of 1 mg/kg."( Development and validation of a LC-MS/MS method for simultaneous determination of six glucocorticoids and its application to a pharmacokinetic study in nude mice.
Guo, Y; Hao, C; Kong, D; Li, J; Tian, X; Xue, J; Yao, Q; Zhou, T, 2020
)
0.56

Compound-Compound Interactions

The purpose of this study was to report the 24-month findings of a randomized clinical trial comparing intravitreal bevacizumab (IVB) injection alone or in combination with triamcinolone acetonide (IVT) versus macular laser photocoagulation (MPC) The clinical efficacy of hydrocolloid dressing as a monotherapy and the pronounced clinical effectiveness of TTT+sTTA were confirmed.

ExcerptReferenceRelevance
" The clinical efficacy of hydrocolloid dressing as a monotherapy and the pronounced clinical efficacy of this occlusive in combination with triamcinolone acetonide were confirmed."( Weekly treatment of psoriasis with a hydrocolloid dressing in combination with triamcinolone acetonide. A controlled comparative study.
Boezeman, JB; Chang, A; Huigen-Tijdink, R; van de Kerkhof, PC; van der Walle, HB; van Vlijmen-Willems, I, 1994
)
0.72
"To investigate the efficacy of posterior sub-Tenon's capsule triamcinolone injection (PSTI) combined with focal laser (FL) photocoagulation in treatment of diffuse clinically significant diabetic macular edema (CSME)."( Posterior sub-Tenon's capsule triamcinolone injection combined with focal laser photocoagulation for diabetic macular edema.
Kaya, M; Onder, HI; Tunc, M, 2005
)
0.33
" A total of 30 eyes received macular focal and grid laser photocoagulation (MP), and the second group of 30 eyes received FL photocoagulation combined with PSTI (FL + PSTI)."( Posterior sub-Tenon's capsule triamcinolone injection combined with focal laser photocoagulation for diabetic macular edema.
Kaya, M; Onder, HI; Tunc, M, 2005
)
0.33
"Posterior sub-Tenon's capsule application of triamcinolone may improve early visual outcome in diffuse diabetic macular edema when combined with FL photocoagulation."( Posterior sub-Tenon's capsule triamcinolone injection combined with focal laser photocoagulation for diabetic macular edema.
Kaya, M; Onder, HI; Tunc, M, 2005
)
0.33
"To evaluate the efficacy and safety of photodynamic therapy with verteporfin combined with intravitreal triamcinolone in choroidal neovascularization secondary to age-related macular degeneration (AMD)."( Verteporfin therapy combined with intravitreal triamcinolone in all types of choroidal neovascularization due to age-related macular degeneration.
Augustin, AJ; Schmidt-Erfurth, U, 2006
)
0.33
"Verteporfin photodynamic therapy combined with intravitreal triamcinolone may improve the outcome of standard verteporfin photodynamic therapy in the treatment of choroidal neovascularization secondary to AMD."( Verteporfin therapy combined with intravitreal triamcinolone in all types of choroidal neovascularization due to age-related macular degeneration.
Augustin, AJ; Schmidt-Erfurth, U, 2006
)
0.33
"To detect patients with neovascular age-related macular degeneration (AMD) who experience retinal pigment epithelium tears after initial verteporfin therapy combined with intravitreal triamcinolone during early follow-up."( Retinal pigment epithelium tears following verteporfin therapy combined with intravitreal triamcinolone.
Aue, A; Geitzenauer, W; Michels, S; Sacu, S; Schmidt-Erfurth, U; Simader, C, 2006
)
0.33
"Forty-five consecutive patients with choroidal neovascularization (CNV) in AMD were treated with verteporfin therapy combined with 4 mg of intravitreal triamcinolone."( Retinal pigment epithelium tears following verteporfin therapy combined with intravitreal triamcinolone.
Aue, A; Geitzenauer, W; Michels, S; Sacu, S; Schmidt-Erfurth, U; Simader, C, 2006
)
0.33
" In combination with PRP, IVTA might be more effective than focal or grid laser photocoagulation and PRP for reducing diabetic macular edema and preventing aggravation of macular edema without transient visual disturbance in patients requiring immediate PRP."( Laser photocoagulation combined with intravitreal triamcinolone acetonide injection in proliferative diabetic retinopathy with macular edema.
Choi, KS; Chung, JK; Lim, SH, 2007
)
0.59
"To examine transpupillary thermotherapy combined with intravitreal triamcinolone for treatment of subfoveal choroidal neovascularization."( Low-power transpupillary thermotherapy combined with intravitreal triamcinolone acetonide for subfoveal choroidal neovascularization.
Jonas, JB; Wang, D; Xu, L; Zhang, X; Zhu, X, 2007
)
0.58
"Transpupillary thermotherapy combined with intravitreal triamcinolone may be a therapeutic option for choroidal neovascularization particularly if other treatment modalities are not available."( Low-power transpupillary thermotherapy combined with intravitreal triamcinolone acetonide for subfoveal choroidal neovascularization.
Jonas, JB; Wang, D; Xu, L; Zhang, X; Zhu, X, 2007
)
0.58
"To report the efficacy of a single intravitreal bevacizumab injection alone or in combination with intravitreal triamcinolone acetonide versus macular laser photocoagulation (MPC) as primary treatment of diabetic macular edema (DME)."( Intravitreal bevacizumab (avastin) injection alone or combined with triamcinolone versus macular photocoagulation as primary treatment of diabetic macular edema.
Ahmadieh, H; Azarmina, M; Bijanzadeh, B; Dehghan, MH; Moradian, S; Peyman, GA; Ramezani, A; Soheilian, M; Tabatabaei, H; Yaseri, M,
)
0.34
"To evaluate the therapeutic effect of photodynamic therapy (PDT) combined with posterior subtenon injection of triamcinolone acetonide (PSTA) in the treatment of choroidal neovascularization (CNV)."( Photodynamic therapy combined with posterior subtenon triamcinolone acetonide injection in the treatment of choroidal neovascularization.
Chen, MS; Ho, TC; Lee, YA; Yang, CH; Yang, CM, 2009
)
0.81
"Compared with PDT alone, PDT combined with PSTA has a better therapeutic effect for both myopic and age-related predominantly classic CNV; the myopic CNV subgroup shows the best response."( Photodynamic therapy combined with posterior subtenon triamcinolone acetonide injection in the treatment of choroidal neovascularization.
Chen, MS; Ho, TC; Lee, YA; Yang, CH; Yang, CM, 2009
)
0.6
"To compare the effectiveness of subthreshold grid laser treatment (SGLT) with infrared micropulse diode laser alone or in combination with intravitreal triamcinolone injection (SGLT-IVTJ) for the treatment of macular oedema (MO) secondary to branch retinal vein occlusion (BRVO)."( Intravitreal triamcinolone acetonide combined with subthreshold grid laser treatment for macular oedema in branch retinal vein occlusion: a pilot study.
Iacono, P; Parodi, MB; Ravalico, G, 2008
)
0.72
"To compare early treatment effect of reduced fluence versus standard photodynamic therapy (rPDT, sPDT, respectively) in combination with intravitreal triamcinolone (IVTA) in neovascular age-related macular degeneration."( Reduced fluence versus standard photodynamic therapy in combination with intravitreal triamcinolone: short-term results of a randomised study.
Michels, S; Polak, K; Sacu, S; Schmidt-Erfurth, U; Varga, A; Vécsei-Marlovits, PV; Weigert, G, 2008
)
0.35
"To report acute visual loss associated with dynamic vascular changes after photodynamic therapy (PDT) combined with intravitreal triamcinolone (IVTA) for the treatment of occult choroidal neovascularization (CNV)."( Acute visual loss and chorioretinal infarction after photodynamic therapy combined with intravitreal triamcinolone.
De Belvis, V; Galan, A; Lo Giudice, G; Piermarocchi, S; Prosdocimo, G,
)
0.13
"To examine the effects of photodynamic therapy (PDT) with verteporfin combined with low-dose intravitreal triamcinolone acetonide (IVTA) for exudative age-related macular degeneration (AMD) that is resistant to PDT alone."( Photodynamic therapy combined with low-dose intravitreal triamcinolone acetonide for age-related macular degeneration refractory to photodynamic therapy alone.
Gotoh, N; Iwama, D; Otani, A; Sasahara, M; Tamura, H; Tsujikawa, A; Yodoi, Y; Yoshimura, N, 2008
)
0.8
"PDT combined with low-dose IVTA for exudative AMD seems to be as effective and safe as combined therapy with the higher-dose IVTA that was reported previously."( Photodynamic therapy combined with low-dose intravitreal triamcinolone acetonide for age-related macular degeneration refractory to photodynamic therapy alone.
Gotoh, N; Iwama, D; Otani, A; Sasahara, M; Tamura, H; Tsujikawa, A; Yodoi, Y; Yoshimura, N, 2008
)
0.59
" The purpose of this study was to determine the changes in the focal macular electroretinograms (FMERGs) after PDT combined with TA for age-related macular degeneration."( Focal macular electroretinograms after photodynamic therapy combined with posterior juxtascleral triamcinolone acetonide.
Ishikawa, K; Ito, Y; Kondo, M; Nishihara, H; Ozawa, S; Piao, CH; Terasaki, H, 2009
)
0.57
"There are current tendencies in the use of photodynamic therapy (PDT) in combination with intravitreal injection of long-acting corticosteroids."( [Photodynamic therapy with visudine in combination with intravitreal kenalog in the treatment of choroidal neovascularization].
Chikovani, KR; Neroev, VV; Neroeva, NV; Riabina, MV,
)
0.13
"To compare the results of intravitreal bevacizumab (IVB) injection alone or in combination with intravitreal triamcinolone acetonide (IVT) versus macular laser photocoagulation (MPC) as a primary treatment of diabetic macular edema (DME)."( Randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus macular photocoagulation in diabetic macular edema.
Ahmadieh, H; Azarmina, M; Bijanzadeh, B; Dehghan, MH; Moradian, S; Obudi, A; Peyman, GA; Ramezani, A; Salehipour, M; Soheilian, M; Yaseri, M, 2009
)
0.57
"To compare the effects of laser photocoagulation combined with subtenon injection of triamcinolone acetonide with photocoagulation alone, for diabetic cystoid macular edema."( Laser photocoagulation combined with subtenon injection of triamcinolone acetonide for diabetic cystoid macular edema.
Chen, YH; Cheng, LS; Kuo, HK; Wu, PC,
)
0.6
"This retrospective comparative study analyzed data for 34 eyes with cystoid macular edema treated with photocoagulation alone (n=17) or combined with triamcinolone (n=17)."( Laser photocoagulation combined with subtenon injection of triamcinolone acetonide for diabetic cystoid macular edema.
Chen, YH; Cheng, LS; Kuo, HK; Wu, PC,
)
0.37
"This study, with a follow-up of 6 months, suggests that subtenon injection of triamcinolone combined with macular photocoagulation provides a better chance of stabilizing vision loss in patients with diabetic cystoid macular edema than photocoagulation alone."( Laser photocoagulation combined with subtenon injection of triamcinolone acetonide for diabetic cystoid macular edema.
Chen, YH; Cheng, LS; Kuo, HK; Wu, PC,
)
0.37
" IA-guided laser photocoagulation combined with STTA might be effective for treating types 1 and 2 idiopathic macular telangiectasia."( Indocyanine green angiography-guided laser photocoagulation combined with sub-Tenon's capsule injection of triamcinolone acetonide for idiopathic macular telangiectasia.
Hirano, Y; Nozaki, M; Ogura, Y; Usui, Y; Yasukawa, T, 2010
)
0.57
"This study aimed to evaluate the course of macular sensitivity (MS) following treatment with reduced fluence photodynamic therapy (RPDT) versus standard photodynamic therapy (SPDT) in combination with intravitreal triamcinolone acetonide (IVTA) in patients with neovascular age-related macular degeneration, and to investigate the correlation between MS and angiographic outcomes."( Changes in macular sensitivity after reduced fluence photodynamic therapy combined with intravitreal triamcinolone.
Dunavoelgyi, R; Pruente, C; Sacu, S; Schmidt-Erfurth, U; Simader, C, 2011
)
0.56
"To investigate the effect of intravitreal bevacizumab (IVB) combined with intravitreal high-dose triamcinolone acetonide (IVTA) for therapy of exudative age-related macular degeneration (AMD) after unsuccessful IVB monotherapy."( Intravitreal bevacizumab combined with intravitreal triamcinolone for therapy-resistant exudative age-related macular degeneration.
Jonas, JB; Tao, Y, 2010
)
0.58
" This study aimed to compare the efficacy and safety of a single intravitreal injection of bevacizumab alone versus bevacizumab combined with triamcinolone acetonide in eyes with diabetic macular edema (DME)."( Intravitreal bevacizumab combined with/without triamcinolone acetonide in single injection for treatment of diabetic macular edema.
Li, MH; Li, X; Su, XN; Wang, HY; Wang, YS; Zhang, ZF, 2011
)
0.83
"05 ml) combined with triamcinolone acetonide (2 mg/0."( Intravitreal bevacizumab combined with/without triamcinolone acetonide in single injection for treatment of diabetic macular edema.
Li, MH; Li, X; Su, XN; Wang, HY; Wang, YS; Zhang, ZF, 2011
)
0.95
"To observe the clinical treatment effectiveness of Clarithromycin combined with nasal glucocorticoids for chronic rhinosinusitis (CRS)."( [Clinical observation of Clarithromycin combined with nasal steroid treatment for chronic rhinosinusitis].
Feng, Z; Hong, Y; Li, Q; Li, X; Liu, J; Liu, L; Lu, X; Wan, Y; Zhong, G, 2011
)
0.37
"The treatment with Long term use of low dosage oral macrolide Clarithromycin combined with nasal steroid on CRS was efficacy."( [Clinical observation of Clarithromycin combined with nasal steroid treatment for chronic rhinosinusitis].
Feng, Z; Hong, Y; Li, Q; Li, X; Liu, J; Liu, L; Lu, X; Wan, Y; Zhong, G, 2011
)
0.37
"To assess serum level changes of antiretinal antibodies (ARA) in patients with exudative age-related macular degeneration (AMD), treated with transpupillary thermotherapy (TTT) alone and with TTT combined with injection of triamcinolone acetonide (sTTA) under posterior Tenon's capsule and to compare the efficacy of TTT and TTT+sTTA."( [Serum antiretinal antibodies (ARA) in patients with exudative age-related macular degeneration (AMD) treated with transpupillary thermotherapy (TTT) alone and with transpupillary thermotherapy (TTT) combined with injection of triamcinolone acetonide (sTT
Kubicka-Trzaska, A; Wilańska, J, 2011
)
0.74
"To compare the effect of an intravitreal injection of bevacizumab alone (IVB) or combined with triamcinolone (IVB/IVT) versus triamcinolone (IVT) in patients with diabetic macular edema (DME)."( Comparison of intravitreal bevacizumab alone or combined with triamcinolone versus triamcinolone in diabetic macular edema: a randomized clinical trial.
Lee, HK; Lim, JW; Shin, MC, 2012
)
0.38
"The purpose of this study was to report the 24-month findings of a randomized clinical trial comparing intravitreal bevacizumab (IVB) injection alone or in combination with intravitreal triamcinolone acetonide (IVT) versus macular laser photocoagulation (MPC) as a primary treatment for diabetic macular edema."( Two-year results of a randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus laser in diabetic macular edema.
Garfami, KH; Peyman, GA; Ramezani, A; Soheilian, M; Yaseri, M, 2012
)
0.57
" The aim of this study was to assess the clinical behaviour and long-term therapeutic response in OFG patients treated with intralesional triamcinolone acetonide (TA) injections alone or in combination with topical pimecrolimus 1%, as adjuvant, in those patients partially responders to TA."( Clinical behaviour and long-term therapeutic response in orofacial granulomatosis patients treated with intralesional triamcinolone acetonide injections alone or in combination with topical pimecrolimus 1%.
Fortuna, G; Leuci, S; Mignogna, MD; Pollio, A; Ruoppo, E, 2013
)
0.8
"To compare the 2-year results after photodynamic therapy (PDT) alone and PDT combined with intravitreal injections of bevacizumab and triamcinolone acetonide (triple therapy) for polypoidal choroidal vasculopathy (PCV)."( Two-year outcome of photodynamic therapy combined with intravitreal injection of bevacizumab and triamcinolone acetonide for polypoidal choroidal vasculopathy.
Akagi-Kurashige, Y; Iwama, D; Nakata, I; Ooto, S; Otani, A; Tsujikawa, A; Ueda-Arakawa, N; Yamashiro, K; Yoshimura, N, 2013
)
0.81
"Local injections of TA therapy combined with traditional interventional techniques for BAS has good curative effect and safety."( [Intralesional triamcinolone acetonide injection combined with conventional interventional modalities for the management of recalcitrant benign central airway stenosis: preliminary experience].
Chen, Y; Li, SY; Wu, HY, 2012
)
0.73
"To report the results of triple therapy with photodynamic therapy (PDT) (PDT combined with intravitreal injection of bevacizumab (IVB) and sub-tenon injection of triamcinolone acetonide (STTA)) for the treatment of age-related macular degeneration (AMD) in Japanese patients."( Photodynamic therapy combined with intravitreal bevacizumab and sub-tenon triamcinolone acetonide injections for age-related macular degeneration.
Hirose, S; Ishida, S; Kitamei, H; Noda, K; Saito, W; Yoshizawa, C, 2013
)
0.82
"This retrospective case series included 38 eyes of 38 patients with exudative AMD treated with PDT combined with IVB (1."( Photodynamic therapy combined with intravitreal bevacizumab and sub-tenon triamcinolone acetonide injections for age-related macular degeneration.
Hirose, S; Ishida, S; Kitamei, H; Noda, K; Saito, W; Yoshizawa, C, 2013
)
0.62
" TA, SA-B, and TA combined with SA-B were consecutively applied intralesionally weekly for 20 weeks."( Efficacy of salvianolic acid B combined with triamcinolone acetonide in the treatment of oral submucous fibrosis.
Jiang, XW; Lu, K; Sun, GL; Yang, SK; Zhang, H; Zhang, Y, 2013
)
0.65
"To evaluate the efficacy of vitrectomy combined with intravitreal injection of triamcinolone acetonide (IVTA) and macular laser photocoagulation for the treatment of nontractional diabetic macular edema (DME) refractory to anti-vascular endothelial growth factor (VEGF) therapy."( Vitrectomy combined with intravitreal triamcinolone acetonide injection and macular laser photocoagulation for nontractional diabetic macular edema.
Ha, HS; Kang, SW; Kim, JH; Kim, JR, 2013
)
0.89
"Vitrectomy combined with IVTA and macular laser photocoagulation had a beneficial effect on both anatomical and functional outcomes in eyes with nontractional DME refractory to anti-VEGF therapy."( Vitrectomy combined with intravitreal triamcinolone acetonide injection and macular laser photocoagulation for nontractional diabetic macular edema.
Ha, HS; Kang, SW; Kim, JH; Kim, JR, 2013
)
0.66
"The purposes of this study were to examine the cartilage degradation effects of triamcinolone acetonide (TA) on normal and osteoarthritic (OA) primary canine chondrocytes and cartilage explants and to examine the cartilage degradation effects of TA in combination with low-molecular-weight hyaluronan (LMWHA)."( In vitro effects of triamcinolone acetonide and in combination with hyaluronan on canine normal and spontaneous osteoarthritis articular cartilage.
Buddhachat, K; Chomdej, S; Euppayo, T; Nganvongpanit, K; Ongchai, S; Pradit, W; Siengdee, P, 2016
)
0.98
" We aimed to compare the efficacy and safety of TAC alone and in combination with 5-FU for the treatment of hypertrophic scars and keloids."( Efficacy and safety of triamcinolone acetonide alone and in combination with 5-fluorouracil for treating hypertrophic scars and keloids: a systematic review and meta-analysis.
Fan, B; Feng, S; Lin, W; Ren, Y; Wei, Z; Zhou, X, 2017
)
0.77
"To compare the results of intravitreal bevacizumab (IVB) injection alone or in combination with intravitreal 1 mg triamcinolone acetonide (IVT) in center-involved diabetic macular edema."( Intravitreal bevacizumab alone or combined with 1 mg triamcinolone in diabetic macular edema: a randomized clinical trial.
Ahmadraji, A; Ghasemi, F; Karkhaneh, R; Mahmoudi, A; Riazi-Esfahani, H; Riazi-Esfahani, M; Roohipoor, R; Yaseri, M, 2018
)
0.69
"TA combined with SA-B were consecutively applied intralesionally 1 time weekly for 30 times."( [Methods and effects of injection of salvianolic acid B combined with triamcinolone acetonide in the treatment of oral submucous fibrosis].
DU, YX; Jian, XC; Xiao, YC; Zheng, L; Zhou, C, 2017
)
0.69
"To evaluate the effect of low-intensity pulsed ultrasound(LIPUS) combined with triamcinolone acetonide on oral mucosal ulcer in syrian hamster in several ways, including healing time, contents of superoxide dismutase(SOD)and malondialdehyde (MDA)."( [Effect of low-intensity pulsed ultrasound combined with triamcinolone acetonide on oral mucosal ulcer healing in syrian hamster].
Fei, CX; Feng, TM; Pan, LL; Sun, J; Wang, C; Xiang, XR; Yang, MC, 2017
)
0.93
"Low-intensity pulsed ultrasound combined with triamcinolone acetonide can effectively improve the activity of SOD and reduce the contents of MDA in ulcerated tissues, and therefore accelerate the process of ulcer healing.."( [Effect of low-intensity pulsed ultrasound combined with triamcinolone acetonide on oral mucosal ulcer healing in syrian hamster].
Fei, CX; Feng, TM; Pan, LL; Sun, J; Wang, C; Xiang, XR; Yang, MC, 2017
)
0.96
"In this paper, we presented a simple yet versatile strategy to generate a high drug payload nanoparticles by the combination with small molecular assembly and polymeric assembly for topical suppression of ocular inflammation."( Directing the nanoparticle formation by the combination with small molecular assembly and polymeric assembly for topical suppression of ocular inflammation.
Huang, J; Li, X; Song, Q; Wang, Q; Yu, X; Zhang, R; Zhou, Y, 2018
)
0.48
" Herein, we conducted a study to compare the efficacy of intralesional triamcinolone used alone, or in combination with BTA, in the treatment of formed keloid scars."( Intralesional triamcinolone alone or in combination with botulinium toxin A is ineffective for the treatment of formed keloid scar: A double blind controlled pilot study.
Bakhshaeekia, A; Feily, A; Gianfaldoni, S; Hadibarhaghtalab, M; Lange, CS; Lotti, T; Matta, J; Pazyar, N; Ramirez-Fort, MK; Ramirez-Pacheco, LA; Rasaii, S; Seifi, V; Sohrabian, N, 2019
)
0.51
"Intralesional 5-fluorouracil (5-FU) in combination with triamcinolone acetonide (TAC) has been recommended as a promising alternative for keloids not responding to silicone-based products, cryotherapy or intralesional corticosteroids alone."( Treatment of keloids using 5-fluorouracil in combination with crystalline triamcinolone acetonide suspension: evaluating therapeutic effects by using non-invasive objective measures.
Gauglitz, GG; Guertler, A; Poetschke, J; Reinholz, M; Schwaiger, H, 2020
)
1.04
"Transurethral resection of the scar tissue combined with intra- and post-operative triamcinolone acetonide injections resulted in a success rate of 92."( Management of highly recurrent bladder neck contractures via transurethral resection combined with intra- and post-operative triamcinolone acetonide injections.
Liu, S; Mu, X; Wu, K; Yang, L; Zhang, L, 2021
)
1.05
"To compare anti-vascular endothelial growth factor (anti-VEGF) monotherapy with anti-VEGF therapy combined with sub-Tenon's capsule injections of triamcinolone acetonide (STTA) in patients with macular edema (ME) associated with branch retinal vein occlusion (BRVO)."( One-year results of anti-vascular endothelial growth factor therapy combined with triamcinolone acetonide for macular edema associated with branch retinal vein occlusion.
Koyama, Y; Miyoshi, Y; Muraoka, Y; Nakano, Y; Osaka, R; Suzuma, K; Takasago, Y; Tsujikawa, A, 2020
)
0.98
"Retrospective observational study METHODS: This study included 186 eyes: 138 eyes received intravitreal injection of ranibizumab (IVR), and the remaining 48 eyes received IVR combined with STTA therapy."( One-year results of anti-vascular endothelial growth factor therapy combined with triamcinolone acetonide for macular edema associated with branch retinal vein occlusion.
Koyama, Y; Miyoshi, Y; Muraoka, Y; Nakano, Y; Osaka, R; Suzuma, K; Takasago, Y; Tsujikawa, A, 2020
)
0.78
"To investigate the incidence and outcomes of cystoid macular edema (CME) after Descemet membrane endothelial keratoplasty (DMEK) alone and DMEK combined with cataract surgery (DMEK triple)."( Incidence and Outcomes of Cystoid Macular Edema after Descemet Membrane Endothelial Keratoplasty (DMEK) and DMEK Combined with Cataract Surgery.
Bae, SS; Ching, G; Covello, AT; Holland, S; Iovieno, A; McCarthy, M; Ritenour, R; Yeung, SN, 2021
)
0.62
" Thereinto, surgery combined with radiotherapy and triamcinolone acetonide injection is considered to be the proper choice for comprehensive treatment of auricular keloids."( Individualized surgery combined with radiotherapy and triamcinolone acetonide injection for the treatment of auricular keloids.
Guo, S; Sun, Q; Tong, S; Yu, ET; Zhou, KJ; Zhou, Y, 2021
)
1.12
"Individualized surgery combined with early postoperative radiotherapy and triamcinolone acetonide injection is an ideal treatment method to ensure good auricular appearance, low incidences of complications and recurrence based on effective treatment of auricular keloids."( Individualized surgery combined with radiotherapy and triamcinolone acetonide injection for the treatment of auricular keloids.
Guo, S; Sun, Q; Tong, S; Yu, ET; Zhou, KJ; Zhou, Y, 2021
)
1.1
"The aim of the present study is to explore the efficacy and safety of using different concentrations of intralesional corticosteroid combined with NB-UVB phototherapy in the treatment of non-segmental vitiligo (NSV) patients."( The use of intralesional corticosteroid combined with narrowband ultraviolet B in vitiligo treatment: clinical, histopathologic, and histometric evaluation.
Abdel-Aziz, RTA; Anbar, TS; El-Domyati, M; Yehia, M, 2022
)
0.72
"Intralesional corticosteroid injections combined with NB-UVB showed a good and well-tolerated therapeutic option for vitiligo."( The use of intralesional corticosteroid combined with narrowband ultraviolet B in vitiligo treatment: clinical, histopathologic, and histometric evaluation.
Abdel-Aziz, RTA; Anbar, TS; El-Domyati, M; Yehia, M, 2022
)
0.72
"To investigate the clinical study of intravitreal injection of anti-VEGF drugs combined with intravitreal injection of tretinoin for the treatment of Coats disease."( Clinical Study of Intravitreal Injection of Anti-VEGF Drugs Combined with Triamcinolone Acetonide in the Treatment of Coats Disease.
Fang, J; Han, F; Wu, S; Xiao, J; Yu, F, 2022
)
0.95
"Intravitreal injection of anti-VEGF drugs combined with tretinoin injection can significantly improve the clinical efficacy of patients with Coats disease and improve visual acuity and central retinal thickness, which has certain reference value for the clinical treatment of Coats disease."( Clinical Study of Intravitreal Injection of Anti-VEGF Drugs Combined with Triamcinolone Acetonide in the Treatment of Coats Disease.
Fang, J; Han, F; Wu, S; Xiao, J; Yu, F, 2022
)
0.95
"The purpose of this study was to investigate the efficacy of surgery combined with triamcinolone acetonide injection in managing the difficult problem of keloid formation after syndactyly release."( Surgical excision and skin grafting combined with intralesional injection of triamcinolone for the treatment of keloids after syndactyly release.
Du, X; Jiang, Y; Sun, W; Tian, J; Wang, B; Zhou, S, 2023
)
1.14
" • Compared with HA treatment, intra-articular injection of biological agents combined with glucocorticoids can not only relieve joint pain but also significantly inhibit joint swelling."( Efficacy of tumor necrosis factor inhibitor combined with intra-articular injection of triamcinolone acetonide in the treatment of refractory rheumatoid arthritis synovitis: a retrospective study.
Cai, Z; Chen, Y; Ma, Y; Yuan, J, 2023
)
1.13
" Intra-lesional injection of triamcinolone acetonide (TAC) in combination with 5-fluorouracil (5-FU) is a commonly used pharmacological regimen and long-term repeated injections can achieve sustained inhibition of keloid proliferation."( Deciphering the single-cell transcriptome network in keloids with intra-lesional injection of triamcinolone acetonide combined with 5-fluorouracil.
Hao, Y; Kuang, X; Liang, Z; Liu, H; Shan, M; Wang, Y; Xia, Y, 2023
)
1.42
"This study aims to evaluate the effectiveness and economic efficiency of Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray in the treatment of chronic rhinosinusitis(CRS)."( [Cost-effectiveness analysis of Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray in treatment of chronic rhinosinusitis].
Gong, WQ; Huang, ZY; Liu, J; Lu, LJ; Zhang, XS, 2023
)
1.35

Bioavailability

The aim of this study was to evaluate the intraocular pressure (IOP) increasing effect and bioavailability of triamcinolone acetonide (TA) microspheres, as a novel drug delivery system, after intravitreal administration.

ExcerptReferenceRelevance
" The results suggested that both corticosteroids were poorly absorbed through normal skin in rats, pigs and humans."( Percutaneous absorption of 14C-9alpha-fluoro-11beta,21-dihydroxy-3,20-dioxopregna-1,4-dieno (17alpha,16alpha-d)-2'-methyloxazolidine-21-acetate (L 6400) in rats, pigs and humans. Comparison with 3H-triamcinolone acetonide.
Cameron, BD; Chasseaud, LF; Franklin, ER; Hawkins, DR; Lewis, JD, 1975
)
0.44
" This indicates that in vitro data can be useful in predicting oral bioavailability of GCS."( Effect of structural alterations on the biotransformation rate of glucocorticosteroids in rat and human liver.
Andersson, P; Lihné, M; Ryrfeldt, A; Thalén, A, 1987
)
0.27
"In order to quantify the intensity of skin blanching and thus predict the bioavailability of topical corticoids, a physical device allowing the measurement of light reflected from skin without any contact between the probe and the skin was used (Leveque et al."( Objective determination of the bioavailability of dermocorticoids--influence of the formulation.
Le Gall, F; Leveque, JL; Poelman, MC, 1984
)
0.27
" An increase in the bioavailability of corticosteroids in the skin after local application cannot be achieved by addition of salicylic acid or sulfur under the conditions chosen."( [Effect of salicylic acid and finely divided sulfur on the bioavailability of corticosteroids in the skin in external therapy].
Gloor, M; Lindemann, L, 1980
)
0.26
" The volume of distribution was 103 L, and oral bioavailability averaged 23%."( Pharmacokinetics of triamcinolone acetonide after intravenous, oral, and inhaled administration.
Barth, J; Derendorf, H; Erdmann, M; Hochhaus, G; Möllmann, H; Rohatagi, S; Sourgens, H, 1995
)
0.61
" The objectives of this study were to determine the absolute bioavailability of triamcinolone acetonide following inhalation administration and to delineate the airway contribution of triamcinolone acetonide absorption relative to the absolute bioavailability."( A pharmacokinetic study to evaluate the absolute bioavailability of triamcinolone acetonide following inhalation administration.
Argenti, D; Heald, D; Shah, B, 1999
)
0.77
" Systemic bioavailability of INSs, by way of nasal and intestinal absorption, can be substantial; but current INSs vary significantly in their degree of first-pass hepatic inactivation and clearance from the body of the swallowed drug."( Systemic effects of intranasal steroids: an endocrinologist's perspective.
Allen, DB, 2000
)
0.31
"The pharmacokinetics and bioavailability of triamcinolone acetonide were determined to investigate buccal absorption from the mucoadhesive gels in rabbits."( Enhanced bioavailability by buccal administration of triamcinolone acetonide from the bioadhesive gels in rabbits.
Bum, JP; Choi, JS; Shin, SC, 2000
)
0.82
" Data support the use of dermatopharmacokinetic methods for bioequivalence and bioavailability assessment of topical drug products."( Comparison of skin stripping, in vitro release, and skin blanching response methods to measure dose response and similarity of triamcinolone acetonide cream strengths from two manufactured sources.
Bakhtian, S; Corlett, JL; Pershing, LK; Poncelet, CE; Shah, VP, 2002
)
0.52
" Hence, the lung bioavailability will determine the overall systemic absorption and the systemic bioactivity."( A novel method for assessing dissolution of aerosol inhaler products.
Davies, NM; Feddah, MR, 2003
)
0.32
"Pre-occlusion showed no effect on the topical bioavailability of TACA in the stratum corneum."( Topical bioavailability of triamcinolone acetonide: effect of occlusion.
Figueiredo, V; Imanidis, G; Pellanda, C; Rufli, T; Strub, C; Surber, C, 2007
)
0.64
" To increase the drug's bioavailability by ocular instillation, TA was encapsulated in nanostructured lipid carriers (NLC), previously optimized by our group using a factorial design approach."( Nanostructured lipid carriers for triamcinolone acetonide delivery to the posterior segment of the eye.
Araújo, J; Egea, MA; Garcia, ML; Nikolic, S; Souto, EB, 2011
)
0.65
"The aim of this study was to evaluate the intraocular pressure (IOP) increasing effect and bioavailability of triamcinolone acetonide (TA) microspheres, as a novel drug delivery system, after intravitreal administration."( Preparation, characterization, and in vivo evaluation of triamcinolone acetonide microspheres after intravitreal administration.
Malaekeh-Nikouei, B; Pourmazar, R; Seyedi, S; Zarei-Ghanavati, S, 2012
)
0.84
"Results of previous studies on the benefits of ocular drug delivery using polymeric mucoadhesive nanoparticles suggested longer presence and better penetration of nanoparticles, and, thus, increased effect and bioavailability of drugs entrapped in nanoparticles."( Improved anti-inflammatory effects in rabbit eye model using biodegradable poly beta-amino ester nanoparticles of triamcinolone acetonide.
Adibkia, K; Atyabi, F; De Geest, BG; Dinarvand, R; Ghahremani, MH; Hashemi, H; Khoshayand, MR; Mohsenzadeh, N; Sabzevari, A, 2013
)
0.6
" Compared to a traditional subtenon injection, this drug film demonstrated superior therapeutic duration, better drug bioavailability in the choroid and retina, and better-targeted drug delivery ability."( Episcleral drug film for better-targeted ocular drug delivery and controlled release using multilayered poly-ε-caprolactone (PCL).
Cheng, L; Lan, B; Li, J; Li, X; Meng, Y; Sun, S; Zhou, S, 2016
)
0.43
" Triamcinolone acetonide (TA) was selected as the model drug since it undergoes extensive first-pass metabolism, leading to poor oral bioavailability of 23%."( Microemulsion-based delivery of triamcinolone acetonide to posterior segment of eye using chitosan and butter oil as permeation enhancer: an in vitro and in vivo investigation.
Khunt, D; Misra, M; Raval, N, 2018
)
1.67
"Despite eye drops generally represent the most convenient, simple and patient-friendly formulations to treat ocular diseases, they suffer from poor retention on the ocular surface and low drug bioavailability leading to the necessity of prolonged and continuous treatment over time."( Microfibrillar polymeric ocular inserts for triamcinolone acetonide delivery.
Carfì Pavia, F; Cavallaro, G; Di Prima, G; Giammona, G; Licciardi, M; Lo Monte, AI, 2019
)
0.78
"Development of topically administered drug delivery systems for the treatment of ocular diseases have majorly focused on enhancing bioavailability of drugs in the ocular tissues."( Spatio-temporal control on the delivery of triamcinolone acetonide using polymeric nanoparticles reduces steroid induced cataract.
Katti, DS; Reddy, GB; Reddy, SS; Srinivasarao, DA, 2019
)
0.78
" Therefore, as a continuation of our previous study using TA-chitosan coated liposomes (TA-CHLs) as a topical drug delivery system, the present study aimed to determine the drug safety, stability, permeability, and bioavailability of TA-CHLs."( Triamcinolone acetonide-chitosan coated liposomes efficiently treated retinal edema as eye drops.
Cheng, T; Cheng, Y; Li, J; Qu, Y; Zhang, X, 2019
)
1.96
" Invasive drug administration via intracameral, subconjunctival, and intravitreal injection can enhance ocular bioavailability and minimize dose and dosing frequency of administration, yet may exacerbate ocular side effects of corticosteroids."( Corticosteroids in ophthalmology: drug delivery innovations, pharmacology, clinical applications, and future perspectives.
Abdelkader, H; Alany, RG; Alqahtani, AM; Elgarhy, O; Gaballa, SA; Kompella, UB; Pierscionek, B, 2021
)
0.62
" Application of these chitosan-coated nanoparticles as eye drops to C57BL/6 mice showed higher bioavailability in choroid and retina when compared to the uncoated nanoparticles."( A non-invasive nanoparticle-based sustained dual-drug delivery system as an eyedrop for endophthalmitis.
Ahamad, N; Baruah, N; Katti, DS; Lavik, E; Mahaling, B; Maisha, N, 2021
)
0.62
"Customized cationic oil-in-water nanoemulsions (NEs) have been produced to improve the bioavailability of poorly water-soluble drugs, such as triamcinolone acetonide (TA)."( Customized cationic nanoemulsions loading triamcinolone acetonide for corneal neovascularization secondary to inflammatory processes.
Dos Santos, T; Fernandes, AR; Garcia, ML; Granja, PL; Sánchez-López, E; Silva, AM; Souto, EB; Vidal, LB, 2022
)
1.19
" Although traditional corticosteroid treatments may demonstrate high levels of efficacy, systemic delivery carries the risk of potentially serious systemic adverse effects (AEs), and standard local modes of delivery may be associated with low bioavailability in posterior ocular tissues and steroid-associated AEs due to anterior ocular tissue exposure."( Suprachoroidal triamcinolone acetonide injectable suspension for macular edema associated with noninfectious uveitis: an in-depth look at efficacy and safety.
Ciulla, T; Yeh, S, 2023
)
1.26

Dosage Studied

Five glucocorticoids, when administered daily to rats for 5-7 days at a dosage of 5mg/kg, were in the following order of effectiveness with respect to their ability to decrease the weight gain of whole animals. Once symptoms are under control, the dosage of aqueous triamcinolone acetonide may be reduced from 220 to 110 mi.

ExcerptRelevanceReference
" Whether similar improvement could have been achieved by a different dosage regimen of corticosteroid tablets or whether it might have ocurred spontaneously was not tested."( Triamcinolone in corticosteroid-resistant asthma.
Cayton, RM; Howard, P; Peake, MD, 1979
)
0.26
"In an attempt to determine whether chronic glucocorticoid treatment affects speed- and strength-related properties of fast-twitch muscle and slow-twitch muscle, in-situ contractile properties of soleus and gastrocnemius muscles were measured in rats after 14 days on a regiment of triamcinolone acetonide injected at a dosage of 2 mg/kg/day."( Contractile responses of rat fast-twitch and slow-twitch muscles to glucocorticoid treatment.
Edgerton, VR; Gardiner, PF,
)
0.31
" Our belief is that this large dosage of corticosteroid was responsible for the late erosion of the medium-sized artery, which caused the hemorrhage."( Late development of hematoma around a breast implant, necessitating removal.
Barwick, W; Georgiade, NG; Serafin, D, 1979
)
0.26
"The parenteral use of triamcinolone acetonide (Kenacort A) is said to have the following advantages: to keep the effect for two weeks by one injection, to be able to reduce the total treatment dosage and to secure the dosage regardless of patients cooperation."( Parenteral treatment of sarcoidosis with triamcinolone.
Hiraga, Y; Mikami, R; Osada, H; Yotsumoto, H, 1977
)
0.57
"Twenty-three steroid-dependent severely asthmatic patients, ranging in age from 20 to 67 years, tolerated reduction in their oral dosage of steroids during a one-year trial of triamcinolone acetonide aerosol."( A one-year trial of triamcinolone acetonide aerosol in severe steroid-dependent asthma.
Chmelik, F; doPico, G; Kriz, RJ; Reed, CE, 1977
)
0.77
" For most patients the monthly injection of 8 ml or less of a solution containing 5 mg/ml of triamcinolone proved to be the most effective dosage schedule."( Intralesional triamcinolone therapy for pretibial myxedema.
Lang, PG; Lynch, PJ; Sisson, JC, 1975
)
0.25
" Conventional doses may not be sufficient to provide control in many patients, and dosing should be tailored to the individual."( Inhaled steroids in asthma.
Dworski, R; Sheller, J, 1992
)
0.28
" The results of this study indicate that 6 weeks of treatment with 220 micrograms/day or 440 micrograms/day of ITAA has no effect on adrenocortical function, but prednisone, at a dosage of 10 mg/day for 6 weeks, produces partial adrenocortical suppression."( A comparative study of the effects of intranasal triamcinolone acetonide aerosol (ITAA) and prednisone on adrenocortical function.
Dockhorn, R; Ellis, E; Feiss, G; Mansfield, L; Morris, R; Rom, D; Smith, JA; Tobey, RE, 1992
)
0.54
" THA must be injected with a rigorous technique and with a dosage adapted to the articular volume."( Complications of intra-articular injections of triamcinolone hexacetonide in chronic arthritis in children.
Job-Deslandre, C; Menkes, CJ,
)
0.13
" Large doses of the corticosteroid had no additional effect on the reduction of retinal detachments, indicating an optimal dosage of 2 mg."( The effect of triamcinolone acetonide on a refined experimental model of proliferative vitreoretinopathy.
Chandler, DB; de Juan, E; Machemer, R; Rozakis, G, 1985
)
0.63
" Pretreatment of ROS cells for 2 days with the glucocorticoid triamcinolone acetonide (TRM), shifted the dose-response curve for PKA activation by PTH upward compared to the control value."( Glucocorticoids and 1,25-dihydroxyvitamin D3 regulate parathyroid hormone stimulation of adenosine 3',5'-monophosphate-dependent protein kinase in rat osteosarcoma cells.
Catherwood, BD; Lorang, MT; Rubin, JE; Titus, L, 1988
)
0.52
" radiata [7]) during gestational days (GD) 23 to 41 using various dosing schedules."( Central nervous system malformations induced by triamcinolone acetonide in nonhuman primates: pathology.
Cordy, DR; Hendrickx, AG; Tarara, RP, 1989
)
0.53
" Doses that cause receptor down-regulation are also effective at inducing tyrosine aminotransferase, suggesting that dexamethasone down-regulates its own receptors over a physiologically meaningful dosage range."( The biopotency of dexamethasone at causing hepatic glucocorticoid receptor down-regulation in the intact mouse.
Svec, F, 1988
)
0.27
" Further studies are indicated to determine appropriate dosage necessary to maximize the beneficial local effects."( The beneficial effect of triamcinolone acetonide on nerve repair with autogenous grafts.
Ellis, J; Lipton, R; McCaffrey, TV, 1986
)
0.57
" These effects were mitigated at a lower dosage especially by the addition of cefoxitin and deoxycortone."( An attempt to develop a model to study the effects of intrathecal steroids.
Rosen, M; Swai, EA, 1986
)
0.27
" Pyrophosphate (PPi) is as effective as ATP in promoting receptor activation, since it elicits similar increases in DNA-cellulose binding, shifts in elution patterns from DEAE-cellulose, and dose-response relationships."( ATP-induced activation of purified rat hepatic glucocorticoid receptors.
Diehl, EE; Schmidt, TJ, 1987
)
0.27
" Female rats were divided into five groups: 1) a sedentary group that received cortisol acetate (CA, 100 mg/kg body wt); 2) a sedentary group that received the dosing vehicle (1% aqueous carboxymethyl cellulose); 3) an exercise group that received CA immediately after each exercise session; 4) an exercise group that received CA 90 min after each exercise session; and 5) an exercise group that received the vehicle."( Initiating regular exercise protects against muscle atrophy from glucocorticoids.
Czerwinski, SM; Hickson, RC; Kurowski, TG; O'Neill, TM, 1987
)
0.27
" These dose-response relationships are consistent with mediation of this effect by the glucocorticoid receptor."( Glucocorticoid receptors and regulation of phenylethanolamine-N-methyltransferase activity in cultured chromaffin cells.
Kelner, KL; Pollard, HB, 1985
)
0.27
"Triamcinolone acetonide was administered in excessive dosage to dogs to study the renal mechanism responsible for polyuria which is a clinically undesirable side effect of long term glucocorticoid therapy."( Renal effects of long term administration of triamcinolone acetonide in normal dogs.
Osbaldiston, GW, 1971
)
1.95
" Five glucocorticoids, when administered daily to rats for 5-7 days at a dosage of 5mg/kg, were in the following order of effectiveness with respect to their ability to decrease the weight gain of whole animals and the vastus lateralis, vastus medialis and gluteus medius muscles: corticosterone( Relative changes in the function of muscle ribosomes and mitochondria during the early phase of steroid-induced catabolism.
Bullock, GR; Carter, EE; Elliott, P; Peters, RF; Simpson, P; White, AM, 1972
)
0.42
"Systemic vitamin A palmitate at three dosage levels was evaluated for its effect on experimental herpes simplex virus (HSV) keratitis in corticosteroid-treated rabbits."( Vitamin A in experimental herpetic keratitis.
Briones, O; Dawson, CR; Oh, J; Starr, MB, 1981
)
0.26
" Calcium transport rates could be partially restored by in vivo administration of 1,25-dihydroxyvitamin D-3 at a dosage which did not affect vesicular calcium uptake in control animals."( Calcium and glucose uptake in rat small intestinal brush-border membrane vesicles. Modulation by exogenous hypercortisolism and 1,25-dihydroxyvitamin D-3.
Birkenhäger, JC; Braun, HJ; De Jonge, HR, 1984
)
0.27
" Dose-response relations were analyzed by the log-probit transformation method."( Dose-response relations of palatal slit, cleft palate, and fetal mortality in mice treated with a glucocorticoid.
Kusanagi, T, 1983
)
0.27
" Significant differences were observed between the liposome-encapsulated dosage form and the solution of the steroid in beta and Vd beta."( Pharmacokinetic profile of intravenous liposomal triamcinolone acetonide in the rabbit.
Abraham, I; Hilchie, JC; Mezei, M, 1983
)
0.52
" The sensitive stages of palatal slit and cleft palate induction were studied and dose-response relations on days 9 and 12 of pregnancy were analyzed by the log-probit transformation method and compared."( Sensitive stages and dose-response analyses of palatal slit and cleft palate in C57BL/6 mice treated with a glucocorticoid.
Kusanagi, T, 1984
)
0.27
"Eighty percent of 26 steroid-dependent, chronically asthmatic adults eliminated oral steroid dosage after 12 weeks of treatment with triamcinolone acetonide aerosol (800 micrograms/day)."( Long-term triamcinolone acetonide aerosol treatment in adult patients with chronic bronchial asthma.
Golub, JR, 1980
)
0.87
" Dose-response curves and kinetic studies show that ADP is as effective as ATP in stabilizing the unoccupied glucocorticoid receptor against heat inactivation."( In vitro stabilization of the unoccupied glucocorticoid receptor by adenosine 5'-diphosphate.
Barnett, CA; Litwack, G; Palmour, RM; Seegmiller, JE, 1983
)
0.27
" It is concluded that the combination of the aromatic retinoid (Ro 10-9359) given in low dosage orally with corticosteroids topically is as effective as therapy with the retinoid in high dosage alone, but with markedly less side-effects."( Combined treatment of psoriasis with a new aromatic retinoid (Tigason) in low dosage orally and triamcinolone acetonide cream topically: a double-blind trial.
Herrmann, WA; Polano, MK; Tijssen, JG; van der Rhee, HJ; Waterman, AH, 1980
)
0.48
" Twenty-four hours after the administration of triamcinolone hexacetonide condyles incorporated significantly less 35SO4, a feature that followed a dose-response relationship."( Studies on hormonal regulation of the growth of the craniofacial skeleton: II. Effects of a glucocorticoid hormone on sulfate incorporation by neonatal condylar cartilage.
Raz, E; Silbermann, M; Weiss, A, 1982
)
0.26
" For children we recommend the short-acting triamcinolone diacetate at 4-week intervals with dosage adjusted to age."( Cushing's syndrome: complication of triamcinolone injection for urethral strictures in children.
Augspurger, RR; Wettlaufer, JN, 1980
)
0.26
"Because some patients may prefer aqueous nasal sprays and once-daily dosing for relief of seasonal allergic rhinitis symptoms, a new aqueous formulation of triamcinolone acetonide (TAA Aqueous) was developed."( Triamcinolone acetonide Aqueous nasal spray in patients with seasonal ragweed allergic rhinitis: a placebo-controlled, double-blind study.
Alderfer, VB; Korenblat, PE; Lumry, W; Murphree, J; Settipane, G; Simpson, B; Smith, JA; Winder, J,
)
1.77
" When using local corticosteroid injections to treat interdigital neuromas, the physician should be familiar with the properties and recommended dosage of the given steroid."( Interdigital neuroma. Local cutaneous changes after corticosteroid injection.
Holder, J; Reddy, PD; Ruotolo, C; Zelicof, SB, 1995
)
0.29
"With use of partial suppression of immediate response to inhaled allergen and 24-hour urinary free cortisol output, three-point dose-response curves were constructed for beclomethasone dipropionate (50 micrograms/puff), triamcinolone acetonide (100 micrograms/puff), and flunisolide (250 micrograms/puff)."( A bioassay for topical and systemic effect of three inhaled corticosteroids.
Ahrens, R; Grandgeorge, S; McCubbin, MM; Milavetz, G; Sargent, C; Vaughan, LM; Weinberger, M, 1995
)
0.48
" Dose-response relationships were shown for each inhaled corticosteroid for both topical and systemic effect."( A bioassay for topical and systemic effect of three inhaled corticosteroids.
Ahrens, R; Grandgeorge, S; McCubbin, MM; Milavetz, G; Sargent, C; Vaughan, LM; Weinberger, M, 1995
)
0.29
" Dose-response analyses also revealed a coordinate down-regulation of GR and c-jun (but not POMC or c-fos) mRNA levels."( Coordinate regulation of glucocorticoid receptor and c-jun mRNA levels: evidence for cross-talk between two signaling pathways' at the transcriptional level.
Barrett, TJ; Vedeckis, WV; Vig, E, 1994
)
0.29
" The varying dosages of TA produced insignificant differences; however, the proportional distribution of the types of filtering blebs differed significantly among the various dosage groups, and complications occurred mostly in the high dosage group of 12 mg."( [A randomized controlled study of the anti-cicatricial effect of preoperative subconjunctival triamcinolone on the filtering bleb].
Wang, NL; Ye, TC; Zhou, WB, 1994
)
0.29
" Transmission electron microscopy showed that FD at a dosage of over 5 micrograms or DL over 20 micrograms was toxic to the retina and that up to 4 mg TA was nontoxic."( Corticosteroids and daunomycin in the prevention of experimental proliferative vitreoretinopathy induced by macrophages.
Cai, YS; Heimann, K; Hui, YN; Kirchhof, B; Liang, HC, 1993
)
0.29
" Dose-response analyses reveal the expected coordinate regulation of both GR and c-jun mRNA and protein in L929 cells (decreasing) and in CEM-C7 cells (increasing)."( Coordinate regulation of glucocorticoid receptor and c-jun gene expression is cell type-specific and exhibits differential hormonal sensitivity for down- and up-regulation.
Barrett, TJ; Vedeckis, WV; Vig, E, 1996
)
0.29
" Once symptoms are under control, the dosage of aqueous triamcinolone acetonide may be reduced from 220 to 110 micrograms/day without loss of effect."( Triamcinolone acetonide. A review of its pharmacological properties and therapeutic efficacy in the management of allergic rhinitis.
Faulds, D; Jeal, W, 1997
)
1.99
" Further dose-ranging studies are required at steady-state in asthmatic subjects in order to see whether differences occur at lower doses on the steep part of the dose-response curve for both plasma and urinary cortisol suppression."( Adrenal suppression with high doses of inhaled fluticasone propionate and triamcinolone acetonide in healthy volunteers.
Clark, DJ; Lipworth, BJ; McFarlane, L; Wilson, AM, 1997
)
0.53
"This study evaluated whether more convenient once-daily dosage times (8 AM and 5:30 PM) produce improvement in asthma equivalent to QID."( Further studies on the chronotherapy of asthma with inhaled steroids: the effect of dosage timing on drug efficacy.
Humeston, TR; Martin, RJ; Pincus, DJ, 1997
)
0.3
" Dosing at 8 AM did not produce results consistently comparable to QID dosing."( Further studies on the chronotherapy of asthma with inhaled steroids: the effect of dosage timing on drug efficacy.
Humeston, TR; Martin, RJ; Pincus, DJ, 1997
)
0.3
" Twice daily dosing may increase compliance with therapy."( A multicenter, placebo-controlled study of twice daily triamcinolone acetonide (800 microg per day) for the treatment of patients with mild-to-moderate asthma.
Bernstein, DI; Cohen, R; Ginchansky, E; Pedinoff, AJ; Tinkelman, DG; Winder, JA, 1998
)
0.55
"At this time, no placebo-controlled studies in the clinical literature compare the efficacy and safety of the most widely prescribed oral inhaled corticosteroids when dosed at their recommended daily doses."( Comparative clinical study of inhaled beclomethasone dipropionate and triamcinolone acetonide in persistent asthma.
Bronsky, E; Chen, R; Harris, AG; Korenblat, P, 1998
)
0.53
" Both treatments were dosed at their most commonly used daily doses (within labeling)."( A comparison of triamcinolone acetonide MDI with a built-in tube extender and beclomethasone dipropionate MDI in adult asthmatics.
Berkowitz, R; Chen, R; Harris, AG; Rachelefsky, G, 1998
)
0.65
"We sought to evaluate the dose-response effect of inhaled BUD and TAA in terms of adrenal, bone, and blood markers."( Dose-response comparison of systemic bioactivity with inhaled budesonide and triamcinolone acetonide in asthmatic adults.
Brewster, HJ; Lipworth, BJ; Wilson, AM, 1998
)
0.53
" There was no evidence of a significant overall dose-response effect for any parameter of hypothalamo-pituitary-adrenocortical axis activity, with neither drug being significantly different from placebo at any dose."( Dose-response comparison of systemic bioactivity with inhaled budesonide and triamcinolone acetonide in asthmatic adults.
Brewster, HJ; Lipworth, BJ; Wilson, AM, 1998
)
0.53
" Chronic dosing did result in a statistically significant 20% reduction in basal 24-hour serum cortisol AUC(0-24) for both compounds."( A study comparing the clinical pharmacokinetics, pharmacodynamics, and tolerability of triamcinolone acetonide HFA-134a metered-dose inhaler and budesonide dry-powder inhaler following inhalation administration.
Argenti, D; Heald, D; Shah, B, 2000
)
0.53
" A review of available information indicates that (1) sensitive tests can measure the effects of INSs on biologic feedback systems, but they do not accurately predict clinically relevant adverse effects; (2) the primary factors that influence the relationship between therapeutic and adverse systemic effects of INSs are dosing frequency and efficiency of hepatic inactivation of swallowed drug; (3) INS treatment in recommended doses does not cause clinically significant hypothalamic-pituitary-adrenal axis suppression; (4) growth suppression can occur with twice-daily administration of certain INSs but does not appear to occur with once-daily dosing or with agents with more complete first-pass hepatic inactivation; (5) harmful effects of INSs on bone metabolism have not yet been adequately studied but would not be expected with the use of an INS dose and dosing frequency that do not suppress basal hypothalamic-pituitary-adrenal axis function or growth; and (6) these conclusions apply to INS treatment alone and in recommended doses-the risk of adverse effects in individual patients who are treated with INSs is increased by excessive dosing or concomitant inhaled corticosteroid or other topical corticosteroid therapy."( Systemic effects of intranasal steroids: an endocrinologist's perspective.
Allen, DB, 2000
)
0.31
" A dosage of 1 mg/0."( Retinal toxicity of triamcinolone acetonide in silicone-filled eyes.
Cheema, R; El-Dessouky, ES; Hegazy, H; Kazi, AA; Kivilcim, M; Peyman, GA,
)
0.45
") dosing was best described by a three-compartment open model."( Pharmacokinetics and metabolic effects of triamcinolone acetonide and their possible relationships to glucocorticoid-induced laminitis in horses.
French, K; Pass, MA; Pollitt, CC, 2000
)
0.57
" In addition, the spacer devices investigated will allow a higher dose of drug to reach the deep lung, which may permit the use of lower dosage regimens with increased therapeutic efficacy."( Investigation of some commercially available spacer devices for the delivery of glucocorticoid steroids from a pMDI.
Barron, MK; Patel, AM; Rogers, TL; Williams, RO, 2001
)
0.31
" The algorithm was designed to calculate CCS based on 5 input parameters: name of drug, dose, dosing interval, time(s) of dosing, and type of inhaler device."( An interactive algorithm for the assessment of cumulative cortisol suppression during inhaled corticosteroid therapy.
Derendorf, H; Hochhaus, G; Krishnaswami, S, 2000
)
0.31
" In summary, based on the results of this PK/PD simulation, the plasma levels observed afternasal administration of the solution or the aqueous suspension are unlikely to induce a clinically relevant cortisol suppression, especially for the recommended dosing regimens of 200 and 220 microg/day."( A new solution-based intranasal triamcinolone acetonide formulation in patients with perennial allergic rhinitis: how does the pharmacokinetic/pharmacodynamic profile for cortisol suppression compare with an aqueous suspension-based formulation?
Dockhorn, RJ; González, MA; Hochhaus, G; Karafilidis, J; Shilstone, J, 2002
)
0.6
" It is likely that once-daily dosing and patient preference for the sensory attributes of TAA AQ may enhance treatment compliance."( A comparison of once-daily triamcinolone acetonide aqueous and twice-daily beclomethasone dipropionate aqueous nasal sprays in the treatment of seasonal allergic rhinitis.
el-Akkad, T; Hampel, F; Kiechel, F; LaForce, C; Lumry, W; Murray, JJ,
)
0.43
" The highest dosage of MPA (10 mg/ml) reduced GAG synthesis less than lower dosages of MPA and all dosages of TA."( Effects of dosage titration of methylprednisolone acetate and triamcinolone acetonide on interleukin-1-conditioned equine articular cartilage explants in vitro.
Baxter, GM; Dechant, JE; Frisbie, DD; McIlwraith, CW; Trotter, GW, 2003
)
0.56
" In contrast, a conventional formulation of triamcinolone-acetonide requires a 10-fold higher drug dosage to achieve a similar effect."( Biological activity and characteristics of triamcinolone-acetonide formulated with the self-regulating drug carriers, Transfersomes.
Blume, G; Cevc, G, 2003
)
0.32
" The duration of the effect of a single intravitreal injection of triamcinolone ranges between 2 and 9 months, probably depending on the dosage used."( [Intravitreal triamcinolone acetonide for the treatment of intraocular edematous and neovascular diseases].
Degenring, RF; Jonas, JB; Kamppeter, B; Kreissig, I, 2004
)
0.68
"The aim of this study was to compare the effectiveness of triamcinolone hexacetonide (THA) and methylprednisolone acetate (MPA), given via the intra-articular route at equipotent dosage to patients with symptomatic knee OA with effusion, in a double-blind randomized comparative trial."( Intra-articular steroids in knee osteoarthritis: a comparative study of triamcinolone hexacetonide and methylprednisolone acetate.
Bhanji, A; Ioannou, Y; Mootoo, R; Pyne, D, 2004
)
0.32
" This information may be helpful in determining the optimal dosage of intravitreal triamcinolone acetonide for the treatment of diffuse diabetic macular edema."( Duration of the effect of intravitreal triamcinolone acetonide as treatment for diffuse diabetic macular edema.
Akkoyun, I; Degenring, RF; Jonas, JB; Kamppeter, BA; Kreissig, I, 2004
)
0.82
" During the follow-up period, recurrent macular edema was retreated with the same dosage and followed for another 6 months."( Intravitreal triamcinolone injection for macular edema secondary to increased retinal vascular permeability.
Lee, WF; Yang, CM, 2004
)
0.32
" Moreover, the transient effect on CMT may warrant further studies to determine optimal timing and dosage of further ivTA injections."( Phacoemulsification with intravitreal triamcinolone in patients with cataract and coexisting diabetic macular oedema: a 6-month prospective pilot study.
Chan, CK; Chan, WM; Fan, DS; Lai, TY; Lai, WW; Lam, DS; Lee, VY; Mohamed, S, 2005
)
0.33
" Due to the transient nature of IVTA, re-treatment seems necessary but the optimal timing and dosage will require further investigations."( Intravitreal triamcinolone for diabetic macular oedema in Chinese patients: six-month prospective longitudinal pilot study.
Chan, CK; Chan, WM; Fan, DS; Lam, DS; Li, KK; Tang, EW, 2004
)
0.32
" It did not have a significantly different therapeutic efficacy from the commercial paste dosage form in the treatment of oral lichen planus."( Formulation and efficacy of triamcinolone acetonide mouthwash for treating oral lichen planus.
Kietthubthew, S; Maneenuan, D; Nittayananta, W; Phadoongsombat, N; Ungphaiboon, S; Vuddhakul, V; Wongpoowarak, W, 2005
)
0.62
" For the second pharmacy, mean triamcinolone acetonide dosage was 23."( Triamcinolone acetonide concentration after filtration of the solvent agent.
Derse, M; Jonas, JB; Papoulis, C; Sagstetter, BU; Schmitz-Valckenberg, P; Spandau, UH; Stiefvater, K, 2005
)
2.06
" The duration of the effect of a single intravitreal injection of triamcinolone depended on the dosage given."( Intravitreal triamcinolone acetonide for treatment of intraocular proliferative, exudative, and neovascular diseases.
Degenring, R; Jonas, JB; Kreissig, I, 2005
)
0.7
" Dosage measurement was performed before filtration."( Dosage dependency of intravitreal triamcinolone acetonide as treatment for diabetic macular oedema.
Derse, M; Jonas, JB; Papoulis, C; Schmitz-Valckenberg, P; Spandau, UH, 2005
)
0.61
"38) correlated with the dosage of intravitreal triamcinolone acetonide."( Dosage dependency of intravitreal triamcinolone acetonide as treatment for diabetic macular oedema.
Derse, M; Jonas, JB; Papoulis, C; Schmitz-Valckenberg, P; Spandau, UH, 2005
)
0.86
"In patients with diffuse diabetic macular oedema receiving intravitreal triamcinolone acetonide, treatment response may last longer and be more pronounced with a dosage of 13 mg than in lower doses of 5 mg or 2 mg."( Dosage dependency of intravitreal triamcinolone acetonide as treatment for diabetic macular oedema.
Derse, M; Jonas, JB; Papoulis, C; Schmitz-Valckenberg, P; Spandau, UH, 2005
)
0.84
" The dosage of oral corticosteroids and/or second-line immunosuppressive medication was reduced or stopped altogether in 18 of 33 eyes (54."( Outcome of intravitreal triamcinolone in uveitis.
Kok, H; Lau, C; Lightman, S; Maycock, N; McCluskey, P, 2005
)
0.33
" The objective of the current study was to compare the relative patient satisfaction with budesonide inhalation powder administered via Turbuhaler (AstraZeneca LP, Wilmington, DE) (200 to 1600 microg/d using one of 3 dosing strengths: 100, 200, or 400 microg per inhalation) and triamcinolone acetonide administered via pressurized metered-dose inhaler (200 to 1600 microg/d) among persons treated in managed care settings."( Patient satisfaction with budesonide Turbuhaler versus triamcinolone acetonide administered via pressurized metered-dose inhaler in a managed care setting.
Liljas, B; Luce, BR; Paramore, LC; Revicki, DA; Weiss, KB, 2005
)
0.75
" In non-vitrectomized eyes, the duration of the effect and side-effects of a single intravitreal injection of triamcinolone is about 6-9 months for a dosage of about 20 mg, and about 2-4 months for a dosage of 4 mg."( Intravitreal triamcinolone acetonide for treatment of intraocular oedematous and neovascular diseases.
Jonas, JB, 2005
)
0.7
"Intravitreal triamcinolone acetonide (TA) has been widely used as a therapeutic method for many ocular diseases, but a consensus on an appropriate safe therapeutic window of dosage for intravitreal injection, and whether vehicle of TA should be reduced or eliminated, has not yet been reached."( Vehicle of triamcinolone acetonide is associated with retinal toxicity and transient increase of lens density.
Kai, W; Xiaoxin, L; Yanrong, J, 2006
)
1.09
" In nonvitrectomized eyes, the duration of the effect and side effects of a single intravitreal injection of triamcinolone is about 6-9 months for a dosage of about 20 mg, and about 2-4 months for a dosage of 4 mg."( Intravitreal triamcinolone acetonide: a change in a paradigm.
Jonas, JB, 2006
)
0.7
"Using a dosage of approximately 20 mg of intravitreal TA, visual acuity temporarily increases for 6 months after injection."( Intravitreal triamcinolone acetonide for diabetic macular edema: a prospective, randomized study.
Harder, B; Jonas, JB; Kamppeter, BA; Sauder, G; Spandau, UH; Vossmerbaeumer, U, 2006
)
0.7
" The AR subjects were administered TAA in a daily dosage of a 220-microg intranasal route."( The effect of triamcinolone acetonide aqueous nasal spray on the nasal carriage of Staphylococcus aureus.
Karabay, O; Kocoglu, E; Koybasi, S; Talay, F; Yilmaz, F,
)
0.49
" During each flare-up, the patient was housebound and required therapeutic dosing of nonsteroidal anti-inflammatory drugs and codeine to control joint pain."( Carbonated apatite-induced arthropathy: a consideration in cases of polyarthritis.
Blair-Levy, JM, 2006
)
0.33
" The duration of the effect of a single IVTA is dosage dependent (about 6-9 months with 20 mg, and about 2-4 months with 4 mg)."( Intravitreal triamcinolone acetonide for diabetic retinopathy.
Jonas, JB, 2007
)
0.71
" This makes it possible to decrease the dosage and duration of topical prednisolone acetate."( Intracameral triamcinolone acetonide to control postoperative inflammation following cataract surgery with phacoemulsification.
Akova, YA; Borazan, M; Karalezli, A, 2008
)
0.72
"Younger age, higher baseline IOP, IVI, and increased TA dosage were associated with TA-induced IOP elevation."( Intraocular pressure elevation after injection of triamcinolone acetonide: a multicenter retrospective case-control study.
Hirano, Y; Hirooka, K; Inatani, M; Iwao, K; Kawaji, T; Matsumura, M; Nakanishi, Y; Negi, A; Ogura, Y; Sakamoto, T; Shima, C; Shimonagano, Y; Shiraga, F; Tanihara, H; Yamamoto, H, 2008
)
0.6
"Differential gene expression profiles of human TM cells treated by TA and DEX, and a dosage effect by TA, were revealed by microarray technology."( Gene expression profiles of human trabecular meshwork cells induced by triamcinolone and dexamethasone.
Fan, BJ; Lam, DS; Pang, CP; Tham, CC; Wang, DY, 2008
)
0.35
"Although the sample in this study was small, there was a dose-response trend toward better visual outcomes and fewer treatments in the group treated with IVT injection and reduced-fluence PDT."( Combination treatment with reduced-fluence photodynamic therapy and intravitreal injection of triamcinolone for subfoveal choroidal neovascularization in macular degeneration.
Saperstein, DA; Singh, CN, 2008
)
0.35
"To evaluate the efficacy of the self-adjustable dosing regimen and explore potential dose-response relationships of intranasal corticosteroids in persistent allergic rhinitis."( Dose-related effect of intranasal corticosteroids on treatment outcome of persistent allergic rhinitis.
Chansaksung, P; Kirtsreesakul, V; Ruttanaphol, S, 2008
)
0.35
"A self-adjustable dosing approach proved to be an efficacious approach to controlling allergic rhinitis."( Dose-related effect of intranasal corticosteroids on treatment outcome of persistent allergic rhinitis.
Chansaksung, P; Kirtsreesakul, V; Ruttanaphol, S, 2008
)
0.35
"75) times and the mean oral dosage of NSAID was (1267 +/- 325) mg."( Continuous epidural block of the cervical vertebrae for cervicogenic headache.
Guo, YN; He, MW; Liu, JJ; Ni, JX; Wang, Q; Yang, LQ, 2009
)
0.35
"In patients with diffuse diabetic macular edema who receive intravitreal TA, effects may last longer after a dosage of 25 mg, than after lower doses of 8 mg or 4 mg."( Dose dependent effects of intravitreal triamcinolone acetonide on diffuse diabetic macular edema.
Bae, JS; Ham, IR; Lee, TG; Park, SJ, 2009
)
0.62
" More studies are required to determine the optimal dosage and treatment frequency in different posterior segment disease."( Pharmacotherapeutic efficacy of preservative-free intravitreal triamcinolone acetonide.
Gillies, M; Kuo, CH; McCluskey, P, 2010
)
0.6
" Other factors, including past medical history and renal function, also need to be taken into account when choosing the proper dosing regimen."( Intrapericardial triamcinolone for acute pericarditis after electrophysiologic procedures.
Crouch, MA; Maxwell, CB, 2010
)
0.36
"A worse treatment outcome despite more clinical improvements during the treatment period in a higher severity score suggests the therapeutic predictive value of pretreatment nasal symptom scoring and the need for more dosing and continuing medication in higher scores, especially in blocked nose."( Impact of pretreatment nasal symptoms on treatment outcome in allergic rhinitis.
Chansaksung, P; Kirtsreesakul, V; Ruttanaphol, S, 2010
)
0.36
" This strategy results in prolonged dosage intervals and reduced tablet intake due to a reduced overall dose that is needed."( [Cushing syndrome after steroid-infiltration in two HIV-patients with antiretroviral therapy].
Günthard, HF; Herold, MA, 2010
)
0.36
" The dosage of immunosuppressive systemic therapy was reduced or able to be stopped in three patients (50%)."( Periocular corticosteroid injection in the management of uveitis in children.
Grigg, JR; Habot-Wilner, Z; Kabasele, PM; Lightman, S; McCluskey, P; Roufas, A; Sallam, A, 2010
)
0.36
" The patient's PM achieved complete remission in both lower extremities after an approximately 6-month period that included seven courses of treatment with a total dosage of 280 mg triamcinolone acetonide."( Multipoint subcutaneous injection of long-acting glucocorticid as a cure for pretibial myxedema.
Deng, A; Song, D, 2011
)
0.56
"The treatment with Long term use of low dosage oral macrolide Clarithromycin combined with nasal steroid on CRS was efficacy."( [Clinical observation of Clarithromycin combined with nasal steroid treatment for chronic rhinosinusitis].
Feng, Z; Hong, Y; Li, Q; Li, X; Liu, J; Liu, L; Lu, X; Wan, Y; Zhong, G, 2011
)
0.37
"Intra-articular and intralesional glucocorticoid injections are commonly used by dermatologists, orthopedic surgeons, and rheumatologists because they offer many advantages over oral or parenteral dosage forms."( Linear rays of hypopigmentation following intra-articular corticosteroid injection for post-traumatic degenerative joint disease.
Feinberg, JS; Javvaji, S; Schwartz, C, 2012
)
0.38
"9% were prepared to investigate the dosage effect on transdermal delivery and anti-inflammatory activity."( A novel transdermal fomulation of 18β-glycyrrhetic acid with lysine for improving bioavailability and efficacy.
Gao, YH; Li, S; Qiu, YQ; Zhang, SH, 2012
)
0.38
"The lack of anatomic and functional efficacy observed in our study does not appear to be related to the method, dosage or timing of injection, nor to the presence of subretinal macroaneurysms."( [Role of intravitreal bevacizumab for resistant macular edema due to central retinal vein occlusion after failure of intravitreal triamcinolone acetonide].
Duncombe, A; Genevois, O; Le Moigne, O; Muraine, M; Portmann, A, 2012
)
0.58
"A low dosage of TA(4 mg) administered via intravitreal injection might be useful as an initial treatment for macular edema secondary to CRVO."( Different dosages of intravitreal triamcinolone acetonide injections for macular edema secondary to central retinal vein occlusion.
Bi, C; Chen, F; Wang, H; Wei, Y; Yang, X; Zu, Z, 2012
)
0.66
"To evaluate the effect of intravitreal triamcinolone acetonide (TA) on healing of retinal photocoagulation lesions using drug and laser dosing typically employed in clinical practice."( Effect of intravitreal triamcinolone acetonide on healing of retinal photocoagulation lesions.
Blumenkranz, MS; Dalal, R; Lavinsky, D; Leung, LS; Nomoto, H; Palanker, D; Paulus, YM, 2013
)
0.97
" The present text provides a systematic review of all previously reported cases of Cushing's syndrome resulting from intralesional TAC in an effort to discover whether an association exists between dosage or frequency of injection and the subsequent development of Cushing's syndrome."( Cushing's syndrome after intralesional triamcinolone acetonide: a systematic review of the literature and multinational survey.
Fredman, R; Tenenhaus, M, 2013
)
0.66
" Survey data reveals that at least 30% (25/84) of plastic surgeons exceed the recommended dosage of TAC and 47% (46/97) are not aware of Cushing's syndrome as a possible complication of intralesional TAC."( Cushing's syndrome after intralesional triamcinolone acetonide: a systematic review of the literature and multinational survey.
Fredman, R; Tenenhaus, M, 2013
)
0.66
" Intralesional dosage should not exceed 30 mg per month in children while noting that at least one reported case of Cushing's syndrome resulted from a smaller dose."( Cushing's syndrome after intralesional triamcinolone acetonide: a systematic review of the literature and multinational survey.
Fredman, R; Tenenhaus, M, 2013
)
0.66
" The dosage of oral corticosteroids and/or second-line immunosuppressive agents was able to be reduced or stopped in 22 patients, 29 of 35 eyes (82."( Intravitreal triamcinolone acetonide as adjunctive treatment with systemic therapy for uveitic macular edema.
Do, HH; Habot-Wilner, Z; Lightman, S; McCluskey, P; Pacheco, PA; Sallam, A, 2011
)
0.74
"The lack of recommendations regarding dosing and administration, an undetermined risk of hypothalamic-pituitary-adrenal axis alteration, and the unknown effectiveness of intramuscular (IM) corticosteroid injection to treat dermatologic disease may be deterrents to use."( A prospective observational study evaluating hypothalamic-pituitary-adrenal axis alteration and efficacy of intramuscular triamcinolone acetonide for steroid-responsive dermatologic disease.
Ananthakrishnan, S; Garg, A; Reddy, S, 2013
)
0.6
" Patients received pro re nata dosing of ranibizumab."( One year results of a phase 1 study of the safety and tolerability of combination therapy using sustained release intravitreal triamcinolone acetonide and ranibizumab for subfoveal neovascular AMD.
Lim, JI; Niec, M; Wong, V, 2015
)
0.62
" The model can estimate drug release from implants or the dissolution of suspensions as a first step in their clearance mechanism, which will be the rate-limiting step for the overall resident time of a candidate dosage form in the vitreous."( The PK-Eye: A Novel In Vitro Ocular Flow Model for Use in Preclinical Drug Development.
Awwad, S; Brocchini, S; Khaw, PT; Lockwood, A, 2015
)
0.42
" Results in the BET group suggest that investigation into types, dose, and dosage schedule of glucocorticoids may facilitate placental maturation."( Localization of TGF-β and TGF-β receptor in bovine term placentome and expression differences between spontaneous and induced parturition.
Fujii, T; Fukuda, S; Hirayama, H; Kageyama, S; Koyama, K; Naito, A; Sawai, K, 2015
)
0.42
"There is insufficient data in the literature concerning optimal intralesional kenalog (ILK) dosing for the treatment of alopecia areata (AA)."( ILK Index and Regrowth in Alopecia Areata.
Bergfeld, WF; Fiessinger, LA; Kyei, A; Mesinkovska, NA; Piliang, MP; Stallings, AM; Velez, MW, 2015
)
0.42
" The validated method was applied for the determination of uniformity of dosage units and the reasons for variability (inhomogeneity and the analytical method error) were analyzed based on the overall uncertainty."( Development of an ultra high performance liquid chromatography method for determining triamcinolone acetonide in hydrogels using the design of experiments/design space strategy in combination with process capability index.
Fariña, JB; Llabrés, M; Monzón, C; Oliva, A; Santoveña, A, 2016
)
0.66
"The HPLC-MS analytical method is an alternative to HPLC-MS/MS methods, sensitive enough for identifying and quantifying steroids in vitreous humor at a therapeutic dosage scale."( Determination of Three Corticosteroids in the Biologic Matrix of Vitreous Humor by HPLC-tandem Mass Spectrometry: Method Development and Validation.
Fraile, JM; Garcia-Martin, E; Mayoral, JA; Otín-Mallada, S; Pablo, LE; Polo-Llorens, V; Prieto, E; Vispe, E, 2017
)
0.46
" The combination of the modified VM and EyeMoS seems a valuable tool for characterizing intravitreal dosage forms in a reproducible simulation of diversified eye movements and a partially liquefied or vitrectomized vitreous body."( Distribution of fluorescein sodium and triamcinolone acetonide in the simulated liquefied and vitrectomized Vitreous Model with simulated eye movements.
Bogdahn, M; Rosenbaum, C; Seidlitz, A; Stein, S; Weitschies, W, 2017
)
0.72
"Despite the higher dosage of triamcinolone, both therapies were safe and effective for treating diabetic macular edema."( Detailed analysis of retinal morphology in patients with diabetic macular edema (DME) randomized to ranibizumab or triamcinolone treatment.
Karst, SG; Kriechbaum, K; Kundi, M; Lammer, J; Mehta, J; Mitsch, C; Schmidt-Erfurth, U; Schober, M; Scholda, C, 2018
)
0.48
" A dose-response effect in duration of maximal analgesic effect was evident (13 weeks with 32 mg versus 9 weeks with 16 mg), with FX006 32 mg providing increased therapeutic benefit relative to FX006 16 mg."( Brief Report: A Phase IIb Trial of a Novel Extended-Release Microsphere Formulation of Triamcinolone Acetonide for Intraarticular Injection in Knee Osteoarthritis.
Berenbaum, F; Bodick, N; Cohen, SB; Conaghan, PG; Johnson, JR; Lufkin, J, 2018
)
0.7
" Following a single intravitreal injection, the proposed TA-SA-Glu hydrogel hardly caused apparent retinal toxicity at a dosage of 69 nmol per eye."( Glycosylation-enhanced biocompatibility of the supramolecular hydrogel of an anti-inflammatory drug for topical suppression of inflammation.
Lei, L; Li, X; Song, Q; Xiong, T; Zhang, R; Zhou, Y, 2018
)
0.48
"A dose-response characteristic was demonstrated in the treatment of trigger finger with triamcinolone acetonide."( Different Dosages of Triamcinolone Acetonide Injection for the Treatment of Trigger Finger and Thumb: A Randomized Controlled Trial.
Kosiyatrakul, A; Loketkrawee, W; Luenam, S, 2018
)
1.02
" Triesence, a preservative-free sterile formulation of triamcinolone acetonide, has been used in a wide spectrum of ocular pathologies, but there have been few large studies validating its dosing or detailing long-term side effects in uveitic disease."( Treatment Duration and Side Effect Profile of Long-Term Use of Intravitreal Preservative-Free Triamcinolone Acetonide in Uveitis.
Arepalli, S; Baynes, K; Bena, J; Ganapathy, PS; Li, M; Lowder, CY; Srivastava, SK, 2018
)
0.95
" However, the clinically used dosage has poor tissue permeability and injection safety."( Transdermal permeability of triamcinolone acetonide lipid nanoparticles.
Ban, J; Chen, D; Chen, F; Qin, Z; Tan, Y; Wang, Y, 2019
)
0.81
"Sixty-three adult patients with ethmoidal involvement in cone beam computerised tomography (CBCT) whose first-line medical treatment with topical corticosteroids had failed and who were candidates for ESS were randomised either to a DES group, which received triamcinolone acetonide stents (n = 34), or to a topical intranasal corticosteroid group (n = 29) that used optimally dosed triamcinolone acetonide nasal spray."( Ethmoidal drug-eluting stent therapy is not superior to nasal corticosteroid spray in the prevention of endoscopic sinus surgery: Results from a randomised, clinical trial.
Numminen, J; Rautiainen, M; Sillanpää, N; Taulu, R, 2020
)
0.74
" The dosage regimens vary from 10 to 40 mg triamcinolone acetonide."( Injection of Steroid in Nasal Polyps: A Systematic Review.
Alanin, MC; Hansen, MB, 2020
)
0.82
" Invasive drug administration via intracameral, subconjunctival, and intravitreal injection can enhance ocular bioavailability and minimize dose and dosing frequency of administration, yet may exacerbate ocular side effects of corticosteroids."( Corticosteroids in ophthalmology: drug delivery innovations, pharmacology, clinical applications, and future perspectives.
Abdelkader, H; Alany, RG; Alqahtani, AM; Elgarhy, O; Gaballa, SA; Kompella, UB; Pierscionek, B, 2021
)
0.62
" The combination of additives and dosage are various and controversial."( Efficacy of Periarticular Multimodal Analgesic Injection Containing High-Dose Ketorolac versus Triamcinolone in Early Postoperative Total Knee Arthroplasty: A Randomized Controlled Trial.
Apinyankul, R; Goodman, SB; Lilakhunakon, K; Vechvitvarakul, M; Witayakom, W, 2022
)
0.72
" Increasing the dosage and duration of keloid scar treatment is required in future studies to determine whether it would result in a significant therapeutic outcome."( Efficacy of a triamcinolone acetonide-loaded dissolving microneedle patch for the treatment of hypertrophic scars and keloids: a randomized, double-blinded, placebo-controlled split-scar study.
Disphanurat, W; Leelawattanachai, J; Sivapornpan, N; Srisantithum, B, 2023
)
1.27
" Reported corticosteroid dosing that one would inject in one specific keloid differed by a factor of 40."( Intralesional corticosteroid administration in the treatment of keloids: a survey among Dutch dermatologists and plastic surgeons.
Gibbs, S; Lapid, O; Louter, JMI; Niessen, FB; van Zuijlen, PPM; Wolkerstorfer, A; Yin, Q, 2023
)
0.91
" Dosing per cm2 could only be compared among ten (26%) studies and varied from 1 to 20 mg."( Intralesional Corticosteroid Administration in the Treatment of Keloids: A Scoping Review on Injection Methods.
Gibbs, S; Lapid, O; Louter, JMI; Niessen, FB; Tasdemir-Kilic, G; van Zuijlen, PPM; Wolkerstorfer, A; Yin, Q, 2023
)
0.91
" However, it is crucial to closely monitor patients for any adverse effects resulting from the treatment, which may arise from high dosage or increased frequency."( Iatrogenic cushing's syndrome post intralesional triamcinolone acetonide in oral submucous fibrosis: 2 case reports.
Choden, K; Gyeltshen, T, 2023
)
1.16
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (2)

RoleDescription
anti-inflammatory drugA substance that reduces or suppresses inflammation.
anti-allergic agentA drug used to treat allergic reactions.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (8)

ClassDescription
11beta-hydroxy steroidAny 11-hydroxy steroid in which the hydroxy group at position 11 has beta- configuration.
20-oxo steroidAn oxo steroid carrying an oxo group at position 20.
21-hydroxy steroid
3-oxo-Delta(4) steroidA 3-oxo steroid conjugated to a C=C double bond at the alpha,beta position.
glucocorticoidGlucocorticoids are a class of steroid hormones that regulate a variety of physiological processes, in particular control of the concentration of glucose in blood.
cyclic ketalA ketal in the molecule of which the ketal carbon and one or both oxygen atoms thereon are members of a ring.
fluorinated steroidA steroid which is substituted with one or more fluorine atoms in any position.
primary alpha-hydroxy ketoneAn alpha-hydroxy ketone in which the carbonyl group and the hydroxy group are linked by a -CH2 (methylene) group.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (44)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Chain A, Beta-lactamaseEscherichia coli K-12Potency89.12510.044717.8581100.0000AID485294
hypoxia-inducible factor 1 alpha subunitHomo sapiens (human)Potency0.02393.189029.884159.4836AID1224846
SMAD family member 2Homo sapiens (human)Potency24.68840.173734.304761.8120AID1346859
ATAD5 protein, partialHomo sapiens (human)Potency0.11580.004110.890331.5287AID504467
SMAD family member 3Homo sapiens (human)Potency24.68840.173734.304761.8120AID1346859
GLI family zinc finger 3Homo sapiens (human)Potency29.06480.000714.592883.7951AID1259368; AID1259369; AID1259392
AR proteinHomo sapiens (human)Potency5.57870.000221.22318,912.5098AID1259243; AID1259247; AID1259381; AID743035; AID743040; AID743042; AID743054; AID743063
hypoxia-inducible factor 1, alpha subunit (basic helix-loop-helix transcription factor)Homo sapiens (human)Potency0.01000.00137.762544.6684AID914; AID915
progesterone receptorHomo sapiens (human)Potency0.00400.000417.946075.1148AID1346784; AID1347036
cytochrome P450 family 3 subfamily A polypeptide 4Homo sapiens (human)Potency17.22450.01237.983543.2770AID1346984; AID1645841
glucocorticoid receptor [Homo sapiens]Homo sapiens (human)Potency0.04300.000214.376460.0339AID720691; AID720692; AID720719
retinoic acid nuclear receptor alpha variant 1Homo sapiens (human)Potency70.83640.003041.611522,387.1992AID1159552; AID1159553; AID1159555
retinoid X nuclear receptor alphaHomo sapiens (human)Potency49.25990.000817.505159.3239AID1159527
estrogen-related nuclear receptor alphaHomo sapiens (human)Potency20.43620.001530.607315,848.9004AID1224841; AID1224848; AID1224849; AID1259401; AID1259403
pregnane X nuclear receptorHomo sapiens (human)Potency31.74570.005428.02631,258.9301AID1346982; AID1346985
estrogen nuclear receptor alphaHomo sapiens (human)Potency12.14220.000229.305416,493.5996AID743069; AID743075; AID743077; AID743079; AID743080; AID743091
cytochrome P450 2D6Homo sapiens (human)Potency15.48710.00108.379861.1304AID1645840
peroxisome proliferator-activated receptor deltaHomo sapiens (human)Potency61.65240.001024.504861.6448AID743215
vitamin D (1,25- dihydroxyvitamin D3) receptorHomo sapiens (human)Potency6.88120.023723.228263.5986AID743222
IDH1Homo sapiens (human)Potency0.46110.005210.865235.4813AID686970
euchromatic histone-lysine N-methyltransferase 2Homo sapiens (human)Potency89.12510.035520.977089.1251AID504332
aryl hydrocarbon receptorHomo sapiens (human)Potency0.27310.000723.06741,258.9301AID743122
cytochrome P450, family 19, subfamily A, polypeptide 1, isoform CRA_aHomo sapiens (human)Potency14.42770.001723.839378.1014AID743083
nuclear factor of kappa light polypeptide gene enhancer in B-cells 1 (p105), isoform CRA_aHomo sapiens (human)Potency9.771219.739145.978464.9432AID1159509
nuclear receptor subfamily 1, group I, member 2Rattus norvegicus (Norway rat)Potency12.58930.10009.191631.6228AID1346983
chromobox protein homolog 1Homo sapiens (human)Potency89.12510.006026.168889.1251AID540317
nuclear factor erythroid 2-related factor 2 isoform 2Homo sapiens (human)Potency0.00410.00419.984825.9290AID504444
heat shock protein beta-1Homo sapiens (human)Potency21.53500.042027.378961.6448AID743210
nuclear receptor ROR-gamma isoform 1Mus musculus (house mouse)Potency12.58930.00798.23321,122.0200AID2551
gemininHomo sapiens (human)Potency0.00460.004611.374133.4983AID624296
lamin isoform A-delta10Homo sapiens (human)Potency10.00000.891312.067628.1838AID1487
Cellular tumor antigen p53Homo sapiens (human)Potency68.58960.002319.595674.0614AID651631
TAR DNA-binding protein 43Homo sapiens (human)Potency0.31621.778316.208135.4813AID652104
ATPase family AAA domain-containing protein 5Homo sapiens (human)Potency0.07230.011917.942071.5630AID651632; AID720516
Ataxin-2Homo sapiens (human)Potency0.00330.011912.222168.7989AID651632
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
ATP-binding cassette sub-family C member 3Homo sapiens (human)IC50 (µMol)133.00000.63154.45319.3000AID1473740
Multidrug resistance-associated protein 4Homo sapiens (human)IC50 (µMol)133.00000.20005.677410.0000AID1473741
Bile salt export pumpHomo sapiens (human)IC50 (µMol)133.00000.11007.190310.0000AID1473738
Glucocorticoid receptorHomo sapiens (human)IC50 (µMol)0.00440.00000.495310.0000AID625263
Glucocorticoid receptorHomo sapiens (human)Ki0.00200.00010.38637.0010AID625263
Glycine receptor subunit alpha-1Rattus norvegicus (Norway rat)IC50 (µMol)0.00440.00150.76005.0740AID625263
Glycine receptor subunit alpha-1Rattus norvegicus (Norway rat)Ki0.00200.00070.76537.0010AID625263
Glycine receptor subunit betaRattus norvegicus (Norway rat)IC50 (µMol)0.00440.00150.76005.0740AID625263
Glycine receptor subunit betaRattus norvegicus (Norway rat)Ki0.00200.00070.78467.0010AID625263
Glycine receptor subunit alpha-2Rattus norvegicus (Norway rat)IC50 (µMol)0.00440.00150.80445.0740AID625263
Glycine receptor subunit alpha-2Rattus norvegicus (Norway rat)Ki0.00200.00070.78467.0010AID625263
Glycine receptor subunit alpha-3Rattus norvegicus (Norway rat)IC50 (µMol)0.00440.00150.76005.0740AID625263
Glycine receptor subunit alpha-3Rattus norvegicus (Norway rat)Ki0.00200.00070.78467.0010AID625263
Canalicular multispecific organic anion transporter 1Homo sapiens (human)IC50 (µMol)133.00002.41006.343310.0000AID1473739
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (221)

Processvia Protein(s)Taxonomy
xenobiotic metabolic processATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
bile acid and bile salt transportATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transportATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
leukotriene transportATP-binding cassette sub-family C member 3Homo sapiens (human)
monoatomic anion transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transport across blood-brain barrierATP-binding cassette sub-family C member 3Homo sapiens (human)
prostaglandin secretionMultidrug resistance-associated protein 4Homo sapiens (human)
cilium assemblyMultidrug resistance-associated protein 4Homo sapiens (human)
platelet degranulationMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic metabolic processMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
bile acid and bile salt transportMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transportMultidrug resistance-associated protein 4Homo sapiens (human)
urate transportMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
cAMP transportMultidrug resistance-associated protein 4Homo sapiens (human)
leukotriene transportMultidrug resistance-associated protein 4Homo sapiens (human)
monoatomic anion transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
export across plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
transport across blood-brain barrierMultidrug resistance-associated protein 4Homo sapiens (human)
guanine nucleotide transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
negative regulation of transcription by RNA polymerase IIGlucocorticoid receptorHomo sapiens (human)
regulation of gluconeogenesisGlucocorticoid receptorHomo sapiens (human)
chromatin organizationGlucocorticoid receptorHomo sapiens (human)
regulation of DNA-templated transcriptionGlucocorticoid receptorHomo sapiens (human)
apoptotic processGlucocorticoid receptorHomo sapiens (human)
chromosome segregationGlucocorticoid receptorHomo sapiens (human)
signal transductionGlucocorticoid receptorHomo sapiens (human)
glucocorticoid metabolic processGlucocorticoid receptorHomo sapiens (human)
gene expressionGlucocorticoid receptorHomo sapiens (human)
microglia differentiationGlucocorticoid receptorHomo sapiens (human)
adrenal gland developmentGlucocorticoid receptorHomo sapiens (human)
regulation of glucocorticoid biosynthetic processGlucocorticoid receptorHomo sapiens (human)
synaptic transmission, glutamatergicGlucocorticoid receptorHomo sapiens (human)
maternal behaviorGlucocorticoid receptorHomo sapiens (human)
intracellular glucocorticoid receptor signaling pathwayGlucocorticoid receptorHomo sapiens (human)
glucocorticoid mediated signaling pathwayGlucocorticoid receptorHomo sapiens (human)
positive regulation of neuron apoptotic processGlucocorticoid receptorHomo sapiens (human)
negative regulation of DNA-templated transcriptionGlucocorticoid receptorHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIGlucocorticoid receptorHomo sapiens (human)
astrocyte differentiationGlucocorticoid receptorHomo sapiens (human)
cell divisionGlucocorticoid receptorHomo sapiens (human)
mammary gland duct morphogenesisGlucocorticoid receptorHomo sapiens (human)
motor behaviorGlucocorticoid receptorHomo sapiens (human)
cellular response to steroid hormone stimulusGlucocorticoid receptorHomo sapiens (human)
cellular response to glucocorticoid stimulusGlucocorticoid receptorHomo sapiens (human)
cellular response to dexamethasone stimulusGlucocorticoid receptorHomo sapiens (human)
cellular response to transforming growth factor beta stimulusGlucocorticoid receptorHomo sapiens (human)
neuroinflammatory responseGlucocorticoid receptorHomo sapiens (human)
positive regulation of miRNA transcriptionGlucocorticoid receptorHomo sapiens (human)
intracellular steroid hormone receptor signaling pathwayGlucocorticoid receptorHomo sapiens (human)
regulation of transcription by RNA polymerase IIGlucocorticoid receptorHomo sapiens (human)
negative regulation of cell population proliferationCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycleCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycle G2/M phase transitionCellular tumor antigen p53Homo sapiens (human)
DNA damage responseCellular tumor antigen p53Homo sapiens (human)
ER overload responseCellular tumor antigen p53Homo sapiens (human)
cellular response to glucose starvationCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
positive regulation of miRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
negative regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
mitophagyCellular tumor antigen p53Homo sapiens (human)
in utero embryonic developmentCellular tumor antigen p53Homo sapiens (human)
somitogenesisCellular tumor antigen p53Homo sapiens (human)
release of cytochrome c from mitochondriaCellular tumor antigen p53Homo sapiens (human)
hematopoietic progenitor cell differentiationCellular tumor antigen p53Homo sapiens (human)
T cell proliferation involved in immune responseCellular tumor antigen p53Homo sapiens (human)
B cell lineage commitmentCellular tumor antigen p53Homo sapiens (human)
T cell lineage commitmentCellular tumor antigen p53Homo sapiens (human)
response to ischemiaCellular tumor antigen p53Homo sapiens (human)
nucleotide-excision repairCellular tumor antigen p53Homo sapiens (human)
double-strand break repairCellular tumor antigen p53Homo sapiens (human)
regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
protein import into nucleusCellular tumor antigen p53Homo sapiens (human)
autophagyCellular tumor antigen p53Homo sapiens (human)
DNA damage responseCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediator resulting in cell cycle arrestCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediator resulting in transcription of p21 class mediatorCellular tumor antigen p53Homo sapiens (human)
transforming growth factor beta receptor signaling pathwayCellular tumor antigen p53Homo sapiens (human)
Ras protein signal transductionCellular tumor antigen p53Homo sapiens (human)
gastrulationCellular tumor antigen p53Homo sapiens (human)
neuroblast proliferationCellular tumor antigen p53Homo sapiens (human)
negative regulation of neuroblast proliferationCellular tumor antigen p53Homo sapiens (human)
protein localizationCellular tumor antigen p53Homo sapiens (human)
negative regulation of DNA replicationCellular tumor antigen p53Homo sapiens (human)
negative regulation of cell population proliferationCellular tumor antigen p53Homo sapiens (human)
determination of adult lifespanCellular tumor antigen p53Homo sapiens (human)
mRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
rRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
response to salt stressCellular tumor antigen p53Homo sapiens (human)
response to inorganic substanceCellular tumor antigen p53Homo sapiens (human)
response to X-rayCellular tumor antigen p53Homo sapiens (human)
response to gamma radiationCellular tumor antigen p53Homo sapiens (human)
positive regulation of gene expressionCellular tumor antigen p53Homo sapiens (human)
cardiac muscle cell apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of cardiac muscle cell apoptotic processCellular tumor antigen p53Homo sapiens (human)
glial cell proliferationCellular tumor antigen p53Homo sapiens (human)
viral processCellular tumor antigen p53Homo sapiens (human)
glucose catabolic process to lactate via pyruvateCellular tumor antigen p53Homo sapiens (human)
cerebellum developmentCellular tumor antigen p53Homo sapiens (human)
negative regulation of cell growthCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
negative regulation of transforming growth factor beta receptor signaling pathwayCellular tumor antigen p53Homo sapiens (human)
mitotic G1 DNA damage checkpoint signalingCellular tumor antigen p53Homo sapiens (human)
negative regulation of telomere maintenance via telomeraseCellular tumor antigen p53Homo sapiens (human)
T cell differentiation in thymusCellular tumor antigen p53Homo sapiens (human)
tumor necrosis factor-mediated signaling pathwayCellular tumor antigen p53Homo sapiens (human)
regulation of tissue remodelingCellular tumor antigen p53Homo sapiens (human)
cellular response to UVCellular tumor antigen p53Homo sapiens (human)
multicellular organism growthCellular tumor antigen p53Homo sapiens (human)
positive regulation of mitochondrial membrane permeabilityCellular tumor antigen p53Homo sapiens (human)
cellular response to glucose starvationCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
entrainment of circadian clock by photoperiodCellular tumor antigen p53Homo sapiens (human)
mitochondrial DNA repairCellular tumor antigen p53Homo sapiens (human)
regulation of DNA damage response, signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of neuron apoptotic processCellular tumor antigen p53Homo sapiens (human)
transcription initiation-coupled chromatin remodelingCellular tumor antigen p53Homo sapiens (human)
negative regulation of proteolysisCellular tumor antigen p53Homo sapiens (human)
negative regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
positive regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
positive regulation of RNA polymerase II transcription preinitiation complex assemblyCellular tumor antigen p53Homo sapiens (human)
positive regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
response to antibioticCellular tumor antigen p53Homo sapiens (human)
fibroblast proliferationCellular tumor antigen p53Homo sapiens (human)
negative regulation of fibroblast proliferationCellular tumor antigen p53Homo sapiens (human)
circadian behaviorCellular tumor antigen p53Homo sapiens (human)
bone marrow developmentCellular tumor antigen p53Homo sapiens (human)
embryonic organ developmentCellular tumor antigen p53Homo sapiens (human)
positive regulation of peptidyl-tyrosine phosphorylationCellular tumor antigen p53Homo sapiens (human)
protein stabilizationCellular tumor antigen p53Homo sapiens (human)
negative regulation of helicase activityCellular tumor antigen p53Homo sapiens (human)
protein tetramerizationCellular tumor antigen p53Homo sapiens (human)
chromosome organizationCellular tumor antigen p53Homo sapiens (human)
neuron apoptotic processCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycleCellular tumor antigen p53Homo sapiens (human)
hematopoietic stem cell differentiationCellular tumor antigen p53Homo sapiens (human)
negative regulation of glial cell proliferationCellular tumor antigen p53Homo sapiens (human)
type II interferon-mediated signaling pathwayCellular tumor antigen p53Homo sapiens (human)
cardiac septum morphogenesisCellular tumor antigen p53Homo sapiens (human)
positive regulation of programmed necrotic cell deathCellular tumor antigen p53Homo sapiens (human)
protein-containing complex assemblyCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to endoplasmic reticulum stressCellular tumor antigen p53Homo sapiens (human)
thymocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of thymocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
necroptotic processCellular tumor antigen p53Homo sapiens (human)
cellular response to hypoxiaCellular tumor antigen p53Homo sapiens (human)
cellular response to xenobiotic stimulusCellular tumor antigen p53Homo sapiens (human)
cellular response to ionizing radiationCellular tumor antigen p53Homo sapiens (human)
cellular response to gamma radiationCellular tumor antigen p53Homo sapiens (human)
cellular response to UV-CCellular tumor antigen p53Homo sapiens (human)
stem cell proliferationCellular tumor antigen p53Homo sapiens (human)
signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
cellular response to actinomycin DCellular tumor antigen p53Homo sapiens (human)
positive regulation of release of cytochrome c from mitochondriaCellular tumor antigen p53Homo sapiens (human)
cellular senescenceCellular tumor antigen p53Homo sapiens (human)
replicative senescenceCellular tumor antigen p53Homo sapiens (human)
oxidative stress-induced premature senescenceCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathwayCellular tumor antigen p53Homo sapiens (human)
oligodendrocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of execution phase of apoptosisCellular tumor antigen p53Homo sapiens (human)
negative regulation of mitophagyCellular tumor antigen p53Homo sapiens (human)
regulation of mitochondrial membrane permeability involved in apoptotic processCellular tumor antigen p53Homo sapiens (human)
regulation of intrinsic apoptotic signaling pathway by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of miRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
negative regulation of G1 to G0 transitionCellular tumor antigen p53Homo sapiens (human)
negative regulation of miRNA processingCellular tumor antigen p53Homo sapiens (human)
negative regulation of glucose catabolic process to lactate via pyruvateCellular tumor antigen p53Homo sapiens (human)
negative regulation of pentose-phosphate shuntCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to hypoxiaCellular tumor antigen p53Homo sapiens (human)
regulation of fibroblast apoptotic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of stem cell proliferationCellular tumor antigen p53Homo sapiens (human)
positive regulation of cellular senescenceCellular tumor antigen p53Homo sapiens (human)
positive regulation of intrinsic apoptotic signaling pathwayCellular tumor antigen p53Homo sapiens (human)
negative regulation of protein phosphorylationTAR DNA-binding protein 43Homo sapiens (human)
mRNA processingTAR DNA-binding protein 43Homo sapiens (human)
RNA splicingTAR DNA-binding protein 43Homo sapiens (human)
negative regulation of gene expressionTAR DNA-binding protein 43Homo sapiens (human)
regulation of protein stabilityTAR DNA-binding protein 43Homo sapiens (human)
positive regulation of insulin secretionTAR DNA-binding protein 43Homo sapiens (human)
response to endoplasmic reticulum stressTAR DNA-binding protein 43Homo sapiens (human)
positive regulation of protein import into nucleusTAR DNA-binding protein 43Homo sapiens (human)
regulation of circadian rhythmTAR DNA-binding protein 43Homo sapiens (human)
regulation of apoptotic processTAR DNA-binding protein 43Homo sapiens (human)
negative regulation by host of viral transcriptionTAR DNA-binding protein 43Homo sapiens (human)
rhythmic processTAR DNA-binding protein 43Homo sapiens (human)
regulation of cell cycleTAR DNA-binding protein 43Homo sapiens (human)
3'-UTR-mediated mRNA destabilizationTAR DNA-binding protein 43Homo sapiens (human)
3'-UTR-mediated mRNA stabilizationTAR DNA-binding protein 43Homo sapiens (human)
nuclear inner membrane organizationTAR DNA-binding protein 43Homo sapiens (human)
amyloid fibril formationTAR DNA-binding protein 43Homo sapiens (human)
regulation of gene expressionTAR DNA-binding protein 43Homo sapiens (human)
xenobiotic metabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
negative regulation of gene expressionCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bile acid and bile salt transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
heme catabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic export from cellCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transepithelial transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
leukotriene transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
monoatomic anion transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell population proliferationATPase family AAA domain-containing protein 5Homo sapiens (human)
positive regulation of B cell proliferationATPase family AAA domain-containing protein 5Homo sapiens (human)
nuclear DNA replicationATPase family AAA domain-containing protein 5Homo sapiens (human)
signal transduction in response to DNA damageATPase family AAA domain-containing protein 5Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorATPase family AAA domain-containing protein 5Homo sapiens (human)
isotype switchingATPase family AAA domain-containing protein 5Homo sapiens (human)
positive regulation of DNA replicationATPase family AAA domain-containing protein 5Homo sapiens (human)
positive regulation of isotype switching to IgG isotypesATPase family AAA domain-containing protein 5Homo sapiens (human)
DNA clamp unloadingATPase family AAA domain-containing protein 5Homo sapiens (human)
regulation of mitotic cell cycle phase transitionATPase family AAA domain-containing protein 5Homo sapiens (human)
negative regulation of intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorATPase family AAA domain-containing protein 5Homo sapiens (human)
positive regulation of cell cycle G2/M phase transitionATPase family AAA domain-containing protein 5Homo sapiens (human)
negative regulation of receptor internalizationAtaxin-2Homo sapiens (human)
regulation of translationAtaxin-2Homo sapiens (human)
RNA metabolic processAtaxin-2Homo sapiens (human)
P-body assemblyAtaxin-2Homo sapiens (human)
stress granule assemblyAtaxin-2Homo sapiens (human)
RNA transportAtaxin-2Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (75)

Processvia Protein(s)Taxonomy
ATP bindingATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type bile acid transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATP hydrolysis activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
icosanoid transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
guanine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ATP bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type xenobiotic transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
urate transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
purine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type bile acid transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
efflux transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
15-hydroxyprostaglandin dehydrogenase (NAD+) activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATP hydrolysis activityMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
RNA polymerase II transcription regulatory region sequence-specific DNA bindingGlucocorticoid receptorHomo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingGlucocorticoid receptorHomo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificGlucocorticoid receptorHomo sapiens (human)
core promoter sequence-specific DNA bindingGlucocorticoid receptorHomo sapiens (human)
DNA-binding transcription repressor activity, RNA polymerase II-specificGlucocorticoid receptorHomo sapiens (human)
DNA-binding transcription activator activity, RNA polymerase II-specificGlucocorticoid receptorHomo sapiens (human)
DNA-binding transcription factor activityGlucocorticoid receptorHomo sapiens (human)
RNA bindingGlucocorticoid receptorHomo sapiens (human)
nuclear receptor activityGlucocorticoid receptorHomo sapiens (human)
nuclear glucocorticoid receptor activityGlucocorticoid receptorHomo sapiens (human)
steroid bindingGlucocorticoid receptorHomo sapiens (human)
protein bindingGlucocorticoid receptorHomo sapiens (human)
zinc ion bindingGlucocorticoid receptorHomo sapiens (human)
TBP-class protein bindingGlucocorticoid receptorHomo sapiens (human)
protein kinase bindingGlucocorticoid receptorHomo sapiens (human)
identical protein bindingGlucocorticoid receptorHomo sapiens (human)
Hsp90 protein bindingGlucocorticoid receptorHomo sapiens (human)
steroid hormone bindingGlucocorticoid receptorHomo sapiens (human)
sequence-specific double-stranded DNA bindingGlucocorticoid receptorHomo sapiens (human)
estrogen response element bindingGlucocorticoid receptorHomo sapiens (human)
transcription cis-regulatory region bindingCellular tumor antigen p53Homo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
cis-regulatory region sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
core promoter sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
TFIID-class transcription factor complex bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription repressor activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription activator activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
protease bindingCellular tumor antigen p53Homo sapiens (human)
p53 bindingCellular tumor antigen p53Homo sapiens (human)
DNA bindingCellular tumor antigen p53Homo sapiens (human)
chromatin bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription factor activityCellular tumor antigen p53Homo sapiens (human)
mRNA 3'-UTR bindingCellular tumor antigen p53Homo sapiens (human)
copper ion bindingCellular tumor antigen p53Homo sapiens (human)
protein bindingCellular tumor antigen p53Homo sapiens (human)
zinc ion bindingCellular tumor antigen p53Homo sapiens (human)
enzyme bindingCellular tumor antigen p53Homo sapiens (human)
receptor tyrosine kinase bindingCellular tumor antigen p53Homo sapiens (human)
ubiquitin protein ligase bindingCellular tumor antigen p53Homo sapiens (human)
histone deacetylase regulator activityCellular tumor antigen p53Homo sapiens (human)
ATP-dependent DNA/DNA annealing activityCellular tumor antigen p53Homo sapiens (human)
identical protein bindingCellular tumor antigen p53Homo sapiens (human)
histone deacetylase bindingCellular tumor antigen p53Homo sapiens (human)
protein heterodimerization activityCellular tumor antigen p53Homo sapiens (human)
protein-folding chaperone bindingCellular tumor antigen p53Homo sapiens (human)
protein phosphatase 2A bindingCellular tumor antigen p53Homo sapiens (human)
RNA polymerase II-specific DNA-binding transcription factor bindingCellular tumor antigen p53Homo sapiens (human)
14-3-3 protein bindingCellular tumor antigen p53Homo sapiens (human)
MDM2/MDM4 family protein bindingCellular tumor antigen p53Homo sapiens (human)
disordered domain specific bindingCellular tumor antigen p53Homo sapiens (human)
general transcription initiation factor bindingCellular tumor antigen p53Homo sapiens (human)
molecular function activator activityCellular tumor antigen p53Homo sapiens (human)
promoter-specific chromatin bindingCellular tumor antigen p53Homo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingTAR DNA-binding protein 43Homo sapiens (human)
DNA bindingTAR DNA-binding protein 43Homo sapiens (human)
double-stranded DNA bindingTAR DNA-binding protein 43Homo sapiens (human)
RNA bindingTAR DNA-binding protein 43Homo sapiens (human)
mRNA 3'-UTR bindingTAR DNA-binding protein 43Homo sapiens (human)
protein bindingTAR DNA-binding protein 43Homo sapiens (human)
lipid bindingTAR DNA-binding protein 43Homo sapiens (human)
identical protein bindingTAR DNA-binding protein 43Homo sapiens (human)
pre-mRNA intronic bindingTAR DNA-binding protein 43Homo sapiens (human)
molecular condensate scaffold activityTAR DNA-binding protein 43Homo sapiens (human)
protein bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
organic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type xenobiotic transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP hydrolysis activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
protein bindingATPase family AAA domain-containing protein 5Homo sapiens (human)
ATP bindingATPase family AAA domain-containing protein 5Homo sapiens (human)
ATP hydrolysis activityATPase family AAA domain-containing protein 5Homo sapiens (human)
DNA clamp unloader activityATPase family AAA domain-containing protein 5Homo sapiens (human)
DNA bindingATPase family AAA domain-containing protein 5Homo sapiens (human)
RNA bindingAtaxin-2Homo sapiens (human)
epidermal growth factor receptor bindingAtaxin-2Homo sapiens (human)
protein bindingAtaxin-2Homo sapiens (human)
mRNA bindingAtaxin-2Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (46)

Processvia Protein(s)Taxonomy
plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basal plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basolateral plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
nucleolusMultidrug resistance-associated protein 4Homo sapiens (human)
Golgi apparatusMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
platelet dense granule membraneMultidrug resistance-associated protein 4Homo sapiens (human)
external side of apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
nucleusGlucocorticoid receptorHomo sapiens (human)
nucleusGlucocorticoid receptorHomo sapiens (human)
nucleoplasmGlucocorticoid receptorHomo sapiens (human)
cytoplasmGlucocorticoid receptorHomo sapiens (human)
mitochondrial matrixGlucocorticoid receptorHomo sapiens (human)
centrosomeGlucocorticoid receptorHomo sapiens (human)
spindleGlucocorticoid receptorHomo sapiens (human)
cytosolGlucocorticoid receptorHomo sapiens (human)
membraneGlucocorticoid receptorHomo sapiens (human)
nuclear speckGlucocorticoid receptorHomo sapiens (human)
synapseGlucocorticoid receptorHomo sapiens (human)
chromatinGlucocorticoid receptorHomo sapiens (human)
protein-containing complexGlucocorticoid receptorHomo sapiens (human)
nuclear bodyCellular tumor antigen p53Homo sapiens (human)
nucleusCellular tumor antigen p53Homo sapiens (human)
nucleoplasmCellular tumor antigen p53Homo sapiens (human)
replication forkCellular tumor antigen p53Homo sapiens (human)
nucleolusCellular tumor antigen p53Homo sapiens (human)
cytoplasmCellular tumor antigen p53Homo sapiens (human)
mitochondrionCellular tumor antigen p53Homo sapiens (human)
mitochondrial matrixCellular tumor antigen p53Homo sapiens (human)
endoplasmic reticulumCellular tumor antigen p53Homo sapiens (human)
centrosomeCellular tumor antigen p53Homo sapiens (human)
cytosolCellular tumor antigen p53Homo sapiens (human)
nuclear matrixCellular tumor antigen p53Homo sapiens (human)
PML bodyCellular tumor antigen p53Homo sapiens (human)
transcription repressor complexCellular tumor antigen p53Homo sapiens (human)
site of double-strand breakCellular tumor antigen p53Homo sapiens (human)
germ cell nucleusCellular tumor antigen p53Homo sapiens (human)
chromatinCellular tumor antigen p53Homo sapiens (human)
transcription regulator complexCellular tumor antigen p53Homo sapiens (human)
protein-containing complexCellular tumor antigen p53Homo sapiens (human)
plasma membraneGlycine receptor subunit betaRattus norvegicus (Norway rat)
intracellular non-membrane-bounded organelleTAR DNA-binding protein 43Homo sapiens (human)
nucleusTAR DNA-binding protein 43Homo sapiens (human)
nucleoplasmTAR DNA-binding protein 43Homo sapiens (human)
perichromatin fibrilsTAR DNA-binding protein 43Homo sapiens (human)
mitochondrionTAR DNA-binding protein 43Homo sapiens (human)
cytoplasmic stress granuleTAR DNA-binding protein 43Homo sapiens (human)
nuclear speckTAR DNA-binding protein 43Homo sapiens (human)
interchromatin granuleTAR DNA-binding protein 43Homo sapiens (human)
nucleoplasmTAR DNA-binding protein 43Homo sapiens (human)
chromatinTAR DNA-binding protein 43Homo sapiens (human)
plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell surfaceCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
intercellular canaliculusCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
Elg1 RFC-like complexATPase family AAA domain-containing protein 5Homo sapiens (human)
nucleusATPase family AAA domain-containing protein 5Homo sapiens (human)
cytoplasmAtaxin-2Homo sapiens (human)
Golgi apparatusAtaxin-2Homo sapiens (human)
trans-Golgi networkAtaxin-2Homo sapiens (human)
cytosolAtaxin-2Homo sapiens (human)
cytoplasmic stress granuleAtaxin-2Homo sapiens (human)
membraneAtaxin-2Homo sapiens (human)
perinuclear region of cytoplasmAtaxin-2Homo sapiens (human)
ribonucleoprotein complexAtaxin-2Homo sapiens (human)
cytoplasmic stress granuleAtaxin-2Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (100)

Assay IDTitleYearJournalArticle
AID1347425Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347407qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical Collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347424RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID346025Binding affinity to beta cyclodextrin2009Bioorganic & medicinal chemistry, Jan-15, Volume: 17, Issue:2
Convenient QSAR model for predicting the complexation of structurally diverse compounds with beta-cyclodextrins.
AID74378Relative binding affinity to glucocorticoid receptor on cytosol from thymus at 4 hr1988Journal of medicinal chemistry, Jun, Volume: 31, Issue:6
Binding of steroids to the progestin and glucocorticoid receptors analyzed by correspondence analysis.
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1150117Alkylating activity of the compound assessed as alkylation of 4-(p-nitrobenzyl)pyridine after 20 mins by colorimetric analysis1977Journal of medicinal chemistry, Sep, Volume: 20, Issue:9
Synthesis and biological action of two glucocorticoid alkylating agents.
AID144114Inhibition of NIH 3T3 cell growth required to induce 50% of maximum response using antiproliferative assay2002Journal of medicinal chemistry, Feb-28, Volume: 45, Issue:5
Synthesis, pharmacokinetics, efficacy, and rat retinal toxicity of a novel mitomycin C-triamcinolone acetonide conjugate.
AID74376Relative binding affinity to glucocorticoid receptor on cytosol from liver at 4 hr1988Journal of medicinal chemistry, Jun, Volume: 31, Issue:6
Binding of steroids to the progestin and glucocorticoid receptors analyzed by correspondence analysis.
AID213396Glucocorticoid induced Tyrosine Aminotransferase activity relative to Dexamethasone1988Journal of medicinal chemistry, Jun, Volume: 31, Issue:6
Binding of steroids to the progestin and glucocorticoid receptors analyzed by correspondence analysis.
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID91225Antiinflammatory activity measured by using McKenzie-Stoughton human vasoconstrictor assay; Potent1986Journal of medicinal chemistry, Nov, Volume: 29, Issue:11
Computer-aided studies of the structure-activity relationships between the structure of some steroids and their antiinflammatory activity.
AID1443047Inhibition of retinal leukostasis in STZ-induced Wistar rat diabetic retinopathy model assessed as adherent leukocyte count per retina at 50 ug/eye administered intravitreally measured after 3 days by FITC-ConA staining based fluorescence microscopic meth2017Bioorganic & medicinal chemistry letters, 04-15, Volume: 27, Issue:8
Curcumolide reduces diabetic retinal vascular leukostasis and leakage partly via inhibition of the p38MAPK/NF-κ B signaling.
AID1219277Activity at recombinant CYP3A4 (unknown origin) assessed as half life at 1 uM by LC-MS analysis2013Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 41, Issue:2
Metabolic pathways of inhaled glucocorticoids by the CYP3A enzymes.
AID162613Relative binding affinity for progestin receptor of uterus of rabbit at 24 hr1988Journal of medicinal chemistry, Jun, Volume: 31, Issue:6
Binding of steroids to the progestin and glucocorticoid receptors analyzed by correspondence analysis.
AID1443048Downregulation of TNFalpha level in STZ-induced Wistar rat diabetic retinopathy model at 50 ug/eye administered intravitreally measured after 3 days by Western blot method2017Bioorganic & medicinal chemistry letters, 04-15, Volume: 27, Issue:8
Curcumolide reduces diabetic retinal vascular leukostasis and leakage partly via inhibition of the p38MAPK/NF-κ B signaling.
AID1473740Inhibition of human MRP3 overexpressed in Sf9 insect cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 10 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID74377Relative binding affinity to glucocorticoid receptor on cytosol from thymus at 24 hr1988Journal of medicinal chemistry, Jun, Volume: 31, Issue:6
Binding of steroids to the progestin and glucocorticoid receptors analyzed by correspondence analysis.
AID1473738Inhibition of human BSEP overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-taurocholate in presence of ATP measured after 15 to 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1443040Inhibition of retinal vascular leakage in STZ-induced Wistar rat diabetic retinopathy model assessed as reduction in FITC-dextran leakage at 50 ug/eye administered intravitreally measured after 3 days by fluorescence microscopic method2017Bioorganic & medicinal chemistry letters, 04-15, Volume: 27, Issue:8
Curcumolide reduces diabetic retinal vascular leukostasis and leakage partly via inhibition of the p38MAPK/NF-κ B signaling.
AID39320Relative binding affinity for androgen receptor of prostate of rat at 2 hr1988Journal of medicinal chemistry, Jun, Volume: 31, Issue:6
Binding of steroids to the progestin and glucocorticoid receptors analyzed by correspondence analysis.
AID188016Anti-inflammatory effect in rat granuloma assay, activity relative to hydrocortisone and hydrocortisone 21-acetate1983Journal of medicinal chemistry, Mar, Volume: 26, Issue:3
Structure-activity relationships in the antiinflammatory steroids: a pattern-recognition approach.
AID74374Relative binding affinity to glucocorticoid receptor on cytosol from hepatoma tissue cells at 4 hr1988Journal of medicinal chemistry, Jun, Volume: 31, Issue:6
Binding of steroids to the progestin and glucocorticoid receptors analyzed by correspondence analysis.
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1150110Growth inhibition of mouse L929 cells at 3 x 10'-7 M preincubated for 48 hrs followed by compound washout1977Journal of medicinal chemistry, Sep, Volume: 20, Issue:9
Synthesis and biological action of two glucocorticoid alkylating agents.
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID977602Inhibition of sodium fluorescein uptake in OATP1B3-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM2013Molecular pharmacology, Jun, Volume: 83, Issue:6
Structure-based identification of OATP1B1/3 inhibitors.
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID144115Maximal percent of fibroblast cell growth inhibition using antiproliferative assay2002Journal of medicinal chemistry, Feb-28, Volume: 45, Issue:5
Synthesis, pharmacokinetics, efficacy, and rat retinal toxicity of a novel mitomycin C-triamcinolone acetonide conjugate.
AID977599Inhibition of sodium fluorescein uptake in OATP1B1-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM2013Molecular pharmacology, Jun, Volume: 83, Issue:6
Structure-based identification of OATP1B1/3 inhibitors.
AID311367Permeability coefficient in human skin2007Bioorganic & medicinal chemistry, Nov-15, Volume: 15, Issue:22
Transdermal penetration behaviour of drugs: CART-clustering, QSPR and selection of model compounds.
AID74375Relative binding affinity to glucocorticoid receptor on cytosol from liver at 24 hr1988Journal of medicinal chemistry, Jun, Volume: 31, Issue:6
Binding of steroids to the progestin and glucocorticoid receptors analyzed by correspondence analysis.
AID1219279Activity at recombinant CYP3A7 (unknown origin) assessed as half life at 1 uM by LC-MS analysis2013Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 41, Issue:2
Metabolic pathways of inhaled glucocorticoids by the CYP3A enzymes.
AID74373Relative binding affinity to glucocorticoid receptor on cytosol from hepatoma tissue cells at 24 hr1988Journal of medicinal chemistry, Jun, Volume: 31, Issue:6
Binding of steroids to the progestin and glucocorticoid receptors analyzed by correspondence analysis.
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID126435Relative binding affinity for mineralocorticoid receptor of rat kidney at 24 hr1988Journal of medicinal chemistry, Jun, Volume: 31, Issue:6
Binding of steroids to the progestin and glucocorticoid receptors analyzed by correspondence analysis.
AID1473741Inhibition of human MRP4 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1443049Downregulation of ICAM-1 level in STZ-induced Wistar rat diabetic retinopathy model at 50 ug/eye administered intravitreally measured after 3 days by Western blot method2017Bioorganic & medicinal chemistry letters, 04-15, Volume: 27, Issue:8
Curcumolide reduces diabetic retinal vascular leukostasis and leakage partly via inhibition of the p38MAPK/NF-κ B signaling.
AID90104Potency relative to fluocinolone 16,17-acetonide in the human vasoconstictor test1983Journal of medicinal chemistry, Mar, Volume: 26, Issue:3
Structure-activity relationships in the antiinflammatory steroids: a pattern-recognition approach.
AID1443041Inhibition of retinal vascular leakage in STZ-induced Wistar rat diabetic retinopathy model assessed as Evans blue albumin level in retina at 50 ug/eye administered intravitreally measured after 3 days (Rvb = 82.94 +/- 11.2 ug/g)2017Bioorganic & medicinal chemistry letters, 04-15, Volume: 27, Issue:8
Curcumolide reduces diabetic retinal vascular leukostasis and leakage partly via inhibition of the p38MAPK/NF-κ B signaling.
AID1219278Activity at recombinant CYP3A5 (unknown origin) assessed as half life at 1 uM by LC-MS analysis2013Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 41, Issue:2
Metabolic pathways of inhaled glucocorticoids by the CYP3A enzymes.
AID1473739Inhibition of human MRP2 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1150112Growth inhibition of mouse L929 cells after 6 days1977Journal of medicinal chemistry, Sep, Volume: 20, Issue:9
Synthesis and biological action of two glucocorticoid alkylating agents.
AID1778704Inhibition of DNP-HAS-stimulated mast cell degranulation in rat RBL-2H3 cells assessed as reduction in beta-hexosaminidase release at 300 uM incubated for 5 mins followed by DNP-HAS stimulation for 1 hr by multiplate reader analysis2021European journal of medicinal chemistry, Oct-05, Volume: 221Hybrids between H
AID504810Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID588459High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, Validation compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588459High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, Validation compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588459High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, Validation compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588461High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, Validation compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588461High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, Validation compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588461High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, Validation compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588460High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, Validation Compound Set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588460High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, Validation Compound Set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588460High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, Validation Compound Set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID504812Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
AID1159550Human Phosphogluconate dehydrogenase (6PGD) Inhibitor Screening2015Nature cell biology, Nov, Volume: 17, Issue:11
6-Phosphogluconate dehydrogenase links oxidative PPP, lipogenesis and tumour growth by inhibiting LKB1-AMPK signalling.
AID1346849Human Glucocorticoid receptor (3C. 3-Ketosteroid receptors)1995Brain research, Jul-10, Volume: 685, Issue:1-2
Distinction between binding of [3H]triamcinolone acetonide to a ligand binding domain on the glucocorticoid receptor complex in cytosol fractions of brain and liver from the rat with intact adrenals.
AID1346849Human Glucocorticoid receptor (3C. 3-Ketosteroid receptors)1981Endocrinology, Apr, Volume: 108, Issue:4
Species-related differences in steroid-binding specificity of glucocorticoid receptors in lung.
AID1347411qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Mechanism Interrogation Plate v5.0 (MIPE) Libary2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1224864HCS microscopy assay (F508del-CFTR)2016PloS one, , Volume: 11, Issue:10
Increasing the Endoplasmic Reticulum Pool of the F508del Allele of the Cystic Fibrosis Transmembrane Conductance Regulator Leads to Greater Folding Correction by Small Molecule Therapeutics.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (5,624)

TimeframeStudies, This Drug (%)All Drugs %
pre-19901838 (32.68)18.7374
1990's554 (9.85)18.2507
2000's1441 (25.62)29.6817
2010's1374 (24.43)24.3611
2020's417 (7.41)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 113.77

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index113.77 (24.57)
Research Supply Index8.88 (2.92)
Research Growth Index4.68 (4.65)
Search Engine Demand Index242.39 (26.88)
Search Engine Supply Index2.25 (0.95)

This Compound (113.77)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials1,017 (16.44%)5.53%
Reviews284 (4.59%)6.00%
Case Studies992 (16.03%)4.05%
Observational28 (0.45%)0.25%
Other3,867 (62.49%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (357)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Randomized Trial Comparing Intravitreal Triamcinolone Acetonide and Laser Photocoagulation for Diabetic Macular Edema [NCT00367133]Phase 3840 participants (Actual)Interventional2004-07-31Completed
The Efficacy of Intra-articular Triamcinolone Acetonide 5mg vs. 10 mg vs. 40 mg in Patients With Knee Osteoarthritis: a Non-inferiority Randomized Controlled Double-blind Study [NCT05806021]Phase 4327 participants (Anticipated)Interventional2023-09-30Not yet recruiting
Active Control,Randomized,Double- Blinded Clinical Trial of BD [NCT03771768]38 participants (Anticipated)Interventional2019-05-25Not yet recruiting
Physiotherapy Alone, in Combination With Corticosteroid Injection or Wait-and-see for Acute Lateral Epicondylitis in General Practice: a Randomised, Placebo-controlled Study With 12 Months Follow-up [NCT00826462]Phase 4177 participants (Actual)Interventional2009-03-31Completed
Analysis of Antalgic Efficacy of an Intra Articular Injection of Botulinum Toxin Versus Corticoids in Gonarthrosis by Perfusion MRI:a Superiority, Randomized, Controlled, Double Blind Study [NCT03726788]Phase 2105 participants (Anticipated)Interventional2019-09-30Not yet recruiting
A Randomized, Open-label Study Comparing the Systemic Exposure to Triamcinolone Acetonide Following a Single Intra-articular Dose of Extended-release FX006 or Immediate-release TAcs (Triamcinolone Acetonide Suspension) in Patients With Osteoarthritis of t [NCT03382262]Phase 255 participants (Actual)Interventional2017-12-18Completed
Three Injections of Intravitreal Bevasizumab Versus Two Injections of Intravitreal Triamcinolone in the Management of Branch Retinal Vein Occlusion [NCT01178697]Phase 20 participants Interventional2010-01-31Recruiting
A Randomized Phase II Double-Blinded Study of The Efficacy of Oleogel-S10 (AP101) Gel for the Treatment of Grade 2/3 Radiation Dermatitis in Breast Cancer Patients [NCT05190770]Phase 250 participants (Anticipated)Interventional2021-12-15Recruiting
Combined Intralesional Triamcinolone Injection With Whole Breast Detection Radical Surgery in Treating Refractory Granulomatous Lobular Mastitis: A Randomized Controlled Trial [NCT05281419]100 participants (Anticipated)Interventional2022-05-01Recruiting
The NOR-CACTUS Trial - A Norwegian Trial Comparing Treatment Strategies for Carpal Tunnel Syndrome [NCT05306548]Phase 4258 participants (Anticipated)Interventional2022-04-08Recruiting
Randomized, Double Masked, Controlled Study Comparing the Safety and Efficacy of Suprachoroidal CLS-TA With Intravitreal Aflibercept Versus Aflibercept Alone in Subject With Diabetic Macular Edema [NCT03126786]Phase 271 participants (Actual)Interventional2017-07-11Completed
MAGNOLIA: Multi-Center, Non-Interventional Extension Study of the Safety and Efficacy of CLS-TA for the Treatment of Macular Edema Associated With Non-Infectious Uveitis [NCT02952001]33 participants (Actual)Observational2017-12-13Completed
Prospective Randomized Trial of EUS Guided Celiac Plexus Block for Chronic Pancreatitis [NCT02399800]1 participants (Actual)Interventional2014-12-31Terminated(stopped due to Low enrollment)
Comparing the Efficacy of Rotator Interval Steroid Injection Versus Steroid Intraarticular Hydrodilatation in the Treatment of Frozen Shoulder [NCT03678038]64 participants (Actual)Interventional2018-09-28Completed
Effectiveness of Corticosteroid vs. Ketorolac Shoulder Injections: A Prospective Double-Blinded Randomized Trial [NCT04115644]Phase 482 participants (Actual)Interventional2017-05-01Terminated(stopped due to Covid-19 and we failed to submit annual report for 2017 and 2018)
SAPPHIRE: A Randomized, Masked, Controlled Trial To Study The Safety And Efficacy Of Suprachoroidal CLS-TA In Conjunction With Intravitreal Aflibercept In Subjects With Retinal Vein Occlusion [NCT02980874]Phase 3460 participants (Actual)Interventional2017-01-31Terminated(stopped due to Primary, 8-week efficacy endpoint not achieved. No additional benefit for subjects receiving a corticosteroid together with an intravitreal anti-VEGF agent.)
Retrobulbar Triamcinolone Acetonide Injection in the Treatment of Nonarteritic Anterior Ischemic Optic Neuropathy [NCT02329288]Phase 360 participants (Anticipated)Interventional2015-05-31Not yet recruiting
25-Gauge Vitrectomy Combine With Ranibizumab or Triamcinolone Acetonide on Proliferative Diabetic Retinopathy in Chinese Patients [NCT02328118]Phase 2/Phase 3120 participants (Anticipated)Interventional2015-02-28Recruiting
A Randomized, Double-Blind Study of the Efficacy of Platelet-Rich Growth Factor (PRGF) Supplementation Compared to Steroid Supplementation After Temporomandibular Joint (TMJ) Arthrocentesis in Female Patients With TMJ Osteoarthritis (OA) [NCT04731233]Phase 436 participants (Anticipated)Interventional2021-03-30Recruiting
A Randomized, Masked, Controlled Trial To Study The Safety And Efficacy Of Suprachoroidal CLS-TA In Combination With An Intravitreal Anti-VEGF Agent In Subjects With Retinal Vein Occlusion [NCT03203447]Phase 3325 participants (Actual)Interventional2018-03-05Terminated(stopped due to The early termination is due to the results obtained from the sister study, SAPPHIRE (CLS1003-301), which did not meet the 8-week primary efficacy endpoint.)
Effectiveness of Corticosteroid vs Ketorolac Shoulder Injections: a Prospective Double-Blinded Randomized Trial [NCT04895280]Phase 4400 participants (Anticipated)Interventional2024-04-30Not yet recruiting
Outcome Comparison of Ultrasound-guided Hydrodissection Between Normal Saline and Combination of Triamcinolone Acetonide, Normal Saline, and Lidocaine in Mild to Moderate Carpal Tunnel Syndrome: A Single Blinded Randomized Clinical Trial [NCT05577676]62 participants (Anticipated)Interventional2022-09-13Recruiting
A Randomized, Double-blind, Active-controlled Study of Canakinumab Prefilled Syringes or Reconstituted Lyophilizate Versus Triamcinolone Acetonide for Treating Acute Gouty Arthritis Flares in Frequently Flaring Patients [NCT01356602]Phase 3397 participants (Actual)Interventional2011-05-31Completed
Economic Impact of Dropless Therapy Versus Usual Care for Cataract Surgery: A Real-World Study. [NCT03640650]Phase 480 participants (Actual)Interventional2018-08-15Terminated(stopped due to COVID-19 pandemic leading to uncertainty in the recruitement)
A Comparative Study of Betamethasone (Diprospan) and Triamcinolone Acetonide as Single Intra-Articular Injection in Knee Osteoarthritis, A Double-Blinded, Randomized Controlled Trial [NCT05139875]Phase 4120 participants (Anticipated)Interventional2022-01-01Recruiting
Formulated Posterior Subtenon Triamcinolone (PSTA) Injection Versus Posterior Subtenon Triamcinolone Alone in the Management of Macular Edema Secondary to Non-ischemic Retinal Vein Occlusions [NCT05385562]78 participants (Actual)Interventional2020-01-02Completed
Open-label Safety Study of Suprachoroidal Triamcinolone Acetonide Injectable Suspension in Patients With Non-Infectious Uveitis [NCT03097315]Phase 338 participants (Actual)Interventional2017-04-04Completed
A Randomized, Controlled, Double-blind Study to Evaluate the Efficacy of Intralesional Triamcinolone in the Treatment of Hidradenitis Suppurativa. [NCT02781818]32 participants (Actual)Interventional2016-06-30Completed
Intralesional Steroid Injection Versus Accent Method of Voice Therapy in Management of Vocal Nodules: A Randomized Controlled Trial [NCT03914092]Phase 440 participants (Anticipated)Interventional2019-09-29Recruiting
Evaluation of Salivary Levels of miR-155 and IL-10 in Oral Lichen Planus Patients Before and After Treatment With Topical Corticosteroid [NCT03871114]30 participants (Actual)Observational2019-03-10Completed
Three Injections of Intravitreal Bevasizumab Versus Two Injections of Intravitreal Triamcinolone in the Management of Branch Retinal Vein Occlusion [NCT01044329]Phase 290 participants (Anticipated)Interventional2010-01-31Recruiting
A Randomized Single Blinded Prospective Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients [NCT03319784]Phase 40 participants (Actual)Interventional2018-09-05Withdrawn(stopped due to never initiated)
Eco-guided Treatment With Triamcinolone-Acetonide in the Treatment of Medial Plica Syndrome - A Pilot Study [NCT04943341]30 participants (Anticipated)Interventional2021-10-28Recruiting
Combined Topical 5% Minoxidil and Potent Topical Corticosteroid Versus Intralesional Corticosteroid in the Treatment of Alopecia Areata A Randomized Controlled Trial [NCT03535233]Phase 440 participants (Actual)Interventional2016-03-31Completed
A Prospective Randomized Comparative Trial of Targeted Injection Via a Transforaminal Approach With Dexamethasone Versus an Epidural Catheter Via an Interlaminar Approach With Particulate Steroid for the Treatment of Cervical Radicular Pain [NCT03382821]Phase 4120 participants (Actual)Interventional2017-09-15Completed
Adjunctive Photodynamic Therapy + Aflibercept vs. Afilbercept Alone for PDA in Patients With Neovascular Age-Related Macular Degeneration [NCT02457026]0 participants (Actual)Interventional2016-01-31Withdrawn
Ketorolac Versus Triamcinolone Intra-articular Knee Injections for the Treatment of Osteoarthritis. A Prospective, Double-Blinded Randomized Trial [NCT02295189]36 participants (Actual)Interventional2013-01-31Completed
Effectiveness Evaluation of Mixed Gel of Hydrocortisone and Aluminium Phosphate Preventing Endoscopic Submucosal Dissection Postoperative Stenosis for Patients With Early Esophageal Cancer Invading More Than 2/3 Esophageal Perimeter [NCT03165344]66 participants (Actual)Interventional2017-02-10Completed
Sonographic Evaluation of Patients With Carpal Tunnel Syndrome Following Steroid Injection [NCT03132051]54 participants (Anticipated)Interventional2013-04-30Recruiting
Platelet-rich Plasma Versus Corticosteroid Injection for the Treatment of Femoroacetabular Impingement [NCT02920177]Phase 44 participants (Actual)Interventional2016-08-01Terminated(stopped due to low enrollment)
Nasal Allergen Challenge - Reproducibility of Biomarkers and Effect of Topical Steroid Treatment [NCT03431961]20 participants (Anticipated)Interventional2018-03-07Recruiting
Efficacy of Oral Zinc Supplement as an Adjunctive Therapy for Erosive Oral Lichen Planus (a Randomized, Controlled Clinical Trial) [NCT06042010]22 participants (Actual)Interventional2023-01-05Completed
Fractional Laser Assisted Steroid Therapy vs Intralesional Steroids in the Treatment of Keloids [NCT02996097]30 participants (Actual)Interventional2016-04-30Completed
Autologous Intra-Articular Micro-Fragmented Adipose Transfer for the Treatment of Thumb Carpometacarpal Joint Arthritis [NCT05005000]Phase 21 participants (Actual)Interventional2022-05-12Terminated(stopped due to Difficulties getting subjects recruited and enrolled.)
Suprachoroidal Triamcinolone Acetonide for the Treatment of Macular Edema Associated With Retinal Vein Occlusion: A Pilot Study [NCT05038072]16 participants (Actual)Interventional2019-07-25Completed
A Double-Blind, Randomized, Parallel Group Comparison of the Effects of FX006 and TCA IR (Triamcinolone Acetonide Suspension) on Blood Glucose in Patients With Osteoarthritis of the Knee and Type 2 Diabetes Mellitus [NCT02762370]Phase 233 participants (Actual)Interventional2016-04-30Completed
Safety and Efficacy of Of Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ Fusion Protein In Acute Gout [NCT05925166]100 participants (Anticipated)Interventional2023-09-01Not yet recruiting
Comparing the Efficacy of Ultrasound Guided Hyaluronic Injection With Ultrasound Guided Corticosteroid Injection in Treatment of Trigger Finger [NCT03131882]Phase 2/Phase 3120 participants (Anticipated)Interventional2016-10-01Recruiting
Cryotherapy Versus Intralesional Corticosteroid Injection In Treatment Of Alopecia Areata: Trichoscopic Evaluation [NCT03473600]Phase 440 participants (Anticipated)Interventional2018-11-30Not yet recruiting
Comparison Between Blind and Ultrasound Guided Injection in Morton Neuroma [NCT03046108]Phase 4100 participants (Anticipated)Interventional2016-01-31Recruiting
Randomized Placebo-controlled Analysis of Superior Laryngeal Nerve Block for Neurogenic Cough [NCT04468542]Phase 365 participants (Anticipated)Interventional2021-01-12Recruiting
Evaluation of the Use of Intraoperative Subconjunctival Injection of Triamcinolone Acetonide and Limited Peritomy During Bare Scleral Pterygium Excision [NCT03377348]30 participants (Actual)Interventional2017-12-01Completed
Efficacy of Neural Prolotherapy Versus Local Corticosteroid Soft Tissue Injection for Treatment of Anserine Bursitis [NCT04509440]43 participants (Actual)Interventional2018-05-01Completed
Open , Randomized Study About Efficacy, Safety and Tolerability od Repeated Dosis of Intravitreous Bevacizumab in Patients With Uveitic Macular Oedema [NCT01095809]Phase 35 participants (Actual)Interventional2010-04-30Terminated(stopped due to New intraocular steroid in the market. Recruitment no longer ethical.)
A Multi-Center Randomized, Double-Blind, Placebo Controlled, Parallel Group Comparison Study of Once Daily Triamcinolone Acetonide 0.5% DuraPeel™ Versus Placebo DuraPeel in the Treatment of Hand Dermatitis [NCT00890968]Phase 256 participants (Actual)Interventional2009-04-30Completed
Triamcinolone Acetonide Injections Compared With Micro Injections (MMP Technique) of Triamcinolone Acetonide for the Treatment of Female Genital Lichen Sclerosus and Atrophic [NCT06079645]Phase 420 participants (Anticipated)Interventional2023-10-20Recruiting
Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa [NCT04582669]Phase 411 participants (Actual)Interventional2022-01-24Terminated(stopped due to This study was administratively closed.)
Acute Pseudophakic Cystoid Macular Edema Treatment Trial: Intravitreal Ranibizumab Versus Triamcinolone Acetonide [NCT02294656]Phase 14 participants (Actual)Interventional2014-11-30Completed
A Randomized, Double-blind, Dose-ranging Trial of Subcutaneous Sodium Deoxycholate Injections With or Without Low Dose Triamcinolone and Low Dose Lidocaine for Reduction of Submental Fat With Reduction of Pain and Swelling [NCT03361176]Phase 430 participants (Actual)Interventional2018-03-26Completed
Open-Label Study of the Safety and Efficacy of Suprachoroidal CLS-TA Alone or in Combination With Intravitreal Aflibercept for the Treatment of Diabetic Macular Edema [NCT02949024]Phase 1/Phase 220 participants (Actual)Interventional2016-11-10Completed
Sub-tenon Triamcinolone Acetonide in Age-Related Macular Degeneration as Adjunct to Ranibizumab [NCT01249937]Phase 230 participants (Anticipated)Interventional2011-01-31Recruiting
Granulation Tissue at G Tube Site: Treatment With Kenalog vs Chemical Cauterization With Silver Nitrate vs Soap Washcloth Abrasion [NCT02519738]Phase 352 participants (Actual)Interventional2015-01-15Terminated(stopped due to enrollment difficulties)
Prospective Study on Endoscopic Ultrasound (EUS) Celiac Bloc Efficacy in Chronic Pancreatitis [NCT01318590]Phase 32 participants (Actual)Interventional2011-11-18Terminated(stopped due to Closed by CHUM REB for incomplete documentation of research activities.)
Implantation of Mesenchymal Stem Cell, Conditioned Medium, or Triamcinolone Acetonide for Keloid Regression: Immunohistochemistry, Histopathology and Imaging Study [NCT04326959]Phase 1/Phase 224 participants (Anticipated)Interventional2020-09-01Not yet recruiting
A 12 Weeks Randomized, Controlled Core Study of ACZ885 (Canakinumab) on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/or Colchicine Are Contraindicated, Not Tolerated or Ineffective, Including a 12-week D [NCT01029652]Phase 3230 participants (Actual)Interventional2009-12-31Completed
A Randomized Controlled Pilot Study Evaluating the Efficacy of Early Glenohumeral Cortisone Injection in Patients With Shoulder Stiffness Following Proximal Humerus Fractures [NCT04216017]Phase 29 participants (Actual)Interventional2020-01-01Completed
A Phase 3 Multi-centre Double-masked Randomised Controlled Trial of Adjunctive Intraocular and Periocular Steroid (Triamcinolone Acetonide) Versus Standard Treatment in Eyes Undergoing Vitreoretinal Surgery for Open Globe Trauma. [NCT02873026]Phase 3300 participants (Actual)Interventional2014-10-31Completed
Arteriovenous Crossing Sheathotomy Versus Intravitreal Triamcinolone Acetonide Injection for Treatment of Macular Edema Associated With Branch Retinal Vein Occlusion [NCT00612261]40 participants (Actual)Interventional2006-10-31Completed
Subacromial Ultrasound-guided or Systemic Steroid Injection for Rotator Cuff Disease, a Randomized Double Blinded Study [NCT00640575]106 participants (Actual)Interventional2005-03-31Completed
A Randomized, Parallel Group, Masked Clinical Study to Evaluate the Efficacy of Triamcinolone and Bevacizumab Through Intravitreal Injection With Individual or Simultaneous Drugs to Treatment of Diabetic Macular Edema [NCT00737971]Phase 4142 participants (Actual)Interventional2008-08-31Completed
Prospective, Controlled Study of the Efficacy of NdYag for Acne Keloidalis Nuchae [NCT00757315]20 participants (Actual)Interventional2008-09-30Active, not recruiting
Suprachoroidal Triamcinolone Acetonide Injection in Two Chorioretinal Diseases: One Year Results [NCT05337332]Phase 2/Phase 350 participants (Anticipated)Interventional2022-04-14Recruiting
Rotator Interval and Intra-articular Corticosteroid Injection for Adhesive Capsulitis (Frozen Shoulder): a Randomised, Double Blind, Placebo Controlled Trial [NCT00840229]122 participants (Actual)Interventional2009-02-28Completed
Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus: A Pilot, Randomized, Clinical and Immunohistochemical Trial [NCT02858297]Phase 430 participants (Actual)Interventional2015-05-31Completed
Multicenter Randomized Controlled Study of Intravitreal Ranibizumab and Triamcinolone Acetonide Combination Therapy Versus Ranibizumab Monotherapy in Patients With Polypoidal Choroidal Vasculopathy [NCT02806752]Phase 4120 participants (Anticipated)Interventional2017-01-31Active, not recruiting
The Evaluation of Effect of the Cervical İnterlaminar Epidural Steroid İnjection on Quality of Life, Neuropathic Pain and Disability in Patients With Cervical Radiculopathy [NCT04235478]78 participants (Actual)Interventional2017-12-27Active, not recruiting
Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide: an Interventional Prospective Study [NCT02221453]Phase 23 participants (Actual)Interventional2015-09-30Completed
One Year Results for Suprachoroidal Triamcinolone Acetonide Injection in Various Retinal Diseases [NCT05496530]100 participants (Anticipated)Interventional2022-07-10Recruiting
Comparative Study on the Efficacy of Periocular Methotrexate Versus Periocular Triamcinolone Injections in Management of Thyroid Associated Orbitopathy [NCT05429450]Phase 218 participants (Actual)Interventional2020-07-01Completed
Symptom Clusters in Children With Exacerbation-prone Asthma [NCT04002362]Phase 2173 participants (Anticipated)Interventional2019-11-13Recruiting
The Use of Triamcinolone Injection in Treatment of Refractory Benign Esophageal Stricture in Children [NCT04524897]Phase 420 participants (Anticipated)Interventional2020-12-01Not yet recruiting
Management of Pain in Oral Lichen Planus Patients: A Comparative Pilot Study [NCT03572959]Phase 424 participants (Actual)Interventional2016-12-27Completed
Alazher University Dean [NCT05464953]75 participants (Actual)Interventional2020-01-20Completed
Comparison of Triamcinolone Acetonide Mucoadhesive Film With Liquorice Mucoadhesive Film On Radiotherapy-Induced Oral Mucositis: A Randomized Double-Blinded Clinical Trial [NCT02075749]Phase 1/Phase 260 participants (Actual)Interventional2013-05-31Completed
Methotrexate With Microneedling Versus Triamcinilone Acetonide With Microneedling in Treatment of Recalcitrant Alopecia Areata [NCT06088147]34 participants (Anticipated)Interventional2023-12-31Not yet recruiting
Local Betamethasone Versus Triamcinolone Injection in Management of Thyroid-Related Upper Lid Retraction With and Without Proptosis [NCT04976816]Phase 2/Phase 392 participants (Actual)Interventional2021-12-01Completed
Comparison of Different Dose of Steroid Injection in Carpal Tunnel Syndrome [NCT03072290]56 participants (Actual)Interventional2017-02-18Completed
Evaluation of the Effectiveness of Photodynamic Therapy in the Treatment of Lesions of the Lichen Planus Type in the Oral Mucosa and Its Diagnostics With the Use of Autofluorescence, in Various Wavelength Ranges, in Combination With the Use of Texture Ana [NCT04991012]Phase 230 participants (Actual)Interventional2020-02-08Completed
Dosing of Intra-articular Triamcinolone Hexacetonide for Knee Synovitis in Chronic Polyarthritis [NCT02437461]Phase 4159 participants (Actual)Interventional2015-04-30Active, not recruiting
A Phase 3, Randomized, Masked, Controlled Clinical Trial to Study the Safety and Efficacy of Triamcinolone Acetonide Injectable Suspension (CLS-TA) for the Treatment of Subjects With Macular Edema Associated With Non-infectious Uveitis [NCT02595398]Phase 3160 participants (Actual)Interventional2015-11-17Completed
OCTA-Directed PDT Triple Therapy for Treatment-Naïve Patients With Exudative Age-Related Macular Degeneration Versus Standard of Care Anti-VEGF(Anti-vascular Endothelial Growth Factor) Monotherapy [NCT04075136]Phase 4150 participants (Anticipated)Interventional2023-03-30Suspended(stopped due to Deviations)
Safety and Effectiveness of Triamcinolone Acetonide in Patients With Serous Pigment Detachment Associated With Age-Related Macular Degeneration [NCT04292756]63 participants (Actual)Interventional2018-03-27Completed
Subtenons Triamcinolone Acetonide Injections for Treatment of Persistent Choroidal Effusions Post Glaucoma Surgery [NCT02917564]Phase 420 participants (Anticipated)Interventional2020-10-14Recruiting
Efficacy of Fractional CO2 Laser Alone and as Transepidermal Drug Delivery for Different Modalities of Treatment in Alopecia Areata [NCT04003376]Phase 440 participants (Anticipated)Interventional2019-07-26Recruiting
A Study of Hyaluronan (Synvisc) for the Treatment of Osteoarthritis in the Thumb: Randomized Control Trial [NCT00398866]Phase 3200 participants (Actual)Interventional2006-08-31Completed
A Comparison of a Single Orbital Floor Injection of Triamcinolone Versus Conventional Steroid and Antibiotic Drops Used Post Operatively in Uneventful Phacoemulsification Surgery [NCT00789971]150 participants (Actual)Interventional2007-03-31Completed
An Adaptive Dose-ranging, Multi-center, Single-blind, Double-dummy, Active-controlled Trial to Determine the Target Dose of Canakinumab (ACZ885) in the Treatment of Acute Flares in Gout Patients Who Are Refractory or Contraindicated to NSAIDs and/or Colch [NCT00798369]Phase 2200 participants (Actual)Interventional2008-11-30Completed
Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars: 3-arm Trial [NCT02823236]Phase 3102 participants (Anticipated)Interventional2016-10-24Recruiting
Office-Based Superior Laryngeal Nerve (SLN) Block for Treatment of Neurogenic Cough [NCT04642352]50 participants (Anticipated)Observational2022-01-03Recruiting
Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis. [NCT05906433]Phase 175 participants (Anticipated)Interventional2023-06-01Recruiting
Effect of Epidural Steroid Injection on Bone Mineral Density In Postmenopausal Women [NCT00941473]Phase 428 participants (Actual)Interventional2007-07-31Completed
Influence of Perception of Patients Suffering of Osteoarthritis of Knee Over the Effectiveness and Tolerance in Intra-articular Injection of Corticoids: a Prospective, Controlled and Randomized Study [NCT02835521]Phase 4100 participants (Anticipated)Interventional2016-08-31Not yet recruiting
Intra-articular Botulinum Toxin Type A Versus Corticosteroids: a Clinical Trial in Osteoarthritis of Knees [NCT02829281]Phase 4105 participants (Anticipated)Interventional2016-07-31Recruiting
Ultrasonographic Evaluation of the Effectiveness of Stellate Ganglion Block in Patients With Breast Cancer Related Lymphedema [NCT04165512]22 participants (Anticipated)Interventional2020-01-07Enrolling by invitation
Efficacy of Ginger Muco-bioadhesive Gel in Management of Oral Lichen Planus: A Randomized Controlled Clinical Trial With Immunohistochemical Analysis [NCT05882864]Phase 428 participants (Anticipated)Interventional2023-08-01Not yet recruiting
Trial Extension Protocol to Add a 39 Week Follow Up to Cingal 16-02, a Randomized, Double-Blind, Active Comparator Controlled, Multi-Center Study of a Single Injection of Cingal to Provide Symptomatic Relief of Knee Osteoarthritis [NCT03390036]Phase 3526 participants (Actual)Interventional2017-12-07Completed
Comparison Between Anterior and Posterior Approaches for Ultrasound-guided Glenohumeral Steroid Injection: A Randomized Controlled Trial [NCT02461368]50 participants (Actual)Interventional2012-12-31Completed
Triamcinolone Assisted Anterior Vitrectomy in Complicated Cataract Surgery and Anterior Segment Reconstruction [NCT01051648]Phase 210 participants (Actual)Interventional2007-12-31Completed
[NCT00987233]Phase 30 participants InterventionalCompleted
Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays: a Randomized Placebo-controlled Study [NCT00279916]Phase 391 participants (Actual)Interventional2005-09-01Completed
Intravitreal Ranibizumab or Triamcinolone Acetonide in Combination With Laser Photocoagulation for Diabetic Macular Edema [NCT00444600]Phase 3691 participants (Actual)Interventional2007-03-31Completed
The PROTECT Study: A Phase II, Open-Label Trial of PROphylactic Skin Toxicity ThErapy With Clindamycin and Triamcinolone in Glioblastoma Patients Treated With Tumor Treating Fields [NCT04469075]Phase 258 participants (Anticipated)Interventional2020-07-09Recruiting
Effects of Intra-articular Versus Subacromial Steroid Injections on Clinical Outcomes in Adhesive Capsulitis [NCT00742846]0 participants (Actual)Interventional2008-08-31Withdrawn(stopped due to No enrollment)
Incidence of Flare Reaction Following Shoulder Steroid Injections: Comparison of Depo-medrol (Methylprednisolone) and Kenalog (Triamcinolone) [NCT05438277]Phase 4421 participants (Actual)Interventional2020-01-01Completed
The Effectiveness of Ultrasound Guided Sub-acromial Bursa Injection With Botulinum Toxin A in for Refractory Shoulder Pain After Stroke. [NCT02618603]Phase 450 participants (Anticipated)Interventional2016-02-29Not yet recruiting
Prospective Randomize Trial Comparing Corticosteroid Injection to High Energy Extracorporeal Shock Wave Therapy for Lateral Epicondylitis [NCT02613455]Phase 480 participants (Anticipated)Interventional2015-07-31Recruiting
Pilot Study of Transforaminal Epidural Injection of Clonidine for the Treatment of Acute Lumbosacral Radiculopathy [NCT00588354]26 participants (Actual)Interventional2006-10-31Terminated(stopped due to Targeted enrollment was not reached.)
Efficacy and Safety of Intra-Articular Injections of Durolane® in the Treatment of Osteoarthritis in the Knee [NCT00731289]Phase 460 participants (Actual)Interventional2003-07-31Completed
Pilot Study of Chinese Medicine Medicated Bath as Complementary Medicine for Mild to Moderate Plaque -Type Psoriasis Patient. [NCT04117919]Phase 230 participants (Anticipated)Interventional2019-10-05Recruiting
Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy [NCT00445003]Phase 3333 participants (Actual)Interventional2007-03-31Completed
A Study to Compare the Efficacy of Triamcinolone 0.1% Cream Occluded With Hydrogel Patch to Triamcinolone 0.1% Cream Without Occlusion in the Treatment of Eczema [NCT00924508]23 participants (Actual)Interventional2008-07-31Terminated(stopped due to Loss of Funding)
Resistant Diabetic Macular Edema and Suprachoroidal Injection [NCT04690608]Early Phase 1100 participants (Anticipated)Interventional2023-12-01Not yet recruiting
Effect of Heated Humidity With Thermosmart™ Compared to an Intranasal Steroid in Improving Compliance and Nasal Symptoms in Patients Using Continuous Positive Airway Pressure [NCT00665977]Phase 344 participants (Anticipated)Interventional2007-09-30Completed
Phase 2 Study of Comparison of Single Intravitreal Injection of Triamcinolone or Bevacizumab for the Treatment of Diabetic Macular Edema. [NCT00874744]Phase 213 participants (Actual)Interventional2008-03-31Completed
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Pharmacodynamic Effect of a 6-week Treatment With Triamcinolone Acetonide Aqueous Nasal Spray 110 μg and 220 μg Once Daily on Basal Hypothalamic-Pituitary-Adr [NCT01154153]Phase 4140 participants (Actual)Interventional2010-06-30Completed
Efficacy of Dextrose Injections, Corticosteroids Injections and Surgical Release for Treatment of the Carpal Tunnel Syndrome: a Prospective, Randomized, Double-blind Controlled Trial [NCT04014244]100 participants (Anticipated)Interventional2021-03-01Recruiting
Efficacy of Post-Surgical Intralesional Injection With Triamcinolone Versus Triamcinolone Plus Fluorouracil in the Treatment of Keloids [NCT04710719]7 participants (Actual)Interventional2021-02-01Completed
Efficacy and Safety of Intravitreal Triamcinolone as Treatment of the Diffuse Diabetic Macular Edema [NCT00309192]Phase 3292 participants (Anticipated)Interventional2006-04-30Completed
Investigator-Initiated, Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout [NCT03636373]Phase 45 participants (Actual)Interventional2019-10-25Terminated(stopped due to The Sponsor has decided to stop funding this study due to lack of enrollment during COVID-19 pandemic and decreased interest in funding investigator initiated studies pertaining to the study drug)
VITRILASE Study: Prospective Randomized Trial Comparing the Effect of Laser, Vitrectomy and Intravitreal Triamcinolone Injection for Diabetic Macular Edema [NCT00764244]Phase 372 participants (Actual)Interventional2005-01-31Completed
Improvement of Short Term Outcome of Mild to Moderate Atopic Dermatitis Using a Combination Treatment of Crisaborole Ointment, 2% and a Concomitant Topical Corticosteroid Over a 8 Week Period [NCT04008784]16 participants (Actual)Observational2019-09-16Completed
A Multi-Center, Open-label, 24-week Clinical Investigation to Evaluate Safety and Tolerability of Treatment With the Oxulumis®, Suprachoroidal Drug Administration Device Delivering 2.4mg Triesence® With Diabetic Macular Edema [NCT05172401]0 participants (Actual)Interventional2022-09-15Withdrawn(stopped due to unforeseen, continued (>12month) global shortage of study medication. Study Drug Triesence, manufacturer Novartis, not supplied throughout 2022)
The Effectiveness of Selective Nerve Root Injections in Preventing the Need for Surgery in Patients With Lumbar Disc Herniations [NCT01073995]Phase 354 participants (Actual)Interventional2010-03-31Completed
Triamcinolone Paste to Reduce the Incidence of Postoperative Sore Throat [NCT00908817]150 participants (Actual)Interventional2008-05-31Completed
A Phase IIb, Randomized, Masked, Sham-Controlled, Clinical Trial to Study the Efficacy and Safety of the Helical Triamcinolone Acetonide Implant (MK0140) in Diabetic Patients With Clinically Significant Macular Edema [NCT00692614]Phase 22 participants (Actual)Interventional2008-06-30Terminated
A Randomized Parallel, Masked to Evaluate the Efficacy of Triamcinolone Associated With Nepafenac (Nevanac) Compared With Intravitreal Injection of Triamcinolone for Treatment of Clinically Significant Diabetic Macular Edema [NCT00780780]Phase 340 participants (Actual)Interventional2007-07-31Completed
Injection Treatment of Slow-Release Corticosteroid to the Sacrospinous Ligament Insertions on Women With Long-Lasting Low Back Pain Starting in Pregnancy. [NCT00757016]38 participants (Actual)Interventional2004-10-31Completed
[NCT00801450]Phase 1/Phase 224 participants (Actual)Interventional2007-09-30Active, not recruiting
Comparison Between Steroid and Two Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia: A Randomized Double-blind Active Drug-controlled Pilot Study [NCT02767635]Phase 390 participants (Anticipated)Interventional2012-01-31Recruiting
The Effect of Intra-articular Bilateral Knee Injections of Zilretta on Osteoarthritis Research Society International (OARSI) Recommended Physical Performance Measures in Adults With Knee Osteoarthritis [NCT03895840]Phase 470 participants (Actual)Interventional2018-03-19Completed
Treatment Of Radiation Retinopathy Trial Subtitle: Treatment of Radiation Retinopathy; Influence of Lucentis® and Kenalog® on Radiation Retinopathy After Irradiation of Choroidal Melanoma. [NCT00811200]Phase 2/Phase 3220 participants (Anticipated)Interventional2009-09-30Not yet recruiting
Comparison of Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Experimentally Induced Skin Irritation [NCT00779792]Phase 436 participants (Actual)Interventional2008-09-30Active, not recruiting
Posterior Subtenon Versus Intravitreal Injection of Triamcinolone Acetonide for Treatment of Uveitic Cystoid Macular Edema (CME) [NCT02598869]Phase 40 participants (Actual)Interventional2015-11-30Withdrawn
Role of Conditioning in the Pharmacotherapy of Psoriasis [NCT00005922]138 participants (Actual)Interventional2000-08-31Completed
A Prospective Study Comparison of Clinical Outcome After Different Rate Infusion in Caudal Epidural Steroid Injection [NCT02939482]112 participants (Actual)Interventional2016-10-01Completed
Single Blind RCT to Evaluate the Effect of Ketorolac in Upper Extremity Tendinopathy and Arthropathy [NCT05292339]Phase 4160 participants (Anticipated)Interventional2023-01-31Recruiting
The Comparison Study of Intralesional Botulinum Toxin A and Corticosteroid Injection for Alopecia Areata [NCT00999869]20 participants (Anticipated)Interventional2009-11-30Recruiting
A Pilot Study of Peribulbar Triamcinolone Acetonide for Diabetic Macular Edema [NCT00369486]Phase 2113 participants (Actual)Interventional2004-12-31Completed
Adrenal Function and Use of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) in Patients With Alopecia Areata [NCT00484679]Phase 218 participants (Actual)Interventional2007-05-31Completed
Intra-articular Corticosteroid Injection Compared With Single-Shot Hyaluronic Acid for Treatment of Osteoarthritis Knee: A Prospective, Double-blind Randomized Controlled Trial [NCT01874574]Phase 4100 participants (Actual)Interventional2011-01-31Completed
Ultrasound Guided Transversus Abdominis Plane Block vs. Trigger Point Injection for Abdominal Wall Pain: A Randomized Comparative Trial [NCT01906944]Phase 262 participants (Actual)Interventional2012-01-31Completed
A Randomized Controlled Trial of Systemic and Topical Treatments for Rash Secondary to Erlotinib in Advanced Stage IIIB or IV Non-Small Cell Lung Cancer [NCT00473083]Phase 2150 participants (Actual)Interventional2009-01-31Completed
Steroid Versus Hyaluronic Acid Ultrasound-guided Injection for Trigger Finger: A Comparative Study of Outcomes [NCT01950793]36 participants (Actual)Interventional2012-11-30Completed
Intralesional Vitamin D3 Injection in Treatment of Alopecia Areata: A Novel Approach [NCT04660786]Phase 1/Phase 240 participants (Anticipated)Interventional2021-11-01Not yet recruiting
Ultrasound-Guided Injection of Hyaluronic Acid Versus Corticosteroid for Treatment of Trigger Finger: Randomized Controlled Study [NCT04645303]Early Phase 1100 participants (Anticipated)Interventional2020-11-06Recruiting
[NCT01961752]111 participants (Actual)Interventional2012-07-31Completed
A Randomised Open Label Placebo Controlled Study to Evaluate Fractional Collagen Synthesis in Keloids and Identify Biomarkers of Keloid Biology for Potential Application in Future Clinical Trials [NCT01978301]Phase 19 participants (Actual)Interventional2014-04-15Terminated(stopped due to Temporary hold on recruitment during staff changes at the site)
Open-Label, Parallel-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Corticosteroid Intra Articular Injection Given 7 Days Before or 7 Days After Lorecivivint Intra-articular Injection Into the Knee of Healthy Volunteers [NCT04598542]Phase 140 participants (Actual)Interventional2020-10-13Completed
Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars) [NCT04593706]40 participants (Anticipated)Interventional2020-11-01Not yet recruiting
Randomized Clinical Control Trial Comparing the Effects of a Steroid Eluting Implant Versus Triamcinolone-impregnated Carboxymethylcellulose Foam on the Postoperative Clinic Experience in Patients That Underwent Functional Endoscopic Surgery for Nasal Pol [NCT03607175]Phase 2/Phase 330 participants (Anticipated)Interventional2023-07-24Not yet recruiting
Assessment Of Pain Subsidence And Sexual Function Amelioration Using Either Pelvic Rehabilitation Or Trigger Point Injections [NCT02022722]Phase 436 participants (Anticipated)Interventional2013-08-31Recruiting
A Multi-center, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Hydros and Hydros-TA Joint Therapies for Management of Pain Associated With Osteoarthritis in the Knee [NCT02022930]Phase 3510 participants (Anticipated)Interventional2014-01-31Completed
Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study [NCT02025023]Phase 3120 participants (Anticipated)Interventional2013-12-31Recruiting
A Randomized Single-blinded Clinical Trial of the Efficacy of Intra-articular Infiltration of Cingal (Sodium Hyaluronate/Triamcinolone) Versus Cortisone (Triamcinolone) in Patients With Osteoarthritis of the Shoulder. [NCT05408065]84 participants (Anticipated)Interventional2023-09-30Not yet recruiting
Efficacy of Platelet Rich Plasma vs. Corticosteroid Injections for Treating Greater [NCT02031367]Early Phase 150 participants (Anticipated)Interventional2014-03-31Not yet recruiting
The Effect of Intralesian Injection of Umbilical Cord Mesenchymal Stem Cells, Its Conditioned Medium, and Triamcinolone Acetonide on Type 1:3 Collagen Ratio and Interleukin-10 Levels in Keloid: A Randomised Controlled Trial [NCT05939817]Phase 424 participants (Actual)Interventional2021-10-01Completed
The Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Patients With Dupuytren's Contracture: a Randomized Controlled Study [NCT00565019]Phase 351 participants (Actual)Interventional2007-11-30Completed
A Randomized, Controlled Study of ACZ885 (Canakinumab) on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/or Colchicine Are Contraindicated, Not Tolerated or Ineffective Including a 12 Weeks Extension Study [NCT01080131]Phase 3226 participants (Actual)Interventional2010-03-31Completed
Topical Erythropoietin Hydrogel in Management of Oral Lichen Planus: A Randomized Controlled Clinical Trial [NCT06135259]Phase 318 participants (Anticipated)Interventional2023-12-20Not yet recruiting
The Effect of Intracameral Triesence (Triamcinolone Acetonide Injectable Suspension) on Ocular Inflammation After Trabeculectomy, Tube Shunt Implantation or Combined Trabeculectomy With Cataract Surgery [NCT00853905]Phase 2/Phase 377 participants (Actual)Interventional2009-02-28Completed
Efficacy of Combined Ultrasound Guided Steroid Injection and Splinting in Patients With Carpal Tunnel Syndrome [NCT02708693]52 participants (Actual)Interventional2013-04-30Completed
The Effect of Ethosomal Gel Bearing Losartan 5% on The Patient and Observer Scar Assessment Scale Score, Degree of Erythema and Pigmentation, Surface Area, Thickness and Pliability of Human Keloids [NCT05893108]Phase 1/Phase 246 participants (Anticipated)Interventional2024-03-30Not yet recruiting
Assessment of the Effectiveness of Ultrasound-guided Acupuncture in the Management of Carpal Tunnel Syndrome [NCT02870673]Phase 2/Phase 372 participants (Anticipated)Interventional2016-08-31Not yet recruiting
Triamcinolone Ketorolac (TriKe) Knee Trial Evaluating the Effectiveness and Possible Superiority of Ketorolac vs. Cortisone When Injected Intra-Articular in Subjects With Osteoarthrosis [NCT05336968]Phase 4150 participants (Anticipated)Interventional2022-09-15Enrolling by invitation
Clinical Trials in Stroke Rehabilitation [NCT00597766]Phase 228 participants (Actual)Interventional2007-12-31Completed
Effect of Intracameral Steroids Injection During Phacoemulsification on Postoperative Corneal Edema and Corneal Endothelium [NCT05271058]Phase 369 participants (Actual)Interventional2019-06-16Completed
Medicated Punctured-Glove-Finger Spacer Study [NCT01420471]Phase 450 participants (Actual)Interventional2011-09-30Completed
Phase I/II Study of Intravitreal Triamcinolone Acetonide Microspheres for Treatment of Diffuse Diabetic Macular Edema Unresponsive to Conventional Laser Photocoagulation Treatment. [NCT00407849]Phase 1/Phase 250 participants (Anticipated)Interventional2006-10-31Active, not recruiting
Comparative Study Between Intralesional Autologous Platelet Rich Plasma and Intralesional Triamcinolone Acetonide in the Oral Erosions of Pemphigus Vulgaris Patients [NCT02828163]Phase 311 participants (Actual)Interventional2016-01-31Completed
Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis: A Randomized Clinical Trial [NCT00554476]Phase 450 participants Interventional2003-01-31Terminated(stopped due to Because the sample volume was completed during three years.)
The Role of Triamcinolone Injection During Cataract Extraction for Diabetic Patients With Pre-Operative Macular Edema [NCT00229931]11 participants (Actual)Interventional2005-11-30Completed
Effectiveness and Tolerance Infiltration Intraarticular Corticosteroid According to Dose [NCT01851278]60 participants (Anticipated)Interventional2013-04-30Recruiting
Additive Effects of Hyaluronidase in Intra-articular Steroid Injection Treating the Initial Stage of Adhesive Capsulitis for Shoulder [NCT04347733]Phase 330 participants (Actual)Interventional2017-05-02Completed
A Randomised, Double-blind, French Multi-centre Study, to Evaluate the Efficacy and Tolerance, in Comparison With Placebo, of Nasacort in Chronic Non Allergic and Non Infectious Rhinitis in Adults [NCT00344942]Phase 377 participants (Actual)Interventional2006-04-30Terminated(stopped due to patient's recruitment too difficult)
Efficacy and Safety of Different Concentrations of Intralesional Triamcinolone Acetonide in Alopecia Areata: A Prospective, Randomized, Double-blind, Placebo-controlled Study [NCT01246284]5 participants (Actual)Interventional2010-12-31Completed
Dosage Dependency of Intravitreal Triamcinolone Acetonide for Treatment of Diabetic Macular Edema [NCT00476918]Phase 160 participants (Anticipated)Interventional2006-07-31Recruiting
Clinical Evaluation of the Safety and Efficacy of Triamcinolone Acetonide Suspension for Visualization During Vitrectomy Surgery [NCT00532415]Phase 360 participants (Actual)Interventional2007-09-30Completed
Dropless Pars Plana Vitrectomy Study [NCT05331664]Phase 4168 participants (Anticipated)Interventional2022-07-25Recruiting
An Open-Label Study to Evaluate the Safety of Lebrikizumab Compared to Topical Corticosteroids in Adult Patients With Persistent, Moderate to Severe Atopic Dermatitis [NCT02465606]Phase 255 participants (Actual)Interventional2015-07-30Completed
Biological Response to Platelet-rich Plasma and Corticosteroid Injections [NCT05657496]Phase 1/Phase 270 participants (Anticipated)Interventional2022-12-28Recruiting
The Effect of Local Analgesia on Postoperative Gluteal Pain in Patients Undergoing Sacrospinous Ligament Fixation: A Randomized Trial [NCT03995641]Phase 419 participants (Actual)Interventional2019-02-02Terminated(stopped due to Never received appropriate formulation.)
A 24-month Randomized, Double-masked, Sham Controlled, Multicenter, Phase IIIB Study Comparing Photodynamic Therapy With Verteporfin (Visudyne®) Plus Two Different Dose Regimens of Intravitreal Triamcinolone Acetonide (1 mg and 4 mg) Versus Visudyne® Plus [NCT00242580]Phase 3111 participants (Actual)Interventional2005-09-30Completed
Assessment of Verapamil as an Adjunct for Prevention of Keloid Recurrence After Surgical Removal [NCT01720056]Phase 414 participants (Actual)Interventional2012-10-31Terminated(stopped due to Objective of study achieved after interim analysis.)
Intra-articular Injection of Botulinum Toxin Type A in Hemiplegic Shoulder Pain: a Multicentric, Double Blind Randomised, Versus Steroid Study [NCT01473277]Phase 252 participants (Anticipated)Interventional2012-01-31Not yet recruiting
Combined Posterior Sub-Tenon Injection of Triamcinolone Acetonide and Laser Photocoagulation for the Treatment of Clinically Significant Macular Edema [NCT00229918]Phase 260 participants Interventional2005-09-30Recruiting
Efficacy of Ultrasound-Guided Deep Perineural Platelet Rich Plasma Versus Corticosteroid Injection in Patients With Ulnar Neuropathy at Elbow, a Comparative Study [NCT05567081]Phase 2/Phase 360 participants (Actual)Interventional2021-06-01Completed
Evaluation of the Effect of Triamcinolone at Different Doses on Local Infiltration Anesthesia During Total Knee Arthroplasty [NCT05997238]90 participants (Anticipated)Observational2023-04-25Recruiting
Combined Phacoemulsification Surgery and Intravitreal Triamcinolone Injection Versus Stand-alone Surgery in Patients With Type 2 Diabetes: A Randomized Controlled Trial [NCT05413330]Phase 2/Phase 373 participants (Actual)Interventional2020-09-12Completed
Evaluation of Diode Laser and Topical Steroid Therapy in the Treatment of Erosive Oral Lichen Planus (A Randomized Controlled Clinical Trial) [NCT05951361]44 participants (Actual)Interventional2022-02-01Completed
A Randomized Trial Comparing Intravitreal Triamcinolone Acetonide and Laser Photocoagulation for Diabetic Macular Edema [NCT00105404]Phase 35 participants Interventional2005-03-09Completed
Triamcinolone as Adjunctive Treatment to Laser Panretinal Photocoagulation for Proliferative Diabetic Retinopathy [NCT00443521]Phase 2/Phase 330 participants Interventional2005-03-31Completed
Intravitreal Bevacizumab Combined With Intravitreal Triamcinolone Acetonide Injection Versus Intravitreal Bevacizumab for Age Related Macular Degeneration [NCT00447031]0 participants (Actual)Interventional2007-03-31Withdrawn(stopped due to Insufficient patients who met inclusion criteria)
Multi-Center, Randomized, Phase II Clinical Trial to Study the Effects of Preservative-Free Triamcinolone Acetonide and Avastin® in Combination With Photodynamic Therapy in Participants With Neovascular Age Related Macular Degeneration [NCT00464347]Phase 2100 participants (Anticipated)Interventional2007-01-31Terminated(stopped due to Study was terminated because of poor enrollment.)
Triamcinolone Acetonide as an Adjunctive Treatment to Verteporfin Therapy in Neovascular Age-Related Macular Degeneration: Randomized Placebo-Controlled Clinical Trial. [NCT00148551]Phase 2/Phase 3120 participants (Anticipated)Interventional2004-01-31Active, not recruiting
Effectiveness of Matrix Metalloproteinase Neutralizing Agent in Treatment of Oral Lichen Planus: A Pilot Study [NCT04336488]Early Phase 140 participants (Anticipated)Interventional2020-01-01Active, not recruiting
Comparison of the Short-term Clinical Effects of Anterior Extra-articular and Posterior Intra-articular Administration of Ultrasound-guided Steroid Injection in the Treatment of Adhesive Capsulitis. A Prospective, Randomized and Single-blind Study [NCT05668286]50 participants (Anticipated)Interventional2023-05-24Recruiting
Can Dexmedetomidine With Hyalase Augment Quality and Duration of Analgesia When Added to Lumbar Epidural Steroid in Failed Back Surgery. Randomized Double Blind Study [NCT05349448]Early Phase 1100 participants (Anticipated)Interventional2022-03-28Recruiting
Vascular Remodeling and the Effects of Angiogenic Inhibition in Diabetic Retinopathy [NCT00411333]Early Phase 1100 participants (Anticipated)Interventional2006-07-31Completed
Intravitreal Bevacizumab Versus Intravitreal Triamcinolone Acetonide for Refractory Diabetic Macular Edema [NCT00468351]Phase 10 participants Interventional2006-04-30Active, not recruiting
[NCT00600301]Phase 30 participants InterventionalRecruiting
Ultrasound-guided Glenohumeral Versus Subacromial Steroid Injections for Impingement Syndrome With Mild Stiffness: A Randomized Controlled Trial [NCT06051370]51 participants (Actual)Interventional2013-01-12Completed
Heated Lidocaine Patch Compared to Subacromial Injections in the Treatment of Pain Associated With Shoulder Impingement Syndrome, A Pilot [NCT01544283]Phase 260 participants (Anticipated)Interventional2012-03-31Recruiting
Comparison of Topical Tacrolimus, Triamcinolone and Placebo in the Treatment of Symptomatic Oral Lichen Planus [NCT01544842]28 participants (Actual)Interventional2004-08-31Terminated(stopped due to Lack of resources)
Multi-Center, Randomized, Phase II/III Clinical Trial to Study the Effects of Preservative-Free Triamcinolone Acetonide as an Adjunct to Photodynamic Therapy in Participants With Neovascular Age-Related Macular Degeneration [NCT00100009]Phase 330 participants Interventional2004-12-09Completed
Phase I Study of Intravitreal Injections Versus Anterior Sub-Tenon Injections of Triamcinolone Acetonide Formulation for Macular Edema in Retinal Disorders [NCT00101764]Phase 1120 participants Interventional2005-01-05Completed
The Standard Care vs. Corticosteroid for Retinal Vein Occlusion (SCORE) Study [NCT00106132]Phase 31,260 participants Interventional2005-03-31Completed
Pilot Study of Intravitreal Injection of Triamcinolone Acetonide Formulation for Retinal Vascular Disorders [NCT00071227]Phase 116 participants Interventional2003-10-15Completed
A Randomized, Single-Masked, Multi-Center, Phase 2 Evaluation Of The Effect Of PDT Using Visudyne In Combination With Intravitreal Injection Of Either 0 mg, 1mg or 4mg of Kenalog In Subfoveal Occult & Minimally Classic CNV Secondary To ARMD [NCT00140803]Phase 2106 participants (Actual)Interventional2003-10-31Completed
Injection After Arthroscopic Partial Meniscectomy [NCT04641351]Phase 4150 participants (Anticipated)Interventional2021-05-27Enrolling by invitation
Differential Efficacy of Corticosteroid Solutions for Non-Operative Treatment of Digit Flexor Tenosynovitis: A Double-Blind Prospective Randomized Clinical Trial [NCT04002037]Phase 4120 participants (Actual)Interventional2019-06-25Terminated(stopped due to Preliminary analysis revealed no difference)
Using Saline for Myofascial Pain Syndromes (USAMPS) [NCT02120261]Phase 451 participants (Actual)Interventional2014-05-31Terminated(stopped due to lack of activity, Primary researcher moved to another institution)
Identifying Variables Associated With Steroid-Induced Hyperglycemia Following Intra-articular Knee Injections Among Diabetic Patients [NCT04317404]11 participants (Actual)Observational2020-11-01Completed
The Effects of Triamcinolone Acetonide With Retrobulbar Anesthesia on Postoperative Pain Control Following Vitreoretinal Surgery [NCT01995045]Phase 458 participants (Actual)Interventional2012-07-31Completed
The Safety and the Efficacy of Combined Vitrectomy, Intravitreal Triamcinolone Acetonide and Macular Focal Laser Photocoagulation for the Treatment of Intractable Diffuse Diabetic Macular Edema [NCT00371410]Phase 10 participants Interventional2005-04-30Completed
A Double-blind, Randomized Study Comparing Steroid Injection and BioDRestore for Patients With Knee Osteoarthritis [NCT02767492]90 participants (Actual)Interventional2017-01-31Completed
Early Anti-inflammatory Treatment in Patients With Acute ACL Tear [NCT01692756]Phase 249 participants (Actual)Interventional2013-03-31Completed
Pilot Study of Peribulbar Triamcinolone Acetonide for Diabetic Macular Edema [NCT00231023]Phase 210 participants Interventional2005-09-30Completed
Phase 1 Prospective, Randomized, Double-Masked, Multicenter Study to Evaluate the Safety and Tolerability of Two Dose Levels of the Helical Intravitreal Triamcinolone Implant in Diabetic Macular Edema [NCT00915837]Phase 131 participants (Actual)Interventional2005-06-30Completed
Neovascular Age Related Macular Degeneration, Periocular Corticosteroids, and Photodynamic Therapy [NCT00305630]Phase 2/Phase 3100 participants Interventional2002-07-31Completed
Botulinum Toxin Versus Steroid Injection for Basal Joint Arthritis of the Thumb: a Randomized, Double Blind, Placebo-controlled Clinical Trial [NCT01045694]Phase 48 participants (Actual)Interventional2011-03-31Terminated(stopped due to Unable to acquire additional funding needed to continue this study.)
A Double-Blind, Randomized, Parallel Group, Dose-Ranging Study Comparing FX006 to Commercially Available Triamcinolone Acetonide Injectable Suspension in Patients With Osteoarthritis of the Knee [NCT01487161]Phase 2229 participants (Actual)Interventional2012-06-30Completed
A Study to Evaluate the Safety, and Efficacy of Minimally Manipulated Autologous Bone Marrow Aspirate to Treat Knee Osteoarthritis in Patients [NCT05288725]Phase 1/Phase 2120 participants (Anticipated)Interventional2022-08-31Not yet recruiting
Changes Noted After Suprachoroidal Triamcinolone Acetonide Injection. [NCT05288192]30 participants (Anticipated)Interventional2022-02-15Recruiting
Bayesian Non-inferiority Trial of Injection Therapies for Acromioclavicular Joint Pain: a Randomized Clinical Trial [NCT05161468]Phase 4150 participants (Anticipated)Interventional2022-07-01Recruiting
An Open-Label, Follow-On Study to Cingal 13-01 to Evaluate the Safety of a Repeat Injection of Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide to Provide Symptomatic Relief of Osteoarthritis of the Knee [NCT02381652]Phase 3242 participants (Actual)Interventional2015-02-28Completed
Ranibizumab (rhuFab V2) and Scatter Laser Photocoagulation in Treatment of Patients With Clinically-significant Diabetic Macular Edema With Peripheral Retinal Nonperfusion (RaScaL) [NCT00815360]Phase 222 participants (Actual)Interventional2008-02-29Completed
25-Gauge Vitrectomy With Ranibizumab or Triamcinolone Acetonide on Proliferative Diabetic Retinopathy in China: a Randomized, Single Blind Trial [NCT02447185]Phase 3200 participants (Anticipated)Interventional2015-06-30Recruiting
An Investigator-Initiated Study to Assess the Cooling Effect of Triamcinolone Acetonide Aerosol When Used for Steroid-Responsive Dermatoses [NCT01736670]30 participants (Actual)Interventional2012-04-30Completed
Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to a Single Intrabursal Injection of Corticosteroids in Patients With Shoulder Calcific Tendinopathy [NCT01652495]Phase 444 participants (Actual)Interventional2012-03-31Completed
Evaluation of the Efficacy of Suprascapular Nerve Block in Adhesive Capsulitis: a Randomized Controlled Superiority Trial [NCT06176248]62 participants (Anticipated)Interventional2024-02-29Not yet recruiting
Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System. [NCT05106192]22 participants (Anticipated)Interventional2024-06-01Not yet recruiting
Efficacy and Safety of Intralesional Triamcinolone Acetonide in Vitiligo: A Prospective, Double-Blind Randomized Controlled Trial [NCT01766609]Phase 218 participants (Anticipated)Interventional2013-01-31Recruiting
PRevention of Macular EDema After Cataract Surgery [NCT01774474]Phase 31,127 participants (Actual)Interventional2013-07-10Completed
The Use of Intraocular Triamcinolone in the Perioperative Period of Congenital Cataract Surgery [NCT01800708]60 participants (Actual)Interventional2010-01-31Completed
Quantitative Comparison of the Efficacy of Subtenon 20-mg Triamcinolone Injection With 0.1% Dexamethasone Eye Drop in Controlling Intraocular Inflammation After Phacoemulsification [NCT01801774]Phase 4140 participants (Anticipated)Interventional2012-05-31Recruiting
A Randomized, Intraindividual, Phase 4 Study to Evaluate the Short-Term Efficacy of Triamcinolone Acetonide (Aristocort® C) in Subjects With Atopic Dermatitis [NCT05844618]Phase 420 participants (Anticipated)Interventional2023-05-09Recruiting
Improvement in Function and Pain Due to Subacromial Bursitis in Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone [NCT02242630]61 participants (Actual)Interventional2014-09-30Completed
[NCT00370539]Phase 30 participants Interventional2006-09-30Recruiting
Safety and Efficacy of Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata [NCT01797432]Phase 214 participants (Actual)Interventional2009-03-31Completed
Open-Label, Safety and Tolerability Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle in Subjects With Non-Infectious Uveitis [NCT01789320]Phase 1/Phase 211 participants (Actual)Interventional2013-02-28Completed
Efficacy and Safety of Intralesional Triamcinolone Acetonide Alone and Its Combination With 5-fluorouracil in Keloids and Hypertrophic Scars [NCT04812626]66 participants (Actual)Interventional2021-01-28Completed
A Randomized, Double-Blind Study of the Efficacy of Steroid Supplementation After Temporomandibular Joint Arthrocentesis [NCT01770912]Phase 224 participants (Actual)Interventional2013-03-31Completed
A Double-Blind, Randomized, Parallel Group, Proof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee [NCT02468583]Phase 26 participants (Actual)Interventional2015-02-28Terminated
Randomized Prospective Study of Particulate Corticosteroid Versus Non-particulate Corticosteroid for Sacroiliac Joint Steroid Injection [NCT03166761]Phase 441 participants (Actual)Interventional2017-09-14Terminated(stopped due to recruitment and staffing)
The Effect of Epidural Steroid Injections on Glycemic Control in Diabetic Patients According to the Doses of Steroids [NCT01435707]125 participants (Actual)Interventional2011-09-30Completed
Success of Long-acting Anti-inflammatories After Anterior Cruciate Ligament and Meniscal Injury [NCT04331002]Phase 21 participants (Actual)Interventional2020-08-21Terminated(stopped due to Funding Termination)
Do Cervical Interlaminar Epidural Steroid Injections With Low-dose Lidocaine Cause Transient Objective Upper Extremity Weakness? A Prospective Randomized Controlled Trial [NCT03127137]Phase 4123 participants (Actual)Interventional2018-08-01Completed
A Randomized, Open-label, Parallel Group Study in Patients With Bilateral Knee Osteoarthritis Comparing the Systemic Exposure of Triamcinolone Acetonide Following Administration Into Both Knees of Either Extended-release FX006 or Immediate-release TAcs (T [NCT03378076]Phase 224 participants (Actual)Interventional2017-12-06Completed
Valchlor Therapy in Conjunction With Triamcinolone 0.1% Ointment for the Treatment of Contact Dermatitis in Patients With Early Stage Cutaneous T-cell Lymphoma (Mechlorethamine Induced Dermatitis Avoidance Study) [NCT03380026]Phase 228 participants (Actual)Interventional2017-12-13Completed
Clinical Evaluation of New Treatment Strategy of Mucous Membrane Pemphigoid Using Large Dose of Prednisolone Plus Intra-lesional of Triamcinolone Acetonide Followed by Combination of Mycophenolate Mofetil, Dapsone and Low Dose Prednisolone [NCT04744623]Phase 2/Phase 310 participants (Actual)Interventional2020-09-30Active, not recruiting
Clinical Effectiveness of Symptomatic Therapy Compared to Standard Step up Care for the Treatment of Low Impact Psoriatic Oligoarthritis: a 2 Arm Parallel Group Feasibility Study [NCT03797872]Phase 41 participants (Actual)Interventional2019-04-17Completed
An Open-Label Study of the Safety and Tolerability of Combining 20089 (Triamcinolone Acetonide Intravitreal Injection) When Used Adjunctively With Lucentis® 0.5 mg Intravitreal Injection in Subjects With Subfoveal Neovascular AMD [NCT01175395]Phase 1/Phase 210 participants (Actual)Interventional2010-09-30Completed
Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases: A Pilot Study [NCT05488860]20 participants (Anticipated)Interventional2022-07-30Recruiting
A Study in Atopic Dermatitis to Determine Serum and Skin Biopsy Biomarkers in Patients Receiving Topical Corticosteroid (TCS) and Following TCS Withdrawal [NCT02317276]Phase 411 participants (Actual)Interventional2014-12-31Terminated(stopped due to Unable to meet the study's recruitment goals)
Prospective, Randomized, Double-blinded Comparison of Steroid Dosages on the Efficacy of Trochanteric Bursa Injection [NCT02126878]120 participants (Actual)Interventional2014-04-30Completed
Intra-Articular Use of Platelet Rich Plasma Versus Corticosteroid: A Clinical Trials in Osteoarthritis of Knee. [NCT03086759]Phase 499 participants (Actual)Interventional2017-01-02Completed
Comparison of the Effects of Ultrasonography-guided Suprascapular Nerve Block and Intra-articular Shoulder Injection on Pain, Functional Status and Range of Motion in Patients With Adhesive Capsulitis; Randomized, Controlled Trial [NCT05909462]60 participants (Actual)Interventional2023-01-21Completed
Steroid and Sodium Hyaluronate Hydrodilatation [NCT05861570]84 participants (Anticipated)Interventional2023-05-18Recruiting
Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis (ADRN-12) [NCT05436535]Phase 4600 participants (Anticipated)Interventional2022-11-21Recruiting
A Prospective Triple-Blinded Single-Center Study of Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid Treatment for Keloids [NCT04786210]Phase 420 participants (Actual)Interventional2021-01-30Completed
Modified SALT Score for Assessment of Alopecia Areata [NCT04412148]Phase 420 participants (Anticipated)Interventional2020-01-01Recruiting
Efficacy of Autologous Adipose Derived Stromal Vascular Fraction in the Treatment of Keloids [NCT04391621]Phase 230 participants (Anticipated)Interventional2021-05-01Recruiting
Subakromiyal sıkışma Sendromunda Hyaluronik Asit, Kortikosteroid ve Elektroterapi [NCT04833738]90 participants (Actual)Interventional2013-09-11Completed
The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study: Two Randomized Trials to Compare the Efficacy and Safety of Intravitreal Injection(s) of Triamcinolone Acetonide With Standard Care to Treat Macular Edema [NCT00105027]Phase 3682 participants (Actual)Interventional2004-10-31Completed
The Effectiveness of Intra-articular Corticosteroid Injection in Patients With Whiplash-related Neck Pain [NCT04959721]32 participants (Anticipated)Interventional2021-07-15Not yet recruiting
Effects of Ultrasound-guide Hypertonic Dextrose Injection for Chronic Subacromial Bursitis [NCT04916353]60 participants (Anticipated)Interventional2021-06-10Recruiting
[NCT00373282]Phase 30 participants Interventional2001-06-30Completed
Comparing Low Dose and High Dose Steroid Injection for Adhesive Capsulitis [NCT04364425]80 participants (Anticipated)Interventional2020-05-04Recruiting
Effect of Combined Ultrasound-guided Subdeltoid Corticosteroid Injections and Physiotherapy in Treatment of Patients With Chronic Subacromial Bursitis [NCT03871465]111 participants (Actual)Interventional2018-08-01Completed
A Randomized, Double-blind, Active-control, Multicenter, Efficacy and Safety Study of 2 Dose Levels of Subcutaneous Anakinra Compared to Intramuscular Triamcinolone in the Treatment of Acute Gouty Arthritis, Followed by an Extension Period of up to 2 Year [NCT03002974]Phase 2165 participants (Actual)Interventional2016-12-31Completed
A Two Different Chemoprophylaxis Approaches After Phacoemulsification Surgery in One Thousand Patients in Iraq :a Clinical Trial [NCT03634852]Phase 41,000 participants (Actual)Interventional2016-10-01Completed
A Clinical and Immunological Study of Phototoxic Doses of Ultraviolet A for Treatment of Alopecia Areata: A Randomized Controlled Clinical Trial [NCT01559584]40 participants (Actual)Interventional2012-03-31Completed
Study to Assess the Safety and Efficacy of FX006 Administered to Patients With Greater Trochanteric Bursitis [NCT04182672]Phase 222 participants (Actual)Interventional2020-08-12Active, not recruiting
Outcome in Shoulder Capsulitis (Frozen Shoulder) Between Corticosteroid and Corticosteroid With Distension Compared to Wait and See Policy, a Randomised Controlled Trial [NCT01570985]Phase 3120 participants (Anticipated)Interventional2010-02-28Active, not recruiting
Randomized Multicenter Clinical Trial of Three Parallel Groups to Estimate the Safety and Efficacy of Triamcinolone Acetonide Combined With Laser, Bevacizumab Combined With Laser Versus Laser Alone for the Treatment of Diffuse Non-tractional Diabetic Macu [NCT01572350]Phase 3105 participants (Anticipated)Interventional2010-10-31Completed
Efficacy of Formulated Posterior Sub Tenon Triamcinolone in Macular Edema Secondary to Non-Ischemic Retinal Vein Occlusions [NCT05345808]46 participants (Actual)Interventional2021-03-01Completed
Needle-Free Injection of Lidocaine for Local Anesthesia Prior to Trigger Digit Injection [NCT02084706]60 participants (Actual)Interventional2014-03-31Completed
Effect of Intra-articular Steroids on Structural Progression of Knee OA: A Randomized Controlled Trial [NCT01230424]Phase 4140 participants (Actual)Interventional2011-03-31Completed
A Randomized, Evaluator Blinded, Within Subject, Single-Centre Evaluation of the Vasoconstriction Properties of MC2-01 Cream, Compared to 5 Other Corticosteroids in Healthy Subjects [NCT03758365]Phase 136 participants (Actual)Interventional2018-11-05Completed
Safety and Effectiveness of Single-dose Subconjunctival Triamcinolone Compared to Topical Prednisolone Eye Drops in Manual Small Incision Cataract Surgery [NCT05248139]100 participants (Anticipated)Interventional2022-10-31Not yet recruiting
Treatment Efficacy of Local Anesthetic/Steroid Mixture Injection for Patients With Odynophonia [NCT05178485]Phase 40 participants (Actual)Interventional2023-07-01Withdrawn(stopped due to Halted prematurely prior to enrollment of first participant)
A Double-Blind, Randomized, Single-Dose Study to Assess the Safety and Efficacy of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee [NCT02357459]Phase 3486 participants (Actual)Interventional2015-01-31Completed
The Efficacy of Local Anesthetics to Reduce Shoulder Pain Post-Steroid Injections [NCT02592629]Phase 419 participants (Actual)Interventional2016-02-01Terminated(stopped due to Lack of time to enroll due to additional responsibilities of the PI and research coordinator.)
Comparing Efficacy of Topical Steroid Cream vs. Ointment Formulations Using Wet Dressings for Treatment of Atopic Dermatitis [NCT02680301]Phase 440 participants (Actual)Interventional2016-03-31Completed
[NCT00369863]Phase 276 participants Interventional2002-06-30Completed
The Effectiveness of Nasal Corticosteroids Versus Placebo in Nasal Obstruction in Patients With Nasal Septal Deviation [NCT02877485]Phase 442 participants (Actual)Interventional2016-08-31Completed
Peripheral Nerve Injections for the Treatment of Upper Extremity Complex Regional Pain Syndrome: A Feasibility Study for a Proposed Randomized Design [NCT04744675]Phase 450 participants (Anticipated)Interventional2021-03-31Not yet recruiting
[NCT00370370]Phase 30 participants Interventional2005-11-30Active, not recruiting
[NCT00370669]Phase 3150 participants Interventional2005-11-30Recruiting
Randomized Controlled Trial Comparing Two Different Bladder Instillation Treatments for Interstitial Cystitis/Bladder Pain Syndrome [NCT03463915]Phase 390 participants (Actual)Interventional2019-01-25Completed
SporTRIA Study: A Multicentre Trial for Excretion Kinetics of Triamcinolone Acetonide Following Sport Related Intra-articular Injections in Knees; Definitions of the Washout Periods [NCT04574232]20 participants (Anticipated)Interventional2023-01-01Recruiting
Transpupillary Thermotherapy (TTT) Alone Versus the Combined Therapy Consisting of TTT and Intravitreal Injection of Triamcinolone to Decrease Exudation in Choroidal Melanoma After Proton Beam Therapy [NCT02379000]Phase 450 participants (Anticipated)Interventional2015-01-31Active, not recruiting
A Stratified Investigation of a Single Injection of ZILRETTA™ (Triamcinolone Acetonide Extended-release Injectable Suspension) for Symptomatic Relief in Patients With Idiopathic Adhesive Capsulitis of the Shoulder [NCT04831255]Phase 150 participants (Anticipated)Interventional2019-06-21Recruiting
An Open-label Extension Study of CACZ885H2356E2 and CACZ885H2357E2 on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/or Colchicine Are Contraindicated, Not Tolerated or Ineffective [NCT01470989]Phase 3136 participants (Actual)Interventional2011-11-30Completed
Ultrasound-guided PRP Versus Steroid Injections in Management of Carpal Tunnel Syndrome; a Comparative Study [NCT04434105]Phase 2/Phase 390 participants (Actual)Interventional2020-02-01Active, not recruiting
Early Effect of Cingal® Compared to Monovisc® in Patients With Osteoarthritis of the Knee (EEFFEK Study) [NCT03062787]60 participants (Actual)Interventional2017-04-05Completed
A Comparison of Clinical Efficiency of Photodynamic Therapy and Topical Corticosteroid in Treatment of Oral Lichen Planus- Split-Mouth Randomised [NCT04976673]Phase 230 participants (Actual)Interventional2020-12-10Completed
Cell Therapy for Patients With Symptomatic Knee Osteoarthritis: Phase I / II, Controlled, Randomized and Double-blind Clinical Trial [NCT04863183]Phase 1/Phase 230 participants (Anticipated)Interventional2021-06-01Not yet recruiting
Randomized, Double-Blind, Active Comparator Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (Cingal™) to Provide Symptomatic Relief of Osteoarthritis of the Knee [NCT03191903]Phase 3576 participants (Actual)Interventional2017-05-25Completed
Triamcinolone Acetonide Levels in Cochlear Perilymph, Lateral Canal and CSF in Patients With Vestibular Schwannomas [NCT04658836]Phase 121 participants (Actual)Interventional2020-02-01Completed
Using Intraoperative Triamcinolone Acetonide Irrigation to Reduce Post-Operative Pain From Scleral Buckle Surgery [NCT04701593]Phase 424 participants (Anticipated)Interventional2020-01-03Recruiting
Effect of ZILRETTA Versus CELESTONE on Quality of Life, Pain, Neuromuscular Function, and Physical Performance [NCT05058209]Phase 420 participants (Actual)Interventional2020-11-30Completed
Suprachoroidal Triamcinolone Acetonide Injection A Novel Therapy for Serous Retinal Detachment in Vogt-Koyanagi Harada's Disease [NCT05031143]Phase 2/Phase 36 participants (Actual)Interventional2020-04-01Completed
An Open-label, Single Administration Study to Characterize the Systemic Pharmacokinetics and Local Extent and Duration of Exposure of Triamcinolone Acetonide From FX006 in Patients With Osteoarthritis of the Knee [NCT02637323]Phase 281 participants (Actual)Interventional2015-11-30Completed
Pilot Study of Traditional Chinese Medicine (Qing-Re-Liang-Xue Decoction) as Complementary Medicine for Psoriasis Vulgaris of Blood-heat Syndrome. [NCT04994951]Phase 2200 participants (Anticipated)Interventional2021-09-30Recruiting
Randomized Trial Evaluating Bevacizumabe or Triamcinolone for Persistent Diabetic Macular Edema [NCT02985619]Phase 2/Phase 3100 participants (Actual)Interventional2016-07-21Completed
Efficacy of Corticosteroid Injection Into Coracohumeral Ligament in Patients With Adhesive Capsulitis of the Shoulder [NCT03013205]60 participants (Anticipated)Interventional2017-02-28Not yet recruiting
Comparison of Ultrasound-guided Corticosteroid Injection Versus Corticosteroid Injection and Hydrodissection for Carpal Tunnel Syndrome [NCT04346030]60 participants (Anticipated)Interventional2020-04-17Recruiting
[NCT01614509]45 participants (Actual)Interventional2012-01-31Completed
A Randomized, Double-blind, Double-dummy, Active Controlled Study of Canakinumab (ACZ885) on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective [NCT01362608]Phase 3136 participants (Actual)Interventional2011-06-20Terminated
A Phase 2, Randomized, Active and Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of Intra-articular Resiniferatoxin to Treat Moderate to Severe Pain From Knee Osteoarthritis [NCT04885972]Phase 2124 participants (Actual)Interventional2021-11-15Active, not recruiting
Benefit of Placebo and Different Concentrations of Triamcinolone Acetonide in Nail Psoriasis [NCT03991936]Phase 410 participants (Actual)Interventional2020-03-11Completed
Transepidermal Delivery of Triamcinolone Acetonide or Platelet Rich Plasma Using Either Fractional Carbon Dioxide Laser or Microneedling in Treatment of Alopecia Areata [NCT04147845]60 participants (Actual)Interventional2019-10-30Completed
A Pilot Study of Intralesional Injection of Triamcinolone Acetonide for Desmoid Tumors [NCT03627741]Phase 110 participants (Actual)Interventional2018-06-07Completed
Strategies Towards Personalised Treatment in Juvenile Idiopathic Arthritis (JIA): The MyJIA Trial. [NCT04614311]Phase 4202 participants (Anticipated)Interventional2020-12-01Recruiting
An Open-label, Single Administration Study to Characterize the Local Duration of Exposure of Triamcinolone Acetonide From FX006 in Patients With Osteoarthritis (OA) of the Knee [NCT02003365]Phase 250 participants (Actual)Interventional2013-11-30Completed
Comparison of Keloid Volume and Symptoms Reduction Between Intralesional Umbilical-Cord Mesenchymal Stem Cells, Its Conditioned Medium, and Triamcinolone Acetonide Injection as Keloid Therapy: A Randomised Controlled Trial [NCT05887804]Phase 424 participants (Actual)Interventional2021-10-01Completed
Prospective, Randomized Trial of Intralesional Steroid Injection Versus Oral Prednisolone in Prevention of Esophageal Stricture After Endoscopic Submucosal Dissection [NCT04498260]Phase 430 participants (Anticipated)Interventional2019-01-21Recruiting
Evaluation of Systemic Administration of Green Tea Polyphenols as a Supportive Antioxidant Agent in the Management of Oral Lichen Planus [NCT02329600]Phase 340 participants (Actual)Interventional2013-06-30Completed
Implications and Stability of Clinical and Molecular Phenotypes of Severe Asthma [NCT01748175]715 participants (Actual)Observational2013-01-31Completed
Effect of the Combination of Photobiomodulation Therapy and the Intralesional Administration of Corticoid in the Preoperative and Postoperative Periods of Keloid Surgery: a Randomized, Controlled, Double-blind Trial [NCT04824612]58 participants (Anticipated)Interventional2021-08-30Enrolling by invitation
Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study [NCT04207931]Phase 4250 participants (Anticipated)Interventional2018-04-30Recruiting
Bevacizumabe e Acetato de Triancinolona Intra-vítreo Associados à Laserterapia em Pacientes Com Edema Macular diabético (IBeTA) [NCT02310295]45 participants (Actual)Interventional2009-01-31Completed
Do Cervical Interlaminar Epidural Steroid Injections With Low-dose Lidocaine Cause Transient Objective Upper Extremity Weakness? A Prospective Randomized [NCT03382925]Phase 416 participants (Actual)Interventional2017-12-20Terminated(stopped due to Not enough cervical interlaminar patients who meet criteria in order to meet recruitment goals.)
The Clinical Application of PLT Combined With Steroid in Lateral Epicondylopathy and Supraspinatus Calcific Tendinopathy [NCT05648032]Phase 3180 participants (Anticipated)Interventional2022-10-06Recruiting
A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (Cingal®) to Provide Symptomatic Relief of Osteoarthritis of the Knee [NCT04231318]Phase 3231 participants (Actual)Interventional2020-09-11Completed
Effect of ZILRETTA Injection on Neuromuscular Function, Gait Biomechanics and Physical Performance [NCT04261049]Phase 135 participants (Actual)Interventional2020-08-01Completed
The ESCRS EPICAT Study: Effectiveness of Periocular Drug Injection in CATaract Surgery [NCT05158699]Phase 3808 participants (Anticipated)Interventional2021-10-13Recruiting
Comparison of Corticosteroid and Repeated Dextrose Hydro-dissection for Carpal Tunnel Syndrome Patients [NCT04579783]60 participants (Anticipated)Interventional2020-11-27Recruiting
Thoracic Epidural Morphine Versus Triamcinolone Acetonide Analgesia in Flail Chest [NCT03413059]Phase 2/Phase 340 participants (Anticipated)Interventional2018-02-01Not yet recruiting
Evaluation of Triamcinolone's Efficacy on the Ultrasound- Guided Infiltration in the Quadratus Lumborum Syndrome: a Double Blind, Randomized, Controlled Study [NCT03407027]Phase 466 participants (Anticipated)Interventional2017-11-01Enrolling by invitation
Painful Inflammatory Carpometacarpal-1 Osteoarthritis Treated With Intraarticular Steroids, Saline or an Occupational Therapy Intervention: the PICASSO Trial. [NCT06084364]Phase 4354 participants (Anticipated)Interventional2023-11-03Recruiting
Pilot Study of Early Postoperative Fractional Ablative Laser Treatment of Skin Grafts for Burns [NCT04176705]9 participants (Actual)Interventional2020-12-14Completed
Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis: A Randomized Placebo-Controlled Clinical Trial [NCT00746889]79 participants (Actual)Interventional2004-03-31Completed
A Double-Blind, Randomized, Parallel Group, Active Comparator Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects (HPA Axis) of FX006 in Patients With Osteoarthritis of the Knee [NCT01487200]Phase 224 participants (Actual)Interventional2012-07-31Completed
Biologics and Blistering - Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation Through Suction Blistering [NCT05535738]Phase 2/Phase 345 participants (Anticipated)Interventional2022-11-15Recruiting
Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo [NCT03365141]12 participants (Anticipated)Interventional2017-11-14Recruiting
Particulate vs. Nonparticulate Epidural Steroid Injections for the Treatment of Symptomatic Unilateral Lumbar Foraminal Stenosis: a Prospective Double-blinded Randomized Study [NCT03245671]Phase 40 participants (Actual)Interventional2017-12-31Withdrawn(stopped due to Unable to address regulatory concerns.)
Comparison of Triamcinolone Acetonide Mucoadhesive Film and Licorice Mucoadhesive Film Effect on the Duration and Symptoms of Lesions That Caused by Symptomatic Oral Lichen Planus [NCT02453503]Phase 260 participants (Actual)Interventional2014-01-31Completed
A Short Term Outcomes of Subacromial Injection of Combined Corticosteroid With Low Volume Compared to High Volume of Local Anesthetic for Rotator Cuff Impingement Syndrome: A Randomized Controlled Trials [NCT03120923]Phase 452 participants (Actual)Interventional2015-01-01Completed
A Multi-Center, Randomized, Two-Arm, Parallel-Group, Single-masked, 24-week, Clinical Trial to Evaluate Safety and Tolerability of Two Dose Levels of Suprachoroidal Triamcinolone Acetonide Administered With the Oxulumis® Ophthalmic Administration Device i [NCT05512962]Phase 220 participants (Actual)Interventional2022-08-31Active, not recruiting
Triamcinolone Levels in Cochlear Perilymph [NCT03248856]Phase 140 participants (Actual)Interventional2017-10-02Completed
A Double-Blind, Randomized Study to Compare Onabotulinumtoxin A Versus Kenalog for Intravaginal Trigger Point Injections in the Treatment of Chronic Pelvic Pain [NCT02369068]21 participants (Actual)Interventional2015-08-31Completed
PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial [NCT02374060]Phase 3192 participants (Actual)Interventional2015-06-16Completed
Comparison of the Efficacy of Intra-articular Hybrid Hyaluronic Acid and Steroid in Patients With Rizoarthrosis [NCT03200886]100 participants (Actual)Observational2017-05-24Active, not recruiting
Efficacy of Intralesional Injection of Autologous Platelet Rich Plasma Versus Intralesional Injection of Corticosteroids on Pain Relief and Ulcers Healing in Patients With Erosive Oral Lichen Planus; Randomized Clinical Trial [NCT03293368]Phase 220 participants (Actual)Interventional2018-01-01Completed
A Phase 4 Multicenter, Randomized, Placebo Controlled Trial of 3 Doses of Intralesional Triamcinolone (KENALOG®) In the Treatment of Mild to Moderate Patch Type Alopecia Areata [NCT01898806]Phase 411 participants (Actual)Interventional2011-09-30Terminated(stopped due to The PI left the Columbia University Medical Center. Study was not Completed.)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00105027 (4) [back to overview]Adverse Ocular Outcomes
NCT00105027 (4) [back to overview]Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography
NCT00105027 (4) [back to overview]The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit
NCT00105027 (4) [back to overview]Changes From Baseline in Best-corrected ETDRS Visual Acuity Score
NCT00242580 (6) [back to overview]Number of Participants Requiring Verteporfin Treatment Throughout the Study
NCT00242580 (6) [back to overview]Percentage of Participants Who Lose Less Than 15 Letters of Best Corrected Visual Acuity (BCVA) at 12 Months From Baseline.
NCT00242580 (6) [back to overview]Percentage of Participants With Gain of 5 or More Letters of Best Corrected Visual Acuity From Baseline to Month 12
NCT00242580 (6) [back to overview]Percentage of Participants With Gain of BCVA of 10 or More Letters at 12 Months
NCT00242580 (6) [back to overview]Percentage of Participants With Gain of BCVA Score of 15 or More Letters at Month 12
NCT00242580 (6) [back to overview]Mean Change From Baseline in Total Area of Lesion at 12 Months
NCT00279916 (8) [back to overview]Complete Normalization of Abnormal Tympanometry Considering the Subjects Who Took Additional Treatment as Having Incomplete Resolution
NCT00279916 (8) [back to overview]Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment
NCT00279916 (8) [back to overview]Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears
NCT00279916 (8) [back to overview]Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual
NCT00279916 (8) [back to overview]Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears
NCT00279916 (8) [back to overview]Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears
NCT00279916 (8) [back to overview]Per-Ear Treatment Outcome
NCT00279916 (8) [back to overview]Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears
NCT00367133 (14) [back to overview]Central Subfield Thickness < 250 Microns at 2 Years
NCT00367133 (14) [back to overview]Central Subfield Thickness at 2 Years
NCT00367133 (14) [back to overview]Central Subfield Thickness on Optical Coherence Tomography (OCT) at Three Years
NCT00367133 (14) [back to overview]Change in Central Subfield Thickness on OCT Baseline to 3 Years
NCT00367133 (14) [back to overview]Change In Visual Acuity [Measured With Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS)]Baseline to 2 Years.
NCT00367133 (14) [back to overview]Change in Visual Acuity From Baseline to 3 Years
NCT00367133 (14) [back to overview]Change in Visual Acuity From Baseline to 3 Years
NCT00367133 (14) [back to overview]Mean Change in Central Subfield Thickness Baseline to 2 Years
NCT00367133 (14) [back to overview]Median Change in Central Subfield Thickness Baseline to 2 Years
NCT00367133 (14) [back to overview]Median Change in Visual Acuity Baseline to 2 Years
NCT00367133 (14) [back to overview]Overall Central Subfield Thickening Decreased by >=50% Baseline to 2 Years
NCT00367133 (14) [back to overview]Percentage of Eyes With a Change in Central Subfield Thickness on OCT <250 Microns From Baseline to 3 Years
NCT00367133 (14) [back to overview]Distribution of Visual Acuity Change Baseline to 3 Years
NCT00367133 (14) [back to overview]Distribution of Change in Visual Acuity Baseline to 2 Years
NCT00369486 (6) [back to overview]Change in Central Subfield Thickening From Baseline Through 34 Weeks
NCT00369486 (6) [back to overview]Reduction of ≥ 50% in Retinal Thickening in the Central Subfield From Baseline Through 34 Weeks
NCT00369486 (6) [back to overview]Central Subfield Thickness <250 Microns From Baseline Through 34 Weeks
NCT00369486 (6) [back to overview]Persistence/Recurrence of Diabetic Macular Edema (DME) Either Retreated or Meeting Criteria for Retreatment at 17 Weeks
NCT00369486 (6) [back to overview]Change in Visual Acuity Letter Score From Baseline Through 34 Weeks
NCT00369486 (6) [back to overview]Mean Visual Acuity Letter Score at Each Follow-up Visit
NCT00398866 (2) [back to overview]Pain Visual Analogue Scale (VAS)
NCT00398866 (2) [back to overview]Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
NCT00444600 (21) [back to overview]Central Subfield Thickness < 250 With at Least a 25 Micron Decrease From Baseline to 1 Year
NCT00444600 (21) [back to overview]Change in Retinal Thickening of Central Subfield on Optical Coherence Tomography From Baseline to 1 Year
NCT00444600 (21) [back to overview]Mean Change in Optical Coherence Tomography Retinal Volume From Baseline to 1 Year
NCT00444600 (21) [back to overview]Mean Change in Visual Acuity (Letters) From Baseline to 1 Year Adjusted for Baseline Visual Acuity
NCT00444600 (21) [back to overview]Mean Optical Coherence Tomography Retinal Volume at 1 Year
NCT00444600 (21) [back to overview]Number of Injections in First Year
NCT00444600 (21) [back to overview]Percentage of Eyes Receiving Laser at the 48 Week Visit (%)
NCT00444600 (21) [back to overview]Cardiovascular Events According to Antiplatelet Trialists' Collaboration Through 1 Year
NCT00444600 (21) [back to overview]Change From Moderately Severe Non-proliferative Diabetic Retinopathy or Better From Baseline to 1-year
NCT00444600 (21) [back to overview]Change From Severe Non-proliferative Diabetic Retinopathy or Worse From Baseline to 1-year
NCT00444600 (21) [back to overview]Change in Visual Acuity From Baseline to 1 Year Among Eyes That Had Prior Treatment for Diabetic Macular Edema
NCT00444600 (21) [back to overview]Change in Visual Acuity From Baseline to 1 Year Among Eyes That Were Pseudophakic at Baseline
NCT00444600 (21) [back to overview]Change in Visual Acuity From Baseline to 1 Year Grouped by Baseline Visual Acuity Letter Score
NCT00444600 (21) [back to overview]Change in Visual Acuity From Baseline to 1 Year Grouped by Diabetic Retinopathy Severity
NCT00444600 (21) [back to overview]Change in Visual Acuity From Baseline to 1 Year Grouped by Diffuse vs. Focal Edema as Characterized by the Investigator
NCT00444600 (21) [back to overview]Change in Visual Acuity From Baseline to 1 Year Grouped by Optical Coherence Tomography Central Subfield Thickness
NCT00444600 (21) [back to overview]Distribution of Change in Visual Acuity (Letters) From Baseline to 1 Year
NCT00444600 (21) [back to overview]Eyes With Alternative Treatments Prior to the 1-year Visit
NCT00444600 (21) [back to overview]Number of Laser Treatments Received Prior to the 1 Year Visit
NCT00444600 (21) [back to overview]Major Ocular Adverse Events During First Year of Follow-Up
NCT00444600 (21) [back to overview]Distribution of Logarithmic Transformation of Optical Coherence Tomography (LogOCT) Improvement and Worsening
NCT00445003 (8) [back to overview]Change in Optical Coherence Tomography Retinal Volume
NCT00445003 (8) [back to overview]Change in Visual Acuity From Baseline
NCT00445003 (8) [back to overview]Eyes With Anti-vascular Endothelial Growth Factor Treatment for Diabetic Macular Edema
NCT00445003 (8) [back to overview]Total Optical Coherence Tomography Retinal Volume
NCT00445003 (8) [back to overview]Additional Treatments for Diabetic Macular Edema
NCT00445003 (8) [back to overview]Number of Eyes With Additional Number of Treatments for Diabetic Macular Edema
NCT00445003 (8) [back to overview]Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 14 Weeks
NCT00445003 (8) [back to overview]Change in Optical Coherence Tomography Central Subfield Thickness
NCT00473083 (7) [back to overview]Duration of Treatment
NCT00473083 (7) [back to overview]Overall Incidence of Grade 3 Rash
NCT00473083 (7) [back to overview]Overall Incidence of Rash
NCT00473083 (7) [back to overview]Overall Survival
NCT00473083 (7) [back to overview]Time to First Presentation of Rash
NCT00473083 (7) [back to overview]Severity of Rash Caused by Erlotinib
NCT00473083 (7) [back to overview]Time Duration From Onset of Rash Until Resolution
NCT00484679 (1) [back to overview]Mean Change in Cortisol Levels From Baseline to Week 24
NCT00588354 (8) [back to overview]Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire
NCT00588354 (8) [back to overview]Pain Disability Score at 4 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire
NCT00588354 (8) [back to overview]Pain Disability Score at 2 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire (ODI)
NCT00588354 (8) [back to overview]Pain Disability Score at 4 Weeks as Measured by the Roland-Morris Disability Questionnaire
NCT00588354 (8) [back to overview]Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)
NCT00588354 (8) [back to overview]Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)
NCT00588354 (8) [back to overview]Pain Score at 2 Weeks as Measured by the Multidimensional Pain Inventory (MPI)
NCT00588354 (8) [back to overview]Pain Score at 4 Weeks as Measured by the Multidimensional Pain Inventory (MPI)
NCT00597766 (4) [back to overview]Pain Free Abduction Range of Motion (ROM)
NCT00597766 (4) [back to overview]Fugl-Meyer Motor Assessment, Upper Limb Domain
NCT00597766 (4) [back to overview]BPI 12 (Brief Pain Inventory, Question 12) Pain Questionnaire
NCT00597766 (4) [back to overview]Pain Free External Rotation Range of Motion (ROM)
NCT00746889 (2) [back to overview]Change in WOMAC Pain Subscale
NCT00746889 (2) [back to overview]Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale
NCT00798369 (7) [back to overview]The Time to 50% Reduction of Baseline Pain Intensity in the Target Joint
NCT00798369 (7) [back to overview]Amount of Rescue Medication Taken for Each Treatment Group
NCT00798369 (7) [back to overview]High Sensitivity C-reactive Protein (hsCRP) at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group
NCT00798369 (7) [back to overview]Serum Amyloid Protein (SAA) Levels at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group
NCT00798369 (7) [back to overview]The Change in Pain Intensity in the Target Joint Following Canakinumab Administration Compared to Triamcinolone Acetonide
NCT00798369 (7) [back to overview]The Dose of Canakinumab for Treatment of Acute Flares in Gout Patients That Leads to the Same Efficacy as Triamcinolone Acetonide With Respect to Pain Intensity on a 0-100 mm Visual Analog Scale (VAS)
NCT00798369 (7) [back to overview]Percentage of Participants With an Excellent or Good Response With Regards to the Patient's Global Assessment of Response to Treatment
NCT00815360 (2) [back to overview]Mean Central Foveal Thickness (CFT) on Optical Coherence Tomography (OCT) in Microns at 6 Months
NCT00815360 (2) [back to overview]Mean Change in Best Corrected Visual Acuity (BCVA), as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters From Baseline to Month 6.
NCT00826462 (33) [back to overview]No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
NCT00826462 (33) [back to overview]No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
NCT00826462 (33) [back to overview]Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
NCT00826462 (33) [back to overview]Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
NCT00826462 (33) [back to overview]Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
NCT00826462 (33) [back to overview]Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
NCT00826462 (33) [back to overview]Pain as Recorded by the Study Doctors on a 100 mm VAS-scale
NCT00826462 (33) [back to overview]Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale).
NCT00826462 (33) [back to overview]Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale).
NCT00826462 (33) [back to overview]Pain as Recorded by the Study Doctors on a Visual Analog Scale (VAS Scale)
NCT00826462 (33) [back to overview]Pain Free Function Index of Everyday Activities
NCT00826462 (33) [back to overview]Pain Free Function Index of Everyday Activities
NCT00826462 (33) [back to overview]Pain Free Function Index of Everyday Activities
NCT00826462 (33) [back to overview]Pain Free Function Index of Everyday Activities
NCT00826462 (33) [back to overview]Pain-free Grip Strength Ratio
NCT00826462 (33) [back to overview]Pain-free Grip Strength Ratio
NCT00826462 (33) [back to overview]Pain-free Grip Strength Ratio
NCT00826462 (33) [back to overview]Pain-free Grip Strength Ratio
NCT00826462 (33) [back to overview]Treatment Success - Event Rates in Each Group
NCT00826462 (33) [back to overview]Maximum Grip Strength Ratio
NCT00826462 (33) [back to overview]Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors
NCT00826462 (33) [back to overview]Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors
NCT00826462 (33) [back to overview]Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors
NCT00826462 (33) [back to overview]Affected Function on a 100 mm VAS-scale as Recorded by the Study Doctors
NCT00826462 (33) [back to overview]Maximum Grip Strength Ratio
NCT00826462 (33) [back to overview]Maximum Grip Strength Ratio
NCT00826462 (33) [back to overview]Maximum Grip Strength Ratio
NCT00826462 (33) [back to overview]No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
NCT00826462 (33) [back to overview]No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
NCT00826462 (33) [back to overview]No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
NCT00826462 (33) [back to overview]No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
NCT00826462 (33) [back to overview]No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
NCT00826462 (33) [back to overview]No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
NCT00853905 (5) [back to overview]Anterior Chamber Inflammation (Flare)
NCT00853905 (5) [back to overview]Patient Comfort
NCT00853905 (5) [back to overview]Ocular Hypotensive Medications
NCT00853905 (5) [back to overview]Intraocular Pressure (IOP)
NCT00853905 (5) [back to overview]Bleb Appearance
NCT00924508 (2) [back to overview]Number of Adverse Events Associated With Treatment
NCT00924508 (2) [back to overview]Change in Disease Severity: Percent Change in Mean EASI Score
NCT01029652 (33) [back to overview]Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale)
NCT01029652 (33) [back to overview]Patient's Global Assessment of Response to Treatment
NCT01029652 (33) [back to overview]Patient's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab
NCT01029652 (33) [back to overview]Percentage of Participants Who Took Rescue Medication
NCT01029652 (33) [back to overview]Percentage of Participants With Maximum Severity of Last Post-baseline Flare (5-point Likert Scale)
NCT01029652 (33) [back to overview]Physician's Assessment of Erythema for Patients Re-treated or Switched to Canakinumab
NCT01029652 (33) [back to overview]Physician's Assessment of Joint Swelling for Patients Re-treated or Switched to Canakinumab
NCT01029652 (33) [back to overview]Physician's Assessment of Joint Tenderness for Patients Re-treated or Switched to Canakinumab
NCT01029652 (33) [back to overview]Physician's Assessment of Range of Motion of the Most Affected Joint
NCT01029652 (33) [back to overview]Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint
NCT01029652 (33) [back to overview]Physician's Global Assessment of Response to Treatment
NCT01029652 (33) [back to overview]Physician's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab
NCT01029652 (33) [back to overview]Time to First New Flare
NCT01029652 (33) [back to overview]High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels for Core and 24 Weeks Overall
NCT01029652 (33) [back to overview]Amount of Rescue Medication Taken
NCT01029652 (33) [back to overview]High-sensitivity C-reactive Protein (hsCRP) Levels for Patients Re-treated With or Switched to Canakinumab
NCT01029652 (33) [back to overview]Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (24 Weeks Overall)
NCT01029652 (33) [back to overview]Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (72 Weeks Overall)
NCT01029652 (33) [back to overview]Flare Rate Per Year
NCT01029652 (33) [back to overview]Mean Number of New Gout Flares Per Patient
NCT01029652 (33) [back to overview]Mean Number of New Gout Flares Per Patient During the 24 Weeks of the Study
NCT01029652 (33) [back to overview]Patient's Assessment of Gout Pain Intensity in the Most Affected Joint on a Visual Analog Scale (VAS) in Extension
NCT01029652 (33) [back to overview]Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks
NCT01029652 (33) [back to overview]Percentage of Participants With Complete Resolution of Pain
NCT01029652 (33) [back to overview]Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100mm VAS)
NCT01029652 (33) [back to overview]SF36 Physical Function Score at Week 12
NCT01029652 (33) [back to overview]Time to at Least a 50% Reduction in Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100mm VAS)
NCT01029652 (33) [back to overview]Time to Complete Resolution of Pain
NCT01029652 (33) [back to overview]Time to First Intake of Rescue Medication After the Last Post Baseline Flare.
NCT01029652 (33) [back to overview]Patient's Assessment of Gout Pain Intensity in the Currently Most-affected Joint (Likert Scale)
NCT01029652 (33) [back to overview]Time to First New Flare
NCT01029652 (33) [back to overview]Time to First New Flare: Survival Analysis by Treatment (72 Weeks Overall)
NCT01029652 (33) [back to overview]Serum Amyloid A Protein (SAA) Levels for Patients Re-treated With or Switched to Canakinumab
NCT01080131 (33) [back to overview]Percentage of Participants Who Took Rescue Medication
NCT01080131 (33) [back to overview]Percentage of Patients With Maximum Severity of New Gout Flares as Severe or Extreme
NCT01080131 (33) [back to overview]Physician's Assessment of Erythema for Participants Re-treated or Switched to Canakinumab
NCT01080131 (33) [back to overview]Physician's Assessment of Joint Swelling for Participants Re-treated or Switched to Canakinumab
NCT01080131 (33) [back to overview]Physician's Assessment of Joint Tenderness for Participants Re-treated or Switched to Canakinumab
NCT01080131 (33) [back to overview]Physician's Assessment of Range of Motion of the Most Affected Joint
NCT01080131 (33) [back to overview]Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint
NCT01080131 (33) [back to overview]Physician's Global Assessment of Response to Treatment
NCT01080131 (33) [back to overview]Physician's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab
NCT01080131 (33) [back to overview]Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100 mm VAS)
NCT01080131 (33) [back to overview]Self-assessed Pain Intensity in the Joint Most Affected at Last Post-Baseline Measured on a Visual Analog Scale (VAS)
NCT01080131 (33) [back to overview]Serum Amyloid A Protein (SAA) Levels for Participants Re-treated With or Switched to Canakinumab
NCT01080131 (33) [back to overview]Time to First Intake of Rescue Medication
NCT01080131 (33) [back to overview]Flare Rate Per Year
NCT01080131 (33) [back to overview]Mean Number of New Gout Flares Per Patient During 24 Weeks
NCT01080131 (33) [back to overview]Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks of the Study
NCT01080131 (33) [back to overview]Pharmacokinetic Concentrations
NCT01080131 (33) [back to overview]Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (VAS) at 72 Hours Post-dose
NCT01080131 (33) [back to overview]SF 36 Physical Function Score at Week 12
NCT01080131 (33) [back to overview]Time to at Least a 50% Reduction in Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (VAS)
NCT01080131 (33) [back to overview]Time to Complete Resolution of Pain; Survival Analysis
NCT01080131 (33) [back to overview]Time to First New Flare: Survival Analysis by Treatment Over 72 Weeks
NCT01080131 (33) [back to overview]Time to First New Flare: Survival Analysis During the 12 Weeks of Study
NCT01080131 (33) [back to overview]Time to the First New Gout Flare During 24 Weeks
NCT01080131 (33) [back to overview]Amount of Rescue Medication Taken
NCT01080131 (33) [back to overview]High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels
NCT01080131 (33) [back to overview]High-sensitivity C-reactive Protein (hsCRP) Levels for Participants Re-treated With or Switched to Canakinumab
NCT01080131 (33) [back to overview]Number of Participants With Adverse Events, Death and Serious Adverse Events (72 Weeks Overall)
NCT01080131 (33) [back to overview]Number of Participants With Adverse Events, Death and Serious Adverse Events During 24 Weeks
NCT01080131 (33) [back to overview]Patient's Assessment of Gout Pain Intensity for Participants Re-treated or Switched to Canakinumab
NCT01080131 (33) [back to overview]Patient's Assessment of Gout Pain Intensity in the Most Affected Joint
NCT01080131 (33) [back to overview]Patient's Global Assessment of Response to Treatment
NCT01080131 (33) [back to overview]Patient's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab
NCT01154153 (6) [back to overview]Ratio of Serum Cortisol Area Under Curve [AUC(0-24 hr)] at the End of Treatment to Baseline
NCT01154153 (6) [back to overview]The Percent of Days of Rescue Medication Use During the Double-blind Treatment Phase
NCT01154153 (6) [back to overview]Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS)
NCT01154153 (6) [back to overview]Number of Participants Using Rescue Medication
NCT01154153 (6) [back to overview]Number of Participants by Relief Level as Evaluated by the Physician
NCT01154153 (6) [back to overview]Number of Participants by Relief Level as Evaluated by the Participant
NCT01175395 (2) [back to overview]To Assess the Safety & Tolerability of 20089 TA (6.9 mg or 13.8 mg) When Used Adjunctively With Lucentis 0.5 mg in Subjects With Sub-foveal Neovascular AMD
NCT01175395 (2) [back to overview]To Determine the Number of Retreatments With Lucentis in Eyes Initially Treated With 20089 TA and Lucentis
NCT01230424 (11) [back to overview]Change in Knee Stiffness During the Past 48 Hours From the WOMAC LK3.1 Stiffness Score Questionnaire.
NCT01230424 (11) [back to overview]Change in Time to Complete 5 Chair Stands.
NCT01230424 (11) [back to overview]Change in Time to Complete a Twenty-meter Walk.
NCT01230424 (11) [back to overview]Change in Function Severity During the Past 48 Hours From the WOMAC LK3.1 Function Score Questionnaire.
NCT01230424 (11) [back to overview]Change in Volume of Peri-articular Bone Marrow Lesions Measured on Knee MRI.
NCT01230424 (11) [back to overview]Change in Patient's Global Assessment (Visual Analogue Scale).
NCT01230424 (11) [back to overview]Change in Mean Cartilage Thickness in the Index Compartment (Compartment With the Most Damage)
NCT01230424 (11) [back to overview]Change in Volumetric Cartilage Damage Index (CDI) Measured on Knee MRI in the Index Compartment (Compartment With the Most Damage).
NCT01230424 (11) [back to overview]Change in Knee Pain Severity During the Past 48 Hours From the WOMAC LK3.1 Pain Score Questionnaire.
NCT01230424 (11) [back to overview]Change in Effusion Volume Measured on Knee MRI.
NCT01230424 (11) [back to overview]Change in Area of Denudation Measured on Knee MRI in the Index Compartment (Compartment With the Most Damage).
NCT01356602 (18) [back to overview]Physician's Assessment of Erythema
NCT01356602 (18) [back to overview]Physician's Assessment of Range of Motion of the Most Affected Joint
NCT01356602 (18) [back to overview]Physician's Assessment of Swelling
NCT01356602 (18) [back to overview]Physician's Assessment of Tenderness
NCT01356602 (18) [back to overview]Amount of Rescue Medication Taken (mg)
NCT01356602 (18) [back to overview]Time to the First New Gouty Arthritis Flare
NCT01356602 (18) [back to overview]Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale
NCT01356602 (18) [back to overview]C-reactive Protein Level
NCT01356602 (18) [back to overview]Number of Patients With at Least One New Gouty Arthritis Flare After Baseline
NCT01356602 (18) [back to overview]Pain Intensity on a 0 - 100 mm VAS Between the Canakinumab 150 mg PFS and Canakinumab 150 mg LYO Groups
NCT01356602 (18) [back to overview]Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups
NCT01356602 (18) [back to overview]Patient's Assessment of Pain Intensity on a 0-100mm VAS
NCT01356602 (18) [back to overview]Proportion of Patients With Rescue Medication Intake
NCT01356602 (18) [back to overview]Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS
NCT01356602 (18) [back to overview]Time to First Rescue Medication Intake
NCT01356602 (18) [back to overview]Time to Resolution of Gouty Arthritis Flare as Reported by Patient
NCT01356602 (18) [back to overview]Patient's Assessment of Pain Intensity on a 5-point Likert Scale
NCT01356602 (18) [back to overview]Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale
NCT01362608 (16) [back to overview]High Sensitivity C-reactive Protein [hsCRP] Measured in the Serum at 72 Hours Post Dose
NCT01362608 (16) [back to overview]The Number of Patients With at Least 1 New Gout Flare
NCT01362608 (16) [back to overview]Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment
NCT01362608 (16) [back to overview]Time to First New Flare: Survival Analysis by Treatment: Kaplan Meier Analysis
NCT01362608 (16) [back to overview]Time to Complete Resolution of Pain: Survival Analysis by Treatment
NCT01362608 (16) [back to overview]Time to at Least a 50% Reduction in Baseline Pain Intensity: Survival Analysis by Treatment
NCT01362608 (16) [back to overview]The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS)
NCT01362608 (16) [back to overview]Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
NCT01362608 (16) [back to overview]Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
NCT01362608 (16) [back to overview]Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
NCT01362608 (16) [back to overview]Time to First Rescue Medication Intake
NCT01362608 (16) [back to overview]Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare.
NCT01362608 (16) [back to overview]Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
NCT01362608 (16) [back to overview]Percent Patients Who Took Rescue Medication
NCT01362608 (16) [back to overview]Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
NCT01362608 (16) [back to overview]Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
NCT01470989 (3) [back to overview]Patient's Assessment of Gout Pain Intensity in the Most Affected Joint
NCT01470989 (3) [back to overview]Number of Incidence Rate (IR) of Adverse Events, Serious Adverse Events and Death Per 100 Patient-years in Participants
NCT01470989 (3) [back to overview]Number of New Flares Per Participant
NCT01487161 (16) [back to overview]Percent of Responders According to OMERACT-OARSI Criteria at Week 8
NCT01487161 (16) [back to overview]Responder Status as Defined by the Proportion of Patients Achieving >20% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8
NCT01487161 (16) [back to overview]Responder Status as Defined by the Proportion of Patients Achieving >30% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8
NCT01487161 (16) [back to overview]Patient Global Impression of Change Scores at Week 8
NCT01487161 (16) [back to overview]Change From Baseline to Each of Weeks 1, 2, 3, 4, 5, 6, 7, 9, and 11 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score.
NCT01487161 (16) [back to overview]Change From Baseline to Week 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg
NCT01487161 (16) [back to overview]Change From Baseline to Week 8 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg
NCT01487161 (16) [back to overview]Change From Baseline to Week 10 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg
NCT01487161 (16) [back to overview]Responder Status as Defined by the Proportion of Patients Achieving >50% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8
NCT01487161 (16) [back to overview]WOMAC A (Pain Subscale) Change From Baseline at Week 8
NCT01487161 (16) [back to overview]WOMAC A1 (Pain on Walking Question) Change From Baseline at Week 8
NCT01487161 (16) [back to overview]WOMAC B (Stiffness Subscale) Change From Baseline at Week 8
NCT01487161 (16) [back to overview]WOMAC C (Function Subscale) Change From Baseline at Week 8
NCT01487161 (16) [back to overview]Change From Baseline to Each of Weeks 8, 10, and 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 10mg and 40 mg vs TCA IR 40 mg
NCT01487161 (16) [back to overview]Average Weekly and Total Consumption of Rescue Medications Over 8 Weeks.
NCT01487161 (16) [back to overview]Clinical Global Impression of Change Scores at Week 8
NCT01487200 (5) [back to overview]Total 24-hour Urinary Free Cortisol Excretion
NCT01487200 (5) [back to overview]Change From Baseline in 24-hour Urinary Free Cortisol Excretion
NCT01487200 (5) [back to overview]Change From Baseline in 24-hour Weighted Mean Serum Cortisol
NCT01487200 (5) [back to overview]Change From Baseline to Each Measured Time Point Post-dose in Morning Serum Cortisol
NCT01487200 (5) [back to overview]Characterize the Pharmacokinetic Profile of FX006 and TCA IR
NCT01614509 (2) [back to overview]Additional Intravitreal Bevacizumab Injection
NCT01614509 (2) [back to overview]Changes of Central Retinal Thickness
NCT01652495 (3) [back to overview]Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis
NCT01652495 (3) [back to overview]Functional Improvement Measured According to Percentage Change in Constant Score
NCT01652495 (3) [back to overview]Reduction of Pain Severity Expressed as Percentage Change in VAS Score
NCT01692756 (13) [back to overview]Synovial Glycosaminoglycans (GAG) Concentration
NCT01692756 (13) [back to overview]Synovial Interleukin-1 Receptor Antagonist (IL-1ra) Concentration
NCT01692756 (13) [back to overview]Synovial Interleukin-1α (IL-1α) Concentration
NCT01692756 (13) [back to overview]Synovial Interleukin-1β (IL-1β) Concentration
NCT01692756 (13) [back to overview]Synovial Matrix Metalloproteinase 1 (MMP-1) Concentration
NCT01692756 (13) [back to overview]Synovial Matrix Metalloproteinase 9 (MMP-9) Concentration
NCT01692756 (13) [back to overview]Synovial TNF-stimulated Gene 6 Protein (TSG-6) Concentration
NCT01692756 (13) [back to overview]Synovial Type I Collagen Cross-Linked N-Telopeptide (NTX-I) Concentration
NCT01692756 (13) [back to overview]Synovial Matrix Metalloproteinase 3 (MMP-3) Concentration
NCT01692756 (13) [back to overview]Efficacy of Kenalog to Alleviate Knee Pain
NCT01692756 (13) [back to overview]Participant Pain Assessment
NCT01692756 (13) [back to overview]Synovial C-terminal Peptide II (CTXII) Concentration
NCT01692756 (13) [back to overview]Synovial Cartilage Oligomeric Matrix Protein (COMP) Concentration
NCT01770912 (15) [back to overview]Change From Pre-Treatment Palpable Muscle Tenderness at 12 Weeks
NCT01770912 (15) [back to overview]Change From Pre-Treatment Functional Pain (Chewing) at 12 Weeks
NCT01770912 (15) [back to overview]Change From Pre-Treatment in TMJ Loading Pain Rating at 2 Weeks
NCT01770912 (15) [back to overview]Change From Pre-Treatment in TMJ Loading Pain Rating at 12 Weeks
NCT01770912 (15) [back to overview]Change From Pre-Treatment in Mandibular Range of Pain-Free Motion at 12 Weeks
NCT01770912 (15) [back to overview]Change From Pre-Treatment in Mandibular Range of Motion Without Pain at 2 Weeks
NCT01770912 (15) [back to overview]Change From Pre-Treatment in TMJ Loading Pain Rating at 6 Weeks
NCT01770912 (15) [back to overview]Change From Pre-Treatment in Mandibular Range of Motion at 6 Weeks
NCT01770912 (15) [back to overview]Change From Pre-Treatment Palpable Muscle Tenderness at 2 Weeks
NCT01770912 (15) [back to overview]Change From Pre-Treatment Palpable Muscle Tenderness at 6 Weeks
NCT01770912 (15) [back to overview]Number of Participants With Change From Pre-Treatment Joint Sounds in 12 Weeks
NCT01770912 (15) [back to overview]Number of Participants With Change From Pre-Treatment Joint Sounds in 2 Weeks
NCT01770912 (15) [back to overview]Change From Pre-Treatment Functional Pain (Chewing) at 6 Weeks
NCT01770912 (15) [back to overview]Change From Pre-Treatment Functional Pain (Chewing) at 2 Weeks
NCT01770912 (15) [back to overview]Number of Participants With Change From Pre-Treatment Joint Sounds in 6 Weeks
NCT01789320 (4) [back to overview]Vitreous Haze Grade
NCT01789320 (4) [back to overview]Change in Intraocular Pressure (IOP)
NCT01789320 (4) [back to overview]Best Corrected Visual Acuity
NCT01789320 (4) [back to overview]Central Subfield Thickness Using Optical Coherence Tomography (OCT)
NCT01797432 (2) [back to overview]Number of Adverse Events Reported by Subjects
NCT01797432 (2) [back to overview]Change in Alopecia Areata Half Head Severity Score (AAHHSS) at 12 Weeks Compared to Baseline
NCT01898806 (1) [back to overview]Number of Adverse Events
NCT01995045 (4) [back to overview]Mean Pain Score
NCT01995045 (4) [back to overview]Mean Oxycodone Intake
NCT01995045 (4) [back to overview]Mean Hydrocodone Intake
NCT01995045 (4) [back to overview]Mean Acetaminophen Intake
NCT02003365 (2) [back to overview]Concentration of Triamcinolone Acetonide in Synovial Fluid
NCT02003365 (2) [back to overview]Plasma Drug Concentrations by Time
NCT02084706 (1) [back to overview]Difference in Visual-analog Score (VAS) for Anticipated Pain Prior to Injection and Actual Pain After Injection
NCT02120261 (4) [back to overview]Pain Intensity
NCT02120261 (4) [back to overview]Pain Intensity
NCT02120261 (4) [back to overview]Pain Intensity
NCT02120261 (4) [back to overview]Duration of Pain Relief
NCT02242630 (2) [back to overview]Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale
NCT02242630 (2) [back to overview]Change in Shoulder Function, as Measured by the QuickDASH ®
NCT02329600 (2) [back to overview]Pain
NCT02329600 (2) [back to overview]Salivary Total Oxidative Capacity
NCT02357459 (14) [back to overview]Responder Status as Defined by Proportion of Patients Experiencing >30% Decrease in Pain From Baseline in Weekly Mean of the ADP Scores at Each Week (Weeks 1-24)
NCT02357459 (14) [back to overview]Responder Status as Defined by Proportion of Patients Experiencing >50% Decrease in Pain From Baseline in Weekly Mean of the ADP Scores at Each Week (Weeks 1-24)
NCT02357459 (14) [back to overview]Area Under the Effect Curve (AUE) of Change From Baseline in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to Placebo
NCT02357459 (14) [back to overview]AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR
NCT02357459 (14) [back to overview]AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 24 for FX006 Relative to Placebo
NCT02357459 (14) [back to overview]Change From Baseline to Week 12 in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR
NCT02357459 (14) [back to overview]Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain (ADP) Intensity Scores for 32 mg FX006 Versus Placebo
NCT02357459 (14) [back to overview]Time to Onset of Pain Relief
NCT02357459 (14) [back to overview]Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
NCT02357459 (14) [back to overview]Change From Baseline Over Time for Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Subscale at Weeks 4, 8, 12 and 24
NCT02357459 (14) [back to overview]Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24.
NCT02357459 (14) [back to overview]Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24
NCT02357459 (14) [back to overview]Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24
NCT02357459 (14) [back to overview]Change From Baseline to Each Week in Weekly Mean of the ADP Scores
NCT02369068 (9) [back to overview]Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS) Questionnaire.
NCT02369068 (9) [back to overview]Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS) Questionnaire.
NCT02369068 (9) [back to overview]Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS).
NCT02369068 (9) [back to overview]Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire.
NCT02369068 (9) [back to overview]Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire.
NCT02369068 (9) [back to overview]Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire.
NCT02369068 (9) [back to overview]Pain Severity Assessed by Change in Overall Pain and Other Related Scores Using Questions 3, 4, 5, and 6 in the Brief Pain Inventory (BPI) Questionnaire.
NCT02369068 (9) [back to overview]Pain Severity Assessed by Change in Overall Pain and Other Related Scores Using Questions 3, 4, 5, and 6 in the Brief Pain Inventory (BPI) Questionnaire.
NCT02369068 (9) [back to overview]Pain Severity Assessed by Change in Overall Pain and Other Related Scores Using Questions 3, 4, 5, and 6 in the Brief Pain Inventory (BPI) Questionnaire.
NCT02374060 (15) [back to overview]Proportion of Eyes With Resolution of Macular Edema at 8 Weeks
NCT02374060 (15) [back to overview]Change in Best-corrected Visual Acuity at 24 Weeks
NCT02374060 (15) [back to overview]Change in Best-corrected Visual Acuity at 8 Weeks
NCT02374060 (15) [back to overview]Cumulative Proportion of Eyes With an IOP Elevation >=24 mm Hg
NCT02374060 (15) [back to overview]Cumulative Proportion of Eyes With an IOP Elevation >=30 mm Hg
NCT02374060 (15) [back to overview]Cumulative Proportion of Eyes With an IOP Elevation of >=10 mm Hg Over Baseline
NCT02374060 (15) [back to overview]Cumulative Proportion of Eyes With Severe Vision Loss
NCT02374060 (15) [back to overview]Number of Eyes With Endophthalmitis
NCT02374060 (15) [back to overview]Number of Eyes With Retinal Tear or Detachment
NCT02374060 (15) [back to overview]Number of Eyes With Vitreous Hemorrhage
NCT02374060 (15) [back to overview]Proportion of Baseline Central Subfield Thickness Observed at 24 Weeks
NCT02374060 (15) [back to overview]Proportion of Baseline Central Subfield Thickness Observed at 8 Weeks
NCT02374060 (15) [back to overview]Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 24 Weeks
NCT02374060 (15) [back to overview]Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 8 Weeks
NCT02374060 (15) [back to overview]Proportion of Eyes With Resolution of Macular Edema at 24 Weeks
NCT02381652 (1) [back to overview]Number of Treatment-Emergent Adverse Events: Cingal 13-02 vs. Cingal 13-01
NCT02519738 (1) [back to overview]Decrease in Size (mm) of Granulation Tissue
NCT02592629 (1) [back to overview]Change in Pain Assessment
NCT02595398 (3) [back to overview]Number of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks
NCT02595398 (3) [back to overview]Mean Change From Baseline in Central Subfield Thickness
NCT02595398 (3) [back to overview]Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
NCT02637323 (4) [back to overview]Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort
NCT02637323 (4) [back to overview]Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort
NCT02637323 (4) [back to overview]Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid
NCT02637323 (4) [back to overview]Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid
NCT02680301 (2) [back to overview]Efficacy of 0.1% Triamcinolone Containing Wet Wrap as an Ointment or as a Cream Formulation in Patients With Moderate to Severe Atopic Dermatitis
NCT02680301 (2) [back to overview]Number of Patients Adhering to Treatment Protocol
NCT02762370 (7) [back to overview]Percent Time Blood Glucose Less Than 70 mg/dl, 70 - 180 mg/dl, 180.1 - 250.0 mg/dl, 250.1 - 350.0 mg/dl, and Greater Than 350.0 mg/dl
NCT02762370 (7) [back to overview]Change in Average Blood Glucose From Baseline (Hour -48 to Hour -1) to Hour 1 to Hour 48 for FX006 32 mg Relative to TCA IR 40 mg.
NCT02762370 (7) [back to overview]Change From Baseline for Average Blood Glucose (mg/dL)
NCT02762370 (7) [back to overview]Change From Baseline for Maximum Blood Glucose: Baseline Average Blood Glucose (Hour -72 to Hour -1) to Maximum Blood Glucose (Hour 1 to Hour 72) for FX006 32 mg Relative to TCA IR 40 mg
NCT02762370 (7) [back to overview]Glycemic Variability Coeffecient of Variation (CV)
NCT02762370 (7) [back to overview]Area Under the Effect (AUE) Curves for Average Blood Glucose - FX006 Versus TCA IR
NCT02762370 (7) [back to overview]Percent Time Blood Glucose Less Than 70 mg/dl, 70 - 180 mg/dl, 180.1 - 250.0 mg/dl, 250.1 - 350.0 mg/dl, and Greater Than 350.0 mg/dl
NCT02767492 (5) [back to overview]Visual Analog Pain Score
NCT02767492 (5) [back to overview]Single Alpha Numeric Evaluation (SANE)
NCT02767492 (5) [back to overview]Lysholm Knee Score
NCT02767492 (5) [back to overview]Knee Injury and Osteoarthritis Outcome Score (KOOS)
NCT02767492 (5) [back to overview]Veterans Rand 12 Item Health Survey
NCT02781818 (3) [back to overview]Patient Rating of Impression of Treatment at Day 14
NCT02781818 (3) [back to overview]Number of Days to Lesion Resolution in Combined Treatment Arms Compared to the Placebo Arm.
NCT02781818 (3) [back to overview]Change in Pain From Baseline to Day 5
NCT02877485 (2) [back to overview]Nasal Obstruction as Measured by Nasal Obstruction Symptom Evaluation (NOSE) Scores Following Therapy With Treatment (Triamcinolone Acetonide) and Placebo (Ayr Saline Spray)
NCT02877485 (2) [back to overview]Nasal Obstruction Symptom Evaluation (NOSE) Score Following Surgery in Subset of Patients Who Elect to Undergo Surgery.
NCT02949024 (5) [back to overview]CLS-TA Injections
NCT02949024 (5) [back to overview]Mean Change From Baseline in Central Subfield Thickness
NCT02949024 (5) [back to overview]Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
NCT02949024 (5) [back to overview]Mean Change From Baseline in Intraocular Pressure
NCT02949024 (5) [back to overview]Best Corrected Visual Acuity
NCT02952001 (4) [back to overview]Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
NCT02952001 (4) [back to overview]Mean Change From Baseline in Best Corrected Visual Acuity
NCT02952001 (4) [back to overview]Time to Additional Therapy for Uveitis
NCT02952001 (4) [back to overview]Mean Change From Baseline in Central Subfield Thickness
NCT02980874 (3) [back to overview]Mean Change From Baseline in Central Subfield Thickness
NCT02980874 (3) [back to overview]Mean Change From Baseline in Best Corrected Visual Acuity
NCT02980874 (3) [back to overview]Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)
NCT02996097 (2) [back to overview]Mean Change in Composite Observer Score for Patient and Observer Scar Assessment Scale (POSAS)
NCT02996097 (2) [back to overview]Mean Change in Composite Patient Score for Patient and Observer Scar Assessment Scale (POSAS)
NCT03002974 (25) [back to overview]Change in Patient-assessed Pain Intensity in the Index Joint From Baseline at Time Points From 6 Hours to 8 Days for the First Gout Flare Treated in the Study as Measured by 5-point Likert Scale
NCT03002974 (25) [back to overview]Change in Patient-assessed Pain Intensity in the Index Joint From Baseline to 24-72 Hours for the First Gout Flare Treated in the Study as Measured by VAS
NCT03002974 (25) [back to overview]Physician's Assessment of Clinical Signs in Index Joint: Tenderness
NCT03002974 (25) [back to overview]Median Time to Response
NCT03002974 (25) [back to overview]The Percent of Patients With at Least One Serious Adverse Event, Including Death
NCT03002974 (25) [back to overview]Median Time to Resolution of Pain
NCT03002974 (25) [back to overview]Health Care Resource Utilization Due to a Gouty Arthritis Flare
NCT03002974 (25) [back to overview]Patient´s Assessment of Global Response to Treatment (5-point Likert Scale)
NCT03002974 (25) [back to overview]Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares
NCT03002974 (25) [back to overview]Change From Baseline in Short Form (36) Health Survey, Acute Version 2 (SF-36®) Physical Functioning Domain Score
NCT03002974 (25) [back to overview]Median Time to First Intake of Rescue Medication From First Investigational Drug Administration
NCT03002974 (25) [back to overview]Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares
NCT03002974 (25) [back to overview]Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares
NCT03002974 (25) [back to overview]Physician's Assessment of Clinical Signs in Index Joint: Erythema
NCT03002974 (25) [back to overview]Change From Baseline in Health Related Quality of Life EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
NCT03002974 (25) [back to overview]Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
NCT03002974 (25) [back to overview]The Percent of Patients With at Least One Adverse Event
NCT03002974 (25) [back to overview]Change From Baseline in the Inflammatory Biomarker C Reactive Protein
NCT03002974 (25) [back to overview]Change From Baseline in the Inflammatory Biomarker Serum Amyloid A
NCT03002974 (25) [back to overview]Median Time to Onset of Effect
NCT03002974 (25) [back to overview]Physician's Assessment of Global Response to Treatment
NCT03002974 (25) [back to overview]Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra
NCT03002974 (25) [back to overview]Proportion of Patients With Neutralizing Antibodies
NCT03002974 (25) [back to overview]Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra
NCT03002974 (25) [back to overview]Physician's Assessment of Clinical Signs in Index Joint: Swelling
NCT03097315 (5) [back to overview]Mean Intraocular Pressure in the Study Eye
NCT03097315 (5) [back to overview]Number of Patients With a Grade of 0 in Anterior Chamber Cells in the Study Eye
NCT03097315 (5) [back to overview]Number of Patients With a Grade of 0 in Anterior Chamber Flare in the Study Eye
NCT03097315 (5) [back to overview]Number of Patients With a Grade of 0 in Vitreous Haze in the Study Eye
NCT03097315 (5) [back to overview]Adverse Events
NCT03126786 (2) [back to overview]Mean Change From Baseline in Best Corrected Visual Acuity Letter Score
NCT03126786 (2) [back to overview]Mean Change From Baseline in Central Subfield Thickness
NCT03127137 (1) [back to overview]Change in Strength in Both Groups After CESI.
NCT03191903 (11) [back to overview]Change From Baseline in Patient Global Assessment at 26 Weeks (ITT Population)
NCT03191903 (11) [back to overview]Change From Baseline in the Evaluator Global Assessment at 26 Weeks (ITT Population)
NCT03191903 (11) [back to overview]Change From Baseline in Total WOMAC Score at 26 Weeks (ITT Population)
NCT03191903 (11) [back to overview]Change From Baseline in WOMAC Pain Score at 1 Week (ITT Population)
NCT03191903 (11) [back to overview]Change From Baseline in WOMAC Pain Score at 26 Weeks (ITT Population)
NCT03191903 (11) [back to overview]Change From Baseline in WOMAC Pain Score at 3 Weeks (ITT Population)
NCT03191903 (11) [back to overview]Change From Baseline in WOMAC Pain Score at 3 Weeks in the Per-Protocol Population
NCT03191903 (11) [back to overview]Change From Baseline in WOMAC Physical Function Score at 26 Weeks (ITT Population)
NCT03191903 (11) [back to overview]Change From Baseline in WOMAC Stiffness Score at 26 Weeks (ITT Population)
NCT03191903 (11) [back to overview]OMERACT-OARSI Responder Index at 26 Weeks Post Treatment Comparing the Cingal Group to the TH Group (ITT Population)
NCT03191903 (11) [back to overview]The Usage of Rescue Medication (Acetaminophen) Through 26 Weeks (ITT Population)
NCT03203447 (3) [back to overview]Mean Change From Baseline in Best Corrected Visual Acuity
NCT03203447 (3) [back to overview]Mean Change From Baseline in Central Subfield Thickness
NCT03203447 (3) [back to overview]Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)
NCT03378076 (2) [back to overview]Incidence of Treatment Emergent Adverse Events
NCT03378076 (2) [back to overview]Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma
NCT03380026 (3) [back to overview]Severity of Dermatitis
NCT03380026 (3) [back to overview]Efficacy of Valchlor vs Valchlor Plus Triamcinolone
NCT03380026 (3) [back to overview]Incidence of Moderate to Severe Contact Dermatitis by SCORD Scoring
NCT03382262 (2) [back to overview]Total Number of Treatment Emergent Adverse Events
NCT03382262 (2) [back to overview]Concentration of Triamcinolone Acetonide (TA) in Blood Plasma
NCT03382821 (4) [back to overview]"The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating Much Improved and Very Much Improved)"
NCT03382821 (4) [back to overview]Neck Disability Index-5
NCT03382821 (4) [back to overview]Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III
NCT03382821 (4) [back to overview]The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score
NCT03390036 (8) [back to overview]Change From Baseline in Patient Global Assessment at 39 Weeks
NCT03390036 (8) [back to overview]Change From Baseline in WOMAC Physical Function Score at 39 Weeks
NCT03390036 (8) [back to overview]Change From Baseline in WOMAC Pain Score at 39 Weeks
NCT03390036 (8) [back to overview]Change From Baseline in Total WOMAC Score at 39 Weeks
NCT03390036 (8) [back to overview]Change From Baseline in WOMAC Stiffness Score at 39 Weeks
NCT03390036 (8) [back to overview]Change From Baseline in Evaluator Global Assessment at 39 Weeks
NCT03390036 (8) [back to overview]The Usage of Rescue Medication (Acetaminophen) at Week 39
NCT03390036 (8) [back to overview]OMERACT-OARSI Responder Rate at 39 Weeks
NCT03463915 (7) [back to overview]Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire
NCT03463915 (7) [back to overview]Change From Baseline in Treatment Response as Measured by the Visual Analogue Scale (VAS) for Pain
NCT03463915 (7) [back to overview]Number of Participants With at Least One Adverse Event
NCT03463915 (7) [back to overview]Pelvic Floor Distress Inventory (PFDI)
NCT03463915 (7) [back to overview]Pelvic Pain and Urgency/Frequency (PUF) Questionnaire
NCT03463915 (7) [back to overview]Sexual Function Measured by the Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) Questionnaire
NCT03463915 (7) [back to overview]Overactive Bladder Questionnaire (OAB-q)
NCT03636373 (4) [back to overview]Patient's Assessment of Response to Treatment
NCT03636373 (4) [back to overview]Physician's Assessment of Response to Treatment
NCT03636373 (4) [back to overview]Joint Pain on Numeric Pain Scale
NCT03636373 (4) [back to overview]Joint Pain Intensity in the Most Affected Joint
NCT03758365 (2) [back to overview]Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle
NCT03758365 (2) [back to overview]Comparison of the Vasoconstriction Potential (Skin Blanching Effect) of the MC2-01 Cream With Active Comparators and Vehicle
NCT03797872 (1) [back to overview]Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study
NCT03895840 (6) [back to overview]30 Second Chair Standing Test
NCT03895840 (6) [back to overview]KOOS-PS (Knee Osteoarthritis Outcome Score - Physical Function Short Form)
NCT03895840 (6) [back to overview]KOOS-QoL (Knee Osteoarthritis Outcome Score - Quality of Life)
NCT03895840 (6) [back to overview]NRS for Pain
NCT03895840 (6) [back to overview]Timed Stair Climb
NCT03895840 (6) [back to overview]40m Fast Paced Walking Test (40m FPWT)
NCT04115644 (8) [back to overview]Visual Analog Scale
NCT04115644 (8) [back to overview]Visual Analog Scale
NCT04115644 (8) [back to overview]Visual Analog Scale
NCT04115644 (8) [back to overview]Visual Analog Scale
NCT04115644 (8) [back to overview]Visual Analog Scale
NCT04115644 (8) [back to overview]Visual Analog Scale
NCT04115644 (8) [back to overview]Visual Analog Scale
NCT04115644 (8) [back to overview]Visual Analog Scale
NCT04216017 (2) [back to overview]Visual Analogue Scale
NCT04216017 (2) [back to overview]American Shoulder Elbow Society Score
NCT04231318 (15) [back to overview]Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score
NCT04231318 (15) [back to overview]The Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index
NCT04231318 (15) [back to overview]The Usage of Rescue Medication (Acetaminophen/Paracetamol) at 26 Weeks
NCT04231318 (15) [back to overview]Change From Baseline in Knee Pain as Measured by Numerical Rating Scale (NRS) Pain Score
NCT04231318 (15) [back to overview]Change From Baseline in the Evaluator Global Assessment (EGA) Score
NCT04231318 (15) [back to overview]Change From Baseline in the Patient Global Assessment (PGA) Score
NCT04231318 (15) [back to overview]Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score
NCT04231318 (15) [back to overview]Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Score
NCT04231318 (15) [back to overview]Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score
NCT04231318 (15) [back to overview]Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score
NCT04231318 (15) [back to overview]Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score
NCT04231318 (15) [back to overview]Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score
NCT04231318 (15) [back to overview]Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score
NCT04231318 (15) [back to overview]Change From Baseline in Knee Pain as Measured by Visual Analog Scale (VAS) Pain Score
NCT04231318 (15) [back to overview]Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Stiffness Score
NCT04582669 (5) [back to overview]Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
NCT04582669 (5) [back to overview]Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
NCT04582669 (5) [back to overview]Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
NCT04582669 (5) [back to overview]Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
NCT04582669 (5) [back to overview]Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
NCT05438277 (1) [back to overview]Incidence of a Flare Reaction

Adverse Ocular Outcomes

(NCT00105027)
Timeframe: 12 months

,,,,,
Interventionevents (Number)
Initiation of IOP-lowering medicationsIOP > 35 mm HGIOP > 10 mm HG above baselineLaser peripheral iridotomyTrabeculectomyTube shuntCataract: lens opacity onset or progressionCataract surgeryInfectious endophthalmitisNoninfectious endophthalmitisRetinal detachmentIris neovascularizationRetinal neovascularizationVitreous hemorrhageYAG capsulotomySector or panretinal photocagulationPars plana vitrectomy
BRVO 1 mg Dose Triamcinolone Acetonide11212000270001111010
BRVO 4 mg Dose Triamcinolone Acetonide571450100384100233141
BRVO Standard Care311000153001152151
CRVO 1 mg Dose Triamcinolone Acetonide18515002200000924092
CRVO 4 mg Dose Triamcinolone Acetonide32824100254000420030
CRVO Observation712000120000244151

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Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography

(NCT00105027)
Timeframe: 12 months

Interventionum (Median)
CRVO Observation-277
CRVO 1 mg Dose Triamcinolone Acetonide-196
CRVO 4 mg Dose Triamcinolone Acetonide-261
BRVO Standard Care-224
BRVO 1 mg Dose Triamcinolone Acetonide-149
BRVO 4 mg Dose Triamcinolone Acetonide-170

[back to top]

The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit

Visual acuity testing was done using electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity testing at 3 meters using the Electronic Visual Acuity Tester by a SCORE certified technician. A masked visual acuity examiner with no knowledge of treatment assignments performed visual acuity testing at the 4-month, 12-month, 24-month and 36-month visits. An E-ETDRS visual acuity score of 85 is approximately 20/20, and a score of 20 letters is approximately 20/400. A visual acuity letter score change of 15 is about three lines on a vision chart. (NCT00105027)
Timeframe: Change from baseline to 12 months

InterventionParticipants (Number)
CRVO Observation5
CRVO 1 mg Dose Triamcinolone Acetonide22
CRVO 4 mg Dose Triamcinolone Acetonide21
BRVO Standard Care35
BRVO 1 mg Dose Triamcinolone Acetonide31
BRVO 4 mg Dose Triamcinolone Acetonide34

[back to top]

Changes From Baseline in Best-corrected ETDRS Visual Acuity Score

(NCT00105027)
Timeframe: 12 months

Interventionletters read (Mean)
CRVO Observation-12.1
CRVO 1 mg Dose Triamcinolone Acetonide-1.2
CRVO 4 mg Dose Triamcinolone Acetonide-1.2
BRVO Standard Care4.2
BRVO 1 mg Dose Triamcinolone Acetonide5.7
BRVO 4 mg Dose Triamcinolone Acetonide4.0

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Number of Participants Requiring Verteporfin Treatment Throughout the Study

Participants received study drug at the Baseline visit and subsequent retreatment at 3 month intervals if leakage was detected on the fluorescein angiogram. The cumulative distribution of the number of treatments is shown per arm. (NCT00242580)
Timeframe: Baseline to Month 12

,,
InterventionParticipants (Number)
Participants who received 1 treatmentParticipants who received 2 treatmentsParticipants who received 3 treatmentsParticipants who received 4 treatments
Verteporfin + 1 mg Triamcinolone111092
Verteporfin + 4 mg Triamcinolone1215122
Verteporfin + Pegaptanib101954

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Percentage of Participants Who Lose Less Than 15 Letters of Best Corrected Visual Acuity (BCVA) at 12 Months From Baseline.

BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decrease in score indicates worsening of vision. This outcome assessed the percentage of participants who lost less than 15 letters of visual acuity at 12 months as compared with baseline. (NCT00242580)
Timeframe: Baseline to Month 12

InterventionPercentage of Participants (Number)
Verteporfin + 1 mg Triamcinolone59.4
Verteporfin + 4 mg Triamcinolone63.4
Verteporfin + Pegaptanib71.1

[back to top]

Percentage of Participants With Gain of 5 or More Letters of Best Corrected Visual Acuity From Baseline to Month 12

BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 5 or more letters of visual acuity at 12 months compared with baseline. (NCT00242580)
Timeframe: Baseline to Month 12

InterventionPercentage of Participants (Number)
Verteporfin + 1 mg Triamcinolone31.3
Verteporfin + 4 mg Triamcinolone12.2
Verteporfin + Pegaptanib28.9

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Percentage of Participants With Gain of BCVA of 10 or More Letters at 12 Months

BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 10 or more letters of visual acuity at 12 months as compared with baseline. (NCT00242580)
Timeframe: Baseline to Month 12

InterventionPercentage of Participants (Number)
Verteporfin + 1 mg Triamcinolone18.8
Verteporfin + 4 mg Triamcinolone2.4
Verteporfin + Pegaptanib23.7

[back to top]

Percentage of Participants With Gain of BCVA Score of 15 or More Letters at Month 12

BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 15 or more letters of visual acuity at 12 months as compared with baseline. (NCT00242580)
Timeframe: Baseline to Month 12

InterventionPercentage of Participants (Number)
Verteporfin + 1 mg Triamcinolone6.3
Verteporfin + 4 mg Triamcinolone0
Verteporfin + Pegaptanib13.2

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Mean Change From Baseline in Total Area of Lesion at 12 Months

Fluorescein angiography (FA) was used to assess total lesion area. All angiographs were sent to the Central Reading Center (CRC) for analysis. (NCT00242580)
Timeframe: Baseline to Month 12

,,
Interventionmm^2 (Mean)
Baseline12 MonthsChange from Baseline
Verteporfin + 1 mg Triamcinolone6.91786.8959-0.0219
Verteporfin + 4 mg Triamcinolone5.64005.81490.1749
Verteporfin + Pegaptanib6.30118.62452.3234

[back to top]

Complete Normalization of Abnormal Tympanometry Considering the Subjects Who Took Additional Treatment as Having Incomplete Resolution

For this outcome measure, the subjects treated with antibiotics or oral decongestants while enrolled in the study were handled as having treatment failures. For this outcome measure, subjects with complete normalization of abnormal tympanometry at 6 weeks had a Type A tympanogram and did not take antibiotics, oral decongestants, nasal spray or a combination. (NCT00279916)
Timeframe: 6 weeks

Interventionparticipants (Number)
Triamcinolone Acetonide5
Placebo9

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Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment

Number of subjects with resolution of eustachian tube dysfunction symptoms, as determined by the change in tympanogram type in both ears from an initial Type B or C result to Type A result at 6 weeks. Type A; peaked pressure measurement under -100 kilo Pascals (kPa). Type B; non-peaked, or flat tympanogram, Type C; peaked pressure measurements more negative than -100 kPa. A Pascal is a unit used to quantify internal pressure. (NCT00279916)
Timeframe: 6 weeks

Interventionparticipants (Number)
Triamcinolone Acetonide7
Placebo12

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Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears

As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse. (NCT00279916)
Timeframe: baseline, 6 weeks

,
Interventionparticipants (Number)
Frequency - MissingFrequency - BetterFrequency - SameFrequency - WorseSeverity - MissingSeverity - BetterSeverity - SameSeverity - Worse
Placebo114214114169
Triamcinolone Acetonide0101315015815

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Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual

As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse. (NCT00279916)
Timeframe: baseline, 6 weeks

,
Interventionparticipants (Number)
Frequency - MissingFrequency - BetterFrequency - SameFrequency - WorseSeverity - MissingSeverity - BetterSeverity - SameSeverity - Worse
Placebo1161581141510
Triamcinolone Acetonide0161480151310

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Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears

As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse. (NCT00279916)
Timeframe: baseline, 6 weeks

,
Interventionparticipants (Number)
Frequency - BetterFrequency - SameFrequency - WorseSeverity - BetterSeverity - SameSeverity - Worse
Placebo82396259
Triamcinolone Acetonide11171091910

[back to top]

Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears

As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse. (NCT00279916)
Timeframe: baseline, 6 weeks

,
Interventionparticipants (Number)
Frequency - MissingFrequency - BetterFrequency - SameFrequency - WorseSeverity - MissingSeverity - BetterSeverity - SameSeverity - Worse
Placebo181813261913
Triamcinolone Acetonide0111413091712

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Per-Ear Treatment Outcome

Initial Tympanogram Type at baseline was compared to Follow-Up Tympanogram Type at 6 weeks. Type A is considered to be normal. Type A; peaked pressure measurement under -100 kilo Pascals (kPa). Type B; non-peaked, or flat tympanogram, Type C; peaked pressure measurements more negative than -100 kPa. A Pascal is a unit used to quantify internal pressure. (NCT00279916)
Timeframe: baseline, 6 weeks

,
Interventionears (Number)
Initial Tympanogram of Type B or C6 weeks Complete Normalization (Type A)
Placebo5720
Triamcinolone Acetonide5512

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Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears

As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse. (NCT00279916)
Timeframe: baseline, 6 weeks

,
Interventionparticipants (Number)
Frequency - BetterFrequency - SameFrequency - WorseSeverity - BetterSeverity - SameSeverity - Worse
Placebo1817518139
Triamcinolone Acetonide111710131411

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Central Subfield Thickness < 250 Microns at 2 Years

Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. (NCT00367133)
Timeframe: 2 Years

InterventionPercentage of Eyes (Number)
Focal/Grid Laser Photocoagulation53
1mg Intravitreal Triamcinolone34
4 mg Intravitreal Triamcinolone38

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Central Subfield Thickness at 2 Years

Median central subfield thickness at two-years. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. (NCT00367133)
Timeframe: 2 Years

InterventionMicrons (Median)
Focal/Grid Laser Photocoagulation243
1mg Intravitreal Triamcinolone305
4 mg Intravitreal Triamcinolone279

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Central Subfield Thickness on Optical Coherence Tomography (OCT) at Three Years

Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. (NCT00367133)
Timeframe: 3 years

InterventionMicrons (Median)
Focal/Grid Laser Photocoagulation211
1mg Intravitreal Triamcinolone269
4 mg Intravitreal Triamcinolone248

[back to top]

Change in Central Subfield Thickness on OCT Baseline to 3 Years

Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement. (NCT00367133)
Timeframe: baseline to 3 years

InterventionMicrons (Mean)Microns (Median)
Focal/Grid Laser Photocoagulation-175
1mg Intravitreal Triamcinolone-124
4 mg Intravitreal Triamcinolone-126
Focal/Grid Laser Photocoagulation-158
1mg Intravitreal Triamcinolone-103
4 mg Intravitreal Triamcinolone-114

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Change In Visual Acuity [Measured With Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS)]Baseline to 2 Years.

Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0. (NCT00367133)
Timeframe: Baseline to 2 Years

InterventionLetter score (Mean)
Focal/Grid Laser Photocoagulation1
1mg Intravitreal Triamcinolone-2
4 mg Intravitreal Triamcinolone-3

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Change in Visual Acuity From Baseline to 3 Years

Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. (NCT00367133)
Timeframe: Baseline to 3 year

InterventionLetter Score (Mean)
Focal/Grid Laser Photocoagulation5
1mg Intravitreal Triamcinolone0
4 mg Intravitreal Triamcinolone0

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Change in Visual Acuity From Baseline to 3 Years

Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best Value on the scale=97, Worst Value=0 (NCT00367133)
Timeframe: Baseline to 3 year

InterventionLetter Score (Median)
Focal/Grid Laser Photocoagulation8
1mg Intravitreal Triamcinolone2
4 mg Intravitreal Triamcinolone4

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Mean Change in Central Subfield Thickness Baseline to 2 Years

Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes and improvement. (NCT00367133)
Timeframe: Baseline to 2 years

InterventionMicrons (Mean)
Focal/Grid Laser Photocoagulation-139
1mg Intravitreal Triamcinolone-86
4 mg Intravitreal Triamcinolone-77

[back to top]

Median Change in Central Subfield Thickness Baseline to 2 Years

Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement. (NCT00367133)
Timeframe: Baseline to 2 Years

InterventionMicrons (Median)
Focal/Grid Laser Photocoagulation-131
1mg Intravitreal Triamcinolone-74
4 mg Intravitreal Triamcinolone-76

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Median Change in Visual Acuity Baseline to 2 Years

Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. (NCT00367133)
Timeframe: Baseline to 2 Years

InterventionLetter score (Median)
Focal/Grid Laser Photocoagulation4
1mg Intravitreal Triamcinolone1
4 mg Intravitreal Triamcinolone2

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Overall Central Subfield Thickening Decreased by >=50% Baseline to 2 Years

Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. (NCT00367133)
Timeframe: Baseline to 2 Years

InterventionPercentage of Eyes (Number)
Focal/Grid Laser Photocoagulation67
1mg Intravitreal Triamcinolone46
4 mg Intravitreal Triamcinolone48

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Percentage of Eyes With a Change in Central Subfield Thickness on OCT <250 Microns From Baseline to 3 Years

Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement. (NCT00367133)
Timeframe: Baseline to 3 years

InterventionPercentage of Eyes (Number)
Focal/Grid Laser Photocoagulation68
1mg Intravitreal Triamcinolone43
4 mg Intravitreal Triamcinolone51

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Distribution of Visual Acuity Change Baseline to 3 Years

Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale=97, worst=0 (NCT00367133)
Timeframe: Baseline to 3 years

,,
InterventionPercentage of Eyes (Number)
>= 15 letters better10-14 letters better5-9 letters betterno change, + - 4 letters5-9 letters worse10-14 letters worse>=15 letters worse
1mg Intravitreal Triamcinolone204172310917
4 mg Intravitreal Triamcinolone21169246616
Focal/Grid Laser Photocoagulation26181821448

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Distribution of Change in Visual Acuity Baseline to 2 Years

Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. (NCT00367133)
Timeframe: baseline to 2 years

,,
InterventionPercentage of Eyes (Number)
>= 15 letter improvement14 to 10 letter improvement9 to 5 letter improvementsame +- 4 letters5-9 letters worse10-14 letters worse>=15 letters worse
1mg Intravitreal Triamcinolone141114279620
4 mg Intravitreal Triamcinolone171115236820
Focal/Grid Laser Photocoagulation1813162410514

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Change in Central Subfield Thickening From Baseline Through 34 Weeks

Change in Central Subfield Thickening from Baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology. Negative changes represent a decrease in retinal thickening. (NCT00369486)
Timeframe: 4, 8, 17, 34 weeks

,,,,
Interventionmicrons (Mean)
4 Weeks8 Weeks17 Weeks34 Weeks
Anterior Peribulbar Injection of 20 mg Triamcinolone-27-38-50-45
Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser-37-44-49-68
Focal Laser Photocoagulation-10-27-30-54
Posterior Peribulbar Injection of 40 mg Triamcinolone-47-29-24-31
Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser-16-25-52-45

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Reduction of ≥ 50% in Retinal Thickening in the Central Subfield From Baseline Through 34 Weeks

Number of eyes that had a reduction in central subfield retinal thickness by ≥ 50% at each follow-up. Change in Central Subfield Thickening from Baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology. (NCT00369486)
Timeframe: 4, 8, 17, 34 weeks

,,,,
Interventioneyes (Number)
4 Weeks8 Weeks17 Weeks34 Weeks
Anterior Peribulbar Injection of 20 mg Triamcinolone2685
Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser8101313
Focal Laser Photocoagulation581122
Posterior Peribulbar Injection of 40 mg Triamcinolone8769
Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser4479

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Central Subfield Thickness <250 Microns From Baseline Through 34 Weeks

Primary criterion for retreatment is central subfield thickness >=250 microns. Central subfield thickness of <250 microns indicates no need for retreatment. Change in Central Subfield Thickening from Baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology. (NCT00369486)
Timeframe: 4, 8, 17, 34 weeks

,,,,
Interventioneyes (Number)
4 Weeks8 Weeks17 Weeks34 Weeks
Anterior Peribulbar Injection of 20 mg Triamcinolone3362
Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser891113
Focal Laser Photocoagulation591119
Posterior Peribulbar Injection of 40 mg Triamcinolone5478
Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser261010

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Persistence/Recurrence of Diabetic Macular Edema (DME) Either Retreated or Meeting Criteria for Retreatment at 17 Weeks

Number of eyes that were retreated at 17 weeks. According to the protocol, primary criterion for retreatment was central subfield thickness >=250 microns or macular edema was still present according to the investigator's judgment. (NCT00369486)
Timeframe: 17 weeks

,,,,
Interventioneyes (Number)
Eyes that were retreatedEyes with ≥ 250 central subfield thickness
Anterior Peribulbar Injection of 20 mg Triamcinolone1416
Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser913
Focal Laser Photocoagulation2226
Posterior Peribulbar Injection of 40 mg Triamcinolone1514
Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser911

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Change in Visual Acuity Letter Score From Baseline Through 34 Weeks

Change in visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the electronic Early Treatment for Diabetic Retinopathy Study(E-ETDRS) technique. Letter score best value = 97 and worst value = 0; an increase in a letter score by 10 is considered clinically significant. Negative changes represent a worsening in visual acuity. (NCT00369486)
Timeframe: 4, 8, 17, and 34 weeks

,,,,
Interventionletter score (Mean)
4 Weeks8 Weeks17 Weeks34 Weeks
Anterior Peribulbar Injection of 20 mg Triamcinolone-1-1-2-1
Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser-10-1-1
Focal Laser Photocoagulation-1-1-2-2
Posterior Peribulbar Injection of 40 mg Triamcinolone10-1-4
Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser-20-1-3

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Mean Visual Acuity Letter Score at Each Follow-up Visit

Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) mean visual acuity letter score: best value = 97; letter score worst value = 0 (NCT00369486)
Timeframe: 4, 8, 17, and 34 weeks

,,,,
Interventionletter score (Mean)
4 Weeks8 Weeks17 Weeks34 Weeks
Anterior Peribulbar Injection of 20 mg Triamcinolone80807980
Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser77777777
Focal Laser Photocoagulation79797878
Posterior Peribulbar Injection of 40 mg Triamcinolone79797876
Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser77807977

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Pain Visual Analogue Scale (VAS)

Pain intensity measured on a Visual Analog Scale with scores ranging from 0 to 100, with 100 = severe pain. (NCT00398866)
Timeframe: Baseline, 26 Weeks

,,
InterventionUnits on a scale (Mean)
Pain VAS at BaselinePain VAS at 26 weeks
Bupivicaine57.142.9
Hylan G-F 2060.749.8
Triamcinolone63.250.1

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Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire

Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire measures degree of disability on a scale of 0 to 100, with a higher score indicating greater disability. (NCT00398866)
Timeframe: Baseline, 26 Weeks

,,
Interventionunits on a scale (Mean)
DASH at BaselineDash at 26 Weeks
Bupivicaine25.724.2
Hylan G-F 2028.826.1
Triamcinolone28.927.0

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Central Subfield Thickness < 250 With at Least a 25 Micron Decrease From Baseline to 1 Year

(NCT00444600)
Timeframe: 1 Year

InterventionEyes (Number)
Sham+Prompt Laser72
0.5 mg Ranibizumab+Prompt Laser91
0.5 mg Ranibizumab+Deferred Laser74
4 mg Triamcinolone+Prompt Laser82

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Change in Retinal Thickening of Central Subfield on Optical Coherence Tomography From Baseline to 1 Year

Negative change denotes an improvement. (NCT00444600)
Timeframe: from baseline to 1 year

Interventionmicrons (Mean)
Sham+Prompt Laser-102
0.5 mg Ranibizumab+Prompt Laser-131
0.5 mg Ranibizumab+Deferred Laser-137
4 mg Triamcinolone+Prompt Laser-127

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Mean Change in Optical Coherence Tomography Retinal Volume From Baseline to 1 Year

(NCT00444600)
Timeframe: from baseline to 1 Year

Interventionmm^3 (Mean)
Sham+Prompt Laser-1.0
0.5 mg Ranibizumab+Prompt Laser-1.4
0.5 mg Ranibizumab+Deferred Laser-1.5
4 mg Triamcinolone+Prompt Laser-1.4

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Mean Change in Visual Acuity (Letters) From Baseline to 1 Year Adjusted for Baseline Visual Acuity

Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0. (NCT00444600)
Timeframe: from baseline to 1 Year

InterventionLetters (Mean)
Sham+Prompt Laser3
0.5 mg Ranibizumab+Prompt Laser9
0.5 mg Ranibizumab+Deferred Laser9
4 mg Triamcinolone+Prompt Laser4

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Mean Optical Coherence Tomography Retinal Volume at 1 Year

(NCT00444600)
Timeframe: 1 Year

Interventionmm^3 (Mean)
Sham+Prompt Laser8.1
0.5 mg Ranibizumab+Prompt Laser7.3
0.5 mg Ranibizumab+Deferred Laser7.4
4 mg Triamcinolone+Prompt Laser7.5

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Number of Injections in First Year

Maximum possible number of injections for each of the following groups: sham+prompt laser=13 sham injections;ranibizumab+prompt laser=13 ranibizumab injections; ranibizumab+deferred laser=13 ranibizumab injections; triamcinolone+prompt laser=4 triamcinolone injections and 9 sham injections. (NCT00444600)
Timeframe: from baseline to 1 year

InterventionInjections (Median)
Sham+Prompt Laser11
0.5 mg Ranibizumab+Prompt Laser8
0.5 mg Ranibizumab+Deferred Laser9
4 mg Triamcinolone+Prompt Laser3

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Percentage of Eyes Receiving Laser at the 48 Week Visit (%)

(NCT00444600)
Timeframe: 1 Year

InterventionEyes (Number)
Sham+Prompt Laser26
0.5 mg Ranibizumab+Prompt Laser16
0.5 mg Ranibizumab+Deferred Laser8
4 mg Triamcinolone+Prompt Laser21

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Cardiovascular Events According to Antiplatelet Trialists' Collaboration Through 1 Year

Antiplatelet Trialists' Collaboration is a collaborative overview of randomised trials of antiplatelet therapy - I: Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients. Antiplatelet Trialists' Collaboration. MBJ 1994; 308:81-106. Nonfatal cerebrovascular accident includes ischemic or hemorrhagic or unknown events. Vascular death includes death from any potential vascular or unknown cause. (NCT00444600)
Timeframe: 1 Year

,,
InterventionParticipants (Number)
Nonfatal myocardial infarctionNonfatal cerebrovascular accidentVascular deathAny ATC cardiovascular event
Ranibizumab13711
Sham35410
Triamcinolone2125

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Change From Moderately Severe Non-proliferative Diabetic Retinopathy or Better From Baseline to 1-year

113 eyes had missing or ungradable photos at 1 year. Criteria are based on the ETDRS fundus photographic risk factors for the progression of diabetic retinopathy. ETDRS report no. 12. Ophthalmology 1991; 98:823-833 (NCT00444600)
Timeframe: from baseline to 1 Year

,,
InterventionEyes (Number)
Improved by 2 or more levelsWorsened by 2 or more levels
Ranibizumab465
Sham611
Triamcinolone202

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Change From Severe Non-proliferative Diabetic Retinopathy or Worse From Baseline to 1-year

Criteria are based on the ETDRS fundus photographic risk factors for the progression of diabetic retinopathy. ETDRS report no. 12. Ophthalmology 1991; 98:823-833, ETDRS Severity Scale = Diabetic retinopathy absent, minimal non-proliferative diabetic retinopathy (PDR), mild to moderately severe non-PDR, severe non-PDR, scars of full pr partial panretinal photocoagulation present PDR absent, mild to moderate PDR, high risk PDR, cannot grade, missing. (NCT00444600)
Timeframe: from baseline to 1 Year

,,
InterventionEyes (Number)
Improved by 2 or more levelsWorsened by 2 or more levels
Ranibizumab181
Sham107
Triamcinolone62

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Change in Visual Acuity From Baseline to 1 Year Among Eyes That Had Prior Treatment for Diabetic Macular Edema

(NCT00444600)
Timeframe: from baseline to 1 Year

,,,
InterventionLetters (Mean)
NoYes
0.5 mg Ranibizumab+Deferred Laser118
0.5 mg Ranibizumab+Prompt Laser99
4 mg Triamcinolone+Prompt Laser35
Sham+Prompt Laser23

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Change in Visual Acuity From Baseline to 1 Year Among Eyes That Were Pseudophakic at Baseline

(NCT00444600)
Timeframe: from baseline to 1 Year

,,,
InterventionLetters (Mean)
Not pseudophakic at baselinePseudophakic at baseline
0.5 mg Ranibizumab+Deferred Laser107
0.5 mg Ranibizumab+Prompt Laser98
4 mg Triamcinolone+Prompt Laser28
Sham+Prompt Laser24

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Change in Visual Acuity From Baseline to 1 Year Grouped by Baseline Visual Acuity Letter Score

Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0. (NCT00444600)
Timeframe: from baseline to 1 Year

,,,
InterventionLetters (Mean)
≥66 (better than 20/50)≤65 (20/50 or worse)
0.5 mg Ranibizumab+Deferred Laser513
0.5 mg Ranibizumab+Prompt Laser612
4 mg Triamcinolone+Prompt Laser17
Sham+Prompt Laser15

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Change in Visual Acuity From Baseline to 1 Year Grouped by Diabetic Retinopathy Severity

Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0. (NCT00444600)
Timeframe: from baseline to 1 Year

,,,
InterventionLetters (Mean)
Moderately severe non-proliferative DR or betterSevere non-proliferative DR or worse
0.5 mg Ranibizumab+Deferred Laser99
0.5 mg Ranibizumab+Prompt Laser108
4 mg Triamcinolone+Prompt Laser35
Sham+Prompt Laser32

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Change in Visual Acuity From Baseline to 1 Year Grouped by Diffuse vs. Focal Edema as Characterized by the Investigator

Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0. (NCT00444600)
Timeframe: from baseline to 1 Year

,,,
InterventionLetters (Mean)
Typical/predominantly focalNeither predominantly focal nor diffuseTypical/predominantly diffuse
0.5 mg Ranibizumab+Deferred Laser8810
0.5 mg Ranibizumab+Prompt Laser8109
4 mg Triamcinolone+Prompt Laser335
Sham+Prompt Laser323

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Change in Visual Acuity From Baseline to 1 Year Grouped by Optical Coherence Tomography Central Subfield Thickness

Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0. (NCT00444600)
Timeframe: from baseline to 1 Year

,,,
InterventionLetters (Mean)
<400 microns≥400 microns
0.5 mg Ranibizumab+Deferred Laser711
0.5 mg Ranibizumab+Prompt Laser711
4 mg Triamcinolone+Prompt Laser36
Sham+Prompt Laser33

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Distribution of Change in Visual Acuity (Letters) From Baseline to 1 Year

Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. (NCT00444600)
Timeframe: from baseline to 1 Year

,,,
InterventionEyes (Number)
≥15 letter improvement14-10 letter improvement9-5 letter improvementSame ±4 letters5-9 letters worse10-14 letters worse≥15 letters worse
0.5 mg Ranibizumab+Deferred Laser52365435524
0.5 mg Ranibizumab+Prompt Laser573834381433
4 mg Triamcinolone+Prompt Laser39223254121215
Sham+Prompt Laser43386786201623

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Eyes With Alternative Treatments Prior to the 1-year Visit

Each combination of treatment only counted once. (NCT00444600)
Timeframe: 1 Year

,,,
InterventionEyes (Number)
Intravitreal bevacizumabIntravitreal triamcinolone acetonideVitrectomyIntravitreal bevacizumab+triamcinolone acetonideTotal number of eyes with alternative treatmentsTotal number of treatments appliedTotal per protocol treatments appliedTotal deviations from protocol treatments applied
0.5 mg Ranibizumab+Deferred Laser00000000
0.5 mg Ranibizumab+Prompt Laser00001110
4 mg Triamcinolone+Prompt Laser10001110
Sham+Prompt Laser3524142559

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Number of Laser Treatments Received Prior to the 1 Year Visit

One eye in the sham+prompt laser group did not receive laser until post 1-year due to an adverse event unrelated to study treatment. One eye in the triamcinolone+prompt laser did not receive laser until after 1-year due to missing 2 consecutive visits at the time of required laser treatment. (NCT00444600)
Timeframe: 1 Year

,,,
InterventionEyes (Number)
01234
0.5 mg Ranibizumab+Deferred Laser124361710
0.5 mg Ranibizumab+Prompt Laser053544618
4 mg Triamcinolone+Prompt Laser146534927
Sham+Prompt Laser1357510756

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Major Ocular Adverse Events During First Year of Follow-Up

(NCT00444600)
Timeframe: 1 Year

,,,
InterventionEyes (Number)
EndophthalmitisPseudoendophthalmitisOcular vascular eventRetinal detachmentVitrectomyVitreous hemorrhageIncrease in intraocular pressure >=10 mmHgIntraocular pressure >=30 mmHgInitiation of intraocular lowering medicationGlaucoma surgeryCataract surgery
0.5 mg Ranibizumab+Deferred Laser10013454708
0.5 mg Ranibizumab+Prompt Laser1010031021206
4 mg Triamcinolone+Prompt Laser012002704679019
Sham+Prompt Laser111071516323011

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Distribution of Logarithmic Transformation of Optical Coherence Tomography (LogOCT) Improvement and Worsening

Logarithmic transformation of optical coherence tomography central subfield thickness is calculated by taking the log base 10 of the ratio of the central subfield thickness divided by 200 and rounding to the nearest hundredth. The change is the change in the log values. (NCT00444600)
Timeframe: 1 Year

,,,
InterventionEyes (Number)
≥2 step improvement≥2 step worsening
0.5 mg Ranibizumab+Deferred Laser710
0.5 mg Ranibizumab+Prompt Laser721
4 mg Triamcinolone+Prompt Laser654
Sham+Prompt Laser816

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Change in Optical Coherence Tomography Retinal Volume

Missing or un-gradable data as follows for the sham plus focal/grid/panretinal photocoagulation laser, triamcinolone plus focal/grid panretinal photocoagulation laser, and Ranibizumab groups were 49, 37, and 39, respectively (NCT00445003)
Timeframe: Baseline to 14 weeks

Interventionmm^3 (Mean)
Sham Injection0.1
0.5mg Ranibizumab-0.4
4-mg Triamcinolone Acetonided-1.3

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Change in Visual Acuity From Baseline

Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best. (NCT00445003)
Timeframe: baseline to 56-weeks

InterventionLetter Score (Mean)
Sham Injection-6
0.5mg Ranibizumab-4
4-mg Triamcinolone Acetonided-5

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Eyes With Anti-vascular Endothelial Growth Factor Treatment for Diabetic Macular Edema

(NCT00445003)
Timeframe: 14 weeks to 56-weeks

InterventionEyes (Number)
Sham Injection28
0.5mg Ranibizumab23
4-mg Triamcinolone Acetonided17

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Total Optical Coherence Tomography Retinal Volume

Missing/ungradable as follows: Sham = 49, Ranibizumab = 37, Triamcinolone = 39. Visits occured between 70 days and 153 days from randomization adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes. Confidence intervals are adjusted for multiple comparisons. (NCT00445003)
Timeframe: Baseline to 14-weeks

Interventionmm^3 (Mean)
Sham Injection9.7
0.5mg Ranibizumab9.3
4-mg Triamcinolone Acetonided7.9

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Additional Treatments for Diabetic Macular Edema

Each combination of treatment is only counted once per treatment eye. Participants could have 2 study eyes, with random assignments to different treatments. (NCT00445003)
Timeframe: 14 weeks to 56-weeks

,,
InterventionEyes (Number)
BevacizumabRanibizumabTriamcinolonePegaptanibLaserVitrectomyBevacizumab plus TriamcinoloneRanibizumab plus TriamcinoloneBevacizumab plus laserRanibizumab plus laserTriamcinolone plus laserPegaptanib plus laserTriamcinolone plus vitrectomyPegaptanib plus vitrectomyTriamcinolone plus laser plus vitrectomyBevacizumab plus triamcinolone plus laser
0.5mg Ranibizumab120801010153401111
4-mg Triamcinolone Acetonided93232102000500000
Sham Injection141303122080710002

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Number of Eyes With Additional Number of Treatments for Diabetic Macular Edema

Treatments include any type or combination of treatment for diabetic macular edema. Eyes were only counted once, when receiving a combination of treatments. (NCT00445003)
Timeframe: 14 weeks to 56-weeks

InterventionEyes (Number)
Sham Injection71
0.5mg Ranibizumab48
4-mg Triamcinolone Acetonided45

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Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 14 Weeks

Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best. (NCT00445003)
Timeframe: baseline to 14 weeks

InterventionLetter Score (Mean)
Sham Injection-4
0.5mg Ranibizumab1
4-mg Triamcinolone Acetonided2

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Change in Optical Coherence Tomography Central Subfield Thickness

(NCT00445003)
Timeframe: Baseline to 14 weeks

InterventionMicrons (Median)
Sham Injection362
0.5mg Ranibizumab312
4-mg Triamcinolone Acetonided265

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Duration of Treatment

(NCT00473083)
Timeframe: Up to one year

Interventionmonths (Median)
Arm 1: Prophylactic Treatment3.6
Arm 2: Reactive Treatment1.8
Arm 3: No Treatment Unless Severe (Grade 3)1.8

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Overall Incidence of Grade 3 Rash

"The overall incidence of grade 3 erlotinib-induced rash among the three treatment arms.~For overall incidence of rash a binary variable will be designed. Data will be summarized with percentages by treatment group." (NCT00473083)
Timeframe: From onset of rash until resolution, up to 4 weeks following progression, on average of 1 year

Interventionpercentage of participants (Number)
Arm 1: Prophylactic Treatment14.3
Arm 2: Reactive Treatment9.5
Arm 3: No Treatment Unless Severe (Grade 3)34.1

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Overall Incidence of Rash

"The overall incidence of any grade of erlotinib-induced rash among the three treatment arms.~For overall incidence of rash a binary variable will be designed. Data will be summarized with percentages by treatment group." (NCT00473083)
Timeframe: From onset of rash until resolution, up to 4 weeks following progression, an average of 1 year

Interventionpercentage of participants (Number)
Arm 1: Prophylactic Treatment84
Arm 2: Reactive Treatment84
Arm 3: No Treatment Unless Severe (Grade 3)82

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Overall Survival

(NCT00473083)
Timeframe: Until death

Interventionmonths (Median)
Arm 1: Prophylactic Treatment7.6
Arm 2: Reactive Treatment8.0
Arm 3: No Treatment Unless Severe (Grade 3)6.0

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Time to First Presentation of Rash

(NCT00473083)
Timeframe: Up to onset of rash while on study treatment

Interventiondays (Mean)
Arm 1: Prophylactic Treatment17.4
Arm 2: Reactive Treatment13.3
Arm 3: No Treatment Unless Severe (Grade 3)12.0

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Severity of Rash Caused by Erlotinib

The maximum severity of rash per subject will be summarized by treatment group. The summary will include only subjects who indicated any occurrence of rash. (NCT00473083)
Timeframe: Onset until resolution, up to 4 weeks following progression, on average of 1 year

,,
Interventionpercentage of participants (Number)
Maximal Rash Grade 1Maximal Rash Grade 2aMaximal Rash Grade 2bMaximal Rash Grade 3
Arm 1: Prophylactic Treatment40.526.219.014.3
Arm 2: Reactive Treatment47.633.39.59.5
Arm 3: No Treatment Unless Severe (Grade 3)46.314.64.934.1

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Time Duration From Onset of Rash Until Resolution

"To investigate if the rash caused by erlotinib is self-limiting.~A time variable will be defined to identify the duration from onset of rash until resolution. Resolution will be defined as resolution to severity Grade 1 for patients with rash of maximum severity grade >1 and resolution to Grade 0 for patients with maximum rash severity = 1. For patients where resolution is not observed the time considered will be the maximum time from onset of rash until end of the study.~The analyses will be performed using the following two sub-populations: subjects with maximum severity of rash of Grade 1, 2a and 2b will constitute one sub-population and Grade 3 will be considered the second sub-population.~The comparisons will be performed primarily for Group 1 vs. Group 3 and Group 2 vs. Group 3 and secondly for Group 1 vs. Group 2." (NCT00473083)
Timeframe: From onset of rash until resolution, up to 4 weeks following progression, an average of 1 year

,,
Interventiondays (Median)
Patients With Max Severity of Rash Gr 1, 2a and 2bPatients With Maximum Severity of Rash Grade 3
Arm 1: Prophylactic Treatment133.0201.0
Arm 2: Reactive Treatment92.076.0
Arm 3: No Treatment Unless Severe (Grade 3)98.054.0

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Mean Change in Cortisol Levels From Baseline to Week 24

Mean change in cortisol levels from baseline to week 24 after four triamcinolone acetonide 10 ml injections 6 weeks apart. (NCT00484679)
Timeframe: baseline, week 24

Interventionmg/dL (Mean)
(Kenalog-10) Intralesional Injections for Alopecia Areata0.187

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Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire

This scale measures functional disability due to back pain. The score of the scale is the total number of items checked, from a minimum of 0 (no disability) to a maximum of 24 (great disability). Roland MO, Morris RW. A study of the natural history of back Pain. Part 1: development of a reliable and sensitive measure of disability in low back pain. Spine 1983; 8:141-144. (NCT00588354)
Timeframe: 2 weeks

InterventionUnits on a scale (Mean)
2% Lidociane and Clonidine (200 or 400 ug)9.6
2% Lidocaine and Triamcinolone (40 mg)5.7

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Pain Disability Score at 4 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire

This questionnaire measures a patient's permanent functional disability. The questionnaire consists of 10 sections with 6 statements each of increasing point value (from 0 to 5). The score is a percentage of the total, with higher score showing greater disability. Minimum detectable change is 10%, with a 90% CI. Change of less than this may be attributable to error in measurement. (NCT00588354)
Timeframe: 4 weeks

InterventionUnits on a scale (Mean)
2% Lidociane and Clonidine (200 or 400 ug)23.9
2% Lidocaine and Triamcinolone (40 mg)17.0

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Pain Disability Score at 2 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire (ODI)

This questionnaire measures a patient's permanent functional disability. The questionnaire consists of 10 sections with 6 statements each of increasing point value (from 0 to 5). The score is a percentage of the total, with higher score showing greater disability. Minimum detectable change is 10%, with a 90% CI. Change of less than this may be attributable to error in measurement. (NCT00588354)
Timeframe: 2 weeks

InterventionUnits on a scale (Mean)
2% Lidocaine and Clonidine (200 or 400 ug)27.0
2% Lidocaine and Triamcinolone (40 mg)21.3

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Pain Disability Score at 4 Weeks as Measured by the Roland-Morris Disability Questionnaire

This scale measures functional disability due to back pain. The score of the scale is the total number of items checked, from a minimum of 0 (no disability) to a maximum of 24 (great disability). Roland MO, Morris RW. A study of the natural history of back Pain. Part 1: development of a reliable and sensitive measure of disability in low back pain. Spine 1983; 8:141-144. (NCT00588354)
Timeframe: 4 weeks

InterventionUnits on a scale (Mean)
2% Lidociane and Clonidine (200 or 400 ug)9.4
2% Lidocaine and Triamcinolone (40 mg)3.5

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Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)

11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain). (NCT00588354)
Timeframe: 2 weeks

InterventionUnits on a scale (Mean)
2% Lidociane and Clonidine (200 or 400 ug)4.1
2% Lidocaine and Triamcinolone (40 mg)4.0

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Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)

11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain). (NCT00588354)
Timeframe: 4 weeks

InterventionUnits on a scale (Mean)
2% Lidociane and Clonidine (200 or 400 ug)4.1
2% Lidocaine and Triamcinolone (40 mg)2.7

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Pain Score at 2 Weeks as Measured by the Multidimensional Pain Inventory (MPI)

The MPI is a comprehensive instrument comprised of 12 scales divided into three parts for assessing a number of dimensions of the chronic pain experience including pain intensity, emotional distress, cognitive and functional adaptation, and social support. Reference: Kearns RO, Turk DC, Rudy TC. The West Haven-Yale Multidimensional Pain Inventory (WHYMPI). Pain 1985; 23:345-356. Subscales were not used; the DOS WHYMPI computer program version 2.1 was used to score the instrument. Scores range from 0 (no pain) to 100 (highest pain). A score of 50 is the mean for patients with chronic pain. (NCT00588354)
Timeframe: 2 weeks

InterventionUnits on a scale (Mean)
2% Lidociane and Clonidine (200 or 400 ug)51.6
2% Lidocaine and Triamcinolone (40 mg)56.0

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Pain Score at 4 Weeks as Measured by the Multidimensional Pain Inventory (MPI)

The MPI is a comprehensive instrument comprised of 12 scales divided into three parts for assessing a number of dimensions of the chronic pain experience including pain intensity, emotional distress, cognitive and functional adaptation, and social support. Reference: Kearns RO, Turk DC, Rudy TC. The West Haven-Yale Multidimensional Pain Inventory (WHYMPI). Pain 1985; 23:345-356. Subscales were not used; the DOS WHYMPI computer program version 2.1 was used to score the instrument. Scores range from 0 (no pain) to 100 (highest pain). A score of 50 is the mean for patients with chronic pain. (NCT00588354)
Timeframe: 4 weeks

InterventionUnits on a scale (Mean)
2% Lidociane and Clonidine (200 or 400 ug)56.7
2% Lidocaine and Triamcinolone (40 mg)56.9

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Pain Free Abduction Range of Motion (ROM)

Difference in least-squares means (Degrees) from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions. (NCT00597766)
Timeframe: Baseline, weeks 4, 8, 12 (4 times)

Interventionunits on a scale (Least Squares Mean)
20mg Triamcinolone33.3
40mg Triamcinolone15.2
60mg Triamcinolone28.0

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Fugl-Meyer Motor Assessment, Upper Limb Domain

"Evaluates and measures recovery in post-stroke hemiplegic patients. Items are scored on a 3-point ordinal scale:~0 = cannot perform~= performs partially~= performs fully Scores for 33 motor function items are summed to arrive at a total score ranging from 0 to 66, where higher scores indicate greater motor function Differences baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions." (NCT00597766)
Timeframe: Baseline, weeks 4, 8, 12 (4 times)

Interventionunits on a scale (Least Squares Mean)
20mg Triamcinolone5.1
40mg Triamcinolone4.5
60mg Triamcinolone2.3

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BPI 12 (Brief Pain Inventory, Question 12) Pain Questionnaire

Change in BPI-12, Worst pain in the last week on 0 (No Pain) to 10 (Worst Pain Possible) scale, from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions. (NCT00597766)
Timeframe: Baseline, weeks 1, 2, 3, 4, 8, 12 (7 times)

Interventionunits on a scale (Least Squares Mean)
20mg Triamcinolone-1.7
40mg Triamcinolone-2.2
60mg Triamcinolone-4.7

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Pain Free External Rotation Range of Motion (ROM)

Differences in least-mean squares (Degrees) from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions. (NCT00597766)
Timeframe: Baseline, weeks 4, 8, 12 (4 times)

Interventionunits on a scale (Least Squares Mean)
20mg Triamcinolone26.7
40mg Triamcinolone12.7
60mg Triamcinolone10.3

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Change in WOMAC Pain Subscale

WOMAC pain subscale range 0-20 (0=best, 20=worst) (NCT00746889)
Timeframe: baseline to 12 weeks

Interventionunits on a scale (Mean)
Inflammatory Patients Who Received Corticosteroid Injections-0.1
Noninflammatory Patients Who Received Corticosteroid Injection-2.0

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Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale

WOMAC pain subscale range 0-20 (0=best, 20=worst) (NCT00746889)
Timeframe: baseline to 4 weeks

Interventionunits on a scale (Mean)
Corticosteroid Injection-2.1
Placebo-0.1

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The Time to 50% Reduction of Baseline Pain Intensity in the Target Joint

The median time in days to at least 50% reduction in Pain intensity from baseline as measured by Visual Analog Scale (VAS) for each treatment group. Participants scored their pain intensity in the target joint on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100). (NCT00798369)
Timeframe: Baseline, within 7 days after randomization

InterventionDays (Median)
Canakinumab 10 mg2.9
Canakinumab 25 mg2.9
Canakinumab 50 mg1.0
Canakinumab 90 mg1.0
Canakinumab 150 mg1.0
Triamcinolone Acetonide 40 mg2.0

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Amount of Rescue Medication Taken for Each Treatment Group

Participants who had difficulty in tolerating their pain after the 6-hour post-dose pain assessments and during the first 7 study days were allowed to take a maximum of 30 mg prednisolone (or equivalent dose of prednisone [30 mg]) orally once a day for a maximum of 5 days. In addition, participants could use 500 mg acetaminophen (paracetamol) and/or 30 mg codeine as needed during the first 7 study days. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/dose or 180 mg/day of codeine was allowed during the first 7 days of the study. (NCT00798369)
Timeframe: 7 days after study drug administration

,,,,,
Interventionmg (Mean)
AcetaminophenCodeinePrednisolone/Prednisone
Canakinumab 10 mg1414.342.913.4
Canakinumab 150 mg607.44.46.2
Canakinumab 25 mg1656.978.623.8
Canakinumab 50 mg2178.649.324.1
Canakinumab 90 mg1646.627.913.1
Triamcinolone Acetonide 40 mg1614.352.013.3

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High Sensitivity C-reactive Protein (hsCRP) at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group

"High sensitivity C-reactive protein (hsCRP) was determined in serum at all visits (Visits 1-5) in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.~ANCOVA with treatment group, protein level at baseline and BMI at baseline as covariates." (NCT00798369)
Timeframe: at 72 hours and 7 days, 4 and 8 weeks post-dose

,,,,,
Interventionmg/L (Least Squares Mean)
72 hrs post-dose (n= 27, 28, 26, 28, 25, 53)7 days post-dose (n= 28, 29, 28, 28, 27, 55)4 week post-dose (n= 27, 28, 27, 28, 27, 55)8 weeks post-dose (n= 26, 28, 27, 28, 27, 54)
Canakinumab 10 mg16.78.03.03.8
Canakinumab 150 mg9.23.74.82.9
Canakinumab 25 mg7.92.52.92.0
Canakinumab 50 mg11.74.32.92.6
Canakinumab 90 mg13.46.34.85.2
Triamcinolone Acetonide 40 mg13.413.79.28.6

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Serum Amyloid Protein (SAA) Levels at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group

"Serum amyloid A (SAA) were determined in serum at all visits (Visits 1-5) in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.~ANCOVA with treatment group, protein level at baseline and BMI at baseline as covariates." (NCT00798369)
Timeframe: at 72 hours and 7 days, 4 and 8 weeks post-dose

,,,,,
Interventionmg/L (Least Squares Mean)
72 hrs post-dose (n= 26, 28, 28, 28, 27, 50)7 days post-dose (n= 28, 28, 28, 28, 26, 49)4 week post-dose (n= 27, 28, 27, 28, 27, 50)8 weeks post-dose (n= 26, 26, 26, 27, 27, 48)
Canakinumab 10 mg50.110.64.45.5
Canakinumab 150 mg26.910.36.24.1
Canakinumab 25 mg27.65.44.24.6
Canakinumab 50 mg70.711.94.95.7
Canakinumab 90 mg29.410.514.38.2
Triamcinolone Acetonide 40 mg52.539.412.918.0

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The Change in Pain Intensity in the Target Joint Following Canakinumab Administration Compared to Triamcinolone Acetonide

The change in pain intensity from baseline to 72 hours and 7 days post dose as measured on a 0-100 mm Visual Analog Scale(VAS): 0= no pain and 100= severe pain. Analysis of Covariance (ANCOVA) with treatment group, VAS at baseline and Body mass Index (BMI) at baseline as covariates. Change from baseline = (post-baseline measurement - baseline). (NCT00798369)
Timeframe: Baseline,at 72 hrs post-dose and 7 days post-dose

,,,,,
InterventionUnits on a scale (Least Squares Mean)
72 hrs post-dose (n= 28, 28, 26, 28, 27, 53)7 days post-dose (n= 26, 28, 27, 27, 26, 51)
Canakinumab 10 mg-48.6-57.6
Canakinumab 150 mg-62.5-66.4
Canakinumab 25 mg-46.6-53.9
Canakinumab 50 mg-48.6-63.4
Canakinumab 90 mg-52.7-61.2
Triamcinolone Acetonide 40 mg-43.3-56.0

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The Dose of Canakinumab for Treatment of Acute Flares in Gout Patients That Leads to the Same Efficacy as Triamcinolone Acetonide With Respect to Pain Intensity on a 0-100 mm Visual Analog Scale (VAS)

Mean target dose at 24, 48 and 72 hours. Four models: Emax, Logistic, Linear in log-dose, Linear were selected to describe the potential dose-response curve and hence estimate the target dose of canakinumab using baseline Visual Analog Scale (VAS) and Body Mass Index (BMI) as covariates. Target dose was defined as the dose for which the efficacy is equivalent to the efficacy of triamcinolone acetonide 40 mg and was identified by assessing the dose response relationship with regards to the pain intensity in the target joint measured on a 0- 100 mm VAS (0= no pain and 100= unbearable pain). (NCT00798369)
Timeframe: at 24,48 and 72 hours post-baseline

Interventionmg (Number)
Target dose at 24 hrs post-baselineTarget dose at 48 hrs post-baselineTarget dose at 72 hrs post-baseline
Linear Model3723NA

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Percentage of Participants With an Excellent or Good Response With Regards to the Patient's Global Assessment of Response to Treatment

Participants scored their global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Slight and Poor. (NCT00798369)
Timeframe: at 72 hours post-baseline

InterventionPercentage of Participants (Number)
Canakinumab 10 mg64
Canakinumab 25 mg62
Canakinumab 50 mg71
Canakinumab 90 mg66
Canakinumab 150 mg89
Triamcinolone Acetonide 40 mg54

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Mean Central Foveal Thickness (CFT) on Optical Coherence Tomography (OCT) in Microns at 6 Months

(NCT00815360)
Timeframe: 6 months

Interventionunits on a scale (microns) (Mean)
Treatment Group 1270
Comparative Group 1350

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Mean Change in Best Corrected Visual Acuity (BCVA), as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters From Baseline to Month 6.

(NCT00815360)
Timeframe: 6 months

InterventionLetters of visual acuity on ETDRS chart (Mean)
Treatment Group 113
Comparative Group 110

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No Pain on Three Point Likert Scale on Isometric Extension of Third Finger

"Percentage of patients reporting no pain on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain." (NCT00826462)
Timeframe: 52 weeks

Interventionpercentage of patients (Number)
Corticosteroid Injection in Combination With Physical Therapy53
Placebo Injection in Combination With Physical Therapy76
Control Group: Wait-and-see Treatment63

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No Pain on Three Point Likert Scale on Isometric Extension of Third Finger

"Percentage of patients reporting no pain on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain." (NCT00826462)
Timeframe: 6 weeks

Interventionpercentage of patients (Number)
Corticosteroid Injection in Combination With Physical Therapy44
Placebo Injection in Combination With Physical Therapy16
Control Group: Wait-and-see Treatment17

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Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors

Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome. (NCT00826462)
Timeframe: 12 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy43
Placebo Injection in Combination With Physical Therapy35
Control Group: Wait-and-see Treatment36

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Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors

Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome. (NCT00826462)
Timeframe: 26 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy36
Placebo Injection in Combination With Physical Therapy19
Control Group: Wait-and-see Treatment18

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Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors

Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome. (NCT00826462)
Timeframe: 52 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy20
Placebo Injection in Combination With Physical Therapy9
Control Group: Wait-and-see Treatment12

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Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors

Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome. (NCT00826462)
Timeframe: 6 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy32
Placebo Injection in Combination With Physical Therapy50
Control Group: Wait-and-see Treatment51

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Pain as Recorded by the Study Doctors on a 100 mm VAS-scale

Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome. (NCT00826462)
Timeframe: 52 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy19
Placebo Injection in Combination With Physical Therapy9
Control Group: Wait-and-see Treatment13

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Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale).

Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome. (NCT00826462)
Timeframe: 12 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy41
Placebo Injection in Combination With Physical Therapy33
Control Group: Wait-and-see Treatment33

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Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale).

Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome. (NCT00826462)
Timeframe: 26 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy38
Placebo Injection in Combination With Physical Therapy21
Control Group: Wait-and-see Treatment19

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Pain as Recorded by the Study Doctors on a Visual Analog Scale (VAS Scale)

Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome. (NCT00826462)
Timeframe: 6 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy29
Placebo Injection in Combination With Physical Therapy45
Control Group: Wait-and-see Treatment44

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Pain Free Function Index of Everyday Activities

Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment. (NCT00826462)
Timeframe: 12 weeks

Interventionscore on a scale (Mean)
Corticosteroid Injection in Combination With Physical Therapy3.42
Placebo Injection in Combination With Physical Therapy3.62
Control Group: Wait-and-see Treatment3.37

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Pain Free Function Index of Everyday Activities

Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment. (NCT00826462)
Timeframe: 26 weeks

Interventionscore on a scale (Mean)
Corticosteroid Injection in Combination With Physical Therapy2.97
Placebo Injection in Combination With Physical Therapy1.83
Control Group: Wait-and-see Treatment2.00

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Pain Free Function Index of Everyday Activities

Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment. (NCT00826462)
Timeframe: 52 weeks

Interventionscore on a scale (Mean)
Corticosteroid Injection in Combination With Physical Therapy1.64
Placebo Injection in Combination With Physical Therapy1.03
Control Group: Wait-and-see Treatment1.40

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Pain Free Function Index of Everyday Activities

Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment. (NCT00826462)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Corticosteroid Injection in Combination With Physical Therapy2.78
Placebo Injection in Combination With Physical Therapy4.40
Control Group: Wait-and-see Treatment4.82

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Pain-free Grip Strength Ratio

Pain free grip strength registered with hand held dynamometer . Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint. (NCT00826462)
Timeframe: 6 weeks

InterventionRatio x 100 (Mean)
Corticosteroid Injection in Combination With Physical Therapy58
Placebo Injection in Combination With Physical Therapy50
Control Group: Wait-and-see Treatment57

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Pain-free Grip Strength Ratio

Pain free grip strength registered with hand held dynamometer 30 31. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint. (NCT00826462)
Timeframe: 12 weeks

InterventionRatio x 100 (Mean)
Corticosteroid Injection in Combination With Physical Therapy64
Placebo Injection in Combination With Physical Therapy55
Control Group: Wait-and-see Treatment63

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Pain-free Grip Strength Ratio

Pain free grip strength registered with hand held dynamometer 30 31. Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint. (NCT00826462)
Timeframe: 26 weeks

InterventionRatio x 100 (Mean)
Corticosteroid Injection in Combination With Physical Therapy82
Placebo Injection in Combination With Physical Therapy76
Control Group: Wait-and-see Treatment74

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Pain-free Grip Strength Ratio

Pain free grip strength registered with hand held dynamometer 30 31. Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint. (NCT00826462)
Timeframe: 52 weeks

InterventionRatio x 100 (Mean)
Corticosteroid Injection in Combination With Physical Therapy100
Placebo Injection in Combination With Physical Therapy90
Control Group: Wait-and-see Treatment91

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Treatment Success - Event Rates in Each Group

Unadjusted event rates of treatment success, defined as participants rating themselves 'much improved' or 'completely recovered' on a six point scale. Percentage with 99% confidence interval. (NCT00826462)
Timeframe: 6 - 52 weeks

,,
Interventionpercentage of participants (Number)
6 weeks12 weeks26 weeks52 weeks
Control Group: Wait-and-see Treatment15486778
Corticosteroid Injection in Combination With Physical Therapy59424275
Placebo Injection in Combination With Physical Therapy24456978

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Maximum Grip Strength Ratio

Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain. (NCT00826462)
Timeframe: 52 weeks

InterventionRatio x 100 (Mean)
Corticosteroid Injection in Combination With Physical Therapy96
Placebo Injection in Combination With Physical Therapy102
Control Group: Wait-and-see Treatment104

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Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors

To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome. (NCT00826462)
Timeframe: 12 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy37
Placebo Injection in Combination With Physical Therapy32
Control Group: Wait-and-see Treatment34

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Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors

To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome. (NCT00826462)
Timeframe: 26 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy28
Placebo Injection in Combination With Physical Therapy17
Control Group: Wait-and-see Treatment16

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Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors

To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome. (NCT00826462)
Timeframe: 6 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy25
Placebo Injection in Combination With Physical Therapy45
Control Group: Wait-and-see Treatment38

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Affected Function on a 100 mm VAS-scale as Recorded by the Study Doctors

To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome. (NCT00826462)
Timeframe: 52 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy16
Placebo Injection in Combination With Physical Therapy9
Control Group: Wait-and-see Treatment10

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Maximum Grip Strength Ratio

Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain. (NCT00826462)
Timeframe: 12 weeks

InterventionRatio x 100 (Mean)
Corticosteroid Injection in Combination With Physical Therapy83
Placebo Injection in Combination With Physical Therapy88
Control Group: Wait-and-see Treatment89

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Maximum Grip Strength Ratio

Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain. (NCT00826462)
Timeframe: 26 weeks

InterventionRatio x 100 (Mean)
Corticosteroid Injection in Combination With Physical Therapy89
Placebo Injection in Combination With Physical Therapy99
Control Group: Wait-and-see Treatment99

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Maximum Grip Strength Ratio

Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain. (NCT00826462)
Timeframe: 6 weeks

InterventionRatio x 100 (Mean)
Corticosteroid Injection in Combination With Physical Therapy87
Placebo Injection in Combination With Physical Therapy80
Control Group: Wait-and-see Treatment74

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No Pain on Three Point Likert Scale on Dorsiflexion of Wrist

"Percentage of patients reporting no pain on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain." (NCT00826462)
Timeframe: 12 weeks

Interventionpercentage of patients (Number)
Corticosteroid Injection in Combination With Physical Therapy22
Placebo Injection in Combination With Physical Therapy12
Control Group: Wait-and-see Treatment17

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No Pain on Three Point Likert Scale on Dorsiflexion of Wrist

"Percentage of patients reporting no pain on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain." (NCT00826462)
Timeframe: 26 weeks

Interventionpercentage of patients (Number)
Corticosteroid Injection in Combination With Physical Therapy19
Placebo Injection in Combination With Physical Therapy29
Control Group: Wait-and-see Treatment38

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No Pain on Three Point Likert Scale on Dorsiflexion of Wrist

"Percentage of patients reporting no pain on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain." (NCT00826462)
Timeframe: 52 weeks

Interventionpercentage of patients (Number)
Corticosteroid Injection in Combination With Physical Therapy36
Placebo Injection in Combination With Physical Therapy60
Control Group: Wait-and-see Treatment50

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No Pain on Three Point Likert Scale on Dorsiflexion of Wrist

"Percentage of patients reporting no pain on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain." (NCT00826462)
Timeframe: 6 weeks

Interventionpercentage of participants (Number)
Corticosteroid Injection in Combination With Physical Therapy36
Placebo Injection in Combination With Physical Therapy3
Control Group: Wait-and-see Treatment8

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No Pain on Three Point Likert Scale on Isometric Extension of Third Finger

"Percentage of patients reporting no pain on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain." (NCT00826462)
Timeframe: 12 weeks

Interventionpercentage of patients (Number)
Corticosteroid Injection in Combination With Physical Therapy36
Placebo Injection in Combination With Physical Therapy24
Control Group: Wait-and-see Treatment22

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No Pain on Three Point Likert Scale on Isometric Extension of Third Finger

"Percentage of patients reporting no pain on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain." (NCT00826462)
Timeframe: 26 weeks

Interventionpercentage of patients (Number)
Corticosteroid Injection in Combination With Physical Therapy31
Placebo Injection in Combination With Physical Therapy53
Control Group: Wait-and-see Treatment58

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Anterior Chamber Inflammation (Flare)

Inflammation in the anterior chamber (called flare), is measured 10 times per eye using the flare meter, a non-invasive measurement. Flare meter measures inflammation in photon counts per millisecond (p/msec). (NCT00853905)
Timeframe: 1 month, 3 month and 6 month post-op visits

,
Interventionphoton counts per millisecond (p/msec) (Mean)
Month 1Month 3Month 6
Treatment 1(Triesence)0.40.60.3
Treatment 2 (Balanced Salt Solution BSS)1.00.40.2

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Patient Comfort

Questionnaire administered to capture feeling of dry eye. Dry eye was graded on a scale of absent, mild, moderate and severe with 0 to 3 units on a scale. (NCT00853905)
Timeframe: 1 day, 1 week, 1 month, 3 month and 6 month post-op visits

,
InterventionPatient comfort questionnaire score (Mean)
Day 1Week 1Month 1Month 3Month 6
Treatment 1(Triesence)0.30.60.30.40.7
Treatment 2 (Balanced Salt Solution BSS)0.10.30.60.40.7

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Ocular Hypotensive Medications

Number of ocular hypotensive ophthalmic solutions (eye drops) needed, if any, to maintain lower eye pressure. (NCT00853905)
Timeframe: 1 week, 1 month, 3 month, and or 6 month post-op visits

,
Interventioneye drops (Mean)
Week 1Month 1Month 3Month 6
Treatment 1(Triesence)0.030.10.080.22
Treatment 2 (Balanced Salt Solution BSS)0.060.030.220.22

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Intraocular Pressure (IOP)

Intraocular pressure (IOP) was measured by applanation tonometry in millimeters of mercury (mmHg). Surgical success was determined if IOP was <21mmHg and 20% less than baseline IOP. Failure was defined as inability to meet criteria for success or IOP was less than 5mmHg. (NCT00853905)
Timeframe: 1 day, 1week, 1 month, 3 month and 6 month post-op visits

,
Interventionmm Hg (Mean)
Day 1Week 1Month 1Month 3Month 6
Treatment 1(Triesence)16.111.716.115.114.6
Treatment 2 (Balanced Salt Solution BSS)12.811.814.412.813.6

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Bleb Appearance

A bleb is a blister on the white part of the eye (sclera) intentionally formed during some glaucoma surgeries. The Indiana Bleb Appearance Grading Scale (IBAGS) measures the bleb appearance in elevation (height), extent and vascularity. The height range is flat, low, moderate and high with 0 to 3 units on a scale. Zero is a flat bleb and 3 is a high bleb. Elevated functioning blebs increase the success of glaucoma surgery. (NCT00853905)
Timeframe: 1 day, 1 week, 1 month, 3 month and 6 month post-op visits

,
Interventionunits on a scale (Mean)
Day 1Week 1Month 1Month 3Month 6
Balanced Salt Solution (BSS Treatment 2)2.11.91.91.82.1
Triesence (Treatment 1)1.71.72.22.01.9

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Number of Adverse Events Associated With Treatment

(NCT00924508)
Timeframe: 6 weeks

InterventionAdverse events (Number)
Hydrogel Patch Alone, TAC 0.1%, TAC + Patch0

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Change in Disease Severity: Percent Change in Mean EASI Score

Percent change in mean EASI score week 0 to week 6: Each lesion was scored using a 12-point modified Eczema Area and Severity Index (EASI) at baseline and 2 weeks after the 4-week treatment period (week6). An experienced evaluator assessed each lesion on the severity of 4 domains, with higher scores indicating more severity: 1) intensity of redness (erythema), 2) thickness (induration, papulation, oedema), 3) scratching (excoriation) and 4) lichenification (lined skin) as as none (0), mild (1), moderate (2) and severe (3). Pictorial and descriptive instructions guided the evaluator in scoring the lesions based on visual appearance. (NCT00924508)
Timeframe: Baseline, 6 weeks

Interventionpercentage change (Mean)
Hydrogel Patch-47
TAC 0.1%-56
Patch + TAC-61

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Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale)

Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). It participant had a new flare, they also scored the maximum amount of acute gout pain in the most affected joint since the onset of a new flare on 5 point Likert scale (none, mild, moderate, severe, extreme). (NCT01029652)
Timeframe: 7 days post dose (randomization), 24 weeks post-dose

,
InterventionPercentage of participants (Number)
None (7 days post-dose) [N= 110, 107]Mild (7 days post-dose) [N= 110, 107]Moderate (7 days post-dose) [N= 110, 107]Severe (7 days post-dose) [N= 110, 107]Extreme (7 days post-dose) [N= 110, 107]None (24 weeks post-dose) [N= 85, 78]Mild (24 weeks post-dose) [N= 85, 78]Moderate (24 weeks post-dose) [N= 85, 78]Severe (24 weeks post-dose) [N= 85, 78]Extreme (24 weeks post-dose) [N= 85, 78]
Canakinumab 150 mg32.748.216.42.70.047.138.812.91.20.0
Triamcinolone Acetonide 40 mg28.041.116.812.11.946.237.215.41.30.0

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Patient's Global Assessment of Response to Treatment

Patients made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. Percentage of participants in each category for both core and extension periods were measured. (NCT01029652)
Timeframe: 72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)

,
InterventionPercentage of participants (Number)
Excellent (Core) [N=113, 111]Good (Core) [N=113, 111]Acceptable (Core) [N=113, 111]Slight (Core) [N=113, 111]Poor (Core) [N=113, 111]Excellent (24 weeks) [N=87, 78]Good (24 weeks) [N=87, 78]Acceptable (24 weeks) [N=87, 78]Slight (24 weeks) [N=87, 78]Poor (24 weeks) [N=87, 78]
Canakinumab 150 mg12.438.937.28.82.7314620.71.11.1
Triamcinolone Acetonide 40 mg12.628.830.612.615.317.944.925.69.02.6

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Patient's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab

Patients made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. Percentage of participants in each category for both core and extension periods were measured. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab. (NCT01029652)
Timeframe: 72 hours post-dose , 7 days post dose for the last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)

,
InterventionPercentage of participants (Number)
Excellent (72 hours post dose) (n=60, 36)Good (72 hours post dose) (n=60, 36)Acceptable (72 hours post dose) (n=60, 36)Slight (72 hours post dose) (n=60, 36)Poor (72 hours post dose) (n=60, 36)Excellent (7 days post dose) (n=68, 36)Good (7 days post dose) (n=68, 36)Acceptable (7 days post dose) (n=68, 36)Slight (7 days post dose) (n=68, 36)Poor (7 days post dose) (n=68, 36)
Randomized to Canakinumab and Re-treated With Canakinumab15.026.750.06.71.723.541.227.97.40.0
Randomized to Triamcinolone and Switched to Canakinumab19.444.427.82.85.627.852.816.72.80.0

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Percentage of Participants Who Took Rescue Medication

Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments. Permitted rescue medications included acetaminophen 500 mg and/ or codeine 30 mg as needed. If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolone as needed per day for 2 days followed by up to 20 mg of prednisolone as needed per day for 3 subsequent days within 7 days after randomization or after re-dose/injection administration. (NCT01029652)
Timeframe: during 12 weeks core, 24 weeks overall

,
InterventionPercentage of participants (Number)
12 weeks :Core (N=113, 115)24 weeks: Overall (N=35, 43)
Canakinumab 150 mg31.048.6
Triamcinolone Acetonide 40 mg52.244.2

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Percentage of Participants With Maximum Severity of Last Post-baseline Flare (5-point Likert Scale)

Maximum severity is the maximum Likert score recorded after the start of the flare. Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). It participant had a new flare, they also scored the maximum amount of acute gout pain in the most affected joint since the onset of a new flare on 5 point Likert scale (none, mild, moderate, severe, extreme). (NCT01029652)
Timeframe: Last post-baseline flare (during 24 weeks overall)

,
InterventionPercentage of participants (Number)
NoneMildModerateSevereExtreme
Canakinumab 150 mg0.00.014.377.18.6
Triamcinolone Acetonide 40 mg0.02.316.360.520.9

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Physician's Assessment of Erythema for Patients Re-treated or Switched to Canakinumab

The study physician assessed the most affected joint for Erythema: Present or absent. The percentage of patients in each category is reported. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab. (NCT01029652)
Timeframe: 72 hours post-dose , 7 days post dose for the last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)

,
InterventionPercentage of participants (Number)
Absent (72 hours post dose) (n=61, 35)Present (72 hours post dose) (n=61, 35)Absent (7 days post dose) (n=67, 36)Present (7 days post dose) (n=67, 36)
Randomized to Canakinumab and Re-treated With Canakinumab82.018.095.54.5
Randomized to Triamcinolone and Switched to Canakinumab80.020.094.45.6

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Physician's Assessment of Joint Swelling for Patients Re-treated or Switched to Canakinumab

The study physician assessed the most affected joint for: Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; The percentage of patients in each category is reported. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab. (NCT01029652)
Timeframe: 72 hours post-dose , 7 days post dose last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)

,
InterventionPercentage of participants (Number)
No Pain (72 hours post dose) (n=61, 35)Pain (72 hours post dose) (n=61, 35)Pain and winces (72 hours post dose) (n=61, 35)Pain, winces, withdraw(72 hrs post dose)(n=61, 35)No pain (7 days post dose) (n=68, 36)Pain (7 days post dose) (n=68, 36)Pain and winces (7 days post dose) (n=68, 36)Pain, winces, withdraw(72 hrs post dose)(n=68, 36)
Randomized to Canakinumab and Re-treated With Canakinumab29.542.624.63.364.725.07.42.9
Randomized to Triamcinolone and Switched to Canakinumab42.948.68.60.075.016.75.62.8

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Physician's Assessment of Joint Tenderness for Patients Re-treated or Switched to Canakinumab

"The study physician assessed the most affected joint for: Tenderness on a 0-3 point scale: No pain, patient states that there is pain, patient states there is pain and winces, and patient states there is pain, winces, and withdraws on palpation or passive movement of the affected study joint; The percentage of patients in each category is reported. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab." (NCT01029652)
Timeframe: 72 hours post-dose , 7 days post dose last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)

,
InterventionPercentage of participants (Number)
No Pain (72 hours post dose) (n=61, 35)Pain (72 hours post dose) (n=61, 35)Pain and winces (72 hours post dose) (n=61, 35)Pain, winces, withdraw(72 hrs post dose)(n=61, 35)No pain (7 days post dose) (n=68, 36)Pain (7 days post dose) (n=68, 36)Pain and winces (7 days post dose) (n=68, 36)Pain, winces, withdraw(72 hrs post dose)(n=61, 36)
Randomized to Canakinumab and Re-treated With Canakinumab27.954.116.41.652.944.12.90.0
Randomized to Triamcinolone and Switched to Canakinumab28.668.62.90.069.427.82.80.0

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Physician's Assessment of Range of Motion of the Most Affected Joint

The study physician assessed the range of motion of the most affected joint for range of motion on a 5-point Likert scale: Normal, mildly restricted, moderately restricted, severely restricted, immobilized. The percentage of patients in each category is reported. (NCT01029652)
Timeframe: 72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (24 weeks overall)

,
InterventionPercentage of participants (Number)
Normal (Core) [N=113, 111]Mildly restricted (Core) [N=113, 111]Moderately restricted (Core) [N=113, 111]Severely restricted (Core) [N=113, 111]Immobilized (Core) [N=113, 111]Normal (24 weeks) [N=87, 79]Mildly restricted (24 weeks) [N=87, 79]Moderately Restricted (24 weeks) [N=87, 79]Severely Restricted (24 weeks) [N=87, 79]Immobilized (24 weeks) [N=87, 79]
Canakinumab 150 mg25.750.421.22.70.066.731.02.30.00.0
Triamcinolone Acetonide 40 mg31.529.727.08.13.665.829.13.81.30.0

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Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint

"The study physician assessed the most affected joint for: Tenderness on a 0-3 point scale: No pain, patient states that there is pain, patient states there is pain and winces, and patient states there is pain, winces, and withdraws on palpation or passive movement of the affected study joint; Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; and Erythema: Present or absent. The percentage of patients in each category is reported." (NCT01029652)
Timeframe: 72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)

,
InterventionPercentage of participants (Number)
TENDERNESS - No pain (Core) [N=113, 110]Pain (Core) [N=113, 110]Pain and winces (Core) [N=113, 110]Pain,winces,withdraws (Core) [N=113,110]SWELLING - No swelling (Core) [N=113, 110]Palpable (Core) [N=113, 110]Visible (Core) [N=113, 110]Bulging beyond joint margin (Core) [N=113, 110]ERYTHEMA - Absent (Core) [N=112, 109]Present (Core) [N=112, 109]TENDERNESS - No pain (24 weeks) [N=87, 80]Pain (24 weeks) [N=87, 80]Pain and winces (24 weeks) [N=87, 80]Pain,winces,withdraws (24 weeks) [N=87, 80]SWELLING - No swelling (24 weeks) [N=87, 80]Palpable (24 weeks) [N=87, 80]Visible (24 weeks) [N=87, 80]Bulging beyond joint margin (24 week)[N=87,80]ERYTHEMA - Absent (24 weeks) [N=87, 80]Present (24 weeks) [N=87, 80]
Canakinumab 150 mg33.656.68.01.838.138.921.21.878.621.482.817.20.00.088.58.03.40.098.91.1
Triamcinolone Acetonide 40 mg26.451.817.34.530.035.529.15.565.134.985.013.81.30.093.85.01.30.01000.0

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Physician's Global Assessment of Response to Treatment

The study physician made a global assessment of the patient's response to treatment using a 5-point Likert scale: Very good, good, fair, poor, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient's assessments (pain intensity [Visual Analog Scale and Likert scale] and patient's global assessment of response to treatment). (NCT01029652)
Timeframe: 72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)

,
InterventionPercentage of participants (Number)
Very good (Core) [N=113,110]Good (Core) [N=113, 110]Fair (Core) [N= 113, 110]Poor (Core) [N= 113, 110]Very poor (Core) [N=113, 110]Very Good ( 24 weeks) [N=87, 79]Good (24 weeks) [N=87, 79]Fair (24 weeks) [N=87, 79]Poor (24 weeks) [N=87, 79]Very Poor (24 weeks) [N=87, 79]
Canakinumab 150 mg16.847.826.57.11.843.750.65.70.00.0
Triamcinolone Acetonide 40 mg15.530.032.714.57.327.850.617.73.80.0

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Physician's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab

The study physician made a global assessment of the patient's response to treatment using a 5-point Likert scale: Very good, good, fair, poor, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient's assessments (pain intensity [Visual Analog Scale and Likert scale] and patient's global assessment of response to treatment). The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab. (NCT01029652)
Timeframe: 72 hours post-dose , 7 days post-dose for the last post-baseline flare for patients re-treated with canakinumab or first post-baseline flare treated with canakinumab for patients switched treatment (during 72 weeks overall)

,
InterventionPercentage of participants (Number)
Very good (72 hours post dose) (n=61, 34)Good (72 hours post dose) (n=61, 34)Fair (72 hours post dose) (n=61, 34)Poor (72 hours post dose) (n=61, 34)Very poor (72 hours post dose) (n=61, 34)Very Good (7 days post dose) (n=68, 34)Good (7 days post dose) (n=68, 34)Fair (7 days post dose) (n=68, 34)Poor (7 days post dose) (n=68, 34)Very Poor (7 days post dose) (n=68, 34)
Randomized to Canakinumab and Re-treated With Canakinumab21.341.031.16.60.036.852.910.30.00.0
Randomized to Triamcinolone and Switched to Canakinumab22.957.117.12.90.033.363.90.00.02.8

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Time to First New Flare

"Kaplan-Meier (KM) estimates of time to first new flare and confidence intervals were determined. Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before the flare has resolved completely." (NCT01029652)
Timeframe: 24 weeks

InterventionDays (Median)
Canakinumab 150 mgNA
Triamcinolone Acetonide 40 mg119

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High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels for Core and 24 Weeks Overall

High sensitivity C-reactive protein (hsCRP) and serum amyloid A (SAA) were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analytes were measured by a central laboratory. The analysis included treatment group, log-transformed protein level at baseline, and body mass index (BMI) at baseline as covariates. (NCT01029652)
Timeframe: 72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)

,
Interventionmg/L (Least Squares Mean)
hsCRP : Core(n= 109, 107)SAA protein : Core (n=105, 106)hsCRP : 24 weeks(n= 31, 32)SAA protein : 24 weeks (n=28, 33)
Canakinumab 150 mg4.506.775.1811.43
Triamcinolone Acetonide 40 mg7.0817.007.1821.11

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Amount of Rescue Medication Taken

"Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:~Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.~If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolon as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare." (NCT01029652)
Timeframe: 7 days last post-baseline flare (during 24 weeks)

,
Interventionmg (Mean)
AcetaminophenCodeinePrednisolone/Prednisone
Canakinumab 150 mg1931.47.74.1
Triamcinolone Acetonide 40 mg2058.146.021.6

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High-sensitivity C-reactive Protein (hsCRP) Levels for Patients Re-treated With or Switched to Canakinumab

High sensitivity C-reactive protein (hsCRP) levels were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analytes were measured by a central laboratory. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab. (NCT01029652)
Timeframe: 24 hours, 72 hours, 7 days, 4 weeks, 8 weeks and 12 weeks post-dose for the last post-baseline flare for patients re-treated with canakinumab or first post-baseline flare treated with canakinumab for patients switched treatment (during 72 weeks overall)

,
Interventionmg/L (Mean)
24 hours post dose (n= 45, 24)72 hours post dose (n=45, 34)7 days post dose (n=67, 39)4 weeks post dose (n=52, 35)8 weeks post dose (n=45, 37)12 weeks post dose (n=42, 33)
Randomized to Canakinumab and Re-treated With Canakinumab28.910.63.39.22.66.5
Randomized to Triamcinolone and Switched to Canakinumab26.07.03.23.23.04.3

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Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (24 Weeks Overall)

This was the primary endpoint of both extension studies. Adverse event is defined as any unfavorable and unintended diagnosis, symptom, sign(including an abnormal laboratory finding),syndrome or disease which either occurs during the study, having been absent at baseline, or,if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. (NCT01029652)
Timeframe: 24 weeks overall

,
InterventionParticipants (Number)
Adverse EventDeathSerious Adverse Event
Canakinumab 150 mg71011
Triamcinolone Acetonide 40 mg5616

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Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (72 Weeks Overall)

This was the primary endpoint of both extension studies. Adverse event is defined as any unfavorable and unintended diagnosis, symptom, sign(including an abnormal laboratory finding),syndrome or disease which either occurs during the study, having been absent at baseline, or,if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. (NCT01029652)
Timeframe: 72 weeks overall

,,,,,
InterventionParticipants (Number)
Adverse EventDeathSerious Adverse Event
All Randomized to Canakinumab76119
Randomized to Canakinumab :After Re-treated With Canakinumab3818
Randomized to Canakinumab :Before Re-treated With Canakinumab4106
Randomized to Triam: After Switched to Canakinumab1900
Randomized to Triam: Before Switched to Canakinumab2002
Randomized to Triamcinolone Acetonide (Triam)60211

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Flare Rate Per Year

"Flare rate was calculated as the number of new flares over the period of observation in years. Flare rate was calculated using only those new flares before switching to canakinumab.~Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before the flare has resolved completely." (NCT01029652)
Timeframe: 72 weeks overall

InterventionNew flares per patient per year (Mean)
Canakinumab 150 mg1.16
Triamcinolone Acetonide 40 mg2.81

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Mean Number of New Gout Flares Per Patient

"Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before the flare has resolved completely." (NCT01029652)
Timeframe: 12 weeks

InterventionNew flares/patient/12 weeks (Mean)
Canakinumab 150 mg0.21
Triamcinolone Acetonide 40 mg0.53

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Mean Number of New Gout Flares Per Patient During the 24 Weeks of the Study

"Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before the flare has resolved completely." (NCT01029652)
Timeframe: 24 weeks

InterventionNew flares/patient/24 weeks (Mean)
Canakinumab 150 mg0.40
Triamcinolone Acetonide 40 mg0.87

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Patient's Assessment of Gout Pain Intensity in the Most Affected Joint on a Visual Analog Scale (VAS) in Extension

Patients scored their pain intensity in the joint most affected at baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The ANCOVA analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates. (NCT01029652)
Timeframe: 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)

Interventionmm (Least Squares Mean)
Canakinumab 150 mg34.6
Triamcinolone Acetonide 40 mg44.9

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Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks

"Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before the flare has resolved completely." (NCT01029652)
Timeframe: 12 weeks

InterventionPercentage of participants (Number)
Canakinumab 150 mg18.6
Triamcinolone Acetonide 40 mg34.8

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Percentage of Participants With Complete Resolution of Pain

Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose. Complete Resolution of Pain is defined as no pain (None) on the Likert Scale. The Kaplan-Meier estimates of cumulative event rate = percentage of participants with event up to the end of the time interval. (NCT01029652)
Timeframe: 7 days post-dose (randomization)

InterventionPercentage of participants (Number)
Canakinumab 150 mg34.5
Triamcinolone Acetonide 40 mg31.3

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Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100mm VAS)

Patients scored their pain intensity in the joint most affected at baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The ANCOVA analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates. (NCT01029652)
Timeframe: 72 hours post-dose (randomization)

Interventionmm (Least Squares Mean)
Canakinumab 150 mg28.1
Triamcinolone Acetonide 40 mg39.5

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SF36 Physical Function Score at Week 12

The SF-36 measures the impact of disease on overall quality of life (QoL). This 36-item survey has 8 subscales that can be aggregated into physical- and mental-component summary scores. Scores are standardized with the use of norm-based methods based on an assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL. A negative change score indicates improvement. An ANCOVA model was used with treatment group and baseline SF-36 physical function subscore as covariates. (NCT01029652)
Timeframe: Week 12

InterventionUnits on a scale (Least Squares Mean)
Canakinumab 150 mg71.76
Triamcinolone Acetonide 40 mg71.48

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Time to at Least a 50% Reduction in Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100mm VAS)

The Kaplan-Meier estimates of the time to at least a 50% reduction in self-assessed pain intensity in the joint most affected at baseline was determined along with the 95% confidence interval. Patients scored their pain intensity on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose. (NCT01029652)
Timeframe: From baseline to 7 days post dose (randomization)

InterventionHours (Median)
Canakinumab 150 mg48.0
Triamcinolone Acetonide 40 mg72.0

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Time to Complete Resolution of Pain

Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Complete Resolution of Pain is defined as no pain (None) on the Likert Scale. Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose. The Kaplan-Meier estimates of time to complete resolution of self-assessed pain intensity in the joint most affected and their confidence intervals were determined. (NCT01029652)
Timeframe: 7 days post-dose (randomization)

InterventionHours (Median)
Canakinumab 150 mgNA
Triamcinolone Acetonide 40 mgNA

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Time to First Intake of Rescue Medication After the Last Post Baseline Flare.

The Kaplan-Meier estimates of medians and 95% confidence intervals were used to calculate the endpoint. (NCT01029652)
Timeframe: 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)

InterventionHours (Median)
Canakinumab 150 mgNA
Triamcinolone Acetonide 40 mgNA

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Patient's Assessment of Gout Pain Intensity in the Currently Most-affected Joint (Likert Scale)

Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). It participant had a new flare, they also scored the maximum amount of acute gout pain in the most affected joint since the onset of a new flare on 5 point Likert scale (none, mild, moderate, severe, extreme). The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab. (NCT01029652)
Timeframe: 72 hours post-dose , 7 days post dose for the last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)

,
InterventionPercentage of participants (Number)
None (72 hours post dose) (n=66, 39)Mild (72 hours post dose) (n=66, 39)Moderate (72 hours post dose) (n=66, 39)Severe (72 hours post dose) (n=66, 39)Extreme (72 hours post dose) (n=66, 39)None (7 days post dose) (n=65, 35)Mild (7 days post dose) (n=65, 35)Moderate (7 days post dose) (n=65, 35)Severe (7 days post dose) (n=65, 35)Extreme (7 days post dose) (n=65, 35)
Randomized to Canakinumab and Re-treated With Canakinumab19.730.045.54.50.041.538.518.51.50.0
Randomized to Triamcinolone and Switched to Canakinumab20.561.515.40.02.657.134.35.70.02.9

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Time to First New Flare

"Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1).~Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before flare has resolved completely." (NCT01029652)
Timeframe: 12 weeks

InterventionDays (Median)
Canakinumab 150 mgNA
Triamcinolone Acetonide 40 mgNA

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Time to First New Flare: Survival Analysis by Treatment (72 Weeks Overall)

"Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1).~Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before flare has resolved completely." (NCT01029652)
Timeframe: 72 weeks overall

Interventiondays (Median)
Canakinumab 150 mg222.0
Triamcinolone Acetonide 40 mg119.0

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Serum Amyloid A Protein (SAA) Levels for Patients Re-treated With or Switched to Canakinumab

Serum Amyloid A Protein (SAA) levels were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analytes were measured by a central laboratory. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab. (NCT01029652)
Timeframe: 24 hours, 72 hours, 7 days, 4 weeks, 8 weeks and 12 weeks post-dose for the last post-baseline flare for patients re-treated with canakinumab or first post-baseline flare treated with canakinumab for patients switched treatment (during 72 weeks overall)

,
Interventionmg/L (Mean)
24 hours post dose (n= 45, 27)72 hours post dose (n=45, 36)7 days post dose (n=67, 39)4 weeks post dose (n=52, 35)8 weeks post dose (n=45, 37)12 weeks post dose (n=42, 33)
Randomized to Canakinumab and Re-treated With Canakinumab151.442.55.431.04.210.7
Randomized to Triamcinolone and Switched to Canakinumab86.526.94.98.55.47.8

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Percentage of Participants Who Took Rescue Medication

"Participants who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:~Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.~If they had insufficient pain relief, participants were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare.~Use of these treatments during the first 7 days of a gout flare was recorded as rescue medication." (NCT01080131)
Timeframe: For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).

,
Interventionpercentage of participants (Number)
Baseline flare [N= 112, 114]Last post-baseline flare [N=25, 46]
Canakinumab 150 mg43.856.0
Triamcinolone Acetonide 40 mg57.041.3

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Percentage of Patients With Maximum Severity of New Gout Flares as Severe or Extreme

For each new flare, participants scored the maximum amount of acute gout pain in the most affected joint since the onset of the new flare and the time they were re-dosed on a 5 point Likert scale as None, Mild, Moderate, Severe or Extreme. The percentage of participants with a maximum new flare severity of severe or extreme is reported for the first post-baseline flare that occurred during the 12-week core study and for the last post-baseline flare that occurred up until the end of the first extension period. (NCT01080131)
Timeframe: From the onset of a new flare until re-dosing. First post-baseline new flare during 12 week core study and the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).

,
InterventionPercentage of participants (Number)
First post-baseline flare [N= 12, 37]Last post-baseline flare [N= 25, 46]
Canakinumab 150 mg66.764.0
Triamcinolone Acetonide 40 mg78.478.3

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Physician's Assessment of Erythema for Participants Re-treated or Switched to Canakinumab

"The study physician assessed the most affected joint for erythema (redness of the skin) as either present, absent or not assessable.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2." (NCT01080131)
Timeframe: 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.

,
Interventionpercentage of participants (Number)
72 hours - Absent [N=56, 38]72 hours - Present [N=56, 38]7 days - Absent [N=58, 39]7 days - Present [N=58, 39]
Re-treated With Canakinumab 150 mg73.226.884.515.5
Triam Switched to Canakinumab92.17.994.95.1

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Physician's Assessment of Joint Swelling for Participants Re-treated or Switched to Canakinumab

"The study physician assessed the most affected joint for swelling on the following 4-point scale:~no swelling;~palpable;~visible;~bulging beyond the joint margins.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2." (NCT01080131)
Timeframe: 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.

,
Interventionpercentage of participants (Number)
72 hours - No swelling [N=56, 38]72 hours - Palpable [N=56, 38]72 hours - Visible [N=56, 38]72 hours - Bulging beyond joint margins [N=56, 38]7 days - No swelling [N=58, 39]7 days - Palpable [N=58, 39]7 days - Visible [N=58, 39]7 days - Bulging beyond joint margins [N=58, 39]
Re-treated With Canakinumab 150 mg55.426.812.55.470.717.210.31.7
Triam Switched to Canakinumab47.434.215.82.679.517.92.60.0

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Physician's Assessment of Joint Tenderness for Participants Re-treated or Switched to Canakinumab

"The study physician assessed the most affected joint for tenderness on the following 4-point scale:~no pain;~participant states that there is pain;~participant states there is pain and winces;~participant states there is pain, winces and withdraws on palpation or passive movement of the affected study joint.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2." (NCT01080131)
Timeframe: 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.

,
Interventionpercentage of participants (Number)
72 hours - No pain [N=56, 38]72 hours - Pain [N=56, 38]72 hours - Pain and winces [N=56, 38]72 hours - Pain, winces and withdraws [N=56, 38]7 days - No pain [N=58, 39]7 days - Pain [N=58, 39]7 days - Pain and winces [N=58, 39]7 days - Pain, winces and withdraws [N=58, 39]
Re-treated With Canakinumab 150 mg51.837.55.45.474.122.43.40.0
Triam Switched to Canakinumab42.150.05.32.679.520.50.00.0

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Physician's Assessment of Range of Motion of the Most Affected Joint

The study physician assessed the range of motion of the most affected joint for range of motion on a 5-point Likert scale: Normal, mildly restricted, moderately restricted, severely restricted, immobilized. The percentage of participants in each category is reported. (NCT01080131)
Timeframe: 72 hours post-dose and 24 weeks post-dose

,
Interventionpercentage of participants (Number)
72 hours - Normal [N=107,109]72 hours - Mildly restricted [N=107,109]72 hours - Moderately restricted [N=107,109]72 hours - Severely restricted [N=107,109]72 hours - Immobilized [N=107,109]24 weeks - Normal [N=79, 71]24 weeks - Mildly restricted [N=79, 71]24 weeks - Moderately restricted [N=79, 71]24 weeks - Severely restricted [N=79, 71]24 weeks - Immobilized [N=79, 71]
Canakinumab 150 mg47.737.413.11.90.086.110.12.51.30.0
Triamcinolone Acetonide 40 mg28.445.920.25.50.097.22.80.00.00.0

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Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint

"The study physician assessed the most affected joint for: Tenderness on a 0-3 point scale: No pain, patient states that there is pain, patient states there is pain and winces, and patient states there is pain, winces, and withdraws on palpation or passive movement of the affected study joint; Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; and Erythema: Present or absent. The percentage of participants in each category is reported." (NCT01080131)
Timeframe: 72 hours post-dose and 24 weeks post-dose

,
Interventionpercentage of participants (Number)
72 hours - Tenderness: No pain [N=107, 109]72 hours - Tenderness: Pain [N=107, 109]72 hours - Tenderness: Pain & winces [N=107, 109]72 hours - Tenderness:Winces/withdraws [N=107,109]24 weeks - Tenderness: No pain [N=79, 71]24 weeks - Tenderness: Pain [N=79, 71]24 weeks - Tenderness: Pain and winces [N=79, 71]24 weeks - Tenderness: Winces/withdraws [N=79, 71]72 hours - Swelling: No swelling [N=107,109]72 hours - Swelling: Palpable [N=107,109]72 hours - Swelling: Visible [N=107,109]72 hours - Swelling: Bulging [N=107,109]24 weeks - Swelling: No swelling [N=79, 71]24 weeks - Swelling: Palpable [N=79, 71]24 weeks - Swelling: Visible [N=79, 71]24 weeks - Swelling: Bulging [N=79, 71]72 hours - Erythema: Absent [N=107, 108]72 hours - Erythema: Present [N=107, 108]24 weeks - Erythema: Absent [N=79, 71]24 weeks - Erythema: Present [N=79, 71]
Canakinumab 150 mg47.743.94.73.788.68.91.31.347.728.022.41.993.75.11.30.074.825.297.52.5
Triamcinolone Acetonide 40 mg30.346.814.78.391.55.61.41.435.829.428.46.494.44.21.40.066.733.397.22.8

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Physician's Global Assessment of Response to Treatment

The study physician made a global assessment of the patient's response to treatment using a 5-point Likert scale: Very good, good, fair, poor, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient's own assessments (pain intensity and patient's global assessment of response to treatment). (NCT01080131)
Timeframe: 72 hours post-dose and 24-weeks post-dose.

,
Interventionpercentage of participants (Number)
72 hours - Very good [N= 107, 109]72 hours - Good [N= 107, 109]72 hours - Fair [N= 107, 109]72 hours - Poor [N= 107, 109]72 hours - Very poor [N= 107, 109]24 weeks - Very good [N=79, 71]24 weeks - Good [N=79, 71]24 weeks - Fair [N=79, 71]24 weeks - Poor [N=79, 71]24 weeks - Very poor [N=79, 71]
Canakinumab 150 mg43.043.011.22.80.077.216.55.11.30.0
Triamcinolone Acetonide 40 mg25.735.826.66.45.566.229.64.20.00.0

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Physician's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab

"The study physician made a global assessment of the patient's response to treatment using a 5-point Likert scale: very good, good, fair, poor or very poor.~The physician completed the physician's global assessment of response to treatment without viewing any of the patient's assessments.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2." (NCT01080131)
Timeframe: 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.

,
Interventionpercentage of participants (Number)
72 hours - Very good [N=56, 38]72 hours - Good [N=56, 38]72 hours - Fair [N=56, 38]72 hours - Poor [N=56, 38]72 hours - Very poor [N=56, 38]7 days - Very good [N=58, 39]7 days - Good [N=58, 39]7 days - Fair [N=58, 39]7 days - Poor [N=58, 39]7 days - Very poor [N=58, 39]
Re-treated With Canakinumab 150 mg39.339.316.15.40.056.925.915.51.70.0
Triam Switched to Canakinumab42.139.518.40.00.059.038.52.60.00.0

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Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100 mm VAS)

Patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), from 6 hours to 7 days post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The ANCOVA analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates. (NCT01080131)
Timeframe: 6, 12, 24, 48, and 72 hours; and 4, 5, 6, and 7 days post-dose (randomization)

,
Interventionmm (Least Squares Mean)
6 hours post-dose12 hours post-dose24 hours post-dose48 hours post-dose72 hours post-dose4 days post-dose5 days post-dose6 days post-dose7 days post-dose
Canakinumab 150 mg58.750.839.129.522.119.216.414.314.0
Triamcinolone Acetonide 40 mg60.352.045.038.931.927.725.422.319.5

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Self-assessed Pain Intensity in the Joint Most Affected at Last Post-Baseline Measured on a Visual Analog Scale (VAS)

Patient's assessment of gout pain intensity in the most affected joint (on a 0-100 mm VAS) for the last post-baseline flare, ranging from no pain (0) to unbearable pain (100), was summarized up to 7 days after receiving a re-dose of study drug by time point. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The covariance analysis included treatment group, Baseline VAS score at that flare, and body mass index (BMI) at Baseline as covariates. (NCT01080131)
Timeframe: 6, 12, 24, 48, and 72 hours; and 4, 5, 6, and 7 days post-dose for last post-baseline flare that occurred up until the end of the first extension study (24 weeks).

,
Interventionmm (Least Squares Mean)
6 hours post-dose12 hours post-dose24 hours post-dose48 hours post-dose72 hours post-dose4 days post-dose5 days post-dose6 days post-dose7 days post-dose
Canakinumab 150 mg57.450.746.242.337.031.329.028.124.1
Triamcinolone Acetonide 40 mg59.153.343.834.226.123.421.620.519.1

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Serum Amyloid A Protein (SAA) Levels for Participants Re-treated With or Switched to Canakinumab

"Serum Amyloid A Protein (SAA) levels in blood serum were measured by a central laboratory in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2." (NCT01080131)
Timeframe: 24 hours, 72 hours, 7 days, 4, 8 and 12 weeks post-dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.

,
Interventionmg/L (Mean)
24-hours post-dose [N=47, 36]72-hours post-dose [N=54, 37]7 days post-dose [N=56, 39]4 weeks post-dose [N=47, 37]8 weeks post-dose [N=38, 35]12 weeks post-dose [N=38, 29]
Re-treated With Canakinumab 150 mg129.045.65.73.43.53.4
Triam Switched to Canakinumab145.945.45.95.05.34.8

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Time to First Intake of Rescue Medication

"Participants who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:~Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.~If they had insufficient pain relief, participants were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare.~Use of these treatments during the first 7 days of a gout flare was recorded as rescue medication.~Kaplan-Meier estimates of the time to first intake of rescue medication, in hours, and the confidence interval were determined for the flare experienced at study entry (Baseline flare) and the last new flare (last post-baseline flare) that occurred up until the end of the first extension period (24 weeks)." (NCT01080131)
Timeframe: For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).

,
Interventionhours (Median)
Baseline flare [N= 112, 114]Last post-baseline flare [N=25, 46]
Canakinumab 150 mgNA32
Triamcinolone Acetonide 40 mg37.5NA

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Flare Rate Per Year

"Flare rate was calculated as the number of new flares over the period of observation in years. Flare rate was calculated using only those new flares before switching to canakinumab.~Participants met the definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Participants did not meet criterion of having new gout flare if:~• Increasing/renewed gout pain in an affected joint before the flare has resolved completely.~Flare rates were estimated from a negative binomial model with body mass index at baseline as a covariate." (NCT01080131)
Timeframe: From randomization to the end of the second extension period (72 weeks).

Interventionflares per patient per year (Mean)
Canakinumab 150 mg1.18
Triamcinolone Acetonide 40 mg2.02

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Mean Number of New Gout Flares Per Patient During 24 Weeks

"Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint(at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Participants did not meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely." (NCT01080131)
Timeframe: 24 weeks

Interventionnew flares per patient (Mean)
Canakinumab 150 mg0.35
Triamcinolone Acetonide 40 mg0.80

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Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks of the Study

The percentage of participants who experienced at least 1 new gout flare during the 12 week study treatment period. (NCT01080131)
Timeframe: Baseline to Week 12

Interventionpercentage of participants (Number)
Canakinumab 150 mg13.4
Triamcinolone Acetonide 40 mg36.8

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Pharmacokinetic Concentrations

Canakinumab concentration was analyzed in serum by means of a competitive Enzyme-linked immunosorbent assay (ELISA) assay with a lower limit of quantification (LOQ) at 100 ng/mL. (NCT01080131)
Timeframe: 12 weeks post-dose

Interventionµg/mL (Mean)
Canakinumab 150 mg2.16

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Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (VAS) at 72 Hours Post-dose

Patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The analysis of covariance (ANCOVA) analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates. (NCT01080131)
Timeframe: 72 hours post-dose (randomization)

Interventionmm (Least Squares Mean)
Canakinumab 150 mg22.1
Triamcinolone Acetonide 40 mg31.9

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SF 36 Physical Function Score at Week 12

SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales that can be aggregated into physical and mental component summary scores. Scores are standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL. Analysis of covariance (ANCOVA) model was used with treatment group and baseline SF-36 physical function subscore as covariates. (NCT01080131)
Timeframe: Week 12

InterventionUnits on a scale (Least Squares Mean)
Canakinumab 150 mg81.46
Triamcinolone Acetonide 40 mg78.75

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Time to at Least a 50% Reduction in Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (VAS)

Kaplan-Meier estimates of the time to at least a 50% reduction in self-assessed pain intensity in the joint most affected at Baseline and the confidence intervals were determined along with 95% confidence interval. Patients scored their pain intensity on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose. (NCT01080131)
Timeframe: Baseline to 7 days post-dose (randomization)

Interventionhours (Median)
Canakinumab 150 mg25.0
Triamcinolone Acetonide 40 mg48.0

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Time to Complete Resolution of Pain; Survival Analysis

Kaplan-Meier estimates of the time to complete resolution of self-assessed pain intensity in the joint most affected and the confidence interval was determined. Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Pain was scored at Baseline; 6 and 12 hours; 1, 2, 3, 4, 5, 6, and 7 days post-dose. (NCT01080131)
Timeframe: Baseline to 7 days post-dose (randomization)

Interventionhours (Number)
Canakinumab 150 mg144.0
Triamcinolone Acetonide 40 mgNA

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Time to First New Flare: Survival Analysis by Treatment Over 72 Weeks

"Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1).~Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~• Increasing/renewed gout pain in an affected joint before flare has resolved completely." (NCT01080131)
Timeframe: From randomization to the end of the second extension period (72 weeks).

Interventiondays (Median)
Canakinumab 150 mg254.0
Triamcinolone Acetonide 40 mg146.0

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Time to First New Flare: Survival Analysis During the 12 Weeks of Study

Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1). Patients met definition of new flare if they had: •Flare in joint, not a previously affected joint (at baseline or during study) •Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely. Patients did not meet criterion of having new gout flare if: • Increasing/renewed gout pain in an affected joint before flare has resolved completely. (NCT01080131)
Timeframe: Baseline to 12 weeks

InterventionDays (Median)
Canakinumab 150 mgNA
Triamcinolone Acetonide 40 mgNA

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Time to the First New Gout Flare During 24 Weeks

"Kaplan-Meier (KM) estimates of the time to first new flare and confidence intervals were determined. Participants met the definition of a new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Participants did not meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely." (NCT01080131)
Timeframe: From randomization to the end of the first extension period (24 weeks).

Interventiondays (Median)
Canakinumab 150 mgNA
Triamcinolone Acetonide 40 mg146

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Amount of Rescue Medication Taken

"Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:~Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.~If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare." (NCT01080131)
Timeframe: For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).

,
Interventionmg (Mean)
Baseline flare: Acetaminophen [N=112, 114]Baseline flare: Codeine [N=112, 114]Baseline flare: Prednisone/Predinisone [N=112,114]Last flare: Acetaminophen [N=25, 46]Last flare: Codeine [N= 25, 46]Last flare: Prednisolone/Predinisone [N= 25, 46]
Canakinumab 150 mg1375.027.29.22292.064.85.6
Triamcinolone Acetonide 40 mg2526.560.619.31541.365.218.3

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High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels

High sensitivity C-reactive protein (hsCRP) and serum amyloid A (SAA) were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analyses were measured by a central laboratory. The analysis included treatment group, log-transformed protein level at baseline, and body mass index (BMI) at baseline as covariates. (NCT01080131)
Timeframe: 72 hours after the first dose for the baseline flare and 72 hours post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).

,
Interventionmg/L (Least Squares Mean)
Baseline flare: hsCRP [N=107, 110]Baseline flare: SAA [N=95, 104]Last post-baseline flare: hsCRP [N= 22, 42]Last post-baseline flare: SAA, [N= 19, 39]
Canakinumab 150 mg3.846.313.696.74
Triamcinolone Acetonide 40 mg6.3815.854.3211.04

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High-sensitivity C-reactive Protein (hsCRP) Levels for Participants Re-treated With or Switched to Canakinumab

"High sensitivity C-reactive protein (hsCRP) levels in blood serum were measured by a central laboratory in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2." (NCT01080131)
Timeframe: 24 hours, 72 hours, 7 days, 4, 8 and 12 weeks post-dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.

,
Interventionmg/L (Mean)
24-hours post-dose [N=48, 36]72-hours post-dose [N=56, 38]7 days post-dose [N=55, 40]4 weeks post-dose [N=46, 37]8 weeks post-dose [N=37, 35]12 weeks post-dose [N=38, 31]
Re-treated With Canakinumab 150 mg30.110.42.81.62.11.3
Triam Switched to Canakinumab39.412.63.52.22.42.9

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Number of Participants With Adverse Events, Death and Serious Adverse Events (72 Weeks Overall)

This was the primary endpoint of extension study 2. An adverse event was defined as any unfavorable and unintended diagnosis, symptom sign including an abnormal laboratory finding, syndrome or disease which either occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. (NCT01080131)
Timeframe: 72 weeks

,,,,,
Interventionparticipants (Number)
Any adverse eventDeathSerious adverse event
All Canakinumab85112
All Triamcinolone Acetonide7004
Canakinumab: After Retreatment3905
Canakinumab: Before Retreatment4401
Triam: After Switch to Canakinumab2703
Triam: Before Switch to Canakinumab2900

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Number of Participants With Adverse Events, Death and Serious Adverse Events During 24 Weeks

This was primary endpoint of extension study 1. Adverse event is defined as any unfavorable and unintended diagnosis, symptom sign including an abnormal laboratory finding, syndrome or disease which either occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen. A serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. (NCT01080131)
Timeframe: During 24 weeks overall

,
InterventionParticipants (Number)
Adverse eventDeathSerious adverse event
Canakinumab 150 mg7817
Triamcinolone Acetonide 40 mg6502

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Patient's Assessment of Gout Pain Intensity for Participants Re-treated or Switched to Canakinumab

"Participants scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe or extreme).~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2." (NCT01080131)
Timeframe: 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.

,
Interventionpercentage of participants (Number)
72 hours - None [N=59, 40]72 hours - Mild [N=59, 40]72 hours - Moderate [N=59, 40]72 hours - Severe [N=59, 40]72 hours - Extreme [N=59, 40]7 days - None [N=57, 37]7 days - Mild [N=57, 37]7 days - Moderate [N=57, 37]7 days - Severe [N=57, 37]7 days - Extreme [N=57, 37]
Re-treated With Canakinumab 150 mg30.544.122.03.40.064.921.110.53.50.0
Triam Switched to Canakinumab25.062.512.50.00.059.535.15.40.00.0

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Patient's Assessment of Gout Pain Intensity in the Most Affected Joint

Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). (NCT01080131)
Timeframe: 72 hours post-dose and 24 weeks post-dose

,
Interventionpercentage of participants (Number)
72 hours - None [N=108, 111]72 hours - Mild [N=108, 111]72 hours - Moderate [N=108, 111]72 hours - Severe [N=108, 111]72 hours - Extreme [N=108, 111]24 weeks - None [N=79, 70]24 weeks - Mild [N=79, 70]24 weeks - Moderate [N=79, 70]24 weeks - Severe [N=79, 70]24 weeks - Extreme [N=79, 70]
Canakinumab 150 mg30.648.120.40.90.072.219.06.32.50.0
Triamcinolone Acetonide 40 mg18.045.027.08.11.867.125.77.10.00.0

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Patient's Global Assessment of Response to Treatment

Participants made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. The percentage of participants in each category is reported. (NCT01080131)
Timeframe: 72 hours post-dose and 24 weeks post-dose

,
Interventionpercentage of participants (Number)
72 hours - Excellent [N=108, 108]72 hours - Good [N=108, 108]72 hours - Acceptable [N=108, 108]72 hours - Slight [N=108, 108]72 hours - Poor [N=108, 108]24 weeks - Excellent [N=79, 72]24 weeks - Good [N=79, 72]24 weeks - Acceptable [N=79, 72]24 weeks - Slight [N=79, 72]24 weeks - Poor [N=79, 72]
Canakinumab 150 mg36.137.018.54.63.759.526.66.36.31.3
Triamcinolone Acetonide 40 mg19.432.413.925.09.340.344.413.91.40.0

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Patient's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab

Participants made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight or poor. Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2. (NCT01080131)
Timeframe: 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.

,
Interventionpercentage of participants (Number)
72 hours - Excellent [N=58, 38]72 hours - Good [N=58, 38]72 hours - Acceptable [N=58, 38]72 hours - Slight [N=58, 38]72 hours - Poor [N=58, 38]7 days - Excellent [N=56, 39]7 days - Good [N=56, 39]7 days - Acceptable [N=56, 39]7 days - Slight [N=56, 39]7 days - Poor [N=56, 39]
Re-treated With Canakinumab 150 mg41.432.812.113.80.051.826.810.77.13.6
Triam Switched to Canakinumab36.839.521.12.60.051.333.37.77.70.0

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Ratio of Serum Cortisol Area Under Curve [AUC(0-24 hr)] at the End of Treatment to Baseline

"Blood samples were collected over a 24-hour period (at 0, 2, 4, 8, 12, 20, and 24 hours), with 0 hour being between 8:00AM to 9:00AM, immediately prior to investigational product (IP) administration. AUC (0-24hr) was calculated using the trapezoid rule, and was normalized by dividing the AUC(0-24 hr) by the actual sample collection interval between 0-hour and 24-hour blood draw times.~Ratio in Serum Cortisol AUC(0-24 hr) = (Serum Cortisol AUC[0-24 hr] at 6 weeks postrandomization)/(Serum Cortisol AUC[0-24 hr] at 1-3 days prerandomization). Log transformation was used for the analysis." (NCT01154153)
Timeframe: 1-3 days prerandomization and 6 weeks postrandomization

InterventionRatio (Geometric Mean)
Placebo0.938
TAA-AQ0.898

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The Percent of Days of Rescue Medication Use During the Double-blind Treatment Phase

The percent of days of rescue medication used during the double-blind treatment phase was calculated. For participants who did not use any rescue medication, the percentage of days using rescue medication was set to be 0. (NCT01154153)
Timeframe: From randomization to 43-50 days postrandomization

InterventionPercentage of days (Mean)
Placebo4.02
TAA-AQ3.07

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Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS)

"Every morning, participants rated the severity of symptoms experienced over the previous 24 hours using scale from 0-3, where 0=symptoms absent, 1=mild, 2=moderate, and 3=severe symptoms (interfere with daily living or sleep) for each symptom (nasal congestion, nasal itching, sneezing, and runny nose). The rTNSS was the sum of the individual symptom scores, ranged from 0-12 (where 12 reflected the worst symptoms).~Change from baseline in the rTNSS = mean rTNSS (double-blind treatment phase) - mean rTNSS (screening phase)." (NCT01154153)
Timeframe: From 8-24 days prerandomization up to 6 weeks postrandomization

InterventionScore on a scale (Mean)
Placebo-0.22
TAA-AQ-1.07

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Number of Participants Using Rescue Medication

The number of participants using the rescue medication (Claritin®) during the single-blind screening phase (the time from 8-24 days before randomization up to the day before randomization) and during the double-blind treatment phase (the time from randomization to end of study). (NCT01154153)
Timeframe: From 8 to 24 days prerandomization and randomization to end of study (43-50 days postrandomization)

,
InterventionParticipants (Number)
Prerandomization periodPostrandomization period
Placebo824
TAA-AQ819

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Number of Participants by Relief Level as Evaluated by the Physician

Efficacy of treatment was assessed by the physician using a scale from 0-4 for relief levels, where 0 = no relief (symptoms unchanged or worsened than before), 1 = slight relief (symptoms present and only minimally improved), 2 = moderate relief (symptoms are present and may be troublesome, but are noticeably improved), 3 = marked relief (symptoms are greatly improved and although present are scarcely troublesome) and 4 = complete relief (virtually no symptom present). (NCT01154153)
Timeframe: At end of study (43-50 days after randomization)

,
InterventionParticipants (Number)
Relief Level 0 (No relief)Relief Level 1 (Slight relief)Relief Level 2 (Moderate relief)Relief Level 3 (Marked relief)Relief Level 4 (Complete relief)
Placebo111816133
TAA-AQ91320176

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Number of Participants by Relief Level as Evaluated by the Participant

Efficacy of treatment was assessed by the participant using a scale from 0-4 for relief levels, where 0 = no relief (symptoms unchanged or worsened than before), 1 = slight relief (symptoms present and only minimally improved), 2 = moderate relief (symptoms are present and may be troublesome, but are noticeably improved), 3 = marked relief (symptoms are greatly improved and although present are scarcely troublesome) and 4 = complete relief (virtually no symptom present). (NCT01154153)
Timeframe: At end of study (43-50 days after randomization)

,
InterventionParticipants (Number)
Relief level 0 (No relief)Relief level 1 (Slight relief)Relief level 2 (Moderate relief)Relief level 3 (Marked relief)Relief level 4 (Complete relief)
Placebo91716145
TAA-AQ52213169

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To Assess the Safety & Tolerability of 20089 TA (6.9 mg or 13.8 mg) When Used Adjunctively With Lucentis 0.5 mg in Subjects With Sub-foveal Neovascular AMD

"The primary objective is to assess the ocular safety of 20089 TA (6.9 mg or 13.8 mg)treatment in combination with Lucentis.~The ocular safety endpoints to be assessed include the number of participants with ocular Adverse Events such as: evidence of endophthalmitis, uveitis, ocular hemorrhage, retinal tear or detachment to be assessed during ophthalmic examinations. Elevated IOP as measured by an applanation tonometer at every visit." (NCT01175395)
Timeframe: 360 Days

InterventionNumber-participants with adverse events (Number)
IBI-20089/Lucentis0

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To Determine the Number of Retreatments With Lucentis in Eyes Initially Treated With 20089 TA and Lucentis

Because of the combination - 20089/Lucentis - treatment, patients may not require monthly Lucentis injections as is the current standard of care practice for AMD. (NCT01175395)
Timeframe: 30 to 360 days

Interventionretreatments (Median)
IBI-20089/Lucentis2

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Change in Knee Stiffness During the Past 48 Hours From the WOMAC LK3.1 Stiffness Score Questionnaire.

"Stiffness subscale score was calculated from patient's responses on the Western Ontario and McMaster Universities Osteoarthritis Index Likert-type 3.1 Questionnaire. The questionnaire includes 24 items divided into 3 subscales, Pain, Stiffness, Physical Function. Only the Stiffness subscale score was used for this outcome measure. The Stiffness subscale consists of two items, each ranging from 0 to 4, making the total Stiffness subscore 0 to 8. Higher scores represent higher levels of stiffness, whereas lower scores represent lower levels of stiffness.~Missing data were imputed." (NCT01230424)
Timeframe: Baseline to 2 years

Interventionunits on a scale (Mean)
Triamcinolone Acetonide-0.6
Sodium Chloride-0.5

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Change in Time to Complete 5 Chair Stands.

Change in time (seconds) to complete 5 chair stands. Missing data were imputed. (NCT01230424)
Timeframe: Baseline to 2 years

Interventionseconds (Mean)
Triamcinolone Acetonide-1.1
Sodium Chloride-1.2

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Change in Time to Complete a Twenty-meter Walk.

Change in time (seconds) to complete a twenty-meter walk. Missing data were imputed. (NCT01230424)
Timeframe: Baseline to 2 years

Interventionseconds (Mean)
Triamcinolone Acetonide-0.3
Sodium Chloride0.1

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Change in Function Severity During the Past 48 Hours From the WOMAC LK3.1 Function Score Questionnaire.

"Physical Function subscale score was calculated from patient's responses on the Western Ontario and McMaster Universities Osteoarthritis Index Likert-type 3.1 Questionnaire. The questionnaire includes 24 items divided into 3 subscales, Pain, Stiffness, Physical Function. Only the Physical Function subscale score was used for this outcome measure. The Physical Function subscale consists of 17 items, each ranging from 0 to 4, making the total Function subscore 0 to 68. Higher scores represent higher levels of difficulty performing daily activities, whereas lower scores represent lower levels of difficulty performing daily activities.~Missing data were imputed." (NCT01230424)
Timeframe: Baseline to 2 years

Interventionunits on a scale (Mean)
Triamcinolone Acetonide-4.1
Sodium Chloride-5.1

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Change in Volume of Peri-articular Bone Marrow Lesions Measured on Knee MRI.

Change in volume of peri-articular bone marrow lesions measured on knee MRI on the log scale. Missing data were imputed. (NCT01230424)
Timeframe: Baseline to 2 years.

Interventionlog mm^3 (Mean)
Triamcinolone Acetonide0.9
Sodium Chloride1.1

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Change in Patient's Global Assessment (Visual Analogue Scale).

"The response to the question, Considering all the ways your knee affects you, how much pain are you having today?, was measured and the change in the scoring was evaluated. The Patient's Global Assessment (PGA) is measured on a scale of 0 to 100 millimeters. Higher scores represent a higher level of disease activity or a worse global health. Missing data were imputed." (NCT01230424)
Timeframe: Baseline to 2 years

Interventionmm (Mean)
Triamcinolone Acetonide-2.7
Sodium Chloride-7.6

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Change in Mean Cartilage Thickness in the Index Compartment (Compartment With the Most Damage)

Mean cartilage thickness was measured on knee MRI (Philips Achieva X-Series 3.0 Tesla scanner). Missing data were imputed. (NCT01230424)
Timeframe: Baseline to 2 years

Interventionmm (Mean)
Triamcinolone Acetonide 40mg-0.21
0.9% Sodium Chloride-0.10

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Change in Volumetric Cartilage Damage Index (CDI) Measured on Knee MRI in the Index Compartment (Compartment With the Most Damage).

Change in volumetric cartilage damage index (CDI) measured on knee MRI in the index compartment (compartment with the most damage). Missing data were imputed. (NCT01230424)
Timeframe: Baseline to 2 years

Interventionmm^3 (Mean)
Triamcinolone Acetonide-133.7
Sodium Chloride-72.4

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Change in Knee Pain Severity During the Past 48 Hours From the WOMAC LK3.1 Pain Score Questionnaire.

"Pain subscale score was calculated from patient's responses on the Western Ontario and McMaster Universities Osteoarthritis Index Likert-type 3.1 Questionnaire. The questionnaire includes 24 items divided into 3 subscales, Pain, Stiffness, Physical Function. Only the Pain subscale score was used for this outcome measure. The Pain subscale consists of five items, each ranging from 0 to 4, making the total Pain subscore 0 to 20. Higher scores represent higher levels of pain, whereas lower scores represent lower levels of pain.~Missing data were imputed." (NCT01230424)
Timeframe: Baseline to 2 years

Interventionunits on a scale (Mean)
Triamcinolone Acetonide-1.2
Sodium Chloride-1.9

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Change in Effusion Volume Measured on Knee MRI.

Change in effusion volume measured on knee MRI on the log scale. Missing data were imputed. (NCT01230424)
Timeframe: Baseline to 2 years

Interventionlog mm^3 (Mean)
Triamcinolone Acetonide-0.1
Sodium Chloride-0.3

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Change in Area of Denudation Measured on Knee MRI in the Index Compartment (Compartment With the Most Damage).

Change in area of denudation measured on knee MRI in the index compartment (compartment with the most damage). Missing data were imputed. (NCT01230424)
Timeframe: Baseline to 2 years

Interventionmm^2 (Mean)
Triamcinolone Acetonide0.4
Sodium Chloride0.4

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Physician's Assessment of Erythema

The study physician assessed the most affected joint for erythema. Erythema was assessed as present, absent or not assessable. (NCT01356602)
Timeframe: 72 hours

,,
InterventionPercentage of Participants (Number)
AbsentPresent
Canakinumab, Lyophilizate (LYO)82.917.1
Canakinumab, Pre-filled Syringes (PFS)88.311.7
Triamcinolone Acetonide68.631.4

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Physician's Assessment of Range of Motion of the Most Affected Joint

The study physician assessed the patient's range of motion of the most affected joint on a 5 point Likert scale (normal, mildly restricted, moderately restricted, severely restricted and immobilized). (NCT01356602)
Timeframe: 72 hours

,,
InterventionPercentage of Participants (Number)
NormalMildly restrictedModerately restrictedSeverely restrictedImmobilized
Canakinumab, Lyophilizate (LYO)44.840.812.02.40.0
Canakinumab, Pre-filled Syringes (PFS)50.037.711.50.80.0
Triamcinolone Acetonide35.537.214.012.40.8

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Physician's Assessment of Swelling

The study physician assessed the most affected joint for swelling. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins. (NCT01356602)
Timeframe: 72 hours

,,
InterventionPercentage of Partipants (Number)
No swellingPalpableVisibleBulging beyond the joint margins
Canakinumab, Lyophilizate (LYO)55.225.617.61.6
Canakinumab, Pre-filled Syringes (PFS)60.826.910.81.5
Triamcinolone Acetonide51.215.724.88.3

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Physician's Assessment of Tenderness

"The study physician assessed the most affected joint for tenderness. Tenderness was measured on a 0 - 3 point scale as follows: 0 = no pain, 1 = patient states that there is pain, 2 = patient states there is pain and winces and 3 = patient states there is pain, winces and withdraws on palpation or passive movement of the affected study joint." (NCT01356602)
Timeframe: 72 hours

,,
InterventionPercentage of Participants (Number)
No painThere is painThere is pain and wincesThere is pain, winces and withdraws
Canakinumab, Lyophilizate (LYO)40.052.86.40.8
Canakinumab, Pre-filled Syringes (PFS)50.043.15.41.5
Triamcinolone Acetonide29.847.114.09.1

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Amount of Rescue Medication Taken (mg)

Patients used a diary to record the time of intake of rescue medication and the amount taken. (NCT01356602)
Timeframe: 14 days

,,
Interventionmilligrams (mg) (Mean)
AcetaminophenCodeinePrednisolone / Prednisone
Canakinumab, Lyophilizate (LYO)1108.323.96.7
Canakinumab, Pre-filled Syringes (PFS)609.212.75.8
Triamcinolone Acetonide2323.160.824.7

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Time to the First New Gouty Arthritis Flare

Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient's perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely. Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated. (NCT01356602)
Timeframe: 12 weeks

InterventionDays (Median)
Canakinumab, Pre-filled Syringes (PFS)NA
Canakinumab, Lyophilizate (LYO)NA
Triamcinolone AcetonideNA

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Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale

A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Study physicians scored their assessment of the patients' response to treatment on a 5-point Likert scale (very good, good, fair, poor, very poor). (NCT01356602)
Timeframe: 72 hours

,,
InterventionPercentage of Participants (Number)
Very goodGoodFairPoorVery poor
Canakinumab, Lyophilizate (LYO)33.648.816.01.60.0
Canakinumab, Pre-filled Syringes (PFS)46.235.415.41.51.5
Triamcinolone Acetonide21.533.923.114.07.4

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C-reactive Protein Level

A central laboratory was used for analysis of all blood samples collected. (NCT01356602)
Timeframe: 72 hours

Interventionmg / L (Least Squares Mean)
Canakinumab, Pre-filled Syringes (PFS)3.65
Canakinumab, Lyophilizate (LYO)3.37
Triamcinolone Acetonide5.2

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Number of Patients With at Least One New Gouty Arthritis Flare After Baseline

Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient's perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely. (NCT01356602)
Timeframe: 12 weeks

InterventionParticpants (Number)
Canakinumab, Pre-filled Syringes (PFS)12
Canakinumab, Lyophilizate (LYO)12
Triamcinolone Acetonide52

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Pain Intensity on a 0 - 100 mm VAS Between the Canakinumab 150 mg PFS and Canakinumab 150 mg LYO Groups

The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method. (NCT01356602)
Timeframe: 72 hours post dose

InterventionMillimeters (Least Squares Mean)
Canakinumab, Pre-filled Syringes (PFS)17.1
Canakinumab, Lyophilizate (LYO)19.7

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Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups

The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method. (NCT01356602)
Timeframe: 72 hours post dose

InterventionMillimeters (Least Squares Mean)
Canakinumab, Pre-filled Syringes (PFS)17.1
Triamcinolone Acetonide32

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Patient's Assessment of Pain Intensity on a 0-100mm VAS

The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity VAS measurements up to 14 days. (NCT01356602)
Timeframe: 14 days

InterventionMillimeters (Least Squares Mean)
Canakinumab, Pre-filled Syringes (PFS)7.9
Canakinumab, Lyophilizate (LYO)8.2
Triamcinolone Acetonide14.8

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Proportion of Patients With Rescue Medication Intake

Patients used a diary to record the time of intake of rescue medication and the amount taken. (NCT01356602)
Timeframe: 12 weeks

InterventionPercentage of Particpants (Number)
Canakinumab, Pre-filled Syringes (PFS)29.0
Canakinumab, Lyophilizate (LYO)31.8
Triamcinolone Acetonide45.7

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Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS

The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Kaplan Meier estimate of time to 50% reduction in baseline pain, along with associated 95% confidence interval, were reported. (NCT01356602)
Timeframe: 14 days

InterventionHours (Median)
Canakinumab, Pre-filled Syringes (PFS)24
Canakinumab, Lyophilizate (LYO)25
Triamcinolone Acetonide48

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Time to First Rescue Medication Intake

Patients used a diary to record the time of intake of rescue medication and the amount taken. (NCT01356602)
Timeframe: 14 days

InterventionHours (Median)
Canakinumab, Pre-filled Syringes (PFS)11
Canakinumab, Lyophilizate (LYO)7.5
Triamcinolone Acetonide11

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Time to Resolution of Gouty Arthritis Flare as Reported by Patient

Patients completed diary entries at 6, 12, 24, 48 and 72 hours post dose and then daily up to 7 days post-dose and/or daily until resolution of the flare. Kaplan Meier estimate of time to resolution of gouty flare as reported by patient, along with associated 95% confiedence interval, were reported. (NCT01356602)
Timeframe: 14 days

InterventionHours (Median)
Canakinumab, Pre-filled Syringes (PFS)142
Canakinumab, Lyophilizate (LYO)120
Triamcinolone Acetonide170

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Patient's Assessment of Pain Intensity on a 5-point Likert Scale

A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity Likert measurements up to 14 days. (NCT01356602)
Timeframe: 72 hours

,,
InterventionPercentage of Patients (Number)
NoneMildModerateSevereExtreme
Canakinumab, Lyophilizate (LYO)32.644.221.71.60
Canakinumab, Pre-filled Syringes (PFS)35.945.815.32.30.8
Triamcinolone Acetonide23.436.721.914.13.9

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Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale

A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their response to treatment on a 5-point Likert scale (excellent, good, acceptable, slight, poor). This outcome measure shows the number of patients indicating each score on the scale. (NCT01356602)
Timeframe: 72 hours

,,
InterventionPercentage of Participants (Number)
ExcellentGoodAcceptableSlightPoor
Canakinumab, Lyophilizate (LYO)34.836.520.07.80.9
Canakinumab, Pre-filled Syringes (PFS)36.043.210.46.44.0
Triamcinolone Acetonide20.431.921.214.212.4

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High Sensitivity C-reactive Protein [hsCRP] Measured in the Serum at 72 Hours Post Dose

(NCT01362608)
Timeframe: 72 hours post dose

Interventionmg/L (Mean)
ACZ885 150 mg5.5
Triamcinolone Acetonide 40 mg7.2

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The Number of Patients With at Least 1 New Gout Flare

(NCT01362608)
Timeframe: 12 weeks

,
Interventionparticipants (Number)
1 new flare2 new flares3 new flares> 3 new flares
ACZ885 150 mg3002
Triamcinolone Acetonide 40 mg15101

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Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment

A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 - 4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm) (NCT01362608)
Timeframe: baseline through 12 weeks

,
Interventionunit on a scale (Mean)
baseline6 hours post-dose12 hours post-dose24 hours post-dose48 hours post-dose72 hours post-dose7 days post-dose4 weeks post-dose8 weeks post-dose12 weeks post-dose
ACZ885 150 mg72.353.041.730.922.017.410.19.56.86.8
Triamcinolone Acetonide 40 mg74.558.851.848.643.936.624.017.916.013.0

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Time to First New Flare: Survival Analysis by Treatment: Kaplan Meier Analysis

Measure canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to the time to the first new gout flare in observation period of 12 weeks (NCT01362608)
Timeframe: 12 weeks

InterventionParticipants (Number)
ACZ885 150 mg5
Triamcinolone Acetonide 40 mg17

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Time to Complete Resolution of Pain: Survival Analysis by Treatment

Kaplan Meier estimate (NCT01362608)
Timeframe: 12 weeks

Interventionhours (Median)
ACZ885 150 mg168.0
Triamcinolone Acetonide 40 mg168.0

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Time to at Least a 50% Reduction in Baseline Pain Intensity: Survival Analysis by Treatment

Kaplan Meier estimate (NCT01362608)
Timeframe: 12 weeks

Interventionhours (Median)
ACZ885 150 mg24.0
Triamcinolone Acetonide 40 mg48.0

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The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS)

A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 - 4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm) (NCT01362608)
Timeframe: at 72 hours post-dose

Interventionunits on a scale (Least Squares Mean)
ACZ885 150 mg18.2
Triamcinolone Acetonide 40 mg37.9

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Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment

Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed). (NCT01362608)
Timeframe: baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose

,
Interventionparticipants (Number)
Baseline No swellingBaseline PalpableBaseline VisibleBaseline Bulging beyond the joint marginsBaseline not assessed72 hours post-dose No swelling72 hours post-dose Palpable72 hours post-dose Visible72 hrs post-dose Bulging beyond the joint margins72 hours post-dose not assessed7 days post-dose No swelling7 days post-dose Palpable7 days post-dose Visible7 days post-dose Bulging beyond the joint margins7 days post-dose not assessed04 weeks post-dose No swelling4 weeks post-dose Palpable4 weeks post-dose Visible4 weeks post-dose Bulging beyond the joint margins4 weeks post-dose not assessed8 weeks post-dose No swelling8 weeks post-dose Palpable8 weeks post-dose Visible8 weeks post-dose Bulging beyond the joint margins8 weeks post-dose not assessed12 weeks post-dose No swelling12 weeks post-dose Palpable12 weeks post-dose Visible12 wks post-dose Bulging beyond the joint margins12 weeks post-dose not assessed
ACZ885 150 mg1132924038151210539310602300630200611200
Triamcinolone Acetonide 40 mg31239150221518103518930409420496400526220

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Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment

Patients will score their current pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme). (NCT01362608)
Timeframe: baseline through week 12

,
Interventionparticipants (Number)
baseline nonebaseline mildbaseline moderatebaseline severebaseline extreme6 hours post-dose none6 hours post-dose mild6 hours post-dose moderate6 hours post-dose severe6 hours post-dose extreme12 hours post-dose none12 hours post-dose mild12 hours post-dose moderate12 hours post-dose severe12 hours post-dose extreme24 hours post-dose none24 hours post-dose mild24 hours post-dose moderate24 hours post-dose severe24 hours post-dose extreme48 hours post-dose none48 hours post-dose mild48 hours post-dose moderate48 hours post-dose severe48 hours post-dose extreme72 hours post-dose none72 hours post-dose mild72 hours post-dose moderate72 hours post-dose severe72 hours post-dose extreme4 days post-dose none4 days post-dose mild4 days post-dose moderate4 days post-dose severe4 days post-dose extreme7 days post-dose none7 days post-dose mild7 days post-dose moderate7 days post-dose severe7 days post-dose extreme4 weeks post-dose none4 weeks post-dose mild4 weeks post-dose moderate4 weeks post-dose severe4 weeks post-dose extreme8 weeks post-dose none8 weeks post-dose mild8 weeks post-dose moderate8 weeks post-dose severe8 weeks post-dose extreme12 weeks post-dose none12 weeks post-dose mild12 weeks post-dose moderate12 weeks post-dose severe12 weeks post-dose extreme
ACZ885 150 mg022537301828172128287134019211048720144580021397003229510431741039222204118320
Triamcinolone Acetonide 40 mg03184440142629021926211420252001021201421226169414291310023251080242560030216202528811

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Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment

Physicians will score their response of erythema on a 4-point Likert scale (absent, present not assessed and not assessable). (NCT01362608)
Timeframe: baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose

,
Interventionparticipants (Number)
Baseline AbsentBaseline presentBaseline not assessedBaseline not assessable72 hours post-dose absent72 hours post-dose present72 hours post-dose not assessed72 hrs post-dose not assessable7 days post-dose absent7 days post-dose present7 days post-dose not assessed7 days post-dose not assessable4 weeks post-dose absent4 weeks post-dose present4 weeks post-dose not assessed4 weeks post-dose not assessable8 weeks post-dose absent8 weeks post-dose present8 weeks post-dose not assessed8 weeks post-dose not assessable12 weeks post-dose absent12 weeks post-dose present12 weeks post-dose not assessed12 wks post-dose not assessable
ACZ885 150 mg19480054110162301631016500062101
Triamcinolone Acetonide 40 mg19500041150057800496005630061100

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Time to First Rescue Medication Intake

(NCT01362608)
Timeframe: 12 weeks

Interventionhours (Mean)
ACZ885 150 mg31.8
Triamcinolone Acetonide 40 mg41.5

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Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare.

Paracetamol / acetaminophen, Prednisolone and Prednisone taken at baseline flare and post baseline flare. (NCT01362608)
Timeframe: 12 weeks

,
Interventionmg (Mean)
Baseline flare Paracetamol / acetaminophenBaseline flare PrednisololBaseline Flare PrednisoneBaseline flare CodeineLast post-baseline flare Paraceta/acetamin n=4,9Last post-baseline flare Prednisolone n=4,9Last post-baseline flare Prednisone n=4,9
ACZ885 150 mg342.51.10.70.0287.55.00.0
Triamcinolone Acetonide 40 mg451.45.05.20.4222.24.40.6

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Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.

Patients will score their response to pain on a 7-point Likert scale (excellent, good ,acceptable, slight,poor,very poor,not done). (NCT01362608)
Timeframe: 72 hours through week 12

,
Interventionparticipants (Number)
72 hours post-dose excellent72 hours post-dose good72 hours post-dose acceptable72 hours post-dose slight72 hours post-dose poor72 hours post-dose very poor72 hours post-dose not done7 days post-dose excellent7 days post-dose good7 days post-dose acceptable7 days post-dose slight7 days post-dose poor7 days post-dose very poor7 days post-dose not done4 weeks post-dose excellent4 weeks post-dose good4 weeks post-dose acceptable4 weeks post-dose slight4 weeks post-dose poor4 weeks post-dose very poor4 weeks post-dose not done8 weeks post-dose excellent8 weeks post-dose good8 weeks post-dose acceptable8 weeks post-dose slight8 weeks post-dose poor8 weeks post-dose very poor8 weeks post-dose not done12 weeks post-dose excellent12 weeks post-dose good12 weeks post-dose acceptable12 weeks post-dose slight12 weeks post-dose poor12 weeks post-dose very poor12 weeks post-dose not done
ACZ885 150 mg740144100163891100153313400018351020001637100103
Triamcinolone Acetonide 40 mg317181110014201871601619147902816189801421217903

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Percent Patients Who Took Rescue Medication

(NCT01362608)
Timeframe: 12 weeks

,
Interventionpercentage (Number)
Baseline flare (n= 29,42)Last post-baseline flare (n=3,4)
ACZ885 150 mg43.375.0
Triamcinolone Acetonide 40 mg60.944.4

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Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment

Physicians will score their response ofrange of motion on a 5-point Likert scale (normal,mildly restricted, moderately restricted, severely restricted and immolbilized). (NCT01362608)
Timeframe: baseline through week 12

,
Interventionparticipants (Number)
baseline normalbaseline mildly restrictedbaseline moderately restrictedbaseline severely restrictedbaseline immobilzed72 hours post-dose normal72 hours post-dose mildly restricted72 hours post-dose moderately restricted72 hours post-dose severely restricted72 hours post-dose immobilized7 days post-dose normal7 days post-dose mildly restricted7 days post-dose moderately restricted7 days post-dose severely restricted7 days post-dose immobilized4 weeks post-dose normal4 weeks post-dose mildly restricted4 weeks post-dose moderately restricted4 weeks post-dose severely restricted4 weeks post-dose immobilized8 weeks post-dose normal8 weeks post-dose mildly restricted8 weeks post-dose moderately restricted8 weeks post-dose severely restricted8 weeks post-dose immobilized12 weeks post-dose normal12 weeks post-dose mildly restrcted12 weeks post-dose moderately restricted12 weeks post-dose severely restricted12 weeks post-dose immobilized
ACZ885 150 mg033227520331120352541049123105112110501210
Triamcinolone Acetonide 40 mg06243901519147126201531252271032186303023630

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Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment

Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed). (NCT01362608)
Timeframe: baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose

,
Interventionparticipants (Number)
Baseline no painBaseline painBaseline pain and wincesBaseline pain, winces and withdrawsBaseline not assessed72 hours post-dose no pain72 hours post-dose pain72 hours post-dose pain and winces72 hours post-dose pain, winces and withdraws72 hours post-dose not assessed7 days post-dose no pain7 days post-dose pain7 days post-dose pain and winces7 days post-dose pain , winces and withdraws7 days post-dose not assessed4 weeks post-dose no pain4 weeks post-dose pain4 weeks post-dose pain and winces4 weeks post-dose pain, winces and withdraws4 weeks post-dose not assessed8 weeks post-dose no pain8 weeks post-dose pain8 weeks post-dose pain and winces8 weeks post-dose pain winces and withdraws8 weeks post-dose not assessed12 weeks post-dose no pain12 weeks post-dose pain12 weeks post-dose pain and winces12 weeks post-dose pain, winces and withdraws12 weeks post-dose not assessed
ACZ885 150 mg015312102337510412320054101005411000537220
Triamcinolone Acetonide 40 mg016292401626113026271020301933038191103922100

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Patient's Assessment of Gout Pain Intensity in the Most Affected Joint

Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none or mild). (NCT01470989)
Timeframe: up to 7 days post-dose

,
InterventionParticipants (Count of Participants)
Baseline FlareLast New Flare
Canakinumab Retreatment102104
Triamcinolone Acetonide- Randomized to Canakinumab Treatment7269

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Number of Incidence Rate (IR) of Adverse Events, Serious Adverse Events and Death Per 100 Patient-years in Participants

Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline,or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards. (NCT01470989)
Timeframe: From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)

,
InterventionIR/100 patient-years (Number)
Adverse EventsNon Fatal SAEsDeath
Canakinumab 150 mg873592
Triamcinolone Acetonide 40 mg451252

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Number of New Flares Per Participant

Flare rate was calculated as the number of new flares over the period of observation in years. New flares occurred before first study medication dose in extension 3 study were considered. (NCT01470989)
Timeframe: From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)

Interventionflares (Mean)
Canakinumab 150 mg1.109
Triamcinolone Acetonide 40 mg2.459

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Percent of Responders According to OMERACT-OARSI Criteria at Week 8

Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International. Responders are defined as participants with high improvement in pain or function. (NCT01487161)
Timeframe: 8 weeks

InterventionParticipants (Count of Participants)
FX006 10 mg52
FX006 40 mg53
FX006 60 mg47
TCA IR 40 mg32

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Responder Status as Defined by the Proportion of Patients Achieving >20% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine." (NCT01487161)
Timeframe: 8 weeks

InterventionParticipants (Count of Participants)
FX006 10 mg47
FX006 40 mg49
FX006 60 mg48
TCA IR 40 mg30

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Responder Status as Defined by the Proportion of Patients Achieving >30% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine." (NCT01487161)
Timeframe: 8 weeks

InterventionParticipants (Count of Participants)
FX006 10 mg42
FX006 40 mg47
FX006 60 mg45
TCA IR 40 mg27

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Patient Global Impression of Change Scores at Week 8

The Patient Global Impression of Change is a scale that aims to evaluate all aspects of participants' (patients') health and determining if there has been an improvement or not. The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. (NCT01487161)
Timeframe: Week 8

Interventionunits on a scale (Least Squares Mean)
FX006 10 mg1.9
FX006 40 mg1.8
FX006 60 mg2.4
TCA IR 40 mg2.5

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Change From Baseline to Each of Weeks 1, 2, 3, 4, 5, 6, 7, 9, and 11 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score.

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine." (NCT01487161)
Timeframe: Weeks 1-7 and Week 9 and 11

,,,
Interventionunits on a scale (Least Squares Mean)
Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 9Week 11
FX006 10 mg-2.7-3.6-3.7-3.8-3.9-4.0-3.9-3.8-3.7
FX006 40 mg-3.0-3.9-4.1-4.3-4.3-4.3-4.4-4.2-3.9
FX006 60 mg-3.0-3.8-4.2-4.2-4.2-4.2-3.9-3.7-3.2
TCA IR 40 mg-3.1-3.5-3.5-3.7-3.5-3.4-3.3-3.3-3.4

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Change From Baseline to Week 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine." (NCT01487161)
Timeframe: 12 weeks

Interventionunits on a scale (Least Squares Mean)
FX006 60 mg-3.2
TCA IR 40 mg-3.3

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Change From Baseline to Week 8 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine." (NCT01487161)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
FX006 60 mg-3.9
TCA IR 40 mg-3.4

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Change From Baseline to Week 10 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine." (NCT01487161)
Timeframe: 10 weeks

Interventionunits on a scale (Least Squares Mean)
FX006 60 mg-3.6
TCA IR 40 mg-3.3

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Responder Status as Defined by the Proportion of Patients Achieving >50% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine." (NCT01487161)
Timeframe: 8 weeks

InterventionParticipants (Count of Participants)
FX006 10 mg35
FX006 40 mg40
FX006 60 mg34
TCA IR 40 mg23

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WOMAC A (Pain Subscale) Change From Baseline at Week 8

The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. (NCT01487161)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
FX006 10 mg-1.23
FX006 40 mg-1.33
FX006 60 mg-1.16
TCA IR 40 mg-0.96

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WOMAC A1 (Pain on Walking Question) Change From Baseline at Week 8

The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. (NCT01487161)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
FX006 10 mg-1.2
FX006 40 mg-1.2
FX006 60 mg-1.1
TCA IR 40 mg-0.8

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WOMAC B (Stiffness Subscale) Change From Baseline at Week 8

The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. (NCT01487161)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
FX006 10 mg-1.37
FX006 40 mg-1.49
FX006 60 mg-1.24
TCA IR (40 mg)-0.99

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WOMAC C (Function Subscale) Change From Baseline at Week 8

The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. (NCT01487161)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
FX006 10 mg-1.22
FX006 40 mg-1.31
FX006 60 mg-1.13
TCA IR 40 mg-0.94

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Change From Baseline to Each of Weeks 8, 10, and 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 10mg and 40 mg vs TCA IR 40 mg

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine." (NCT01487161)
Timeframe: Weeks 8, 10 and 12

,,
Interventionunits on a scale (Least Squares Mean)
8 Weeks10 Weeks12 Weeks
FX006 10 mg-3.9-3.8-3.6
FX006 40 mg-4.3-4.1-3.7
TCA IR 40 mg-3.4-3.3-3.3

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Average Weekly and Total Consumption of Rescue Medications Over 8 Weeks.

(NCT01487161)
Timeframe: 8 weeks

Interventiontablets (1tablet= 500 mg) (Least Squares Mean)
FX006 10 mg1.0
FX006 40 mg1.0
FX006 60 mg1.1
TCA IR 40 mg1.2

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Clinical Global Impression of Change Scores at Week 8

The Clinical Global Impression of Change is a scale that the clinician uses to assess the participants' global function and determine if there has been an improvement or not. The clinician selects one response from the response options that gives the most accurate description of the participant's state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. (NCT01487161)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
FX006 10 mg1.9
FX006 40 mg1.8
FX006 60 mg2.5
TCA IR 40 mg2.6

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Total 24-hour Urinary Free Cortisol Excretion

(NCT01487200)
Timeframe: Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)

,,,
Interventionnmol/24h (Geometric Mean)
Day 1 to 2Day 14 to 15Day 42 to 43
FX006 10mg75.6657.1455.74
FX006 40mg29.9430.9134.62
FX006 60 mg29.3626.4651.16
TCA IR 40 mg18.7736.2236.38

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Change From Baseline in 24-hour Urinary Free Cortisol Excretion

(NCT01487200)
Timeframe: Baseline to Days 1-2, Baseline to Days 14-15 (Week 2) and Baseline to Days 42-43 (Week 6)

,,,
Interventionnmol/24h (Least Squares Mean)
Day 1 to 2Day 14 to 15Day 42 to 43
FX006 10mg47.913.07.7
FX006 40mg-43.8-42.4-38.3
FX006 60 mg-50.1-59.0-13.1
TCA IR 40 mg-58.5-14.7-21.3

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Change From Baseline in 24-hour Weighted Mean Serum Cortisol

The primary pharmacodynamic endpoint was change from baseline (pre-dose) to Day 1-2, Day 14-15 (Week 2) and Day 42-43 (Week 6) in 24-hour weighted mean serum cortisol. This is defined as AUC over the 0-24 hour measurement period divided by 24 (NCT01487200)
Timeframe: Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)

,,,
Interventionweighted mean serum cortisol (nmol/L) (Least Squares Mean)
Change from BL to Days 1 to 2Change from BL to Days 14 to 15Change in BL to Days 42 to 43
FX006 10mg-7.7-11.1-9.0
FX006 40mg-42.7-33.4-18.0
FX006 60 mg-62.2-49.5-11.8
TCA IR 40 mg-59.0-19.7-4.8

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Change From Baseline to Each Measured Time Point Post-dose in Morning Serum Cortisol

Least square mean difference against TCA IR 40 mg (NCT01487200)
Timeframe: Baseline to Days 2, 3, 4, 5, 8, 14, 15, 22, 29, 36, 42 and 43

,,,
Interventionnmol/L (Least Squares Mean)
Day 2Day 3Day 4Day 5Day 8Day 14Day 15Day 22Day 29Day 36Day 42Day 43
FX006 10mg-30.2-24.9-13.9-12.4-29.8-7.6-24.43.3-4.5-6.4-18.3-22.1
FX006 40mg-42.3-40.8-37.1-35.1-37.4-35.5-28.1-28.5-21.1-19.5-27.0-14.9
FX006 60 mg-78.2-80.2-77.2-73.0-61.7-40.4-46.4-14.4-6.3-3.0-19.1-13.4
TCA IR 40 mg-85.4-86.2-73.1-49.8-8.6-27.3-8.3-11.30.811.7-21.43.0

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Characterize the Pharmacokinetic Profile of FX006 and TCA IR

Concentrations below the limit of quantification of 50 pg/mL were treated as 0. (NCT01487200)
Timeframe: Day 1 (1, 2, 4, 6, 8, 12 and 24 hours post dose) and Days 3, 4, 5, 8, 15, 22, 29, 36 and 43

,,,
Interventionpg/mL (Geometric Mean)
1 hour postdose2 hours postdose4 hours postdose6 hours postdose8 hours postdose12 hours postdoseDay 2 (24 hrs post dose)Day 3 (48 hrs post dose)Day 4 (72 hrs post dose)Day 5 (96 hrs post dose)Day 8 (168 hrs post dose)Day 15 (336 hrs post dose)Day 22 (504 hrs post dose)Day 29 (672 hrs post dose)Day 36 (840 hrs post dose)Day 43 (1008 hrs post dose)
FX006 10mg140.941226.058280.406261.231249.298230.506242.764233.138224.987242.533185.257113.0020.0000.0000.0000.000
FX006 40mg638.447779.819860.476814.647748.962691.962763.568743.344675.086690.857586.977365.970238.529189.4220.000138.660
FX006 60 mg862.5741164.0131251.7761182.9251227.6581127.4761309.2601294.0421270.9531252.0211070.823718.787521.843369.683246.176187.435
TCA IR 40 mg12268.83514243.60416282.65914560.88613543.42710112.8635421.8942371.7781310.061822.243235.9380.0000.0000.0000.0000.000

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Additional Intravitreal Bevacizumab Injection

Comparison of the additional intravitreal bevacizumab injection of intravitreal bevacizumab monotherapy or combined therapy of posterior subtenon triamcinolone acetonide and intravitreal bevacizumab during 6 months (NCT01614509)
Timeframe: 6 months

Interventiontimes of injection (Mean)
Monotherapy Group0.96
Combined Group0.44

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Changes of Central Retinal Thickness

Changes of central retinal thickness on optical coherence tomography (OCT) at baseline and 1, 3, 6 month after injection (NCT01614509)
Timeframe: baseline, 1, 3, 6 months after injection

,
Interventionmicrometer (Mean)
at baseline1 month after injection3 months after injection6 months after injection
Combined Group468.22233.33233.22217.83
Monotherapy Group510.35291.48265.35246.48

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Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis

"Evaluation of blood cortisol and ACTH, free urinary cortisol, urinary levels of methylprednisolone or triamcinolone (depending on the administered drug) by RIA immunoassay and tandem mass assays~Persistent suppression of the HPA axis at the end of the follow up is based on the evidence of ACTH, plasmatic and urinary cortisol levels under reference values" (NCT01652495)
Timeframe: 45 days after treatment

Intervention% of patients with HPA suppression (Number)
Methylprednisolone Acetate Group0
Triamcinolone Acetonide Group15

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Functional Improvement Measured According to Percentage Change in Constant Score

"Patients will be evaluated clinically by Constant Score~Constant score: range 0 (total shoulder impairment) to 100 (non impaired shoulder). The score is obtained from two subjective (pain and relation between pain and daily-life activities) - and two objective physician-assessed (strength and range of motion) measurements~Reference: Constant CR and Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4." (NCT01652495)
Timeframe: 180 days after treatment

Interventionpercentage of improvement Constant score (Mean)
Methylprednisolone Acetate Group99
Triamcinolone Acetonide Group95

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Reduction of Pain Severity Expressed as Percentage Change in VAS Score

"VAS score~VAS score is a 10 -cm graduated scale with scores ranging from 0 (no pain) to 10 (unbearable pain) self- reported by patients~Reference: Langley GB and Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int 1985;5(4):145-148." (NCT01652495)
Timeframe: 180 days after treatment

Interventionpercentage of pain reduction (Mean)
Methylprednisolone Acetate Group82
Triamcinolone Acetonide Group96

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Synovial Glycosaminoglycans (GAG) Concentration

Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure GAG concentration using an immunoassay. Data will be presented as the change in GAG concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult. (NCT01692756)
Timeframe: Up to seven days

Interventionμg/mL (Mean)
Kenalog or Placebo-73.1
Kenalog Then Placebo155.8
Kenalog Only-49.0
Placebo-167.4

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Synovial Interleukin-1 Receptor Antagonist (IL-1ra) Concentration

Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1ra concentration using an immunoassay. Data will be presented as the change in IL-1ra concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult. (NCT01692756)
Timeframe: Up to seven days

Interventionpg/mL (Mean)
Kenalog or Placebo-3352.5
Kenalog Then Placebo-4955.6
Kenalog Only-7278.4
Placebo-6888.5

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Synovial Interleukin-1α (IL-1α) Concentration

Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1α concentration using an immunoassay. Data will be presented as the change in IL-1α concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult. (NCT01692756)
Timeframe: Up to seven days

Interventionpg/mL (Mean)
Kenalog or Placebo4.30
Kenalog Then Placebo7.68
Kenalog Only1.77
Placebo3.11

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Synovial Interleukin-1β (IL-1β) Concentration

Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1β concentration using an immunoassay. Data will be presented as the change in IL-1β concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult. (NCT01692756)
Timeframe: Up to seven days

Interventionpg/mL (Mean)
Kenalog or Placebo-1.08
Kenalog Then Placebo0.75
Kenalog Only-0.28
Placebo-0.19

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Synovial Matrix Metalloproteinase 1 (MMP-1) Concentration

Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-1 concentration using an immunoassay. Data will be presented as the change in MMP-1 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult. (NCT01692756)
Timeframe: Up to seven days

Interventionng/mL (Mean)
Kenalog or Placebo249.0
Kenalog Then Placebo-183.0
Kenalog Only-395.5
Placebo-100.4

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Synovial Matrix Metalloproteinase 9 (MMP-9) Concentration

Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-9 concentration using an immunoassay. Data will be presented as the change in MMP-9 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult. (NCT01692756)
Timeframe: Up to seven days

Interventionng/mL (Mean)
Kenalog or Placebo-71.1
Kenalog Then Placebo-28.9
Kenalog Only-17.7
Placebo-14.0

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Synovial TNF-stimulated Gene 6 Protein (TSG-6) Concentration

Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure TSG-6 concentration using an immunoassay. Data will be presented as the change in TSG-6 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult. (NCT01692756)
Timeframe: Up to seven days

Interventionng/ml (Mean)
Kenalog or Placebo68.0
Kenalog Then Placebo57.6
Kenalog Only111.4
Placebo-4.9

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Synovial Type I Collagen Cross-Linked N-Telopeptide (NTX-I) Concentration

Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure NTX-I concentration using an immunoassay. Data will be presented as the change in NTX-I concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult. (NCT01692756)
Timeframe: Up to seven days

Interventionµg/mL (Mean)
Kenalog or Placebo3.5
Kenalog Then Placebo0.6
Kenalog Only2.6
Placebo5.8

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Synovial Matrix Metalloproteinase 3 (MMP-3) Concentration

Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-3 concentration using an immunoassay. Data will be presented as the change in MMP-3 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult. (NCT01692756)
Timeframe: Up to seven days

Interventionng/mL (Mean)
Kenalog or Placebo2702.9
Kenalog Then Placebo504.0
Kenalog Only-512.4
Placebo1295.9

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Efficacy of Kenalog to Alleviate Knee Pain

The efficacy of Kenalog with be determined using the Knee Injury and Osteoarthritis Outcome Score (KOOS) instrument. Participants will self-report knee pain and function through the KOOS questionnaire during the initial orthopedic consult and during the pre-op assessment prior to surgery, between 1 and 7 days later. The scale scores range from 100 (no symptoms) to zero (extreme symptoms). (NCT01692756)
Timeframe: Up to seven days

Interventionunits on a scale (Mean)
Kenalog or Placebo37.37
Kenalog Then Placebo18.94
Kenalog Only30.56
Placebo28.93

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Participant Pain Assessment

Participants with be given a Visual Analog Scale (VAS) pain assessment questionnaire which scores the participant's perceived pain on a scale of 0-10 were zero is no pain and 10 is the worst pain imaginable. The scale will be administered during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult. (NCT01692756)
Timeframe: Up to seven days

Interventionunits on a scale (Mean)
Kenalog or Placebo-3.9
Kenalog Then Placebo-2.2
Kenalog Only-3.6
Placebo-4.3

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Synovial C-terminal Peptide II (CTXII) Concentration

Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure CTXII concentration using an immunoassay. Data will be presented as the change in CTXII concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult. (NCT01692756)
Timeframe: Up to seven days

Interventionng/mL (Mean)
Kenalog or Placebo0.32
Kenalog Then Placebo0.23
Kenalog Only0.19
Placebo1.32

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Synovial Cartilage Oligomeric Matrix Protein (COMP) Concentration

Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure COMP concentration using an immunoassay. Data will be presented as the change in COMP concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult. (NCT01692756)
Timeframe: Up to seven days

Interventionμg/mL (Mean)
Kenalog or Placebo-4.9
Kenalog Then Placebo-21.7
Kenalog Only-11.7
Placebo-22.1

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Change From Pre-Treatment Palpable Muscle Tenderness at 12 Weeks

Palpable muscle tenderness of masticatory muscles using ordinal ratings of 0-3 (none, mild, moderate, severe pain to palpation) are summed. A standardized muscle palpation pressure is used at specific locations on each side of the face for a total of 20 locations. The range of possible scores is 0-60. The rating of each muscle palpation site is added for a composite muscle tenderness score. (NCT01770912)
Timeframe: Baseline and 12 weeks post-treatment

Interventionunits on a scale (Median)
Lactated Ringers0
Triamcinolone Acetonide-2

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Change From Pre-Treatment Functional Pain (Chewing) at 12 Weeks

"Pain is assessed for average chewing pain intensity using a 100 mm visual analog scale with 0 representing no pain and 100 representing the most intense chewing pain imaginable." (NCT01770912)
Timeframe: Baseline and 12 weeks post-treatment

Interventionunits on a scale (Mean)
Lactated Ringers-26
Triamcinolone Acetonide-43

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Change From Pre-Treatment in TMJ Loading Pain Rating at 2 Weeks

TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity). (NCT01770912)
Timeframe: Baseline and 2 weeks post-treatment

Interventionunits on a scale (Median)
Lactated Ringers-1
Triamcinolone Acetonide-2

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Change From Pre-Treatment in TMJ Loading Pain Rating at 12 Weeks

TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity). (NCT01770912)
Timeframe: Baseline and 12 weeks post-treatment

Interventionunits on a scale (Median)
Lactated Ringers-1
Triamcinolone Acetonide-2

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Change From Pre-Treatment in Mandibular Range of Pain-Free Motion at 12 Weeks

Mandibular range of motion is measured in millimeters (mm) of vertical opening between the upper and lower central incisors plus vertical overlap of the incisors. These measures are made for jaw unassisted opening without pain, maximum unassisted opening and maximum assisted opening. Horizontal mandibular range of motion is measured in millimeters (mm) assessed for maximal right and left mandibular lateral movements and mandibular protrusion. A positive value represents an improvement (or larger range of motion) in mandibular opening/lateral movement. (NCT01770912)
Timeframe: Baseline and 12 weeks post-treatment

Interventionmm (Mean)
Lactated Ringers5.3
Triamcinolone Acetonide10.0

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Change From Pre-Treatment in Mandibular Range of Motion Without Pain at 2 Weeks

Mandibular range of motion is measured in millimeters (mm) of vertical opening between the upper and lower central incisors plus vertical overlap of the incisors. These measures are made for jaw unassisted opening without pain, maximum unassisted opening and maximum assisted opening. Horizontal mandibular range of motion is measured in millimeters (mm) assessed for maximal right and left mandibular lateral movements and mandibular protrusion. A positive value represents an improvement (or larger range of motion) in mandibular opening/lateral movement. (NCT01770912)
Timeframe: Baseline and 2 weeks post-treatment

Interventionmm (Mean)
Lactated Ringers3.9
Triamcinolone Acetonide9.7

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Change From Pre-Treatment in TMJ Loading Pain Rating at 6 Weeks

TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity). (NCT01770912)
Timeframe: Baseline and 6 weeks post-treatment

Interventionunits on a scale (Median)
Lactated Ringers-1
Triamcinolone Acetonide-2

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Change From Pre-Treatment in Mandibular Range of Motion at 6 Weeks

Mandibular range of motion is measured in millimeters (mm) of vertical opening between the upper and lower central incisors plus vertical overlap of the incisors. These measures are made for jaw unassisted opening without pain, maximum unassisted opening and maximum assisted opening. Horizontal mandibular range of motion is measured in millimeters (mm) assessed for maximal right and left mandibular lateral movements and mandibular protrusion. A positive value represents an improvement (or larger range of motion) in mandibular opening/lateral movement. (NCT01770912)
Timeframe: Baseline and 6 weeks post-treatment

Interventionmm (Mean)
Lactated Ringers6.9
Triamcinolone Acetonide7.4

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Change From Pre-Treatment Palpable Muscle Tenderness at 2 Weeks

Palpable muscle tenderness of masticatory muscles using ordinal ratings of 0-3 (none, mild, moderate, severe pain to palpation) are summed. A standardized muscle palpation pressure is used at specific locations on each side of the face for a total of 20 locations. The range of possible scores is 0-60. The rating of each muscle palpation site is added for a composite muscle tenderness score. (NCT01770912)
Timeframe: Baseline and 2 weeks post-treatment

Interventionunits on a scale (Median)
Lactated Ringers-2
Triamcinolone Acetonide-1

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Change From Pre-Treatment Palpable Muscle Tenderness at 6 Weeks

Palpable muscle tenderness of masticatory muscles using ordinal ratings of 0-3 (none, mild, moderate, severe pain to palpation) are summed. A standardized muscle palpation pressure is used at specific locations on each side of the face for a total of 20 locations. The range of possible scores is 0-60. The rating of each muscle palpation site is added for a composite muscle tenderness score. (NCT01770912)
Timeframe: Baseline and 6 weeks post-treatment

Interventionunits on a scale (Median)
Lactated Ringers-1
Triamcinolone Acetonide-1

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Number of Participants With Change From Pre-Treatment Joint Sounds in 12 Weeks

Opening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face. (NCT01770912)
Timeframe: Baseline and 12 weeks post-treatment

InterventionParticipants (Count of Participants)
Lactated Ringers4
Triamcinolone Acetonide5

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Number of Participants With Change From Pre-Treatment Joint Sounds in 2 Weeks

Opening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face. (NCT01770912)
Timeframe: Baseline and 2 weeks post-treatment

InterventionParticipants (Count of Participants)
Lactated Ringers1
Triamcinolone Acetonide5

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Change From Pre-Treatment Functional Pain (Chewing) at 6 Weeks

"Pain is assessed for average chewing pain intensity using a 100 mm visual analog scale with 0 representing no pain and 100 representing the most intense chewing pain imaginable." (NCT01770912)
Timeframe: Baseline and 6 weeks post-treatment

Interventionunits on a scale (Mean)
Lactated Ringers-33
Triamcinolone Acetonide-47

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Change From Pre-Treatment Functional Pain (Chewing) at 2 Weeks

"Pain is assessed for average chewing pain intensity using a 100 mm visual analog scale with 0 representing no pain and 100 representing the most intense chewing pain imaginable." (NCT01770912)
Timeframe: Baseline and 2 weeks post-treatment

Interventionunits on a scale (Mean)
Lactated Ringers-30
Triamcinolone Acetonide-37

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Number of Participants With Change From Pre-Treatment Joint Sounds in 6 Weeks

Opening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face. (NCT01770912)
Timeframe: Baseline and 6 weeks post-treatment

InterventionParticipants (Count of Participants)
Lactated Ringers3
Triamcinolone Acetonide6

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Vitreous Haze Grade

Vitreous haze scale (Nussenblatt 1985 as modified in Lowder 2011). Scores include value 0 (no inflammation), +0.5 (trace inflammation), +1 (mild blurring of the retinal vessels and optic nerve), +1.5 (optic nerve head and posterior retina view obscuration greater than +1 but less than +2), +2 (moderate blurring of the optic nerve head), +3 (marked blurring of the optic nerve head), and +4 (optic nerve head not visible) A higher score indicates a worse outcome. (NCT01789320)
Timeframe: Change from baseline at 8 weeks and 26 weeks

Interventionscore on a scale (Mean)
Week 8Week 26
Triamcinolone Acetonide (Triesence®)-0.75-0.75

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Change in Intraocular Pressure (IOP)

Intraocular pressure is the fluid pressure inside the eye. Intraocular pressure change from baseline at week 8 was measured by Goldmann applanation tonometry. Tonometry is the method eye care professionals use to determine this pressure. Intraocular pressure is typically measured in millimeters of mercury. A higher pressure inside the eye can be a risk factor for developing glaucoma or glaucoma progression leading to optic nerve damage. A negative change indicates a reduction in intraocular pressure. (NCT01789320)
Timeframe: Change from baseline in IOP at 8 weeks

Interventionmm Hg (Mean)
Triamcinolone Acetonide (Triesence®)-0.1

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Best Corrected Visual Acuity

Visual acuity (VA) rates a person's ability to recognize small details with precision. Best corrected VA refers to this measurement when the best vision has be achieved following refraction. Visual acuity change from baseline at 8 and 26 weeks was measured following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol using standardized lighting and lanes and an ETDRS eye chart. This eye chart comprises rows of letters, with 5 letters per row, and with the letter size from line to line varying logarithmically and is used to estimate visual acuity. Visual acuity is scored with reference to the logarithm of the minimum angle of resolution or logMAR. Zero logMAR indicates standard vision, positive values indicate poor vision and negative values indicate good vision. A negative changes indicates an improvement in visual acuity. (NCT01789320)
Timeframe: Change from baseline at 8 weeks and 26 weeks.

InterventionlogMAR (Mean)
Week 8Week 26
Triamcinolone Acetonide (Triesence®)-0.25-0.28

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Central Subfield Thickness Using Optical Coherence Tomography (OCT)

Central subfield thickness (CST) is a measure of the thickness of the retina in the 1 mm diameter circle centered on the fovea or center of the macular where eyesight is the sharpest. CST change from baseline at 8 and 26 weeks was measured using optical coherence tomography (OCT). OCT is a diagnostic imaging technique used to capture 2 and 3 dimensional images within biological tissue, e.g., for determining the amount of edema contained in the retina. CST is typically measured in microns. A negative change represents a reduction in retinal thickness and an improvement in cases of retinal edema. (NCT01789320)
Timeframe: Change from baseline at 8 weeks and 26 weeks.

InterventionMicrons (Mean)
Week 8Week 26
Triamcinolone Acetonide (Triesence®)-153.7-107.0

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Number of Adverse Events Reported by Subjects

To assess the safety of IL triamcinolone acetonide 10 mg/cc and Restylane® in the management of AA. (NCT01797432)
Timeframe: 12 weeks

Interventionadverse events (Number)
Combined IL Kenalog and Restylane25

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Change in Alopecia Areata Half Head Severity Score (AAHHSS) at 12 Weeks Compared to Baseline

The primary endpoint of evaluating the efficacy of administration of IL triamcinolone acetonide 10 mg/cc and Restylane® in the management of AA is the alopecia areata half head severity score (AAHHSS) comparing week 12 with baseline hair loss. Four discreet areas of the scalp are examined. The percent of terminal hair loss in each area is measured by visual estimation. Those percent figures are multiplied by the total area on one half of the scalp represented by the four respective areas. 1) Left parietal scalp (18% of area), right parietal scalp (18% of area), frontal scalp (40% of area), and occipital scalp (24% of area). Scores range from 0 to 50, with higher scores indicating more hair loss. (NCT01797432)
Timeframe: 12 weeks

Interventionscore on a scale (Mean)
Combined IL Kenalog and Restylane-17.75

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Number of Adverse Events

Incidence and severity of adverse events (AEs) including the presence and degree of skin atrophy, as well as incidence of treatment-emergent laboratory abnormalities. (NCT01898806)
Timeframe: 48 weeks

Interventionadverse events (Number)
All Participants0

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Mean Pain Score

The mean pain score assessed by the Visual Analog Pain Scale ranging from 0-10; 10 being the worst possible pain. (NCT01995045)
Timeframe: Post-Operative Day 1 (Up to 24 hours)

Interventionunits on a scale (Mean)
Bupivicaine & Triamcinolone2.9
Salt Solution, Bupivacaine, and Cefazolin3.8

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Mean Oxycodone Intake

The mean oxycodone use post surgery in milligrams(mg). (NCT01995045)
Timeframe: Post Surgery (Up to 24 hours)

Interventionmilligrams (Mean)
Bupivicaine & Triamcinolone6.7
Salt Solution, Bupivacaine, and Cefazolin9.0

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Mean Hydrocodone Intake

The mean hydrocodone use post surgery in milligrams(mg). (NCT01995045)
Timeframe: Post Surgery (Up to 24 hours)

Interventionmilligrams (Mean)
Bupivicaine & Triamcinolone.7
Salt Solution, Bupivacaine, and Cefazolin2.8

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Mean Acetaminophen Intake

The mean acetaminophen use post surgery in milligrams(mg). (NCT01995045)
Timeframe: Post Surgery (Up to 24 hours)

Interventionmilligrams (Mean)
Bupivicaine & Triamcinolone819
Salt Solution, Bupivacaine, and Cefazolin962

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Concentration of Triamcinolone Acetonide in Synovial Fluid

"Analyses of synovial fluid drug concentrations were performed using the Synovial Fluid Drug Concentration Population.~Values recorded as lower limit of quantification (LLOQ) (< 50 pg/mL) were counted as half the value below limit of quantification (BLQ)." (NCT02003365)
Timeframe: 12 to 20 weeks

,,
Interventionpg/mL (Geometric Mean)
Week 12Week 16Week 20
FX006 10 mg477.5NANA
FX006 40 mg923.7224.333.3
TCA IR 40 mg250.1NANA

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Plasma Drug Concentrations by Time

"Plasma Drug Concentration Population. Analyses of plasma drug concentrations were performed using the Plasma Drug Concentration Population.~Values recorded as lower limit of quantification (LLOQ) (< 10 pg/mL) were counted as half the value below limit of quantification (BLQ)." (NCT02003365)
Timeframe: Weeks 6, 12, 16 and 20

,,
Interventionpg/mL (Geometric Mean)
Week 6Week 12Week 16Week 20
FX006 10 mg26.56.6NANA
FX006 40 mg100.18.926.410.1
TCA IR 40 mg21.19.4NANA

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Difference in Visual-analog Score (VAS) for Anticipated Pain Prior to Injection and Actual Pain After Injection

Members of both study groups completed the Visual Analog Scale (VAS) pain assessment both prior for anticipated pain and after injection for actual pain; these recorded scores were the primary study endpoint and were later compared to determine the difference in anticipated pain versus actual pain experienced. The VAS ranges from 0-10, where 0 is no pain and 10 is worst possible pain. The outcome measure is the mean anticipated pain minus the actual pain experienced. (NCT02084706)
Timeframe: Our outcome measure was collected within the 60 seconds before and following the steroid injection.

Interventionunits on a scale (Mean)
Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley1.6
J-tip Lidocaine Administration, Then Steroid Injection2.8

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Pain Intensity

The level of pain intensity is quantified using a standard 0-10 Numerical Rating Scale with 10 being the most severe pain intensity and 0 the absence of pain. (NCT02120261)
Timeframe: at discharge (a few minutes after receiving intervention)

Interventionunits on a scale (Mean)
TPI With Normal Saline1.52
TPI With Lidocaine & Triamcinolone Acetonide1.76

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Pain Intensity

The level of pain intensity is quantified using a standard 0-10 Numerical Rating Scale with 10 being the most severe pain intensity and 0 the absence of pain. (NCT02120261)
Timeframe: 2 weeks

Interventionunits on a scale (Mean)
TPI With Normal Saline4.29
TPI With Lidocaine & Triamcinolone Acetonide4.14

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Pain Intensity

The level of pain intensity is quantified using a standard 0-10 Numerical Rating Scale with 10 being the most severe pain intensity and 0 the absence of pain. (NCT02120261)
Timeframe: baseline

Interventionunits on a scale (Mean)
TPI With Normal Saline7.69
TPI With Lidocaine & Triamcinolone Acetonide7.44

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Duration of Pain Relief

If the patient experienced pain relief with the trigger point injection and the pain came back later, the number of days after the injection at which the pain had returned was recorded. (NCT02120261)
Timeframe: 16 days

Interventiondays (Median)
TPI With Normal Saline3
TPI With Lidocaine & Triamcinolone Acetonide1

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Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale

Change in shoulder pain reported by the subject after injection at 6 weeks. The subject will report shoulder pain on a scale from 0 (no pain) to 10 (maximal pain) after injection. A 2 point change is expected. (NCT02242630)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Methylprednisolone, 20 mg1.0
Methylprednisolone, 40 mg1.8
Triamcinolone, 20 mg1.9
Triamcinolone, 40 mg1.8

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Change in Shoulder Function, as Measured by the QuickDASH ®

The primary outcome of this study will be to compare the dose and type of intrabursal corticosteroid received to improvements in a functional measure of the shoulder, the QuickDASH. The QuickDASH is a validated questionnaire of shoulder function consisting of 11 questions with a score from 100 (maximal dysfunction) to 0 (no dysfunction). It is expected that improvements will lead to at least a 10 point improvement (minimal clinically important difference) (NCT02242630)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Methylprednisolone, 20 mg19.2
Methylprednisolone, 40 mg21.3
Triamcinolone, 20 mg19.1
Triamcinolone, 40 mg24.7

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Pain

pain was assessed by visual analogue scale (1-10) 1 indicates better and 10 worse, 1 month after treatment (NCT02329600)
Timeframe: one month after treatment

Interventionunits on a scale (Mean)
Control Subjects0
OLP and Corticosteroid4
OLP and Corticosteroid and Green Tea4.4

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Salivary Total Oxidative Capacity

total oxidative capacity was assessed in whole unstimulated saliva by ezyme-linked immunosorbent assay (umol/L) at 1 month after treatment (NCT02329600)
Timeframe: one month after treatment

Interventionumol/L (Mean)
Control Subjects6.37
OLP and Corticosteroid58.41
OLP and Corticosteroid and Green Tea23.27

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Responder Status as Defined by Proportion of Patients Experiencing >30% Decrease in Pain From Baseline in Weekly Mean of the ADP Scores at Each Week (Weeks 1-24)

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine." (NCT02357459)
Timeframe: Weeks 1-24

,,
InterventionParticipants (Count of Participants)
Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12Week 13Week 14Week 15Week 16Week 17Week 18Week 19Week 20Week 21Week 22Week 23Week 24
FX006 32 mg6699109107106113112109107107107103979588918481868482797770
Placebo426361646973757479787880818079818275787976747974
TCA IR 40 mg819610110810911111210710910910510410610097978693888783788474

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Responder Status as Defined by Proportion of Patients Experiencing >50% Decrease in Pain From Baseline in Weekly Mean of the ADP Scores at Each Week (Weeks 1-24)

(NCT02357459)
Timeframe: Weeks 1-24

,,
InterventionParticipants (Count of Participants)
Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12Week 13Week 14Week 15Week 16Week 17Week 18Week 19Week 20Week 21Week 22Week 23Week 24
FX006 32 mg397381868592979791878380797673716966646056565147
Placebo213740475151495355576056575455595952545454525449
TCA IR 40 mg576777808084858283848075777270706766676261576356

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Area Under the Effect Curve (AUE) of Change From Baseline in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to Placebo

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates no pain and 10 indicates pain as bad as you can imagine." (NCT02357459)
Timeframe: Baseline to 12 Weeks

InterventionADP Pain Scores * Week (Least Squares Mean)
FX006 32mg-247.3
Placebo-145.3

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AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates no pain and 10 indicates pain as bad as you can imagine." (NCT02357459)
Timeframe: Baseline to 12 Weeks

InterventionADP Pain Scores * Week (Least Squares Mean)
FX006 32 mg-247.3
TCA IR 40 mg-231.9

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AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 24 for FX006 Relative to Placebo

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates no pain and 10 indicates pain as bad as you can imagine." (NCT02357459)
Timeframe: Baseline to 24 Weeks

InterventionADP Pain Scores * Week (Least Squares Mean)
FX006 32mg-432.5
Placebo-297.0

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Change From Baseline to Week 12 in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates no pain and 10 indicates pain as bad as you can imagine." (NCT02357459)
Timeframe: Baseline through 12 Weeks

Interventionunits on a scale (Least Squares Mean)
FX006 32 mg-3.12
TCA IR 40 mg-2.86

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Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain (ADP) Intensity Scores for 32 mg FX006 Versus Placebo

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates no pain and 10 indicates pain as bad as you can imagine." (NCT02357459)
Timeframe: Baseline and 12 Weeks

Interventionunits on a scale (Least Squares Mean)
FX006 32mg-3.12
Placebo-2.14

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Time to Onset of Pain Relief

Time to onset of pain relief is defined as the time from administration of study drug to the first daily pain assessment showing >30% improvement from the weekly mean of the ADP scores at baseline (NCT02357459)
Timeframe: Baseline to >30% improvement (measured up to 30 days)

Interventiondays (Median)
FX006 32 mg4
Placebo11
TCA IR 40 mg3

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Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)

(NCT02357459)
Timeframe: Weeks 1-24

,,
Interventiontablets (1 tablet = 500 mg) (Least Squares Mean)
Week1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12Week 13Week 14Week 15Week 16Week 17Week 18Week 19Week 20Week 21Week 22Week 23Week 24
FX006 32 mg1.010.690.690.580.600.560.600.630.660.670.730.620.680.670.670.710.820.870.710.690.920.980.940.95
Placebo1.311.391.351.281.211.241.191.241.111.211.121.131.141.181.251.151.171.151.231.221.231.211.201.18
TCA IR 40 mg1.101.001.020.900.830.870.890.850.911.010.890.930.970.980.900.930.951.080.980.941.020.980.971.04

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Change From Baseline Over Time for Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Subscale at Weeks 4, 8, 12 and 24

"The Knee injury and Osteoarthritis Outcome Score (KOOS) is a participant (patient)-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury and also consequences of primary osteoarthritis (OA). It holds 42 items in five separately scored subscales: KOOS Pain, KOOS Symptoms, Function in daily living (KOOS ADL), Function in Sport and Recreation (KOOS Sport/Rec), and knee-related Quality of Life (KOOS QOL).~A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems). Each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. Higher scores indicate better quality of life." (NCT02357459)
Timeframe: Weeks 4, 8, 12, and 24

,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12Week 24
FX006 32 mg23.5023.3021.1911.95
Placebo8.9310.7012.2210.25
TCA IR 40 mg15.6018.0215.7711.44

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Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24.

The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. (NCT02357459)
Timeframe: Weeks 4, 8, 12, 16, 20, and 24

,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12Week 16Week 20Week 24
FX006 32 mg-1.10-1.02-0.88-0.67-0.61-0.63
Placebo-0.50-0.48-0.50-0.54-0.51-0.49
TCA IR 40 mg-0.87-0.81-0.70-0.64-0.60-0.56

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Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24

The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. (NCT02357459)
Timeframe: Weeks 4, 8, 12, 16, 20 and 24

,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12Week 16Week 20Week 24
FX006 32 mg-1.11-1.09-0.93-0.69-0.65-0.59
Placebo-0.51-0.53-0.56-0.59-0.56-0.51
TCA IR 40 mg-0.87-0.80-0.72-0.62-0.57-0.54

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Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24

The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. (NCT02357459)
Timeframe: Weeks 4, 8, 12, 16, 20 and 24

,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12Week 16Week 20Week 24
FX006 32 mg-1.23-1.24-1.03-0.80-0.66-0.67
Placebo-0.51-0.54-0.59-0.64-0.64-0.58
TCA IR 40 mg-1.00-0.92-0.80-0.71-0.58-0.57

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Change From Baseline to Each Week in Weekly Mean of the ADP Scores

"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates no pain and 10 indicates pain as bad as you can imagine." (NCT02357459)
Timeframe: Weeks 1-11 & Weeks 13-24

,,
Interventionunits on a scale (Least Squares Mean)
Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 13Week 14Week 15Week 16Week 17Week 18Week 19Week 20Week 21Week 22Week 23Week 24
FX006 32 mg-1.9-2.95-3.20-3.23-3.34-3.48-3.48-3.48-3.45-3.31-3.21-2.96-2.91-2.84-2.73-2.66-2.60-2.57-2.44-2.27-2.18-2.14-1.99
Placebo-1.04-1.61-1.66-1.84-1.87-1.95-2.01-1.96-2.06-2.08-2.13-2.21-2.18-2.12-2.22-2.18-2.13-2.19-2.18-2.16-2.20-2.12-2.16
TCA IR 40 mg-2.13-2.69-2.93-3.11-3.11-3.20-3.03-3.04-3.06-3.07-3.01-2.87-2.73-2.75-2.67-2.57-2.55-2.48-2.46-2.27-2.29-2.30-2.18

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Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS) Questionnaire.

The pain visual analog scale (VAS) is a tool used by the patient to describe their pain intensity. Utilizing the VAS, the patient describes their pain at baseline, before receiving trigger point injections. The VAS ranges from 0 (no pain) to 10 (worst possible pain). Thus, a lower value represents a better outcome. (NCT02369068)
Timeframe: Baseline and Six Months

Interventionunits on a scale (Median)
Onabotulinumtoxin A-1
Kenalog-1

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Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS) Questionnaire.

The visual analog scale asks subjects to rate their level of pain on a scale from 0-10, with 0 being 'No pain' and 10 being 'Worst pain imaginable', hence lower scores are better. The baseline and follow-up visual analog scale for pain was obtained at every visit regardless if the patient received Trigger Point Injections. The difference between visual analog scale at 3 months and the visual analog scale at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 3 months and negative numbers indicates that the severity of the pain decreased. (NCT02369068)
Timeframe: Baseline and Three Months

Interventionunits on a scale (Median)
Onabotulinumtoxin A-1
Kenalog-1

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Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS).

The visual analog scale asks subjects to rate their level of pain on a scale from 0-10, with 0 being 'No pain' and 10 being 'Worst pain imaginable', hence lower scores are better. The baseline and follow-up visual analog scale for pain was obtained at every visit regardless if the patient received Trigger Point Injections. The difference between visual analog scale at 1 month and the visual analog scale at baseline was calculated. Positive numbers indicate the pain increased from baseline to 1 month and negative numbers indicates that pain decreased. (NCT02369068)
Timeframe: Baseline and One Month

Interventionunits on a scale (Median)
Onabotulinumtoxin A-2
Kenalog-1

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Proportion of Eyes With Resolution of Macular Edema at 8 Weeks

Proportion of eyes with resolution of macular edema defined as normalization of the macular thickness (i.e., < 260 um on the standardized scale) at 8 weeks. The greater the proportion the more eyes achieved resolution of macular edema. (NCT02374060)
Timeframe: Over 8 weeks of follow-up

InterventionProportion of eyes (Number)
Periocular Triamcinolone 40mg0.20
Intravitreal Triamcinolone 4mg0.47
Dexamethasoneintravitreal Implant0.61

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Change in Best-corrected Visual Acuity at 24 Weeks

Mean change in best-corrected visual acuity from baseline to 24 weeks. Participants' visual acuity was measured by certified examiners with best refractive correction in place.Participants were challenged with reading letters on lines of the standard ETDRS eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until no more meaningful readings could be made and were scored by how many letters could be correctly identified. More letters read is associated with higher visual acuity. (NCT02374060)
Timeframe: Over 24 weeks of follow-up

InterventionStandard letters (Mean)
Periocular Triamcinolone 40mg4.07
Intravitreal Triamcinolone 4mg9.60
Dexamethasoneintravitreal Implant9.21

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Change in Best-corrected Visual Acuity at 8 Weeks

Mean change in best-corrected visual acuity from baseline to 8 weeks. Participants' visual acuity was measured by certified examiners with best refractive correction in place.Participants were challenged with reading letters on lines of the standard ETDRS eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until no more meaningful readings could be made and were scored by how many letters could be correctly identified. More letters read is associated with higher visual acuity. (NCT02374060)
Timeframe: Over 8 weeks of follow-up

InterventionStandard letters (Mean)
Periocular Triamcinolone 40mg4.37
Intravitreal Triamcinolone 4mg9.70
Dexamethasoneintravitreal Implant9.53

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Cumulative Proportion of Eyes With an IOP Elevation >=24 mm Hg

Cumulative proportion of eyes with uveitic macular edema that experience elevated IOP to >=24 mm Hg during 24 weeks of follow-up. (NCT02374060)
Timeframe: During 24 weeks of follow-up

InterventionCumulative proportion of eyes at 24 wks (Number)
Periocular Triamcinolone 40mg0.20
Intravitreal Triamcinolone 4mg0.30
Dexamethasoneintravitreal Implant0.41

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Cumulative Proportion of Eyes With an IOP Elevation >=30 mm Hg

Cumulative proportion of eyes with uveitic macular edema that experience elevated IOP to >=30 mm Hg during 24 weeks of follow-up. (NCT02374060)
Timeframe: During 24 weeks of follow-up

InterventionCumulative proportion of eyes at 24 wks (Number)
Periocular Triamcinolone 40mg0.06
Intravitreal Triamcinolone 4mg0.06
Dexamethasoneintravitreal Implant0.04

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Cumulative Proportion of Eyes With an IOP Elevation of >=10 mm Hg Over Baseline

Cumulative proportion of eyes with uveitic macular edema that experience an IOP elevation of >=10 mm Hg higher than the baseline level during 24 weeks of follow-up. (NCT02374060)
Timeframe: During 24 weeks of follow-up

InterventionCumulative proportion of eyes at 24 wks (Number)
Periocular Triamcinolone 40mg0.14
Intravitreal Triamcinolone 4mg0.26
Dexamethasoneintravitreal Implant0.39

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Cumulative Proportion of Eyes With Severe Vision Loss

Cumulative proportion of eyes with uveitic macular edema who experience severe vision loss (>= 15 standard letters) during the 24 weeks of follow-up. (NCT02374060)
Timeframe: During 24 weeks of follow-up

InterventionCumulative proportion of eyes at 24 wks (Number)
Periocular Triamcinolone 40mg0.11
Intravitreal Triamcinolone 4mg0.10
Dexamethasoneintravitreal Implant0.05

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Number of Eyes With Endophthalmitis

Count of eyes with an occurrence of endophthalmitis (NCT02374060)
Timeframe: During 24 weeks of folllow-ip

InterventionEyes with uveitic macular edema (Number)
Periocular Triamcinolone 40mg1
Intravitreal Triamcinolone 4mg0
Dexamethasoneintravitreal Implant0

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Number of Eyes With Retinal Tear or Detachment

Count of eyes with retinal tears or detachments during the course of follow-up. (NCT02374060)
Timeframe: During 24 weeks of follow-up

InterventionEyes with uveitic macular edema (Number)
Periocular Triamcinolone 40mg1
Intravitreal Triamcinolone 4mg0
Dexamethasoneintravitreal Implant0

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Number of Eyes With Vitreous Hemorrhage

Count of eyes with vitreous hemorrhage as an immediate complication of injection. (NCT02374060)
Timeframe: During 24 weeks of follow-up

InterventionEyes with uveitic macular edema (Number)
Periocular Triamcinolone 40mg1
Intravitreal Triamcinolone 4mg0
Dexamethasoneintravitreal Implant1

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Proportion of Baseline Central Subfield Thickness Observed at 24 Weeks

The primary outcome is the change in central subfield thickness from baseline to 24 weeks measured on a relative scale as the the proportion of the baseline central subfield thickness. Values less than 1 indicate a decrease in retinal thickness with lower values indicating greater decreases. Smaller values are better.The time point of 24 weeks was chosen to evaluate the duration of response and the need for additional injections.Retinal thickness was evaluated using masked assessments of OCT images. (NCT02374060)
Timeframe: At baseline and the 24 week visit

Interventionproportion of baseline retinal thickness (Mean)
Periocular Triamcinolone 40mg0.68
Intravitreal Triamcinolone 4mg0.64
Dexamethasoneintravitreal Implant0.61

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Proportion of Baseline Central Subfield Thickness Observed at 8 Weeks

"The primary outcome is the change in central subfield thickness from baseline to 8 weeks measured on a relative scale as the the proportion of the baseline central subfield thickness. Values less than 1 indicate a decrease in retinal thickness with lower values indicating greater decreases. Smaller values are better.~The time point of 8 weeks was chosen for assessment of the primary outcome because it encompasses the window for maximum benefit for all three treatment strategies. Retinal thickness was evaluated using masked assessments of OCT images." (NCT02374060)
Timeframe: At baseline and 8 weeks

Interventionproportion of baseline retinal thickness (Mean)
Periocular Triamcinolone 40mg.77
Intravitreal Triamcinolone 4mg.61
Dexamethasoneintravitreal Implant.54

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Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 24 Weeks

Proportion of eyes with >=20% reduction in macular thickness (or normalization of macular thickness even if there is <20% reduction) at 24 weeks (NCT02374060)
Timeframe: Over 24 weeks of follow-up

InterventionProportion of eyes (Number)
Periocular Triamcinolone 40mg0.61
Intravitreal Triamcinolone 4mg0.73
Dexamethasoneintravitreal Implant0.74

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Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 8 Weeks

Proportion of eyes with >=20% reduction in macular thickness (or normalization of macular thickness even if there is <20% reduction) at 8 weeks. (NCT02374060)
Timeframe: Over 8 weeks of follow-up

InterventionProportion of eyes (Number)
Periocular Triamcinolone 40mg0.41
Intravitreal Triamcinolone 4mg0.79
Dexamethasoneintravitreal Implant0.84

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Proportion of Eyes With Resolution of Macular Edema at 24 Weeks

Proportion of eyes with resolution of macular edema defined as normalization of the macular thickness (i.e., <260 um on the standard scale) at 24 weeks. (NCT02374060)
Timeframe: Over 24 weeks of follow-up

InterventionProportion of eyes (Number)
Periocular Triamcinolone 40mg0.35
Intravitreal Triamcinolone 4mg0.36
Dexamethasoneintravitreal Implant0.41

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Number of Treatment-Emergent Adverse Events: Cingal 13-02 vs. Cingal 13-01

The primary outcome measure will compare safety results (all adverse events, whether related to the study injection or not) for Cingal 13-01 and Cingal 13-02. (NCT02381652)
Timeframe: Baseline through 6 weeks post-injection

InterventionAdverse events (Number)
Cingal 13-02 Adverse Events73

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Decrease in Size (mm) of Granulation Tissue

Measurements are calculated from photographs taken with a millimeter ruler next to granulation tissue on a horizontal plane and a vertical plane. The horizontal and vertical diameters are averaged and then halved, to give a radius which is squared and multiplied by Pi for an approximate area. The area at 8 weeks is subtracted from the area at baseline, to calculate the change and then they are averaged across the individuals with pre and post data for the arm. This approximation is limited by the fact that the shape and all the dimensions of the granulation tissue are highly variable. In order to measure the change the horizontal and vertical diameters were averaged as if they were a circle. This is a limitation of the analysis. (NCT02519738)
Timeframe: 8 weeks

,,
Interventionmm^2 (Mean)
Pre-TreatmentPost-TreatmentChange from pre-post
Kenalog (Triamcinolone)83.1445.0637.95
Silver Nitrate101.1222.3678.77
Washcloth Abrasion121.72140.54-18.81

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Change in Pain Assessment

Pain assessed on a visual analog scale from 1 (no pain) to 10 (worst pain imaginable). Pain score at 10 minutes post-injection is subtracted from baseline pre-injection score. Positive numbers to represent increases and negative numbers to represent decreases. (NCT02592629)
Timeframe: change from baseline assessment before injection at 10 minutes post injection

Interventionunits on a scale (Mean)
no Topical or Subcutaneous Anesthetic3
Subcutaneous Lidocaine4.21
Topical Ethyl Chloride5.6

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Number of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks

Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on electronic Visual Acuity (eVA). An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement. (NCT02595398)
Timeframe: Baseline, 24 weeks

InterventionParticipants (Count of Participants)
4mg CLS-TA Suprachoriodal Injection45
Sham Procedure10

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Mean Change From Baseline in Central Subfield Thickness

Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema. Only images that were gradable by the central reading center were included in the analysis. (NCT02595398)
Timeframe: Baseline, 24 weeks

Interventionmicrons (Mean)
4mg CLS-TA Suprachoriodal Injection-152.6
Sham Procedure-17.9

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Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Number of subjects with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) reported between the first dose of study drug and study exit. (NCT02595398)
Timeframe: Baseline to 24 weeks

,
InterventionParticipants (Count of Participants)
Experiencing at least one TEAEExperiencing at least one SAE
4mg CLS-TA Suprachoriodal Injection673
Sham Procedure450

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Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort

All baseline (pre-treatment) values and all post-baseline values that are recorded as below LLOQ were set to zero for analysis and were included in the descriptive mean calculations. Values below LLOQ were not included in geometric mean calculations. (NCT02637323)
Timeframe: Up to 20 Weeks

Interventionpg/mL (Geometric Mean)
Day 1 - Hour 1Day 1 - Hour 2Day 1 - Hour 4Day 1 - Hour 6Day 1 - Hour 8Day 1 - Hour 10Day 1 - Hour 12Day 2 - Hour 24Week 1Week 6Week 12Week 16Week 20
FX006 32 mg670.0736.5759.5747.1740.2720.7706.6836.4600.9118.653.773.8108.2

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Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort

All baseline (pre-treatment) values and all post-baseline values that are recorded as below LLOQ were set to zero for analysis and were included in the descriptive mean calculations. Values below LLOQ were not included in geometric mean calculations. (NCT02637323)
Timeframe: Up to 20 Weeks

Interventionpg/mL (Geometric Mean)
Day 1 - Hour 1Day 1 - Hour 2Day 1 - Hour 4Day 1 - Hour 6Day 1 - Hour 8Day 1 - Hour 10Day 1 - Hour 12Day 2 - Hour 24Week 6
TCA IR 40 mg6968.88494.79628.89314.38421.37439.36678.74991.1149.4

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Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid

All baseline (pre-treatment) values and all post-baseline values recorded as below LLOQ (<50 pg/mL) were set to zero. Geometric mean summary statistics were computed on adjusted concentration values. One (1) was added to each concentration value observed. BLQ values for the computation of geometric mean are included in the summary with a value of 1 (0+1). (NCT02637323)
Timeframe: Up to 20 Weeks

Interventionpg/mL (Geometric Mean)
Baseline (pre-treatment)Week 6
TCA IR 40 mg1.07.7

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Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid

All baseline (pre-treatment) values and all post-baseline values recorded as below LLOQ (<50 pg/mL) were set to zero. Geometric mean summary statistics were computed on adjusted concentration values. One (1) was added to each concentration value observed. BLQ values for the computation of geometric mean are included in the summary with a value of 1 (0+1). (NCT02637323)
Timeframe: Up to 20 Weeks

Interventionpg/mL (Geometric Mean)
Baseline (pre-treatment)Week 1Week 6Week 12Week 16Week 20
FX006 32 mg1.0231328.93590.0290.61.01.0

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Efficacy of 0.1% Triamcinolone Containing Wet Wrap as an Ointment or as a Cream Formulation in Patients With Moderate to Severe Atopic Dermatitis

"Change in atopic dermatitis based on physician global assessment scale: 0=clear; 1=almost clear; 2=mild disease; 3=moderate disease; 4=severe disease; 5- very severe disease~Lower scores represent a better outcome." (NCT02680301)
Timeframe: 3-5 days

Interventionunits on a scale (Mean)
Cream0.717
Ointment0.589

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Number of Patients Adhering to Treatment Protocol

Patient-reported adherence to wet-wrap protocol. Medication logs were used to evaluate adherence to the treatment protocol for both steroid formulations. Patents were determined to be adhering to the protocol if the number of wet-wraps for each study arm (cream or ointment) were the same. Because the total number of wraps varied between patients (the protocol required 1-2 wraps per day for 3-5 days), we reviewed medication logs to determine that each patient completed an equivalent number of ointment and cream wraps. (NCT02680301)
Timeframe: 3-5 days

InterventionParticipants (Count of Participants)
All Subjects39

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Percent Time Blood Glucose Less Than 70 mg/dl, 70 - 180 mg/dl, 180.1 - 250.0 mg/dl, 250.1 - 350.0 mg/dl, and Greater Than 350.0 mg/dl

The glycemic variability was calculated as the coefficient of variation (CV) of the hourly averages in each of these time periods: Hour 1-24, Hour 1-48, Hour 1-72, Hour 1-168, and Hour 1-360. The % CV for each patient was derived using the formula: (SD/mean)*100, using the values for each hourly average glucose measurement over the time period. Average % CV in the FX006 40 mg group was compared to the TCA IR 40 mg group using a linear model (ANCOVA) with fixed effects for treatment group. Model covariates were study center and baseline (72-hour) blood glucose average. (NCT02762370)
Timeframe: Baseline to Days 1-3

,
InterventionPercentage of time (Number)
Less than 7070 - 180180.1 - 250.0250.1 - 350.0Greater than 350.0
FX006 32 mg2.263.323.79.51.3
TCA IR 40 mg0.449.724.521.14.3

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Change in Average Blood Glucose From Baseline (Hour -48 to Hour -1) to Hour 1 to Hour 48 for FX006 32 mg Relative to TCA IR 40 mg.

(NCT02762370)
Timeframe: Baseline (Hour -48 to Hour -1) to Hour 1 to Hour 48

Interventionmg/dL (Least Squares Mean)
FX006 32 mg16.33
TCA IR 40 mg43.62

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Change From Baseline for Average Blood Glucose (mg/dL)

Average blood glucose was analyzed with a mixed model for repeated measures (MMRM) (NCT02762370)
Timeframe: Baseline and 72 Hours post intra-articular (IA) injection

Interventionmg/dL (Least Squares Mean)
FX006 32 mg14.66
TCA IR 40 mg33.88

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Change From Baseline for Maximum Blood Glucose: Baseline Average Blood Glucose (Hour -72 to Hour -1) to Maximum Blood Glucose (Hour 1 to Hour 72) for FX006 32 mg Relative to TCA IR 40 mg

(NCT02762370)
Timeframe: Baseline (Hour -72 to Hour -1) to Hour 1 to Hour 72

Interventionmg/dL (Least Squares Mean)
FX006 32 mg110.04
TCA IR 40 mg158.46

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Glycemic Variability Coeffecient of Variation (CV)

The glycemic variability was calculated as the coefficient of variation (CV) of the hourly averages in each of these time periods: Hour 1-24, Hour 1-48, Hour 1-72, Hour 1-168, and Hour 1-360. The % CV for each patient was derived using the formula: (SD/mean)*100, using the values for each hourly average glucose measurement over the time period. Average % CV in the FX006 40 mg group was compared to the TCA IR 40 mg group using a linear model (ANCOVA) with fixed effects for treatment group. Model covariates were study center and baseline (72-hour) blood glucose average. (NCT02762370)
Timeframe: Baseline to 72 hours post injection (hourly average blood glucose measurement over the time period)

Interventionmg/dL (Least Squares Mean)
FX006 32 mg22.43
TCA IR 40 mg27.05

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Area Under the Effect (AUE) Curves for Average Blood Glucose - FX006 Versus TCA IR

(NCT02762370)
Timeframe: Baseline to 72 hours post injection (-72 hr, 0 hr, and 1, 2, 3, 7, and 15 days post-dose)

,
Interventionhr*mg/dL (Least Squares Mean)
Baseline (Hour -72 to Hour -1)Day 1Days 1-2Days 1-3Days 1-7Days 1-15
FX006 32 mg22089.03703.37902.611772.327245.752112.8
TCA IR 40 mg23669.14483.29251.712950.925987.049532.2

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Percent Time Blood Glucose Less Than 70 mg/dl, 70 - 180 mg/dl, 180.1 - 250.0 mg/dl, 250.1 - 350.0 mg/dl, and Greater Than 350.0 mg/dl

(NCT02762370)
Timeframe: Baseline to Days 1-2

,
InterventionPercentage of time (Number)
Less than 70.070.0 - 180.0180.1 - 250.0250.1 - 350.0Greater than 350.0
FX006 32 mg1.264.123.09.91.7
TCA IR 40 mg0.342.727.425.24.4

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Visual Analog Pain Score

Patient reported level of pain on a scale of 0-10, with 10 being extreme pain and 0 being no pain. (NCT02767492)
Timeframe: Surgery through 12 months post-op/

Interventionscore on a scale (Mean)
BioDRestore™2.49
Corticosteroid3.25

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Single Alpha Numeric Evaluation (SANE)

"Percentage of normal for affected knee between 0 to 100, with 100 being a perfectly normal knee and 0 being a completely abnormal knee." (NCT02767492)
Timeframe: Surgery to 12 months post-op.

Interventionscore on a scale (Mean)
BioDRestore™66.14
Corticosteroid60.49

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Lysholm Knee Score

Patient reported knee function scores on a scale of 0-100, with 100 being a excellent outcome indicating no symptoms. (NCT02767492)
Timeframe: Surgery to 12 months post-op.

Interventionscore on a scale (Mean)
BioDRestore™75.26
Corticosteroid61.00

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Knee Injury and Osteoarthritis Outcome Score (KOOS)

Knee outcome measure assessed via Knee Injury and Osteoarthritis Outcome Score (KOOS) on a scale of 0 to 100. The higher score of 100 indicates a fully functional knee without knee pain or problems. (NCT02767492)
Timeframe: Surgery to 12 months post op

Interventionscore on a scale (Mean)
BioDRestore™64.10
Corticosteroid55.67

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Veterans Rand 12 Item Health Survey

Patient reported quality of life. Score contains a physical component and mental component score. Both scales are continuous and values range from 0 to 70, with higher scoring indicating higher physical and mental component scores (NCT02767492)
Timeframe: Sugery to 12 months post-op

Interventionscore on a scale (Mean)
BioDRestore™56.95
Corticosteroid58.01

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Patient Rating of Impression of Treatment at Day 14

"Patients will rate their impression of the treatment for each site as follows:~0. Made it worse;~Not helpful;~A little bit helpful;~Moderately helpful;~Very helpful~Comparison of rating of impression of treatment between the combined treatment groups and placebo will be performed. Similar comparison will be performed between the triamcinolone 10mg/ml and triamcinolone 40mg/ml treatment arms." (NCT02781818)
Timeframe: 14 days

Interventionunits on a scale (Mean)
Triamcinolone Acetonide 10mg/mL2.5
Triamcinolone Acetonide 40mg/mL2.5
Normal Saline Placebo2.4

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Number of Days to Lesion Resolution in Combined Treatment Arms Compared to the Placebo Arm.

Mean number of days that patient reports it takes for a lesion to resolve. This is defined as a return of the skin to baseline in the treated area and an absence of pain. (NCT02781818)
Timeframe: 1-14 days

InterventionDays (Mean)
Triamcinolone Acetonide 10mg/mL10.8
Triamcinolone Acetonide 40mg/mL10.9
Normal Saline Placebo9.35

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Change in Pain From Baseline to Day 5

Patients will rate pain on a scale of 1-10 (1 being no pain, 10 being the worst possible pain) at the baseline visit and on day 5. A secondary outcome will compare reduction in pain on day 5 in the combined treatment groups compared to the placebo group, and between the two treatment arms. (NCT02781818)
Timeframe: Baseline, Day 5

Interventionunits on a scale (Mean)
Triamcinolone Acetonide 10mg/mL2
Triamcinolone Acetonide 40mg/mL2.3
Normal Saline Placebo2.6

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Nasal Obstruction as Measured by Nasal Obstruction Symptom Evaluation (NOSE) Scores Following Therapy With Treatment (Triamcinolone Acetonide) and Placebo (Ayr Saline Spray)

"Nasal Obstruction Symptom Evaluation (NOSE) scale:~A quality of life (QOL) instrument developed to assess nasal obstruction symptoms in patients undergoing septoplasty. It consists of a 5-item questionnaire, scored on a 5-point (0-4) Likert scale. The raw score ranges from 0-20, which is scaled to a score of 0-100 by multiplying the raw score by 5, where '0' represents 'no problem' and, and '100' represent 'worst problem.'" (NCT02877485)
Timeframe: Pre-spray NOSE score - 6 weeks Post spray NOSE score- 2 weeks washout - Pre spray Pre-spray NOSE score - 6 weeks Post spray NOSE score

,
Interventionscore on a scale (Mean)
Baseline: Pre - spray 1 NOSE scorePost - spray 1 / pre- spray 2 NOSE scorePost - spray 2 NOSE score
Ayr Spray Then Triamcinolone Acetonide68.565.861.5
Triamcinolone Acetonide Then Ayr Spray69.165.264.1

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Nasal Obstruction Symptom Evaluation (NOSE) Score Following Surgery in Subset of Patients Who Elect to Undergo Surgery.

"Nasal Obstruction Symptom Evaluation (NOSE) scale:~A quality of life (QOL) instrument developed to assess nasal obstruction symptoms in patients undergoing septoplasty. It consists of a 5-item questionnaire, scored on a 5-point (0-4) Likert scale. The raw score ranges from 0-20, which is scaled to a score of 0-100 by multiplying the raw score by 5, where '0' represents 'no problem' and, and '100' represent 'worst problem.'" (NCT02877485)
Timeframe: Postoperative time interval (months): 1-2 , 3-5 , 6-9, 9-12, >12.

Interventionscore on a scale (Mean)
Baseline NOSE scorePostoperative period: 1-2 monthsPostoperative period:3-5 monthsPostoperative period:6-9 monthsPostoperative period: 9-12 monthsPostoperative period: >12 months
Surgery Patients7016.217.617.222.220

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CLS-TA Injections

After the initial treatment with CLS-TA, with or without intravitreal aflibercept, at Baseline, retreatment with CLS-TA was allowed in either treatment group from Month 2 through Month 6 if pre-defined retreatment criteria were met. Number of patients receiving 0, 1, 2, 3, 4 or 5 retreatments with CLS-TA. (NCT02949024)
Timeframe: 2 to 6 months following initial treatment with study drug

,
InterventionParticipants (Count of Participants)
0 additional injections1 additional injection2 additional injections3 additional injections4 additional injections
Previous TX Arm13204
TX Naïve Arm42022

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Mean Change From Baseline in Central Subfield Thickness

Baseline and change from baseline at 6 months in central subfield thickness. Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema. (NCT02949024)
Timeframe: Baseline and 6 months

,
InterventionMicrons (Mean)
BaselineMonth 6
Previous TX Arm421.6-90.9
TX Naïve Arm472.7-119.6

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Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events

Number of participants with treatment emergent adverse events and serious adverse events reported over 6 months of follow-up (NCT02949024)
Timeframe: Over 6 months of follow-up

,
InterventionParticipants (Count of Participants)
Number of participants with treatment emergent adverse eventsNumber of participants with serious adverse events
Previous TX Arm90
TX Naïve Arm80

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Mean Change From Baseline in Intraocular Pressure

Baseline and change from baseline at 6 months in intraocular pressure as measured by applanation tonometry (NCT02949024)
Timeframe: Baseline and 6 months

,
Interventionmm Hg (Mean)
BaselineMonth 6
Previous TX Arm13.32.8
TX Naïve Arm14.2-0.3

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Best Corrected Visual Acuity

Baseline and Change from baseline at 6 months in best corrected visual acuity before and after treatment Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured as the number of letters read correctly on an ETDRS eye chart. A positive change from baseline value represents an improvement in vision. (NCT02949024)
Timeframe: Baseline and 6 months

,
InterventionLetters (Mean)
BaselineMonth 6
Previous TX Arm67.21.1
TX Naïve Arm67.28.5

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Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events

Number of participants with treatment emergent adverse events and serious adverse events reported during the extension study. (NCT02952001)
Timeframe: 6 months following exit from Parent study

,
InterventionParticipants (Count of Participants)
Treatment-emergent adverse eventsSerious adverse events
4 mg CLS-TA Suprachoriodal Injection161
Sham Procedure30

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Mean Change From Baseline in Best Corrected Visual Acuity

Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement. (NCT02952001)
Timeframe: 6 months following exit from Parent study

Interventionletters (Mean)
4 mg CLS-TA Suprachoriodal Injection12.1
Sham Procedure14.0

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Time to Additional Therapy for Uveitis

This time to event outcome was calculated as the number of days between the date of initiation of additional therapy for uveitis and the date of first treatment in the Parent study CLS1001-301 (NCT02595398). (NCT02952001)
Timeframe: 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year

Interventiondays (Median)
4 mg CLS-TA Suprachoriodal Injection344.0
Sham Procedure332.0

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Mean Change From Baseline in Central Subfield Thickness

Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema. (NCT02952001)
Timeframe: 6 months following exit from Parent study

Interventionmicrons (Mean)
4 mg CLS-TA Suprachoriodal Injection-174.5
Sham Procedure19.5

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Mean Change From Baseline in Central Subfield Thickness

Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema. (NCT02980874)
Timeframe: 6 months

InterventionMicrons (Least Squares Mean)
Active-354.3
Control-416.2

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Mean Change From Baseline in Best Corrected Visual Acuity

Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. A positive change from baseline value represents an improvement in vision. (NCT02980874)
Timeframe: 6 months

InterventionLetters (Least Squares Mean)
Active15.5
Control20.5

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Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)

Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement. (NCT02980874)
Timeframe: 2 months

InterventionParticipants (Count of Participants)
Active114
Control127

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Mean Change in Composite Observer Score for Patient and Observer Scar Assessment Scale (POSAS)

Data from POSAS Observer Scale will be collected and reported to assess vascularity, pigmentation, thickness, relief, pliability, and surface area of the keloids chosen for the research study. Total score range: 6-60; Higher scores mean a worse outcome. Mean composite score of the final visit was compared to the mean baseline score. (NCT02996097)
Timeframe: Once every 4 weeks for 16 weeks

Interventionscore on a scale (Mean)
CO2 Ablative Laser PLUS Intralesional Triamcinolone Acetonide-9.5
Intralesional Triamcinolone Acetonide Only-8.9

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Mean Change in Composite Patient Score for Patient and Observer Scar Assessment Scale (POSAS)

Data from POSAS Observer Scale will be collected and reported to assess vascularity, pigmentation, thickness, relief, pliability, and surface area of the keloids chosen for the research study. Total score range: 6-60; Higher scores mean a worse outcome. Mean composite score of the final visit was compared to the mean baseline score. (NCT02996097)
Timeframe: Once every 4 weeks for 16 weeks

Interventionscore on a scale (Mean)
CO2 Ablative Laser PLUS Intralesional Triamcinolone Acetonide-22.6
Intralesional Triamcinolone Acetonide Only-18.8

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Change in Patient-assessed Pain Intensity in the Index Joint From Baseline at Time Points From 6 Hours to 8 Days for the First Gout Flare Treated in the Study as Measured by 5-point Likert Scale

"Patients will score their pain intensity in the joint most affected at baseline (index joint) on a 5-point Likert scale (0-4 point scale: none, mild, moderate, severe, extreme) at time points baseline (pre-dose) and at 6, 12, 18, 24, 36, 48 and 72 hours and Day 5, 6, 7 and 8." (NCT03002974)
Timeframe: At baseline (pre-dose) and at 6, 12, 18, 24, 36, 48 and 72 hours and Day 5, 6, 7 and 8 for the first gout flare treated in the study

,,
InterventionScore on a scale (Mean)
6 hours12 hours18 hours24 hours36 hours48 hours72 hoursDay 5Day 6Day 7Day 8
Anakinra 100 mg-0.8-1.1-1.2-0.9-1.3-1.4-1.6-1.8-2.2-2.2-2.1
Anakinra 200 mg-0.4-0.5-0.8-1.1-1.1-1.5-1.7-1.8-1.9-1.9-2.1
Triamcinolone 40 mg-0.6-0.9-0.8-1.0-1.3-1.5-1.6-1.8-1.9-2.4-1.9

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Change in Patient-assessed Pain Intensity in the Index Joint From Baseline to 24-72 Hours for the First Gout Flare Treated in the Study as Measured by VAS

Patients will score their pain intensity in the joint most affected at baseline (index joint) on a 0-100 mm visual analogue scale (VAS), ranging from no pain (0) to unbearable pain (100). Average of the assessments performed at 24, 48 and 72 hours. (NCT03002974)
Timeframe: At baseline (pre-dose) and at 24, 48 and 72 hours for the first gout flare treated in the study

,,
InterventionUnits on a scale (Mean)
24 hours48 hours72 hours
Anakinra 100 mg-32.5-42.9-51.6
Anakinra 200 mg-31.1-43.6-49.1
Triamcinolone 40 mg-26.1-43.4-45.2

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Physician's Assessment of Clinical Signs in Index Joint: Tenderness

4-point Likert scale (0=no pain, 1= mild/patient states there is pain when touched, 2= moderate/patient states there is pain and Winces, 3=severe/patient states there is pain, winces and withdraws (NCT03002974)
Timeframe: at 72 hours, Day 8 and Day 15 for the first flare treated in the study

,,
InterventionParticipants (Count of Participants)
72 hours : None72 hours : Mild72 hours : Moderate72 hours : Severe72 hours : MissingDay 8 : NoneDay 8 : MildDay 8 : ModerateDay 8 : SevereDay 8 : MissingDay 15 : NoneDay 15 : MildDay 15 : ModerateDay 15 : SevereDay 15 : Missing
Anakinra 100 mg18284332819243389513
Anakinra 200 mg162591330171153212505
Triamcinolone 40 mg822174419254163710116

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Median Time to Response

Response defined as 50% change from baseline pain intensity on a visual analogue scale (VAS) (NCT03002974)
Timeframe: From baseline (predose) up to Day15 of the first flare treated in the study

InterventionHours (Median)
Triamcinolone 40 mg47.6
Anakinra 100 mg43.0
Anakinra 200 mg46.9

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The Percent of Patients With at Least One Serious Adverse Event, Including Death

Serious Adverse Events (SAE) will be collected from informed consent until week 12 for each flare. Any SAE with suspected causal relationship should be reported irrespective of the time of occurrence. (NCT03002974)
Timeframe: Through study completion, at 12 weeks after last flare treated during the extension period

InterventionPercent (Number)
Triamcinolone 40 mg0
Anakinra 100 mg7.3
Anakinra 200 mg0

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Median Time to Resolution of Pain

Resolution of pain defined as <10 mm on VAS, a continuous 0 to 100 mm visual analogue scale, ranging from no pain (0) to unbearable pain (100), in the index joint (NCT03002974)
Timeframe: From baseline (predose) up to Day15 of the first flare

InterventionHours (Median)
Triamcinolone 40 mg167.5
Anakinra 100 mg131.8
Anakinra 200 mg119.8

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Health Care Resource Utilization Due to a Gouty Arthritis Flare

Exploratory objective: number of days with hospitalization and un-scheduled outpatient visits (NCT03002974)
Timeframe: Recorded up to Day 15 for the first flare and subsequent flares treated during the extension period

,,
Interventiondays (Mean)
Hospitalization : First flare : Day 1-7Hospitalization : First flare : Day 8-15Hospitalization : First flare : Day 1-15Hospitalization : Second flare : Day 1-7Hospitalization : Second flare : Day 8-15Hospitalization : Second flare : Day 1-15Hospitalization : Third flare : Day 1-7Hospitalization : Third flare : Day 8-15Hospitalization : Third flare : Day 1-15Hospitalization : Fourth flare : Day 1-7Hospitalization : Fourth flare : Day 8-15Hospitalization : Fourth flare : Day 1-15Hospitalization : Fifth flare : Day 1-7Hospitalization : Fifth flare : Day 8-15Hospitalization : Fifth flare : Day 1-15Unscheduled outpatient visits:First flare: Day 1-7Unscheduled outpatient visits:First flare:Day 8-15Unscheduled outpatient visits:First flare:Day 1-15Unscheduled outpatient visits:Second flare:Day 1-7Unscheduled outpatient visit:Second flare:Day 8-15Unscheduled outpatient visit:Second flare:Day 1-15Unscheduled outpatient visits:Third flare:Day 1-7Unscheduled outpatient visits:Third flare:Day 8-15Unscheduled outpatient visits:Third flare:Day 1-15Unscheduled outpatient visitstFourth flare:Day 1-7Unscheduled outpatient visitsFourth flare:Day 8-15Unscheduled outpatient visitsFourth flare:Day 1-15Unscheduled outpatient visit:Fifth flare : Day 1-7Unscheduled outpatient visitFifth flare : Day 8-15Unscheduled outpatient visit Fifth flare:Day 1-15
Anakinra 100 mg00000000000000000.10.1000000000000
Anakinra 200 mg0000000000000000.100.1000000000000
Triamcinolone 40 mg0000000000000000.10.30.40.20.20.50.40.40.8000000

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Patient´s Assessment of Global Response to Treatment (5-point Likert Scale)

5-point Likert scale (0- to 4-point scale: 0=excellent, 1=very good, 2=good, 3=fair, 4=poor response to treatment) where lower rate indicates better response to treatment (NCT03002974)
Timeframe: at 72 hours, Day 8 and Day 15 for the first flare treated in the study

,,
InterventionParticipants (Count of Participants)
72 hours : Excellent72 hours : Very good72 hours : Good72 hours : Fair72 hours : Poor72 hours : MissingDay 8 : ExcellentDay 8 : Very goodDay 8 : GoodDay 8 : FairDay 8 : PoorDay 8 : MissingDay 15 : ExcellentDay 15 : Very goodDay 15 : GoodDay 15 : FairDay 15 : PoorDay 15 : Missing
Anakinra 100 mg10191441816216607191385011
Anakinra 200 mg18915318191372112211110318
Triamcinolone 40 mg11137741391685512149106313

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Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares

"The WPAI yeilds four types of scores of which Work productivity loss is one.~SHP is derived from WPAI as follows:~The WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity as follows:~Questions:~Q1 = currently employed Q2 = hours missed due to specified problem Q3 = hours missed other reasons Q4 = hours actually worked Q5 = degree problem affected productivity while working Q6 = degree problem affected regular activities~Scores:~Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10 The answer on Q5 is given on a scale from 0 (PROBLEM had no effect on work) to 10 (PROBLEM completely prevented me from working).~Thus the analysis values from which mean and SD have been calculated and reported are the outcomes from Q5 (ranging from 0 to 10) multiplied with 100 and divided by 10." (NCT03002974)
Timeframe: Recorded up to Day 15 for the first flare and subsequent flares treated during the extension period

Interventionpercent (Mean)
First flare : Day 8First flare : Day 15Second flare : Day 8Second flare : Day 15Third flare : Day 8Third flare : Day 15Fourth flare : Day 8Fourth flare : Day 15Fifth flare : Day 8Fifth flare : Day 15
Anakinra 200 mg20.521.624.013.810.023.320.05.026.713.3

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Change From Baseline in Short Form (36) Health Survey, Acute Version 2 (SF-36®) Physical Functioning Domain Score

SF-36® measures the impact of disease on overall quality of life. It consists of 8 individual domains. Score range from 0 to 100, where 0 represents the worst possible health and 100 is perfect health. (NCT03002974)
Timeframe: at baseline, Day 8 and Day 15 for the first flare treated in the study

,,
Interventionunits on a scale (Mean)
Day 8Day 15
Anakinra 100 mg10.512.2
Anakinra 200 mg10.49.4
Triamcinolone 40 mg8.011.8

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Median Time to First Intake of Rescue Medication From First Investigational Drug Administration

Time to first intake of rescue medication for acute gout, measured in hours from first investigational drug administration (NCT03002974)
Timeframe: From Day 1 to Day 15 for the first flare treated

InterventionHours (Median)
Triamcinolone 40 mgNA
Anakinra 100 mgNA
Anakinra 200 mgNA

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Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares

"The WPAI yeilds four types of scores of which Work productivity loss is one.~SHP is derived from WPAI as follows:~The WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity as follows:~Questions:~Q1 = currently employed Q2 = hours missed due to specified problem Q3 = hours missed other reasons Q4 = hours actually worked Q5 = degree problem affected productivity while working Q6 = degree problem affected regular activities~Scores:~Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10 The answer on Q5 is given on a scale from 0 (PROBLEM had no effect on work) to 10 (PROBLEM completely prevented me from working).~Thus the analysis values from which mean and SD have been calculated and reported are the outcomes from Q5 (ranging from 0 to 10) multiplied with 100 and divided by 10." (NCT03002974)
Timeframe: Recorded up to Day 15 for the first flare and subsequent flares treated during the extension period

Interventionpercent (Mean)
First flare : Day 8First flare : Day 15Second flare : Day 8Second flare : Day 15Third flare : Day 8Third flare : Day 15Fifth flare : Day 15
Anakinra 100 mg32.612.624.020.05.020.040.0

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Percent Impairment While Working During Last Week Due to Gout During the First Flare and Subsequent Flares

"The WPAI yeilds four types of scores of which Work productivity loss is one.~SHP is derived from WPAI as follows:~The WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity as follows:~Questions:~Q1 = currently employed Q2 = hours missed due to specified problem Q3 = hours missed other reasons Q4 = hours actually worked Q5 = degree problem affected productivity while working Q6 = degree problem affected regular activities~Scores:~Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10 The answer on Q5 is given on a scale from 0 (PROBLEM had no effect on work) to 10 (PROBLEM completely prevented me from working).~Thus the analysis values from which mean and SD have been calculated and reported are the outcomes from Q5 (ranging from 0 to 10) multiplied with 100 and divided by 10." (NCT03002974)
Timeframe: Recorded up to Day 15 for the first flare and subsequent flares treated during the extension period

Interventionpercent (Mean)
First flare : Day 8First flare : Day 15Second flare : Day 8Second flare : Day 15Third flare : Day 8Third flare : Day 15Fourth flare : Day 8Fifth flare : Day 8Fifth flare : Day 15
Triamcinolone 40 mg36.123.342.916.010.010.030.060.020.0

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Physician's Assessment of Clinical Signs in Index Joint: Erythema

Physicians assessment of clinical signs with 2 outcomes: Absent=no erythema, present=erythema (NCT03002974)
Timeframe: at 72 hours, Day 8 and Day 15 for the first flare treated in the study

,,
InterventionParticipants (Count of Participants)
Baseline : AbsentBaseline : PresentBaseline : Missing72 hours : Absent72 hours : Present72 hours : MissingDay 8 : AbsentDay 8 : PresentDay 8 : MissingDay 15 : AbsentDay 15 : PresentDay 15 : Missing
Anakinra 100 mg84803914343944754
Anakinra 200 mg84513714340954095
Triamcinolone 40 mg35112922443664726

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Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra

This endpoint represents the level of of endogenous interleukin-1 receptor antagonist /anakinra (NCT03002974)
Timeframe: Baseline (predose) and at 72 hours, Day 8, Day 15, Day 28 and Week 12 for the first flare and subsequent flares treated during the extension period

,
Interventionng/mL (Mean)
First flare : BaselineFirst flare : 72 hoursFirst flare : Day 8First flare : Day 15First flare : Day 28First flare : Week 12Second flare : BaselineSecond flare : 72 hoursSecond flare : Day 8Second flare : Day 15Second flare : Day 28Second flare : Week 12Third flare : BaselineThird flare : 72 hoursThird flare : Day 8Third flare : Day 15Third flare : Day 28Third flare : Week 12Fourth flare : BaselineFourth flare : 72 hoursFourth flare : Day 8Fourth flare : Day 15Fourth flare : Day 28Fourth flare : Week 12Fifth flare : BaselineFifthe flare : 72 hoursFifthe flare : Day 8Fifthe flare : Day 15Fifthe flare : Day 28Fifth flare : Week 12
Anakinra 200 mg1.950628.05334.7771.5741.7791.7191.500719.66748.7851.5001.5001.6921.50431.6310.701.502.471.501.50916.6220.621.501.501.501.50292.356.391.501.501.50
Triamcinolone 40 mg2.0321.9741.6921.5331.6351.5001.7481.6283.1411.8451.9752.9202.051.851.501.501.852.851.501.501.501.501.501.501.501.501.501.501.501.50

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The Percent of Patients With at Least One Adverse Event

All adverse events to be recorded Day 1 - Day 28 for each flare. Serious adverse events (SAE) will be collected from informed consent until week 12 for each flare. Any SAE with suspected causal relationship should be reported irrespective of the time of occurrence. (NCT03002974)
Timeframe: Through study completion, at 12 weeks after last flare treated during the extension period

InterventionPercent (Number)
Triamcinolone 40 mg40.7
Anakinra 100 mg38.2
Anakinra 200 mg55.8

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Change From Baseline in the Inflammatory Biomarker C Reactive Protein

This endpoint represents the change from baseline, mg/dL, of the inflammatory biomarker C reactive protein (NCT03002974)
Timeframe: baseline (predose) and at 72 hours, Day 8 and Day 15 for the first flare treated in the study

,,
Interventionmg/dL (Mean)
72 hoursDay 8Day 15
Anakinra 100 mg-1.435-1.334-0.724
Anakinra 200 mg-1.3621.406-0.607
Triamcinolone 40 mg-0.362-0.321-1.102

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Change From Baseline in the Inflammatory Biomarker Serum Amyloid A

This endpoint represents the change from baseline, mg/L, of the inflammatory biomarker Serum amyloid A (NCT03002974)
Timeframe: baseline (predose) and at 72 hours, Day 8 and Day 15 for the first flare treated in the study

,,
Interventionmg/L (Mean)
72 hoursDay 8Day 15
Anakinra 100 mg-45.160-46.561-25.328
Anakinra 200 mg-34.510-35.88714.370
Triamcinolone 40 mg8.950-6.363-50.524

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Median Time to Onset of Effect

Onset of effect defined as 20% change from baseline pain intensity in the index joint on a visual analogue scale (VAS) (NCT03002974)
Timeframe: From baseline (predose) up to Day15 of the first flare treated in the study

InterventionHours (Median)
Triamcinolone 40 mg22.3
Anakinra 100 mg11.8
Anakinra 200 mg19.8

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Physician's Assessment of Global Response to Treatment

"5-point Likert scale (0- to 4-point scale: none, mild, moderate, severe, extreme) where higher score mean worse outcome" (NCT03002974)
Timeframe: At 72 hours, Day 8 and Day 15 for the first flare treated in the study

,,
InterventionScore on a scale (Mean)
72 hoursDay 8Day 15
Anakinra 100 mg1.250.900.80
Anakinra 200 mg1.250.810.78
Triamcinolone 40 mg1.541.261.04

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Proportion of Patients With Anti-drug Antibodies (ADA) Against Anakinra

Confirmed ADA positive samples will be analysed for the presence of neutralizing antibodies (NCT03002974)
Timeframe: Baseline (predose) and at 72 hours, Day 8, Day 15, Day 28 and Week 12 for the first flare and subsequent flares treated treated during the extension period

,,
Interventionparticipants (Number)
First flare : BaselineFirst flare : Day 8First flare : Day 15First flare : Day 28First flare : Week 12Second flare : BaselineSecond flare : Day 8Second flare : Day 15Second flare : Day 28Second flare : Week 12Third flare : BaselineThird flare : Day 8Third flare : Day 15Third flare : Day 28Third flare : Week 12Fourth flare : BaselineFourth flare : Day 8Fourth flare : Day 15Fourth flare : Day 28Fourth flare : Week 12Fifth flare : BaselineFifth flare : Day 8Fifth flare : Day 15Fifth flare : Day 28Fifth flare : Week 12
Anakinra 100 mg5454401110011100111101210
Anakinra 200 mg2342022011244002341012220
Triamcinolone 40 mg2100000000000000000000000

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Proportion of Patients With Neutralizing Antibodies

Confirmed ADA positive samples will be analysed for the presence of neutralizing antibodies (NCT03002974)
Timeframe: Baseline (predose) and at 72 hours, Day 8, Day 15, Day 28 and Week 12 for the first flare and subsequent flares treated during the extension period

,,
Interventionparticipants (Number)
First flare : BaselineFirst flare : Day 8First flare : Day 15First flare : Day 28First flare : Week 12Second flare : Study baselineSecond flare : Flare baselineSecond flare : Day 8Second flare : Day 15Second flare : Day 28Second flare : Week 12Third flare : Study baselineThird flare : Flare baselineThird flare : Day 8Third flare : Day 15Third flare : Day 28Third flare : Week 12Fourth flare : Study baselineFourth flare : Flare baselineFourth flare : Day 8Fourth flare : Day 15Fourth flare : Day 28Fourth flare : Week 12Fifth flare : Study baselineFifth flare : Flare baselineFifth flare : Day 8Fifth flare : Day 15Fifth flare : Day 28Fifth flare : Week 12
Anakinra 100 mg00000000000000000001000000000
Anakinra 200 mg00000000000000000000100000000
Triamcinolone 40 mg00000000000000000000000000000

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Serum Concentration of Endogenous Interleukin-1 Receptor Antagonist /Anakinra

This endpoint represents the level of of endogenous interleukin-1 receptor antagonist /anakinra (NCT03002974)
Timeframe: Baseline (predose) and at 72 hours, Day 8, Day 15, Day 28 and Week 12 for the first flare and subsequent flares treated during the extension period

Interventionng/mL (Mean)
First flare : BaselineFirst flare : 72 hoursFirst flare : Day 8First flare : Day 15First flare : Day 28First flare : Week 12Second flare : BaselineSecond flare : 72 hoursSecond flare : Day 8Second flare : Day 15Second flare : Day 28Second flare : Week 12Third flare : BaselineThird flare : 72 hoursThird flare : Day 8Third flare : Day 15Third flare : Day 28Third flare : Week 12Fourth flare : BaselineFourth flare : 72 hoursFourth flare : Day 8Fourth flare : Day 15Fourth flare : Day 28Fourth flare : Week 12Fifth flare : BaselineFifthe flare : 72 hoursFifthe flare : Day 8Fifthe flare : Day 15Fifthe flare : Day 28
Anakinra 100 mg4.883267.7446.7501.5881.6591.6251.718254.9307.0481.5951.6921.6811.50196.675.561.631.501.501.50184.401.891.501.502.661.50129.201.501.503.31

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Physician's Assessment of Clinical Signs in Index Joint: Swelling

4-point Likert scale (0=no swelling, 1= mild swelling, 2=moderate swelling, 3=severe swelling or bulging beyond joint margins) (NCT03002974)
Timeframe: at 72 hours, Day 8 and Day 15 for the first flare treated in the study

,,
InterventionParticipants (Count of Participants)
Baseline : NoneBaseline : MildBaseline : ModerateBaseline : SevereBaseline : Missing72 hours : None72 hours : Mild72 hours : Moderate72 hours : Severe72 hours : MissingDay 8 : NoneDay 8 : MildDay 8 : ModerateDay 8 : SevereDay 8 : MissingDay 15 : NoneDay 15 : MildDay 15 : ModerateDay 15 : SevereDay 15 : Missing
Anakinra 100 mg0142715027187133713213446303
Anakinra 200 mg072818117267133892053414105
Triamcinolone 40 mg0923230142210542516716379216

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Mean Intraocular Pressure in the Study Eye

Intraocular pressure is the fluid pressure inside the eye. Tonometry is the method eye care professionals use to determine this. IOP is an important aspect in the evaluation of patients at risk of glaucoma. Tonometers in this study were calibrated to measure pressure in millimeters of mercury. (NCT03097315)
Timeframe: Baseline, 24 Weeks

InterventionmmHg (Mean)
BaselineWeek 24
4 mg CLS-TA Suprachoriodal Injection13.315.2

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Number of Patients With a Grade of 0 in Anterior Chamber Cells in the Study Eye

The anterior chamber is the aqueous humor-filled space inside the eye between the iris and the cornea's innermost surface, the endothelium. The grading of cellular reaction in the anterior chamber helps in the assessment of the severity of uveitis. In this study, anterior chamber cells were graded following the Standardization of Uveitis Nomenclature working group recommendations. The following scale was used to grade the cells in the field: 0 = <1, 0.5+ = 1-5, 1+ = 6-15, 2+ = 16-25, 3+ = 26-50, and 4+ = >50 cells. A lower grade represents less inflammation in the eye. (NCT03097315)
Timeframe: Baseline, 24 Weeks

InterventionParticipants (Count of Participants)
BaselineWeek 24
4 mg CLS-TA Suprachoriodal Injection1731

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Number of Patients With a Grade of 0 in Anterior Chamber Flare in the Study Eye

The anterior chamber is the aqueous humor-filled space inside the eye between the iris and the cornea's innermost surface, the endothelium. The grading of intraocular inflammation or flare in the anterior chamber helps in the assessment of the severity of uveitis. In this study, anterior chamber flare was graded following the Standardization of Uveitis Nomenclature working group recommendations. The following scale was used to grade the flare: 0 = none, 1+ = faint, 2+ moderate (iris and lens details clear), 3+ = marked (iris and lens details hazy), 4+ = intense (fibrin or plastic aqueous). A lower grade represents less inflammation in the eye. (NCT03097315)
Timeframe: Baseline, 24 Weeks

InterventionParticipants (Count of Participants)
BaselineWeek 24
4 mg CLS-TA Suprachoriodal Injection2734

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Number of Patients With a Grade of 0 in Vitreous Haze in the Study Eye

The vitreous body is that part of the eye that fills the space in the center of the eye. The primary purpose of the vitreous body is to keep the center of the eye clear so that light can get to the retina and vision can begin. Vitreous haze involves the obstruction of the back of the eye by vitreous cells and protein exudation. In this study, vitreous haze was graded following a standardized photographic scale ranging from 0 to 4. The following scale was used to grade the vitreous haze: 0 = no inflammation, +0.5 = trace inflammation, +1 = mild blurring of the retinal vessels and optic nerve, +1.5 = optic nerve head and posterior retina view obscuration greater than +1 but less than +2, +2 = moderate blurring of the optic nerve head, +3 = marked blurring of the optic nerve head, +4 = optic nerve head not visible. A lower grade represents less inflammation in the eye. (NCT03097315)
Timeframe: Baseline, 24 Weeks

InterventionParticipants (Count of Participants)
BaselineWeek 24
4 mg CLS-TA Suprachoriodal Injection1734

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Adverse Events

Number of patients with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). An adverse event (AE) is the development of an undesirable medical condition or the deterioration of a preexisting medical condition after or during exposure to a pharmaceutical product, whether or not considered causally related to the product. A TEAE is an AE occurring on or after the date of the first dose of study drug or worsening relative to the pre-treatment state. An SAE is an AE that fulfils one or more of the following: results in death; is immediately life-threatening; requires hospitalization nor prolongation of hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; or is an important medical event that may jeopardize the subject or may require medical intervention to present one of the outcomes listed above. (NCT03097315)
Timeframe: Baseline to 24 weeks

InterventionParticipants (Count of Participants)
Treatment-Emergent Adverse EventsSerious Adverse Events
4 mg CLS-TA Suprachoriodal Injection271

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Mean Change From Baseline in Best Corrected Visual Acuity Letter Score

Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement. (NCT03126786)
Timeframe: Baseline, 6 months

Interventionletters (Least Squares Mean)
Active11.4
Control13.8

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Mean Change From Baseline in Central Subfield Thickness

Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema. (NCT03126786)
Timeframe: Baseline, 6 months

Interventionmicrons (Least Squares Mean)
Active-212.1
Control-178.6

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Change in Strength in Both Groups After CESI.

Change in strength in both groups greater than or equal to 20% weakness in one or more myotomes 30 minutes after CESI using a hand held Dynamometer. (NCT03127137)
Timeframe: 30 minutes after the CESI procedure

,
InterventionParticipants (Count of Participants)
Yes, greater or equal to 20% weakness in greater or equal to 1 or more myotomeNo, greater or equal to 20% weakness in greater or equal to 1 or more myotome
Experimental Group 1 With Lidocaine2535
Experimental Group 2 With Saline3030

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Change From Baseline in Patient Global Assessment at 26 Weeks (ITT Population)

"The change from baseline in the Patient Global Assessment (PGA) between the Cingal and TH arms (ITT population). The PGA is completed by the subject answering the question Considering all the ways the osteoarthritis in your index knee bothers you, what is your assessment of how much your knee is bothering you today? The PGA is scored on a visual analog scale, where 0 = the patient is not bothered to 100 mm = the patient is bothered to the highest degree. A negative number for the change from baseline indicates an improvement in the patient assessment. A greater negative difference means a better outcome." (NCT03191903)
Timeframe: 26 weeks

Interventionscore on a scale (Mean)
Cingal-37.2
Monovisc-37.3
Triamcinolone Hexacetonide (TH)-37.9

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Change From Baseline in the Evaluator Global Assessment at 26 Weeks (ITT Population)

"The change from baseline in the Evaluator Global Assessment between the Cingal and TH arms (ITT population). The Evaluator Global Assessment is completed by the Blinded Outcomes Assessor, and answers the question Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today? The Evaluator Global Assessment is scored on a visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the change from baseline indicates improvement in the assessment. A greater negative difference means a better outcome." (NCT03191903)
Timeframe: 26 weeks

Interventionscore on a scale (Mean)
Cingal-37.4
Monovisc-36.4
Triamcinolone Hexacetonide (TH)-38.8

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Change From Baseline in Total WOMAC Score at 26 Weeks (ITT Population)

The change from baseline in Total Score as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) comparing the Cingal group to the TH group. The Total WOMAC Score combines the three 0-to-100 point scores from the WOMAC Pain Score, the WOMAC Stiffness Score, and the WOMAC Physical Function Score for a Total Score from 0 = no symptoms to 300 = highest degrees of pain, stiffness, and functional limitation symptoms. A negative number for the change from baseline indicates reduction in pain, stiffness and function limitations. A greater negative difference from baseline means a better outcome. (NCT03191903)
Timeframe: 26 weeks

Interventionscore on a scale (Mean)
Cingal-128.3
Monovisc-130.1
Triamcinolone Hexacetonide (TH)-125.9

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Change From Baseline in WOMAC Pain Score at 1 Week (ITT Population)

The change from baseline in knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal group to the Monovisc group. The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the change from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome. (NCT03191903)
Timeframe: 1 week

Interventionscore on a scale (Mean)
Cingal-35.3
Monovisc-33.0
Triamcinolone Hexacetonide-34.5

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Change From Baseline in WOMAC Pain Score at 26 Weeks (ITT Population)

The change from baseline in knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal group to the TH group. The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the change from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome. (NCT03191903)
Timeframe: 26 weeks

Interventionunits on a scale (Mean)
Cingal-46.4
Monovisc-46.6
Triamcinolone Hexacetonide (TH)-45.0

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Change From Baseline in WOMAC Pain Score at 3 Weeks (ITT Population)

The change from baseline in knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal group to the Monovisc group. The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the change from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome. (NCT03191903)
Timeframe: 3 weeks

Interventionscore on a scale (Mean)
Cingal-42.6
Monovisc-39.5
Triamcinolone Hexacetonide (TH)-41.3

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Change From Baseline in WOMAC Pain Score at 3 Weeks in the Per-Protocol Population

The change from baseline in knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal group to the Monovisc group. The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the change from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome. (NCT03191903)
Timeframe: 3 Weeks

Interventionscore on a scale (Mean)
Cingal-43.4
Monovisc-39.8
Triamcinolone Hexacetonide (TH)-42.5

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Change From Baseline in WOMAC Physical Function Score at 26 Weeks (ITT Population)

The change from baseline of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score comparing the Cingal and TH arms (ITT Population). The WOMAC Physical Function Score is a validated visual analog scale from 0 = no limitations in function to 100 mm = highest limitations in function. A negative number for the change from baseline indicates improvement in physical function. A greater negative difference from baseline means a better outcome. (NCT03191903)
Timeframe: 26 weeks

Interventionunits on a scale (Mean)
Cingal-42.6
Monovisc-42.4
Triamcinolone Hexacetonide (TH)-42.4

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Change From Baseline in WOMAC Stiffness Score at 26 Weeks (ITT Population)

The change from baseline in knee stiffness as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score comparing the Cingal group to the TH group. The WOMAC Stiffness Score is a validated visual analog scale from 0 = no stiffness to 100 = highest stiffness level. A negative number for the change from baseline indicates reduction in knee stiffness. A greater negative difference from baseline means a better outcome. (NCT03191903)
Timeframe: 26 weeks

Interventionunits on a scale (Mean)
Cingal-39.4
Monovisc-41.1
Triamcinolone Hexacetonide (TH)-38.5

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OMERACT-OARSI Responder Index at 26 Weeks Post Treatment Comparing the Cingal Group to the TH Group (ITT Population)

The responder rate as identified by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) responder index at 26 weeks post treatment comparing the Cingal® group to the TH group. The OMERACT-OARSI responder index is a proportion of subjects that met the criteria to be a responder. (NCT03191903)
Timeframe: 26 weeks

Interventionpercentage of subjects (Number)
Cingal91.24
Monovisc93.63
Triamcinolone Hexacetonide (TH)94.59

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The Usage of Rescue Medication (Acetaminophen) Through 26 Weeks (ITT Population)

The usage of rescue medication (acetominophen) through 26 weeks post treatment in the Cingal group compared to the TH group using the ITT population. (NCT03191903)
Timeframe: 26 weeks

Interventionpills (Mean)
Cingal5.4
Monovisc5.9
Triamcinolone Hexacetonide (TH)6.3

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Mean Change From Baseline in Best Corrected Visual Acuity

Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. A positive change from baseline value represents an improvement in vision. (NCT03203447)
Timeframe: 6 months

Interventionletters (Least Squares Mean)
Active13.8
Control20.7

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Mean Change From Baseline in Central Subfield Thickness

Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema. (NCT03203447)
Timeframe: 6 months

Interventionmicrons (Least Squares Mean)
Active-353.6
Control-374.7

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Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)

Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement. (NCT03203447)
Timeframe: 2 months

InterventionParticipants (Count of Participants)
Active64
Control76

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Incidence of Treatment Emergent Adverse Events

"Safety analyses were conducted using the safety population.~Analyses of adverse events will be performed for those events that are considered treatment emergent, where treatment emergent is defined as any adverse event with onset after the administration of study medication in the first knee through the end of the study or any event that was present at baseline but worsened in intensity through the end of the study. Severity of Adverse events were graded by the Principal Investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The grading went from Grade 1 (Mild) to Grade 5 (Death related to AE)." (NCT03378076)
Timeframe: 43 days

,
Interventionparticipants (Number)
Patients with TEAE Grade 1Patients with TEAE Grade 2Patients with TEAE Grade 3Patients with TEAE Grade 4Patients with TEAE Grade 5
FX006 32 mg61100
TAcs 40 mg32000

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Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma

"Plasma drug concentrations (pg/mL) by Time Point across FX006 and TAcs treatment arms in plasma.~For the PK analysis and individual concentration vs. time plots, a concentration that is BLOQ is assigned a value of zero if it occurs in a profile before the first measurable concentration. If a BLOQ value occurs after a measurable concentration in a profile and is followed by a value above the lower limit of quantification, then the BLOQ is treated as missing data. If a BLOQ value occurs at the end of the collection interval (after the last quantifiable concentration) it is set to zero. If two BLOQ values occur in succession after Cmax, the profile is deemed to have terminated at the first BLOQ value and any subsequent concentrations are set to zero for PK calculations" (NCT03378076)
Timeframe: 43 days

,
Interventionpg/mL (Geometric Mean)
Day 1- Hour 1Day 1 - Hour 2Day 1 - Hour 3Day 1 - Hour 4Day 1 - Hour 5Day 1 - Hour 6Day 1 - Hour 8Day 1 - Hour 10Day 1 - Hour 12Day 2 - Hour 24Day 8Day 15Day 29Day 43
FX006 32 mg1801.51893.61958.12013.81914.41900.21928.11839.81793.91948.81397.0956.2445.8265.8
TAcs 40 mg4507.95140.15443.85454.25338.95430.65199.04948.84507.84185.4450.8428.7334.6241.0

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Severity of Dermatitis

"Scoring Atopic Dermatitis (SCORAD) differences between lesions treated with Valchlor and Triamcinolone versus lesions treated with Valchlor only. SCORAD measures the extent and severity of dermatitis. The percentage of total body surface area (0-100) covered by a lesion is measured by an investigator, and this number corresponds to score A. The intensity criteria are met by scoring erythema, edema/papulation, oozing/crusting, excoriation, xerosis, and thickness on a scale of 0-3 (0=none, 1=mild, 2=Moderate, 3=Severe). These values are summed to give a total score, B. Subjective symptoms of pruritus and insomnia are then scored using visual analogue scales ranging from 0-10 (0=none, 10=worst imaginable), and the result of each is summed to give score C. The final score is then calculated by the formula A/5 + 7B/2 + C. The lowest possible score is 0, and the highest possible score is 103. A higher score indicates a worse outcome.~A lower score would be a better outcome." (NCT03380026)
Timeframe: 4 months

Interventionscore on a scale (Mean)
Valchlor 0.016% Topical Gel24.8
Valchlor Plus Triamcinolone12.7

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Efficacy of Valchlor vs Valchlor Plus Triamcinolone

Efficacy of Valchlor therapy with Triamcinolone compared to Valchlor using a composite assessment of index lesion severity (CAILS). CAILS is an objective, quantitative, method to assess the extent of skin lesions. Skin lesions and erythema will be evaluated using CAILS. A Composite Assessment will be generated for each time point by a summation of the grades for each index lesion's erythema, scaling, plaque elevation, hypopigmentation or hyperpigmentation, and area of involvement. The index lesion grade at baseline will be divided into the grade at each subsequent study visit to determine the subject's response to treatment. Any ratio of the grade obtained at the visit vs. the one obtained at baseline that is >1.0 will indicate worsening of disease. (NCT03380026)
Timeframe: 4 months

,
InterventionCAILS score (Mean)
Average CAILS score at BaselineAverage CAILS score at Month 4
Valchlor 0.016% Topical Gel8.611.4
Valchlor Plus Triamcinolone7.012.0

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Incidence of Moderate to Severe Contact Dermatitis by SCORD Scoring

Incidence of moderate to severe contact dermatitis in patients treated concurrently with Triamcinolone 0.1% ointment versus those that are not. Dermatitis will be defined as a finding of cutaneous inflammatory reaction occurring as a result of treatment. This will be assessed by the SCORD (SCORing Dermatitis) tool and may be confirmed by biopsy of the specimen. Moderate to Severe Contact dermatitis is defined as >25 by SCORD. (NCT03380026)
Timeframe: 4 months

Interventionpatients (Number)
Valchlor 0.016% Topical Gel16
Valchlor Plus Triamcinolone11

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Total Number of Treatment Emergent Adverse Events

Analyses of adverse events (AE) were performed for events considered treatment-emergent (TE). TE was defined as any AE with onset after administration of the 1st dose of study drug or any event present at baseline but worsened in intensity through the study. Severity was graded by the PI using the Common Terminology Criteria for AEs Version 4.0. Grading went from Grade 1 (Mild) to Grade 5 (Death Related to AE). (NCT03382262)
Timeframe: 12 Weeks

InterventionEvents (Number)
FX006 32 mg Shoulder10
TAcs 40 mg Shoulder7
FX006 32 mg Hip8
TAcs 40 mg Hip17

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Concentration of Triamcinolone Acetonide (TA) in Blood Plasma

"Characterize the Pharmacokinetic Profile of FX006 and TCA IR [Time Frame: Day 1 (pre-treatment,1, 2, 3, 4, 5, 6, 8,10, and 12 hrs. post-dose) and Days 2, 3, 5, 8, 15, 22, 29, 57,and 85]~For the PK analysis and individual concentration vs. time plots, a concentration that is BLOQ is assigned a value of zero if it occurs in a profile before the first measurable concentration. If a BLOQ value occurs after a measurable concentration in a profile and is followed by a value above the lower limit of quantification, then the BLOQ is treated as missing data. If a BLOQ value occurs at the end of the collection interval (after the last quantifiable concentration) it is set to zero. If two BLOQ values occur in succession after Cmax, the profile is deemed to have terminated at the first BLOQ value and any subsequent concentrations are set to zero for PK calculations" (NCT03382262)
Timeframe: 12 Weeks

,,,
Interventionpg/mL (Geometric Mean)
Day 1 - Hour 1Day 1 - Hour 2Day 1 - Hour 3Day 1 - Hour 4Day 1 - Hour 5Day 1 - Hour 6Day 1 - Hour 8Day 1 - Hour 10Day 1 - Hour 12Day 2 - Hour 24Day - 3Day - 5Day - 8Day - 15Day - 22Day - 29Day - 57Day - 85
FX006 32 mg Hip681.8752.2748.0776.1792.9743.5705.0698.2675.1791.0682.1562.4472.3382.6235.0256.3225.1112.0
FX006 32 mg Shoulder1061.81117.61140.01142.41093.81052.81016.2951.4903.8943.4903.4754.6678.1397.6268.3201.0151.8100.1
TAcs 40 mg Hip3862.34052.44519.34557.84672.64469.84102.33615.63276.23218.81723.6897.3525.3444.7331.6281.8133.192.5
TAcs 40 mg Shoulder1104.11344.81501.81594.11662.71689.61668.31506.31531.31467.01413.11038.2857.8722.7476.7418.7200131.4

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"The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating Much Improved and Very Much Improved)"

"Patient Global Impression of Change is a scale which measures participant reported satisfaction after an intervention. The outcome was measured as the percent of patients reporting a PGIC score of 6-7 (indicating much improved and very much improved)" (NCT03382821)
Timeframe: 1 month, 3 month, 6 month, and 1 year follow up

,
Interventionpercentage of participants (Number)
One monthThree monthsSix monthsOne year
Transforaminal Catheter-targeted ESI With Triamcinolone59575361
Transforaminal ESI With Dexamethasone41425557

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Neck Disability Index-5

Percentage of patients with >30% improvement in Neck Disability Index-5 score. (NCT03382821)
Timeframe: 1 month, 3 month, 6 month, and 1 year follow up

,
Interventionpercentage of participants (Number)
One monthThree monthSix monthOne year
Transforaminal Catheter-targeted ESI With Triamcinolone62585660
Transforaminal ESI With Dexamethasone48565547

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Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III

The Medication Quantification Scale (MQS) is an instrument used for clinical and research applications for quantifying medication regimen use in chronic pain populations. A 6.8 point reduction is considered equivalent to 10 morphine eqivalents. (NCT03382821)
Timeframe: 1 month, 3 month, 6 month, and 1 year follow up

,
Interventionpercentage of participants (Number)
One monthThree monthSix monthOne year
Transforaminal Catheter-targeted ESI With Triamcinolone1917198
Transforaminal ESI With Dexamethasone1620157

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The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score

The Percentage of Participants with Reduction of 50% or More of Neck and Arm Pain NRS score (NCT03382821)
Timeframe: 1 month follow up

Interventionpercentage of participants (Number)
Transforaminal ESI With Dexamethasone49.1
Interlaminar Catheter-targeted ESI With Triamcinolone68.5

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Change From Baseline in Patient Global Assessment at 39 Weeks

"Comparison of the change of the Patient Global Assessment from baseline to 39 weeks between the Cingal and Triamcinolone Hexacetonide arms (ITT population). The Patient Global Assessment is done by the subject, and answers the question Considering all the ways the osteoarthritis in your index knee bothers you, what is your assessment of how much your knee is bothering you today? The Patient Global Assessment is scored on a 0 to 100 mm visual analog scale, where a higher number means the patient is bothered to a higher degree. A negative number for the change from baseline indicates a reduction (improvement) in the assessment." (NCT03390036)
Timeframe: 39 Weeks

,,
InterventionMillimeters (mm) (Mean)
Change from Baseline in Patient Global 39 weeksBaseline Patient Global in mm39 Week Patient Global in mm
Cingal-38.657.018.4
Monovisc-38.256.017.8
Triamcinolone Hexacetonide (TH)-36.758.221.5

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Change From Baseline in WOMAC Physical Function Score at 39 Weeks

This endpoint compares the change of the WOMAC Physical Function Score from baseline to Week 39 between the Cingal and Triamcinolone Hexacetonide arms. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score is a validated visual analog scale from 0 to 100 mm, where a higher score is equal to a higher degree of functional limitation. A negative number for the change from baseline indicates improvement in physical function. (NCT03390036)
Timeframe: 39 Weeks

,,
InterventionMillimeters (mm) (Mean)
Change from Baseline WOMAC Function 39 WeeksBaseline WOMAC Function39 Week WOMAC Function
Cingal-42.560.818.4
Monovisc-43.560.817.3
Triamcinolone Hexacetonide (TH)-41.161.820.7

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Change From Baseline in WOMAC Pain Score at 39 Weeks

The change from baseline in knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score at 39 weeks post treatment comparing the Cingal group to the Triamcinolone Hexacetonide group. The WOMAC Pain Score is a validated visual analog scale from 0 to 100 mm, where a higher score is equal to a higher pain level. A negative number for the difference from baseline indicates improvement in pain. A greater negative difference from baseline indicates a better outcome. (NCT03390036)
Timeframe: 39 Weeks

,,
InterventionMillimeters (mm) (Mean)
Change from Baseline in WOMAC Pain 39 WeeksBaseline WOMAC Pain in mm39 Week WOMAC Pain in mm
Cingal-46.363.317.0
Monovisc-47.263.316.0
Triamcinolone Hexacetonide (TH)-43.663.820.1

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Change From Baseline in Total WOMAC Score at 39 Weeks

The change from baseline as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 39 weeks post treatment comparing the Cingal group to the Triamcinolone Hexacetonide group. The Total WOMAC Score is determined from the SUM of the scores from the WOMAC Pain Score, the WOMAC Stiffness Score, and the WOMAC Physical Function Score, resulting in a final range for Total Score from 0 mm to 240 mm. A higher Total WOMAC Score indicates a higher overall degree of pain, stiffness and functional limitations. A negative number for the change from baseline indicates improvement in the Total WOMAC Score. (NCT03390036)
Timeframe: 39 Weeks

,,
InterventionMillimeters (mm) (Mean)
Change from Baseline in Total WOMAC 39 WeeksBaseline Total WOMAC in mm39 Week Total WOMAC in mm
Cingal-128.4181.853.4
Monovisc-132.6183.450.8
Triamcinolone Hexacetonide (TH)-122.7183.560.8

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Change From Baseline in WOMAC Stiffness Score at 39 Weeks

The change from baseline in knee stiffness as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score at 39 weeks post treatment comparing the Cingal group to the Triamcinolone Hexacetonide group. The WOMAC Stiffness Score is a validated visual analog scale from 0 to 100 mm, where a higher score is equal to a higher degree of stiffness. A negative number for the change from baseline indicates improvement in knee stiffness. (NCT03390036)
Timeframe: 39 Weeks

,,
InterventionMillimeters (mm) (Mean)
Change from Baseline in WOMAC Stiffness 39 WeeksBaseline WOMAC Stiffness in mm39 Week WOMAC Stiffness in mm
Cingal-39.857.717.9
Monovisc-42.059.217.2
Triamcinolone Hexacetonide (TH)-38.057.919.9

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Change From Baseline in Evaluator Global Assessment at 39 Weeks

"Comparison of the change of the Evaluator Global Assessment from baseline to 39 weeks between the Cingal and Triamcinolone Hexacetonide arms (ITT population). The Evaluator Global Assessment is done by the Blinded Outcomes Assessor, and answers the question Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today? The Evaluator Global Assessment is scored on a 0 to 100 mm visual analog scale, where a higher number means the Evaluator assesses that the patient is bothered to a higher degree. A negative number for the change from baseline indicates a reduction (improvement) in the assessment." (NCT03390036)
Timeframe: 39 Weeks

,,
InterventionMillimeters (mm) (Mean)
Change from Baseline in Evaluator Global 39 eeksBaseline Evaluator Global in mm39 Week Evaluator Global in mm
Cingal-37.152.915.8
Monovisc-37.752.314.6
Triamcinolone Hexacetonide (TH)-39.156.617.4

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The Usage of Rescue Medication (Acetaminophen) at Week 39

The usage of rescue medication (number of pills of acetominophen) at Week 39 weeks post treatment in the Cingal group compared to the Triamcinolone Hexacetonide group. (NCT03390036)
Timeframe: 39 Weeks

InterventionNumber of pills (Mean)
Cingal7.9
Monovisc6.0
Triamcinolone Hexacetonide (TH)6.9

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OMERACT-OARSI Responder Rate at 39 Weeks

"The post treatment Responder Rate at 39 weeks is determined through a calculation defined by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. The OMERACT-OARSI Responder Index reports the percentage of subjects that met the criteria to be a good responder. The criteria for response are (1) improvement in pain or physical function ≥50% and an absolute change ≥20 mm; or (2) improvement of ≥20% with an absolute change ≥10 mm in at least two of the following three categories: pain, physical function, and patient's global assessment.~A higher percentage of subjects responding indicates a better outcome." (NCT03390036)
Timeframe: 39 weeks

InterventionPercentage of subjects (Number)
Cingal91.2
Monovisc92.4
Triamcinolone Hexacetonide (TH)93.2

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Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire

Total scores range: 0-36 (0= no symptoms to 36= the most severe symptoms) (NCT03463915)
Timeframe: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported

Interventionscores on a scale (Mean)
Bladder Instillation WITH Triamcinolone Acetonide-6.7
Bladder Instillation WITHOUT Triamcinolone Acetonide-5.8

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Change From Baseline in Treatment Response as Measured by the Visual Analogue Scale (VAS) for Pain

VAS is measured on marking on a 10-centimeter (cm) ruler (measured in cm, 0= no pain and 10= most severe pain possible) (NCT03463915)
Timeframe: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported

Interventionscore on a scale (Mean)
Bladder Instillation WITH Triamcinolone Acetonide-1.9
Bladder Instillation WITHOUT Triamcinolone Acetonide-1.8

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Number of Participants With at Least One Adverse Event

Adverse events will only be those determined to be related to the study drug (NCT03463915)
Timeframe: End of study (6 weeks)

InterventionParticipants (Count of Participants)
Bladder Instillation WITH Triamcinolone Acetonide1
Bladder Instillation WITHOUT Triamcinolone Acetonide5

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Pelvic Floor Distress Inventory (PFDI)

20 question self-administered questionnaire on the presence and absence of pelvic floor symptoms. Score ranges from 0 (least distress) to 300 (most distress). (NCT03463915)
Timeframe: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported

Interventionscore on a scale (Mean)
Bladder Instillation WITH Triamcinolone Acetonide-5.3
Bladder Instillation WITHOUT Triamcinolone Acetonide-6.4

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Pelvic Pain and Urgency/Frequency (PUF) Questionnaire

Total scores range: 0-35 (0= no symptoms to 35= the most severe symptoms) (NCT03463915)
Timeframe: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported

Interventionscore on a scale (Mean)
Bladder Instillation WITH Triamcinolone Acetonide-5.3
Bladder Instillation WITHOUT Triamcinolone Acetonide-2.7

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Sexual Function Measured by the Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) Questionnaire

Measures sexual function in women with pelvic floor disorders. Queries about arousal, orgasm, partner-related issues, sexual quality, and desire. The tool also takes into account those who are not sexually active. The questionnaire was used in the study solely to determine if patients had improved dyspareunia (as a categorical variable). (NCT03463915)
Timeframe: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported

Interventionparticipants (Number)
Bladder Instillation WITH Triamcinolone Acetonide4
Bladder Instillation WITHOUT Triamcinolone Acetonide4

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Overactive Bladder Questionnaire (OAB-q)

Total scores range: 0-100 (higher scores on the symptom-severity scale suggestive of greater severity of symptoms and higher scores on the quality-of-life scale suggestive of better quality of life) (NCT03463915)
Timeframe: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported

Interventionscore on a scale (Mean)
Bladder Instillation WITH Triamcinolone Acetonide-24.2
Bladder Instillation WITHOUT Triamcinolone Acetonide-18.8

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Patient's Assessment of Response to Treatment

Patient's global assessment of response to treatment (Likert), options are None, Poor, Acceptable, Good, Excellent (NCT03636373)
Timeframe: Day 4, 7 and 14

InterventionParticipants (Count of Participants)
Visit 2 (Day 4)72266691Visit 2 (Day 4)72266690Visit 3 (Day 7)72266690Visit 3 (Day 7)72266691Visit 4 (Day 14)72266691Visit 4 (Day 14)72266690
NoneAcceptableGoodExcellentPoor
Etanercept1
Triamcinolone Acetonide0
Etanercept0
Triamcinolone Acetonide2
Triamcinolone Acetonide1

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Physician's Assessment of Response to Treatment

Physician's global assessment of response to treatment None, Poor, Acceptable, Good, Excellent (NCT03636373)
Timeframe: Post-dose days 4, 7 and 14

InterventionParticipants (Count of Participants)
Visit 2 (Day 4)72266692Visit 2 (Day 4)72266693Visit 3 (Day 7)72266693Visit 3 (Day 7)72266692Visit 4 (Day 14)72266692Visit 4 (Day 14)72266693
NonePoorAcceptableGoodExcellent
Triamcinolone Acetonide0
Etanercept1
Etanercept0
Triamcinolone Acetonide1
Etanercept2
Triamcinolone Acetonide2

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Joint Pain on Numeric Pain Scale

Patient's assessment of joint pain intensity in the most affected baseline joint on a numeric 0-10 Visual Analog Scale at Baseline and post-dose Days with 0 indicating no pain and 10 indicating intense pain. Higher score indicating a worse outcome. (NCT03636373)
Timeframe: Baseline, Days 4, 7, and 14

,
Interventionscore on a scale (Mean)
Visit 1 (Baseline)Visit 2 (Day 4)Visit 3 (Day 7)Visit 4 (Day 14)
Etanercept7.67530.5
Triamcinolone Acetonide61.511

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Joint Pain Intensity in the Most Affected Joint

Pain intensity in the most affected baseline joint measured by the numeric 0-10 Visual Analog Scale at 72 hours with 0 indicating no pain and 10 indicating intense pain. Higher score indicating a worse outcome. (NCT03636373)
Timeframe: 72 hours

Interventionscore on a scale (Mean)
Etanercept5
Triamcinolone Acetonide1.5

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Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle

The local tolerability of the creams will be assesed using a predefined scale: 0 = No reaction; 0.5 = Only slight erythema; 1 = Only erythema; 2 = Erythema with papules or oedema; 3 = Erythema, oedema with papules, oedema with vesicle; 4 = Blisters (NCT03758365)
Timeframe: Day 2

InterventionParticipants (Count of Participants)
MC2-01 Cream72211385Clobetasol Propionate 0.05% Lotion72211385Betamethasone Dipropionate 0.05% Cream72211385Triamcinolone Acetonide 0.1% Cream72211385Hydrocortisone Butyrate 0.1% Cream72211385Desonide 0.05% Cream72211385Vehicle Cream72211385
Erythema with papules or oedemaNo reactionOnly Slight reactionOnly erythemaErythema, oedema with papules, oedema with vesicleBlisters
MC2-01 Cream + Comparators0
MC2-01 Cream + Comparators36

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Comparison of the Vasoconstriction Potential (Skin Blanching Effect) of the MC2-01 Cream With Active Comparators and Vehicle

Blanching of the skin will be assessed individually by two trained observers blinded to treatment. The observers will score the blanching of the skin from 0-4 (0 = No change in color skin; 1 = Slight (barely visible) blanching; 3 = Obvious blanching; 4 = Blanching judged to be maximal). The results is presented as Mean ± SD. (NCT03758365)
Timeframe: Day 2

Interventionscore on a scale (Mean)
MC2-01 CreamClobetasol Propionate 0.05% LotionBetamethasone Dipropionate 0.05% CreamTriamcinolone Acetonide 0.1% CreamHydrocortisone Butyrate 0.1% CreamDesonide 0.05% CreamVehicle Cream
MC2-01 Cream + Comparators1.663.052.451.922.062.110.14

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Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study

To establish acceptability of this treatment approach assessing proportion of patients who are eligible, consent and complete the 48 week study. We will examine how many patients in the MONITOR cohort are eligible per year. All eligible patients in the MONITOR cohort will be approached and invited to join the study. We will then review how many patients complete the 48 week study period attending all visits from baseline to 48 weeks (0, 12, 24, 36 and 48). (NCT03797872)
Timeframe: 48 weeks

InterventionParticipants (Count of Participants)
Standard Care0

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30 Second Chair Standing Test

The 30 second Chair Standing Test is one of three Osteoarthritis Research Society International (OARSI) recommended minimal core set of performance-based outcome measures in OA research and clinical practice.In this test, the subject will stand up completely from the sitting position so hips and knees are fully extended, then completely back in the seated position. This will be repeated for 30 seconds and the total number of chair stands will be recorded (up and down equals one stand). (NCT03895840)
Timeframe: 12 weeks

Interventionstands (Least Squares Mean)
Intra-articular Zilretta Injection9.5

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KOOS-PS (Knee Osteoarthritis Outcome Score - Physical Function Short Form)

KOOS-Physical Function (KOOS-PS) Short Form is a parsimonious measure of physical function derived from the KOOS, which is a self-reported outcome score. The KOOS-Physical Function Short Form ranges from 0 to 100 where higher values represents a worse outcome. (NCT03895840)
Timeframe: 12 weeks

Interventionscore on a scale (Least Squares Mean)
Intra-articular Zilretta Injection70.0

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KOOS-QoL (Knee Osteoarthritis Outcome Score - Quality of Life)

KOOS-QoL a self-reported measure consisting of 4 questions assessing quality of life, which is part of the five patient-relevant subscales of KOOS.The sub scale ranges from 0 to 100 where higher values represents a better outcome (NCT03895840)
Timeframe: 12 weeks

Interventionscore on a scale (Least Squares Mean)
Intra-articular Zilretta Injection51.9

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NRS for Pain

The Numeric Rating Scale for Pain (NRS for Pain) is a measure of pain intensity. The subject will rate their knee pain bilaterally on a scale from no pain (0) to worst pain imaginable (10). (NCT03895840)
Timeframe: 12 weeks

Interventionunits on a scale (Least Squares Mean)
Intra-articular Zilretta Injection3.3

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Timed Stair Climb

The stair climb test is one of the three Osteoarthritis Research Society International recommended minimal core set of performance-based outcome measures in OA research and clinical practice. The subject will be timed while ascending and descending 9 steps of stairs. (NCT03895840)
Timeframe: 12 weeks

Interventionseconds (Least Squares Mean)
Intra-articular Zilretta Injection15.0

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40m Fast Paced Walking Test (40m FPWT)

The 40-meter fast paced walk test is one of the three Osteoarthritis Research Society International recommended minimal core set of performance-based outcome measures in OA research and clinical practice.The subjects will be timed to complete a 40 m track course. (NCT03895840)
Timeframe: 12 weeks

Interventionseconds (Least Squares Mean)
Intra-articular Zilretta Injection35.9

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Visual Analog Scale

Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain. (NCT04115644)
Timeframe: Week 6

Interventionscore on a scale (Mean)
Group 1 (Control)3.357
Group 2 (Ketorolac)2.757
Group 3 (Kenalog)2.687

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Visual Analog Scale

Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain. (NCT04115644)
Timeframe: Week 4

Interventionscore on a scale (Mean)
Group 1 (Control)3.547
Group 2 (Ketorolac)2.67
Group 3 (Kenalog)2.317

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Visual Analog Scale

Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain. (NCT04115644)
Timeframe: Week 2

Interventionscore on a scale (Mean)
Group 1 (Control)3.547
Group 2 (Ketorolac)2.67
Group 3 (Kenalog)2.57

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Visual Analog Scale

Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain. (NCT04115644)
Timeframe: Week 12

Interventionscore on a scale (Mean)
Group 1 (Control)3.447
Group 2 (Ketorolac)1.417
Group 3 (Kenalog)2.027

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Visual Analog Scale

Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain. (NCT04115644)
Timeframe: Week 1

Interventionscore on a scale (Mean)
Group 1 (Control)3.397
Group 2 (Ketorolac)3.7
Group 3 (Kenalog)3.257

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Visual Analog Scale

Pain as measured by the Visual Analog Scale prior to first injection. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain. (NCT04115644)
Timeframe: Baseline - pre-injection

Interventionscore on a scale (Mean)
Group 1 (Control)5.77
Group 2 (Ketorolac)4.57
Group 3 (Kenalog)4.67

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Visual Analog Scale

Pain as measured by the Visual Analog Scale after first injection. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain. (NCT04115644)
Timeframe: Baseline - immediately after the injection

Interventionscore on a scale (Mean)
Group 1 (Control)3.197
Group 2 (Ketorolac)3.577
Group 3 (Kenalog)3.677

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Visual Analog Scale

Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain. (NCT04115644)
Timeframe: Day 2

Interventionscore on a scale (Mean)
Group 1 (Control)2.347
Group 2 (Ketorolac)2.837
Group 3 (Kenalog)2.67

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Visual Analogue Scale

pain scale - high is bad - low is good 0-100 (NCT04216017)
Timeframe: 24 weeks

Interventionunits on a scale (Mean)
Controls4
Cases1

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American Shoulder Elbow Society Score

Outcome Instrument high is good low is bad 0-100 The ASES is a condition-specific scale that is intended to measure functional limitations and pain of the shoulder. (NCT04216017)
Timeframe: 24 weeks

Interventionscore on a scale (Mean)
Controls46
Cases87

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Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score

"The change from Baseline in overall clinical improvement in the knee post-treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score comparing the Cingal, TH, and Placebo arms. WOMAC Total Score combines the three 0-to-100 point scores from the WOMAC Pain Score, the WOMAC Stiffness Score, and the WOMAC Function Score to calculate a TOTAL Score from 0 = No Symptoms to 100 = Highest Degrees of Pain, Stiffness and Functional Limitation Symptoms.~A negative value for the change from Baseline in WOMAC Total Score indicates reduction in pain, stiffness, and improved function. A larger negative value indicates a better overall clinical outcome." (NCT04231318)
Timeframe: 26 Weeks

Interventionscore on a scale (Mean)
Cingal-41.4
Triamcinolone Hexacetonide (TH)-37.3
Placebo-35.6

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The Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index

"The post-treatment responder rate is determined through a calculation defined by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. The OMERACT-OARSI Responder Index reports the percentage of subjects that met the criteria to be a good responder to treatment. The criteria for response are (1) improvement in pain or physical function >50% and an absolute change >20 mm; or (2) improvement of >20% with an absolute change >10 mm in at least of the following three categories: pain, physical function, and patient's global assessment.~A higher percentage of subjects responding indicates a better outcome.~OMERACT-OARSI responder rates were compared between the Cingal, TH and Placebo arms." (NCT04231318)
Timeframe: 26 Weeks

Interventionpercentage of participants (Number)
Cingal89.9
Triamcinolone Hexacetonide (TH)80.8
Placebo78.8

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The Usage of Rescue Medication (Acetaminophen/Paracetamol) at 26 Weeks

"The usage of Rescue Medication (RM) as based on the average number of acetominophen/paracetamol pills taken among participants at 26 Weeks post treatment comparing between the Cingal, Triamcinolone Hexacetonide (TH) and Placebo arms.~A smaller value in average RM indicates that fewer pills were taken by the participants, which may correlate to a better clinical outcome in terms of pain." (NCT04231318)
Timeframe: 26 Weeks

InterventionPills (Mean)
Cingal8.5
Triamcinolone Hexacetonide (TH)14.2
Placebo19.1

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Change From Baseline in Knee Pain as Measured by Numerical Rating Scale (NRS) Pain Score

Change in knee pain was obtained from participant responses using a Numerical Rating Scale (NRS) Pain Score. This NRS Pain Score ranged from 0 = No Pain to 10 = Highest Pain Level. A negative value for the change in Pain Score indicates less pain post-treatment. A larger negative value indicates a higher level of improvement, and a better outcome. (NCT04231318)
Timeframe: 26 Weeks

Interventionscore on a scale (Mean)
Cingal-3.5
Triamcinolone Hexacetonide (TH)-3.3
Placebo-2.3

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Change From Baseline in the Evaluator Global Assessment (EGA) Score

"The change from Baseline in knee pain post-treatment as measured by the Evaluator Global Assessment (EGA) Score comparing the Cingal, TH, and Placebo arms. EGA Score records the Study Evaluator's assessment of how much the patient's STUDY (treated) knee is bothering them today . The EGA Score is a validated 100 mm visual analog scale (VAS) from 0 mm = No Pain to 100 mm = Extreme Pain.~A negative value for the change from Baseline indicates improvement in EGA Score. A larger negative value indicates less pain, and a better clinical outcome." (NCT04231318)
Timeframe: 26 Weeks

Interventionscore on a scale (Mean)
Cingal-40.1
Triamcinolone Hexacetonide (TH)-33.3
Placebo-32.6

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Change From Baseline in the Patient Global Assessment (PGA) Score

"The change from Baseline in knee pain post-treatment as measured by the Patient Global Assessment (PGA) Score comparing the Cingal, TH, and Placebo arms. PGA Score records participant responses to their assessment of how much their STUDY (treated) knee is bothering them today . The PGA Score is a validated 100 mm visual analog scale (VAS) from 0 mm = No Pain to 100 mm = Extreme Pain.~A negative value for the change from Baseline indicates improvement in PGA Score. A larger negative value indicates less pain, and a better clinical outcome." (NCT04231318)
Timeframe: 26 Weeks

Interventionscore on a scale (Mean)
Cingal-42.3
Triamcinolone Hexacetonide (TH)-37.6
Placebo-34.0

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Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score

The change from Baseline in knee pain post-treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal arm to the TH arm, the Cingal arm to the Placebo arm, and the TH arm to the Placebo arm. WOMAC Pain is a validated 100 mm visual analog scale (VAS) from 0 mm = No Pain to 100 mm = Highest Pain Level. A negative value for the change from Baseline indicates improvement in the WOMAC Pain Score, i.e. less pain post-treatment. A larger negative value indicates lower pain levels and a better outcome. (NCT04231318)
Timeframe: 26 Weeks

Interventionscore on a scale (Mean)
Cingal-44.3
Triamcinolone Hexacetonide (TH)-37.5
Placebo-36.1

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Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Score

The change from Baseline in knee function post-treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Score comparing the Cingal, TH, and Placebo arms. WOMAC Function Score records participant responses regarding the difficulty they have performing daily activities. The WOMAC Function Score is a validated 100 mm visual analog scale (VAS) from 0 mm = No Difficulty to 100 mm = Extreme Difficulty. A negative value for the change from Baseline indicates improvement in WOMAC Function Score. A larger negative value indicates improvement in performing daily activities, and a better outcome. (NCT04231318)
Timeframe: 26 Weeks

Interventionscore on a scale (Mean)
Cingal-40.8
Triamcinolone Hexacetonide (TH)-37.5
Placebo-35.2

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Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score

The change from Baseline in knee pain post-treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal arm to the TH arm, the Cingal arm to the Placebo arm, and the TH arm to the Placebo arm. WOMAC Pain is a validated 100 mm visual analog scale (VAS) from 0 mm = No Pain to 100 mm = Highest Pain Level. A negative number for the change from Baseline indicates improvement in the WOMAC Pain Score, i.e. less pain post-treatment. (NCT04231318)
Timeframe: 12 Weeks

Interventionscore on a scale (Mean)
Cingal-44.1
Triamcinolone Hexacetonide (TH)-38.9
Placebo-37.4

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Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score

The change from Baseline in knee pain post-treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal arm to the TH arm, the Cingal arm to the Placebo arm, and the TH arm to the Placebo arm. WOMAC Pain is a validated 100 mm visual analog scale (VAS) from 0 mm = No Pain to 100 mm = Highest Pain Level. A negative number for the change from Baseline indicates improvement in the WOMAC Pain Score, i.e. less pain post-treatment. (NCT04231318)
Timeframe: 1 Week

Interventionscore on a scale (Mean)
Cingal-40.9
Triamcinolone Hexacetonide (TH)-35.6
Placebo-24.8

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Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score

The change from Baseline in knee pain post-treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal arm to the TH arm, the Cingal arm to the Placebo arm, and the TH arm to the Placebo arm. WOMAC Pain is a validated 100 mm visual analog scale (VAS) from 0 mm = No Pain to 100 mm = Highest Pain Level. A negative number for the change from Baseline indicates improvement in the WOMAC Pain Score, i.e. less pain post-treatment. (NCT04231318)
Timeframe: 18 Weeks

Interventionscore on a scale (Mean)
CINGAL-44.5
Triamcinolone Hexacetonide (TH)-40.2
Placebo-36.7

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Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score

The change from Baseline in knee pain post-treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal arm to the TH arm, the Cingal arm to the Placebo arm, and the TH arm to the Placebo arm. WOMAC Pain is a validated 100 mm visual analog scale (VAS) from 0 mm = No Pain to 100 mm = Highest Pain Level. A negative number for the change from Baseline indicates improvement in the WOMAC Pain Score, i.e. less pain post-treatment. (NCT04231318)
Timeframe: 3 Weeks

Interventionscore on a scale (Mean)
Cingal-45.1
Triamcinolone Hexacetonide (TH)-37.7
Placebo-34.0

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Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score

The change from Baseline in knee pain post-treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal arm to the TH arm, the Cingal arm to the Placebo arm, and the TH arm to the Placebo arm. WOMAC Pain is a validated 100 mm visual analog scale (VAS) from 0 mm = No Pain to 100 mm = Highest Pain Level. A negative number for the change from Baseline indicates improvement in the WOMAC Pain Score, i.e. less pain post-treatment. (NCT04231318)
Timeframe: 6 Weeks

Interventionscore on a scale (Mean)
Cingal-46.0
Triamcinolone Hexacetonide (TH)-40.4
Placebo-36.2

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Change From Baseline in Knee Pain as Measured by Visual Analog Scale (VAS) Pain Score

Change in knee pain was obtained from participant responses using a 100 mm Visual Analog Scale (VAS) Pain Score at each time point. This VAS scale ranged from 0 mm = No Pain to 100 mm = Highest Pain Level. A negative value for the change in pain indicates less pain post-treatment. A larger negative value indicates a higher level of improvement, and a better outcome. (NCT04231318)
Timeframe: 26 Weeks

Interventionscore on a scale (Mean)
Cingal-35.1
Triamcinolone Hexacetonide (TH)-31.9
Placebo-27.1

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Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Stiffness Score

The change from Baseline in knee stiffness post-treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score comparing the Cingal, TH, and Placebo arms. WOMAC Stiffness Score records participant responses regarding the sensation of ease in moving their joint. The WOMAC Stiffness Score is a validated 100 mm visual analog scale (VAS) from 0 mm = No Stiffness to 100 mm = Extreme Stiffness. A negative value for the change from Baseline indicates improvement in WOMAC Stiffness Score. A larger negative value indicates less stiffness, and a better outcome. (NCT04231318)
Timeframe: 26 Weeks

Interventionscore on a scale (Mean)
Cingal-39.4
Triamcinolone Hexacetonide (TH)-34.6
Placebo-32.1

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Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.

"Evaluate the morphologic changes in participant's skin from baseline, specifically assessing~Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris~Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.~Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules." (NCT04582669)
Timeframe: Day 6

InterventionParticipants (Count of Participants)
Sodium Chloride 0.9%0
Intralesional Triamcinolone 10 mg/mL0
Intralesional Triamcinolone 20 mg/mL0
Intralesional Triamcinolone 40 mg/mL0

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Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.

"Evaluate the morphologic changes in participant's skin from baseline, specifically assessing~Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris~Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.~Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules." (NCT04582669)
Timeframe: Day 2

InterventionParticipants (Count of Participants)
Sodium Chloride 0.9%0
Intralesional Triamcinolone 10 mg/mL0
Intralesional Triamcinolone 20 mg/mL0
Intralesional Triamcinolone 40 mg/mL0

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Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.

"Evaluate the morphologic changes in participant's skin from baseline, specifically assessing~Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris~Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.~Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules." (NCT04582669)
Timeframe: Day 14

InterventionParticipants (Count of Participants)
Sodium Chloride 0.9%0
Intralesional Triamcinolone 10 mg/mL0
Intralesional Triamcinolone 20 mg/mL0
Intralesional Triamcinolone 40 mg/mL0

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Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.

"Evaluate the morphologic changes in participant's skin from baseline, specifically assessing~Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris~Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.~Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules." (NCT04582669)
Timeframe: Baseline

InterventionParticipants (Count of Participants)
Sodium Chloride 0.9%0
Intralesional Triamcinolone 10 mg/mL0
Intralesional Triamcinolone 20 mg/mL0
Intralesional Triamcinolone 40 mg/mL0

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Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.

"Evaluate the morphologic changes in participant's skin from baseline, specifically assessing~Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris~Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.~Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules." (NCT04582669)
Timeframe: Day 28

InterventionParticipants (Count of Participants)
Sodium Chloride 0.9%0
Intralesional Triamcinolone 10 mg/mL0
Intralesional Triamcinolone 20 mg/mL0
Intralesional Triamcinolone 40 mg/mL0

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Incidence of a Flare Reaction

A flare reaction was defined as an increase of two or more points of Visual Analog Score (VAS) score during the first week following injection. The VAS is a patient reported pain score from zero to ten where zero is no pain and ten is the most pain. (NCT05438277)
Timeframe: Post-injection day 1 through 7

,
InterventionPerson-visits (Count of Units)
Flare reaction (Yes)Flare reaction (No)Unknown
Methylprednisolone Acetate (MPA)4414916
Triamcinolone Acetonide (TA)819128

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