Page last updated: 2024-11-05

erythromycin stearate

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Erythromycin stearate is an ester derivative of the macrolide antibiotic erythromycin. It is synthesized by reacting erythromycin with stearic acid. The stearate salt increases the drug's stability and absorption in the gastrointestinal tract, making it more suitable for oral administration. Erythromycin stearate is effective against a wide range of gram-positive and some gram-negative bacteria. It acts by inhibiting protein synthesis in bacteria. It has been used for treating a variety of infections, including pneumonia, pharyngitis, and skin infections. Erythromycin stearate is studied for its potential applications in treating bacterial infections and its potential for developing new antibiotics with improved properties. Due to its low cost and effectiveness, it is a crucial component of the antibiotic arsenal for treating bacterial infections. Its mechanism of action and its potential to be modified to overcome antibiotic resistance are the main reasons for studying it.'

Cross-References

ID SourceID
PubMed CID12559
CHEMBL ID1200510
CHEBI ID34742
MeSH IDM0057778

Synonyms (77)

Synonym
wyamycin s
bristamycin
ethril 250
meberyt
erythromycin, stearate (salt)
erythromycin octadecanoate (salt)
gallimycin
pfizer-e
erythrocin stearate
dowmycin e
ccris 1504
abboticine
ethril 500
einecs 211-396-1
qidmycin
erypar
erythromycin stearate (salt)
hsdb 4178
ethril
eratrex
oe 7
erythromycin steraric acid salt
nci-c55674
erythromycin stearate
NCGC00180891-01
D02184
erythromycin stearate (jp17/usp)
bristamycin (tn)
nsc-756747
CHEMBL1200510
erythromycini stearas
sk-erythromycin
HMS501D19
HMS3264B08
nsc756747
pharmakon1600-01500281
CCG-39117
unii-lxw024x05m
erythromycin stearate [usp:ban:jan]
lxw024x05m ,
nsc 756747
erythromycin stearate [who-dd]
erythromycin stearate [jan]
erythromycin stearate [vandf]
erythromycin stearate [hsdb]
erythromycin stearate [mi]
erythromycini stearas [who-ip latin]
erythromycin stearate [who-ip]
erythromycin stearate [usp monograph]
erythromycin stearate [orange book]
erythromycin stearate [usp impurity]
erythromycin stearate [usp-rs]
erythromycin stearate [mart.]
erythromycin stearate, antibiotic for culture media use only
W-104851
erythromycin, octadecanoate (salt)
SR-01000872741-1
sr-01000872741
HY-108875
CHEBI:34742
SBI-0207065.P001
mfcd00084690
erythromycin stearate/ >550ug/mg
Q27283244
erythromycin stearate for impurity s identification
CS-0031206
AT37747
erythromycin stearate (usp monograph)
octadecanoic acid, compound with erythromycin (1:1)
erythromycin stearate (usp-rs)
stearic acid, compound with erythromycin (1:1)
(2r,3s,4s,5r,6r,8r,10r,11r,12s,13r)-5-(3,4,6-trideoxy-3-dimethylamino-beta-d-xylo-hexopyranosyloxy)-3-(2,6-dideoxy-3-c-methyl-3-o-methyl-alpha-l-ribo-hexopyranosyloxy)-6,11,12-trihydroxy-2,4,6,8,10,12-hexamethyl-9-oxopentadecan-13-olide monostearate
erythromycin stearate (usp impurity)
erythromycin stearic acid salt
erythromycin stearate (mart.)
erythromycin stearate (usp:ban:jan)
dtxcid20571

Research Excerpts

Overview

Erythromycin stearate is an acid labile antibiotic. Fear and apprehension, which are known to affect gastric motility, may produce erratic absorption resulting in lower serum levels.

ExcerptReferenceRelevance
"Erythromycin stearate is an acid labile antibiotic, therefore fear and apprehension, which are known to affect gastric motility, may produce erratic absorption resulting in lower serum levels. "( Dental anxiety and the absorption of orally administered erythromycin stearate.
Coffey, A; Coulter, WA; Linden, GJ; McGimpsey, JG; Strawbridge, J, 1995
)
1.98

Toxicity

ExcerptReferenceRelevance
" The enteric-coated tablet was associated with a higher incidence of individual adverse reactions; more patients discontinued it because of adverse GI effects."( Gastrointestinal side effects with erythromycin preparations.
Carter, BL; Cole, KJ; Milavetz, G; Woodhead, JC, 1987
)
0.27
"This epidemiologic study surveyed pet owners for observations of adverse reactions to oral antibacterials which were prescribed to outpatients at a university teaching hospital."( Adverse side effects of oral antibacterial therapy in dogs and cats: an epidemiologic study of pet owners' observations.
Keisling, K; Kunkle, GA; Sundlof, S,
)
0.13

Pharmacokinetics

ExcerptReferenceRelevance
" Based on the pharmacokinetic profiles, it is suggested that 1,200,000 IU benzathine penicillin G given every 4 weeks is an appropriate regimen for preventing the recurrence of rheumatic fever in Thai adults."( Pharmacokinetics of rheumatic fever prophylaxis regimens.
Kobwanthanakun, S; Lertluknithi, R; Pruksachatvuthi, S; Thamlikitkul, V, 1992
)
0.28

Bioavailability

ExcerptReferenceRelevance
" Hence EA has a good bioavailability essential for treatment and prophylaxis of bacterial infections in dentistry."( Penetration of erythromycin into periapical lesions after repeated doses of erythromycin acistrate and erythromycin stearate: a pilot study.
Gordin, A; Kokkonen, P; Lehtinen, R; Peltola, J; Pohto, P; Tuominen, RK; Wikberg, R, 1991
)
0.5
" The bioavailability of EA was slightly inferior to that of ES."( Efficacy of erythromycin acistrate (2'-acetyl erythromycin stearate) and erythromycin stearate in experimental infections in mice.
Hanhijärvi, H; Havas, A; Komulainen, H; Männistö, PT; Rauramaa, V; Vuorela, A, 1989
)
0.54
" EPAC showed a better bioavailability than ES with longer-lasting serum levels of active antibiotic."( Human pharmacokinetics of erythromycin propionate-N-acetylcysteinate: comparative evaluation with erythromycin stearate and N-acetylcysteine.
De Bernardi, M; Feletti, F; Fregnan, GB; Gazzani, G, 1988
)
0.49
"As a part of the quality control of drugs The National Medicine Control Laboratory in Finland has started comparative bioavailability studies of synonym preparations in human volunteers by taking all the products containing the same active ingredients for absorption studies at the same time."( The value of comparative bioavailability studies of marketed drugs in drug control. An example with erythromycin stearate.
Konno, K; Palva, ES; Stenfors, E; Venho, VM, 1987
)
0.49
"2 h), the extent of gastrointestinal absorption and bioavailability of erythromycin is apparently greater for the base pellets than for the stearate and ethylsuccinate formulations."( Relative bioavailability of enteric coated pellets, stearate and ethylsuccinate formulations of erythromycin.
De Schepper, PJ; Josefsson, K; Mullie, A; Tjandramaga, TB; Van Hecken, A; Verbesselt, R; Verbist, L, 1984
)
0.27
" The bioavailability of erythromycin stearate in tablet form and of erythromycin base in the form of enteric-coated pellets thus appears comparable when taken on an empty stomach."( Absorption of erythromycin stearate and enteric-coated erythromycin base after a single oral dose immediately before breakfast.
Digranes, A; Schreiner, A,
)
0.8
" In contrast, when a commercially available film-coated preparation of erythromycin base was evaluated in multidose fashion between meals (fasting), the drug was about 25% less well absorbed than commercially available enteric-coated base tablets."( Influence of study design in assessing food effects on absorption of erythromycin base and erythromycin stearate.
Chodos, DJ; DiSanto, AR, 1981
)
0.48
" The ratio of the in vivo dissolution rate, the in vivo decomposition rate and the absorption rate between CAM and EMS were well correlated to the ratio of the in vitro intrinsic dissolution rate, the decomposition rate in the acidic solution, and partition coefficient, respectively."( Comparative study of pharmacokinetic parameters between clarithromycin and erythromycin stearate in relation to their physicochemical properties.
Ishii, K; Itai, S; Nagai, T; Nemoto, M; Saito, Y; Takayama, K, 1998
)
0.53

Dosage Studied

ExcerptRelevanceReference
"The effects of a new fluorinated macrolide (P-0501A) on drug metabolizing enzymes of rat liver were compared with three erythromycins--the base, the stearate and the estolate--after 7 days of dosing (1."( Effects of a new fluorinated macrolide (P-0501A) and other erythromycins on drug metabolizing enzymes in rat liver.
Bartosek, I; Casacci, F; Corti, F; De Marchi, F; Guaitani, A; Pacei, E; Villa, P, 1986
)
0.27
" The dosage of EA was 400 mg tid and that of ES 500 mg tid."( Efficacy and tolerability of erythromycin acistrate and erythromycin stearate in acute skin infections of patients with atopic eczema.
Antikainen, R; Brandt, H; Gordin, A; Salo, OP, 1988
)
0.52
" The dosage of EA was 400 mg tid and that of ES 500 mg tid."( Erythromycin acistrate and erythromycin stearate in the treatment of non-gonococcal urethritis.
Antikainen, R; Gordin, A; Rostila, T; Visa, K, 1988
)
0.57
"Concentrations of erythromycin and 2'-acetyl erythromycin were analysed in serum or plasma and tonsil tissue after repeated dosage of erythromycin acistrate (EA), a new erythromycin prodrug, in two separate studies in 61 young patients."( Tonsillar penetration of erythromycin and its 2'-acetyl ester in patients with chronic tonsillitis.
Antikainen, R; Gordin, A; Haataja, H; Männistö, PT; Savolainen, S; Tuominen, RK; Ylikoski, J, 1988
)
0.27
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (1)

ClassDescription
aminoglycoside
[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]

Bioassays (6)

Assay IDTitleYearJournalArticle
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.
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.
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.
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.
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.
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.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (93)

TimeframeStudies, This Drug (%)All Drugs %
pre-199061 (65.59)18.7374
1990's20 (21.51)18.2507
2000's4 (4.30)29.6817
2010's7 (7.53)24.3611
2020's1 (1.08)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 65.60

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 Index65.60 (24.57)
Research Supply Index4.88 (2.92)
Research Growth Index4.44 (4.65)
Search Engine Demand Index110.28 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (65.60)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials27 (25.96%)5.53%
Reviews3 (2.88%)6.00%
Case Studies10 (9.62%)4.05%
Observational0 (0.00%)0.25%
Other64 (61.54%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (72)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Methylnaltrexone vs Erythromycin for Facilitating Gastric Emptying Time in Critically Ill Patients Intolerant to Enteral Feeding [NCT01117376]Phase 242 participants (Anticipated)Interventional2010-05-31Terminated(stopped due to The study was prematurely terminated because of unavailibility of Methylnaltrexone in the region)
A Phase 1, Open-Label, Randomized, Cross-Over Study to Evaluate the Effects of Multiple Doses of Erythromycin on the Pharmacokinetics of a Single Dose of Pregabalin Controlled Release in Healthy Subjects [NCT01342198]Phase 118 participants (Actual)Interventional2011-06-30Completed
Investigating Anti-inflammatory Effects of Topical Antibiotics in an LPS Skin Challenge Model [NCT03779360]32 participants (Actual)Interventional2018-10-12Completed
To Determine the Role of Prokinetics in Feed Intolerance in Critically Ill Cirrhosis- A Randomized Placebo Controlled Study [NCT02528760]83 participants (Actual)Interventional2015-09-24Completed
Erythromycin Versus Neomycin Treatment for Overt Hepatic Encephalopathy: a Double-blind, Randomised, Controlled Trial. [NCT01097811]20 participants (Actual)Interventional2008-06-30Active, not recruiting
A Randomized, Placebo-controlled, Evaluator-blinded, Study to Assess the Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Patients With Inflammatory Facial Acne [NCT03883269]Phase 430 participants (Anticipated)Interventional2018-03-20Recruiting
Selections of Subjects With Dramatic Changes in Their Cardiac Repolarization Parameters After a Pharmacologic Stimulus Aiming to Collect Their Skin Biopsy and Blood Cells [NCT01338441]Phase 1130 participants (Anticipated)Interventional2011-03-31Completed
Treatment of Dowling Maera Type of Epidermolysis Bullosa Simplex by Oral Erythromycin [NCT01340235]Phase 38 participants (Anticipated)Interventional2011-06-30Recruiting
The Efficacy and Safety Study of Medical Thoracoscope Cryotherapy Combined With Standard First-line Treatment of Advanced Non-small Cell Lung Cancer and Malignant Pleural Effusion: a Multicenter, Prospective, Randomized, Controlled Clinical Trial [NCT05291403]141 participants (Anticipated)Interventional2022-04-06Recruiting
A Drug-drug Interaction Study of Ibrutinib With Moderate and Strong CYP3A Inhibitors in Patients With B-cell Malignancy [NCT02381080]Phase 126 participants (Actual)Interventional2015-05-19Completed
Assessing the Effectiveness of Integrative Treatment That Combines Interior and Exterior Treatment Plans in Pediatric Pneumonia: a Program by the Special Scientific Research Fund of Public Welfare Profession of China [NCT02362906]1,500 participants (Anticipated)Interventional2014-04-30Recruiting
Erythromycin Treatment for Readthrough of APC Gene Stop Codon Mutation in Familial Adenomatous Polyposis-protocol is Identical to Study No. 0519-10-TLV- Minors' Adjusted Version [NCT02354560]Phase 415 participants (Anticipated)Interventional2015-06-30Not yet recruiting
Pilot Study for Use of Prokinetics in Early Enteral Feeding of Preterm Infants ; Double Blind; Cross Over Study Comparing Eryththromycin, Metoclopramide and Placebo [NCT01569633]0 participants (Actual)Interventional2011-10-31Withdrawn(stopped due to very poor enrollment)
An Open-label, Parallel Group, Multiple-dose Investigation of the Pharmacokinetics of Tipranavir Soft Elastic Capsules SEDDS and Ritonavir Soft Gel Capsules and Their Effects on Cytochrome P-450 (3A4) Activity in Normal Healthy Volunteers [NCT02251132]Phase 1113 participants (Actual)Interventional2000-10-31Completed
Prospective Randomized Study to Compare Clinical Outcomes in Patients With Osteomyelitis Treated With Intravenous Antibiotics Versus Intravenous Antibiotics With an Early Switch to Oral Antibiotics [NCT02099240]Early Phase 111 participants (Actual)Interventional2014-03-06Terminated(stopped due to Not enough patient enrollment and lack of staffing)
Erythromycin as a Novel Therapy Against Familial Adenomatous Polyposis and Sporadic Colorectal Cancer by APC Nonsense Mutation Readthrough. [NCT02175914]Phase 420 participants (Anticipated)Interventional2014-06-30Recruiting
A Prospective, Multicenter Study on the Long-term Prognosis of Children With Bronchiectasis Treated With Low-dose Erythromycin [NCT03966066]70 participants (Anticipated)Interventional2019-08-31Not yet recruiting
An Open-Label Study to Estimate the Effect of Multiple Doses of Erythromycin on the Pharmacokinetics, Pharmacodynamics and Safety of a Single Dose of Rivaroxaban in Subjects With Renal Impairment and Normal Renal Function [NCT01309438]Phase 129 participants (Actual)Interventional2011-02-28Completed
A Phase 1, Single-center, Open-label, 2-part, 2-treatment Period, 1-sequence, Cross-over, Drug-drug Interaction Study to Investigate the Effect of Erythromycin on SAR443820 (Part A) and the Effect of Itraconazole on SAR443820 (Part B) in Healthy Adult Par [NCT05797753]Phase 116 participants (Actual)Interventional2022-02-18Completed
Risk of QT-prolongation and Torsade de Pointes in Patients Treated With Acute Medication in a University Hospital [NCT02068170]178 participants (Actual)Observational2014-02-28Completed
A Phase 1, 3-Part, Open-label, Drug-Drug Interaction Study to Evaluate the Effect of a Moderate CYP3A4 Inhibitor, and of Strong and Moderate CYP3A4 Inducers on the Pharmacokinetics of TAK-279 in Healthy Subjects [NCT05995249]Phase 148 participants (Anticipated)Interventional2023-08-11Recruiting
An Open-label, Fixed-sequence Study in Healthy Study Participants to Evaluate the Effect of Coadministered Erythromycin on the Pharmacokinetics and Safety of Padsevonil [NCT03480243]Phase 128 participants (Actual)Interventional2018-03-27Completed
TREAT: Treatment of ppROM With Erythromycin vs. Azithromycin Trial [NCT03060473]Phase 3324 participants (Anticipated)Interventional2017-02-23Recruiting
ANTERO-4: A Clinical Investigation of the Effects of Erythromycin on Gastric Motility, Assessed With the VIPUN Gastric Monitoring System in Healthy Adults [NCT04066231]5 participants (Actual)Interventional2019-09-07Terminated(stopped due to Investigational medical device no longer available)
Immunomodulatory Role and Clinical Impact of Erythromycin in Critically Septic Patients: a Randomized Clinical Trial [NCT04665089]110 participants (Actual)Interventional2022-01-01Completed
A Phase I, 2-panel, Open-label, Randomized, Crossover Trial in Healthy Subjects to Investigate the Pharmacokinetic Interaction Between TMC435 and CYP3A Inhibitors, Erythromycin and Darunavir/Ritonavir (DRV/r) [NCT01323257]Phase 149 participants (Actual)Interventional2011-03-31Completed
Relationship Between Gastric Emptying and Glycemic Variability in Type 1 Diabetes Mellitus [NCT02755064]Phase 130 participants (Actual)Interventional2010-06-30Completed
An Open, Prospective, Randomized, Multi-Center Study of the Efficacy and Safety of Intravenous Followed by Oral Azithromycin vs. Cefuroxime Monotherapy or Plus Oral Erythromycin for the Treatment of Chinese Hospitalized Patients With Community- Acquired P [NCT00648726]Phase 3139 participants (Actual)Interventional2003-01-31Completed
The Role of Induced Phase 3 Contractions in the Control of Hunger and Food Intake [NCT02633579]28 participants (Actual)Interventional2012-10-31Completed
Randomized Phase III Trial of Cefazolin or Combination of Cefazolin and Erythromycin or Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of the Membranes [NCT01401179]Phase 3101 participants (Actual)Interventional2005-04-30Completed
Effect of Intravenous Bolus Infusion of Erythromycin Prior to Endoscopy in Patients Presenting With Variceal Bleeding: A Prospective, Randomized, Double- Blind ,Placebo Controlled, Trial [NCT01060267]102 participants (Actual)Interventional2007-01-31Completed
Transplacental Transfer of Drugs Used in Pregnant Women [NCT02622802]250 participants (Actual)Interventional2012-11-30Completed
[NCT00999232]Phase 40 participants Interventional2004-10-31Completed
A Randomized, Open Label Study to Compare the Use of the Dermatological Creams Verutex, Eritex and Fisiogel in the Management of Skin Rash Associated With Tarceva Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer. [NCT00718315]Phase 3201 participants (Actual)Interventional2009-04-30Completed
[NCT00000120]Phase 30 participants Interventional1985-01-31Completed
Phase II Study of Tailored-Dose Docetaxel in Metastatic Breast Cancer [NCT00148070]Phase 245 participants (Actual)Interventional1999-03-31Completed
The Effect of Intravenous Erythromycin on Gastric Emptying in Patients Undergoing Rapid Sequence Intubation for Full Stomach - A Randomised, Placebo-controlled, Double-blind Study [NCT00827216]Phase 2132 participants (Actual)Interventional2009-01-31Completed
Pilot Study of a Multi-Drug Regimen for Severe Pulmonary Fibrosis in Hermansky-Pudlak Syndrome [NCT00467831]Phase 1/Phase 23 participants (Actual)Interventional2007-04-30Terminated(stopped due to insufficient enrollment)
Erythromycin Versus Amoxicillin for Treatment of Antenatal Chlamydia Trachomatis Infection: A Randomized Controlled Trial [NCT01946256]Phase 2220 participants (Actual)Interventional2013-10-31Completed
[NCT02212821]Phase 414 participants (Actual)Interventional2014-09-30Completed
Comparison of Two Macrolides, Azithromycin and Erythromycin, for Symptomatic Treatment of Gastroparesis [NCT01323582]Phase 226 participants (Actual)Interventional2009-02-28Terminated(stopped due to Original investigator left this institution, replacement investigator retired.)
Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair [NCT00671203]Phase 3500 participants (Anticipated)Interventional2007-06-30Completed
Comparison of the Effect of Metoclopramide Versus Erythromycin on Gastric Residual Volume [NCT04682691]Early Phase 145 participants (Actual)Interventional2021-01-01Enrolling by invitation
A Comparative Study in the Clinical and Microbial Efficacy of Topical Besifloxocin Ophthalmic Suspension 0.6% With Erythromycin Ophthalmic Ointment 0.5% BID for the Management of Acute Blepharitis [NCT01478256]Phase 430 participants (Actual)Interventional2011-08-31Completed
Phase II Study of Tailored-Dose Docetaxel + Trastuzumab in Her-2 Positive Metastatic Breast Cancer [NCT00146042]Phase 222 participants (Actual)Interventional1999-03-31Completed
Red Low Level LASER Versus Narrow Band Ultraviolet B in the Treatment of Facial Acne Vulgaris [NCT04254601]45 participants (Actual)Interventional2018-04-01Completed
Preterm Premature Rupture of Membranes: Erythromycin Versus Azithromycin a Randomized Trial Comparing Their Efficacy to Prolong Latency (PEACE Trial) [NCT01556334]Phase 30 participants (Actual)Interventional2010-04-30Withdrawn(stopped due to Terminated before starting due to need for IND determined by FDA.)
Phase III Trial of Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission [NCT00021671]Phase 33,720 participants InterventionalCompleted
Randomised Double Blind Placebo Controlled Trial of Effects of Long Term Low Dose Oral Erythromycin Therapy in Patients With Chronic Obstructive Pulmonary Disease [NCT00147667]Phase 2/Phase 3120 participants Interventional2004-04-30Active, not recruiting
Effects of Erythromycin on Binge Eating and GI Function in Bulimia Nervosa [NCT00304187]Phase 229 participants (Actual)Interventional2004-09-30Completed
In Urgency Hight Digestive Haemorrhage : Gastric Preparation for Endoscopy [NCT00259220]Phase 3270 participants (Actual)Interventional2005-12-31Completed
The Effect of Concomitant Administration of Erythromycin and Diltiazem on CYP3A Activity in Healthy Volunteers [NCT00318201]Phase 47 participants (Actual)Interventional2006-04-30Completed
Effect of Erythromycin Before Endoscopy of Patients With Subtotal Gastrectomy (STG), High Risk of Gastric Stasis : Randomized and Prospective Study [NCT01659619]Phase 2114 participants (Actual)Interventional2012-04-30Completed
Comparison of Two Preemptive Treatment Strategies of Panitumumab Mediated Skin Toxicity and Assessment of Quality of Life in Patients With Ras-wildtype Colorectal Cancer [NCT01668498]Phase 288 participants (Actual)Interventional2011-05-31Completed
Erythromycin Versus Gastric Lavage to Improve Quality of Endoscopic Examination in Patients With Upper Gastrointestinal Bleeding. A Prospective Randomized Trial. [NCT01716572]Phase 3122 participants (Anticipated)Interventional2012-02-29Active, not recruiting
Study of Erythromycin in GER-Associated Apnea of the Newborn [NCT01825473]40 participants (Anticipated)Interventional2012-09-30Recruiting
COVGIC20482: A Multicenter, Consecutive, Randomized Study to Optimize the Bowel Preparation Regimen for the PillCam COLON 2 Capsule Endoscopy Procedure [NCT02481219]122 participants (Actual)Interventional2015-05-31Completed
Low-Dose Long-Term Prescription of Erythromycin in Mustard-Induced Bronchiolitis Obliterans [NCT00367419]Phase 40 participants InterventionalCompleted
An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4. [NCT00002194]Phase 136 participants InterventionalCompleted
A Phase 2/3, Randomized, Open-Label, Multi-center Study to Determine the Safety and Efficacy of Solithromycin in Adolescents and Children With Suspected or Confirmed Community-Acquired Bacterial Pneumonia [NCT02605122]Phase 2/Phase 397 participants (Actual)Interventional2016-04-30Terminated(stopped due to Development not proceeding)
A Phase 1, Randomised, Open Label, Two Sequence, Two Treatment, Two Way Crossover Study to Estimate the Steady-state Effect of Erythromycin on the Single Dose Pharmacokinetics of Ph-797804 in Healthy Subjects [NCT01589614]Phase 112 participants (Actual)Interventional2012-06-30Completed
A Two-Part, Open-Label, Fixed-Sequence, Two-Period Crossover Study to Assess the Effects of Erythromycin on the Pharmacokinetics of Relugolix, Estradiol, and Norethindrone After Administration of the Relugolix/Estradiol/Norethindrone Acetate Fixed-Dose Co [NCT04714554]Phase 143 participants (Actual)Interventional2021-01-06Completed
Randomized Control Trial Comparing Prokinetics and Their Influence on Endoscopy Outcomes for Upper GI Bleed. [NCT02017379]4 participants (Actual)Interventional2014-06-30Terminated(stopped due to Could not recruit any subjects)
[NCT00373919]0 participants InterventionalNot yet recruiting
[NCT00368342]Phase 40 participants InterventionalCompleted
Antibiotics and the Prolongation of Pregnancy in Preterm Labor With an Advanced Cervical Exam [NCT00589329]20 participants (Actual)Interventional2007-12-31Terminated(stopped due to published data suggest potential harm in other investigations.)
Comparative Study Between Different Methods of Enteral Feeding in Acute Severe Pancreatitis [NCT04406506]60 participants (Actual)Observational [Patient Registry]2018-06-10Completed
Influence of Erythromycin on ad Libitum Food Intake and the Evaluation of Motilin in Food Timing in Healthy Volunteers and Patients [NCT03024879]Phase 415 participants (Anticipated)Interventional2014-03-31Enrolling by invitation
Magnetic Resonance (MR) Evaluation of the Effect of Erythromycin Upon Gastric and Small Bowel Motility [NCT01379183]Phase 2/Phase 340 participants (Actual)Interventional2011-06-30Completed
Establishment a Nucleic Acid Rapid Detection Technology Platform for Detecting Pathogenic Bordetella and Its Drug Resistance Genes [NCT04535505]0 participants (Actual)Observational2022-07-31Withdrawn(stopped due to Not as a lead unit)
Effects of a Physiotherapy Program in Patients Hospitalized Due to Pneumonia [NCT02515565]60 participants (Anticipated)Interventional2015-09-30Recruiting
Erythromycin in Parkinson's Disease: A Pilot Study of Its Effects on Levodopa Pharmacokinetics and Pharmacodynamics [NCT02005029]18 participants (Actual)Interventional2013-04-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00304187 (2) [back to overview]Binge Frequency
NCT00304187 (2) [back to overview]Percent of Meal Remaining/Minute
NCT00467831 (1) [back to overview]Survival at 2 Years
NCT00589329 (2) [back to overview]Respiratory Distress
NCT00589329 (2) [back to overview]Length of Pregnancy Prolongation
NCT00718315 (9) [back to overview]Percentage of Participants With Pruritus
NCT00718315 (9) [back to overview]Time to Appearance of Skin Rash
NCT00718315 (9) [back to overview]Percentage of Participants With Erythema Stratified by Severity Grade
NCT00718315 (9) [back to overview]Percentage of Participants With Pain Stratified by Severity Grade
NCT00718315 (9) [back to overview]Percentage of Participants With Pruritus Stratified by Severity Grade
NCT00718315 (9) [back to overview]Percentage of Participants With Skin Rash Stratified by Severity Grade
NCT00718315 (9) [back to overview]Percentage of Participants With Pain
NCT00718315 (9) [back to overview]Percentage of Participants Who Develop Skin Rash
NCT00718315 (9) [back to overview]Percentage of Participants With Erythema
NCT01323582 (8) [back to overview]Change in Time to 50% Emptying: Post Test Less Baseline Pooled Over Orderings
NCT01323582 (8) [back to overview]Change in Time to 50% Gastric Emptying: Post Test Less Baseline Pooled Over Orderings
NCT01323582 (8) [back to overview]TLAG (Time From Ingestion of Meal to Start of Gastric Emptying)
NCT01323582 (8) [back to overview]Time in Minutes for 50% of the Ingested Meal to Empty the Stomach With a Standardized Breath Test: Half the of the Week 11 Value (Period 2) Less Half the of the Week 4 Value (Period 1). This Estimates the Effect Size.
NCT01323582 (8) [back to overview]NDI Score
NCT01323582 (8) [back to overview]Gastroparesis Cardinal Symptom Index (GCSI) Score Change From Baseline to Post Treatment
NCT01323582 (8) [back to overview]Gastroparesis Cardinal Symptom Index (GCSI) Score
NCT01323582 (8) [back to overview]Does GCSI Score Improve (Lower) on Treatment, Pooling the AZ Patients Over Their Treatment Periods? Endpoint is Difference in Post-test Less Baseline
NCT01379183 (6) [back to overview]Small Intestine Volume
NCT01379183 (6) [back to overview]Small Intestine and Colon Volume
NCT01379183 (6) [back to overview]Jejunal Volume
NCT01379183 (6) [back to overview]Ileal Volume
NCT01379183 (6) [back to overview]Gastric Volume
NCT01379183 (6) [back to overview]Colonic Volume
NCT01478256 (2) [back to overview]Improvement in Signs and Symptoms of Blepharitis
NCT01478256 (2) [back to overview]Evaluate Improvement of Bacterial Cultures With Two Different Topical Antibiotics
NCT02005029 (11) [back to overview]Area Under the Curve 0-4 Hours for Plasma Levodopa After Erythromycin Versus Placebo
NCT02005029 (11) [back to overview]Change in Dyskinesia
NCT02005029 (11) [back to overview]Comfortable 20 Feet Gait Speed (CGS)
NCT02005029 (11) [back to overview]Five Times Sit-to-stand Test
NCT02005029 (11) [back to overview]Gastric Emptying Time
NCT02005029 (11) [back to overview]Mean Cmax of Plasma Levodopa After Erythromycin Versus Placebo
NCT02005029 (11) [back to overview]Timed up and go Test (TUAG) Comfortable Speed
NCT02005029 (11) [back to overview]Timed up and go Test (TUAG) Fast Speed
NCT02005029 (11) [back to overview]MDS-UPDRS Part 3 (Movement Disorders Society- Unified Parkinson's Disease Rating Scale)
NCT02005029 (11) [back to overview]9-hole Peg Test Right Hand
NCT02005029 (11) [back to overview]9-hole Peg Test Left Hand
NCT02481219 (6) [back to overview]Colonic Transit Time of Two Different Bowel Preparation Methods for PillCam CCE
NCT02481219 (6) [back to overview]Comparing of Completion Rate of Capsule of Two Different Bowel Preparation Methods for PillCam CCE
NCT02481219 (6) [back to overview]Excretion Rate of Capsule Within 12 Hours of Two Different Bowel Preparation Methods for PillCam CCE
NCT02481219 (6) [back to overview]Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
NCT02481219 (6) [back to overview]Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE
NCT02481219 (6) [back to overview]Adverse Events Rate Between Two Different Bowel Preparation Methods for PillCam CCE
NCT02605122 (4) [back to overview]Summary of Clinical Cure
NCT02605122 (4) [back to overview]Summary of Clinical Improvement
NCT02605122 (4) [back to overview]Summary of Early Clinical Response
NCT02605122 (4) [back to overview]Overview of Adverse Events By Treatment Arm
NCT03480243 (28) [back to overview]Apparent Elimination Rate Constant (Lambdaz) of Padsevonil for Multiple Doses in Plasma
NCT03480243 (28) [back to overview]Apparent Terminal Elimination Half-life at Steady-state (t1/2,ss) of Padsevonil for Multiple Doses in Plasma
NCT03480243 (28) [back to overview]Apparent Total Clearance at Steady-state (CL/Fss) of Padsevonil for Multiple Doses in Plasma
NCT03480243 (28) [back to overview]Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours (AUC(0-12)) of Padsevonil for Single Dose
NCT03480243 (28) [back to overview]Area Under the Plasma Concentration-time Curve Over a Dosing Interval (12 Hours) (AUCtau) of Padsevonil for Multiple Doses
NCT03480243 (28) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Padsevonil for Single Dose
NCT03480243 (28) [back to overview]Maximum Observed Steady-state Plasma Concentration (Cmax, ss) of Padsevonil for Multiple Doses
NCT03480243 (28) [back to overview]Minimum Observed Plasma Concentration (Cmin) of Padsevonil for Single Dose
NCT03480243 (28) [back to overview]Percentage of Participants Experiencing Treatment-Emergent Non-serious Adverse Events (AEs) During the Study
NCT03480243 (28) [back to overview]Formation Clearance (CLform) of Padsevonil Metabolites (1, 2, and 3) in the Urine for Multiple Doses
NCT03480243 (28) [back to overview]Cumulative Amount (Ae) of Padsevonil and Metabolites (1, 2, and 3) Excreted Into the Urine for Single Dose
NCT03480243 (28) [back to overview]Cumulative Amount (Ae) of Padsevonil and Metabolites (1, 2, and 3) Excreted Into the Urine for Multiple Doses
NCT03480243 (28) [back to overview]Area Under the Plasma Concentration-time Curve Over a Dosing Interval (12 Hours) (AUCtau) of Padsevonil Metabolites (1 and 2) for Multiple Doses
NCT03480243 (28) [back to overview]Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours (AUC(0-12)) of Padsevonil Metabolites (1 and 2) for Single Dose
NCT03480243 (28) [back to overview]Time of Maximum Plasma Concentration (Tmax) of Padsevonil for Single Dose
NCT03480243 (28) [back to overview]Time of Maximum Plasma Concentration (Tmax) of Padsevonil for Multiple Doses
NCT03480243 (28) [back to overview]Predose Observed Plasma Concentration (Ctrough) of Padsevonil for Multiple Doses
NCT03480243 (28) [back to overview]Renal Clearance (CLr) of Padsevonil and Metabolites (1 and 2) for Single Dose in Urine
NCT03480243 (28) [back to overview]Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) During the Study
NCT03480243 (28) [back to overview]Renal Clearance (CLr) of Padsevonil and Metabolites (1 and 2) for Multiple Doses in Urine
NCT03480243 (28) [back to overview]Metabolite-to-parent Ratio for Cmax of Padsevonil Metabolites (1 and 2) in Plasma
NCT03480243 (28) [back to overview]Metabolite-to-parent Ratio for AUCtau of Padsevonil Metabolites (1 and 2) in Plasma
NCT03480243 (28) [back to overview]Metabolite-to-parent Ratio for AUC(0-12) of Padsevonil Metabolites (1 and 2) in Plasma
NCT03480243 (28) [back to overview]Maximum Observed Steady-state Plasma Concentration (Cmax, ss) of Padsevonil Metabolites (1 and 2) for Multiple Doses
NCT03480243 (28) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Padsevonil Metabolites (1 and 2) for Single Dose
NCT03480243 (28) [back to overview]Fraction (fe) of Padsevonil and Metabolites (1, 2, and 3) Excreted Into the Urine for Single Dose
NCT03480243 (28) [back to overview]Fraction (fe) of Padsevonil and Metabolites (1, 2, and 3) Excreted Into the Urine for Multiple Doses
NCT03480243 (28) [back to overview]Formation Clearance (CLform) of Padsevonil Metabolites (1, 2, and 3) in the Urine for Single Dose

Binge Frequency

Binge frequency was assessed by patient diary. All patients were asked to keep a diary of the number of daily binge eating and vomiting episodes which was collected at each weekly visit. (NCT00304187)
Timeframe: Measured at Week 7

InterventionBinge Episodes/Week (Mean)
Erythromycin10.4
Placebo11.3

[back to top]

Percent of Meal Remaining/Minute

percent of meal remaining/minute (NCT00304187)
Timeframe: Measured at Week 7

Interventionpercent of meal remaining/minute (Mean)
Erythromycin-.339
Placebo-.177

[back to top]

Survival at 2 Years

The number of subjects surviving after 24 months on study. (NCT00467831)
Timeframe: 24 months

Interventionparticipants (Number)
Multi-Drug Regimen0

[back to top]

Respiratory Distress

Respiratory distress will be defined by the clinical record documentation of the neonatal team. (NCT00589329)
Timeframe: newborn nursery

InterventionParticipants (Count of Participants)
Group A2
Group B1

[back to top]

Length of Pregnancy Prolongation

The length of time (in hours) from initiation of therapy to delivery will establish the latency (NCT00589329)
Timeframe: Measured from randomization to delivery in hours

Interventionhours (Mean)
Group A4
Group B4

[back to top]

Percentage of Participants With Pruritus

Pruritus is defined as intense localized itching (NCT00718315)
Timeframe: Days 0, 15, and 30

Interventionpercentage of participants (Number)
Fisiogel36.1
Stiemicyn47.6
Verutex29.5

[back to top]

Time to Appearance of Skin Rash

Time to occurence of skin rash was calculated as the number of days from Day 0 until the first appearance of skin rash as defined by NCI-CTCAE (NCT00718315)
Timeframe: Days 0, 15, and 30

InterventionDays (Median)
Fisiogel16.0
Stiemicyn15.0
Verutex15.0

[back to top]

Percentage of Participants With Erythema Stratified by Severity Grade

The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist. (NCT00718315)
Timeframe: 30 Days

,,
Interventionpercentage of participants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4Grade 5
Fisiogel37.739.323.0000
Stiemicyn39.736.522.21.600
Verutex52.539.36.61.600

[back to top]

Percentage of Participants With Pain Stratified by Severity Grade

The severity of pain was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist. (NCT00718315)
Timeframe: 30 Days

,,
Interventionpercentage of participants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4Grade 5
Fisiogel82.011.54.91.600
Stiemicyn73.022.24.8000
Verutex85.26.66.61.600

[back to top]

Percentage of Participants With Pruritus Stratified by Severity Grade

The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist. (NCT00718315)
Timeframe: 30 Days

,,
Interventionpercentage of participants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4Grade 5
Fisiogel63.919.714.81.600
Stiemicyn52.431.714.31.600
Verutex70.524.63.31.600

[back to top]

Percentage of Participants With Skin Rash Stratified by Severity Grade

The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death (NCT00718315)
Timeframe: 30 Days

,,
Interventionpercentage of participants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4Grade 5
Fisiogel29.821.149.1000
Stiemicyn25.018.356.7000
Verutex18.343.335.03.300

[back to top]

Percentage of Participants With Pain

Pain is defined as an unpleasant feeling often caused by intense or damaging stimuli (NCT00718315)
Timeframe: Days 0, 15, and 30

Interventionpercentage of participants (Number)
Fisiogel16.4
Stiemicyn25.4
Verutex13.4

[back to top]

Percentage of Participants Who Develop Skin Rash

"Skin rash was assessed by the investigator and dermatologists (the latter ones only through pictures) and scored according to (National cancer Institute -Common Terminology Criteria for Adverse Events ) NCI-CTCAE ( version 3 (line Rash/desquamation - short name rash)." (NCT00718315)
Timeframe: 30 Days

Interventionpercentage of participants (Number)
Fisiogel60.0
Stiemicyn69.2
Verutex73.1

[back to top]

Percentage of Participants With Erythema

Erythema is defined as redness of the skin or mucous membranes, caused by hyperemia of superficial capillaries (NCT00718315)
Timeframe: Days 0, 15, and 30

Interventionpercentage of participants (Number)
Fisiogel56.7
Stiemicyn56.7
Verutex43.3

[back to top]

Change in Time to 50% Emptying: Post Test Less Baseline Pooled Over Orderings

Patients will be given a standardized meal enriched with a labeled material and the breath samples are then collected and analyzed. The estimated time to reaching 50% of the accumulated contents is recorded. (NCT01323582)
Timeframe: at baseline before initiation of the treatment and after completion of each treatment period.

Interventionminutes (Mean)
Azithromycin-15.0

[back to top]

Change in Time to 50% Gastric Emptying: Post Test Less Baseline Pooled Over Orderings

Patients will be given a standardized meal enriched with a labeled material and the breath samples are then collected and analyzed. The estimated time to reaching 50% of the accumulated contents is recorded. (NCT01323582)
Timeframe: Baseline and end of treatment period

InterventionMinutes (Mean)
Erythromycin-11.8

[back to top]

TLAG (Time From Ingestion of Meal to Start of Gastric Emptying)

This is defined as the time from ingestion of the meal to the beginning of the emptying process in minutes. Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies. (NCT01323582)
Timeframe: Weeks 4 and 11 (end of periods)

InterventionMinutes (Mean)
Erythromycin First Then Azithromycin-1.71
Azithromycin Then Erythromycin-0.22

[back to top]

Time in Minutes for 50% of the Ingested Meal to Empty the Stomach With a Standardized Breath Test: Half the of the Week 11 Value (Period 2) Less Half the of the Week 4 Value (Period 1). This Estimates the Effect Size.

Patients will be given a standardized meal enriched with a labeled material and the breath samples are then collected and analyzed. The estimated time to empty 50% (t 1/2) of the accumulated contents is recorded. Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies. (NCT01323582)
Timeframe: Weeks 4 and 11 (end of periods)

InterventionMinutes (Mean)
Erythromycin First Then Azithromycin-1.6
Azithromycin Then Erythromycin-5.2

[back to top]

NDI Score

"Nepean Dyspepsia Index (NDI) is a measure of symptom status and quality of life in functional dyspepsia. This scale is scored using each subscale (Tension, interference with daily activities), Eating/drinking, Knowledge/control, work/study) and adding up the items for each of the five subscale score (2-10). Total score range would be 10-50).~For the NDI, a lower number is better meaning the symptom is not effecting quality of life and a higher score closer to 50 is worse meaning it is effecting patients quality of life.~Reference: Talley NJ, Verlinden M, Jones M. Quality of life in functional dyspepsia: responsiveness of the Nepean Dyspepsia Index and developement of a new 10-iten short form. Aliment Pharmacol Ther 2001: 15: 207-216.~Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies." (NCT01323582)
Timeframe: Weeks 4 and 11 (end of periods)

Interventionunits on a scale (Median)
Erythromycin First Then Azithromycin1.65
Azithromycin Then Erythromycin1.30

[back to top]

Gastroparesis Cardinal Symptom Index (GCSI) Score Change From Baseline to Post Treatment

"This is a Validated instrument for measuring symptom severity in patients with gastroparesis. This scoring is based on a Likert Scale from (0-5) with zero being no symptom and five being very severe symptoms on 9 subscales, making the overall score range from 0-45. The higher the score, the more severe patient's symptoms are. The scale is reported in the references. The change was calculated by measuring the end of treatment minus baseline GCSI score.~Negative value reflects this change." (NCT01323582)
Timeframe: Baseline and end of treatment period

Interventionunits on a scale (Mean)
Erythromycin-5.32

[back to top]

Gastroparesis Cardinal Symptom Index (GCSI) Score

"This is a Validated instrument for measuring symptom severity in patients with gastroparesis. This scoring is based on a Likert Scale from (0-5) with zero being no symptoms and five being very severe symptoms on 9 subscales, making the overall score range from 0-45. The higher the score, the more severe patient's symptoms.~Reference for GCSI: Revicki DA, REntz AM, Dubois D, et al. Development and validation of a patient-assessed gastroparesis symptoms severity measure: the Gastroparesis Cardinal Symptom Index. Ailment Pharm Ther 2003; 18: 141:50.~Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies." (NCT01323582)
Timeframe: Weeks 4 and 11 (end of periods)

Interventionunits on a scale (Mean)
Erythromycin First Then Azithromycin-1.6
Azithromycin Then Erythromycin-2.9

[back to top]

Does GCSI Score Improve (Lower) on Treatment, Pooling the AZ Patients Over Their Treatment Periods? Endpoint is Difference in Post-test Less Baseline

"This is a Validated instrument for measuring symptom severity in patients with gastroparesis. This scoring is based on a Likert Scale from (0-5) with zero being no symptom and five being very severe symptoms on 9 subscales, making the overall score range from 0-45. The higher the score, the more severe patient's symptoms are. The scale is reported in the references.~This is a calculation taken with GCSI score at end of treatment minus baseline. Negative value reflects this change." (NCT01323582)
Timeframe: Baseline and end of treatment period

Interventionunits on a scale (Median)
Azithromycin-6.40

[back to top]

Small Intestine Volume

A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath. (NCT01379183)
Timeframe: Approximately 60 minutes after beginning ingestion of fluid volume

InterventionmL (Mean)
Erythromycin698
Placebo607

[back to top]

Small Intestine and Colon Volume

A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath. (NCT01379183)
Timeframe: Approximately 60 minutes after beginning ingestion of fluid volume

InterventionmL (Mean)
Erythromycin910
Placebo781

[back to top]

Jejunal Volume

The jejunum is the section of the small intestine between the duodenum and the ileum. A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath. (NCT01379183)
Timeframe: Approximately 60 minutes after beginning ingestion of fluid volume

InterventionmL (Mean)
Erythromycin450
Placebo359

[back to top]

Ileal Volume

The Ileal is the terminal portion of the small intestine extending from the jejunum to the cecum. A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath. (NCT01379183)
Timeframe: Approximately 60 minutes after beginning ingestion of fluid volume

InterventionmL (Mean)
Erythromycin248
Placebo248

[back to top]

Gastric Volume

A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. MR images of the abdomen were acquired with a torso phased array coil and a 1.5 tesla magnet MRI. Gastric volumes were assessed with an axial 3D axial gradient echo sequence, which imaged the entire stomach in 13 seconds. (NCT01379183)
Timeframe: Approximately 60 minutes after beginning ingestion of fluid volume

InterventionmL (Mean)
Erythromycin262
Placebo718

[back to top]

Colonic Volume

A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath. (NCT01379183)
Timeframe: Approximately 60 minutes after beginning ingestion of fluid volume

InterventionmL (Mean)
Erythromycin190
Placebo180

[back to top]

Improvement in Signs and Symptoms of Blepharitis

Signs and symptoms of blepharitis were scored and determined before and after treatment with two different antibiotics (NCT01478256)
Timeframe: Four weeks

Interventionparticipants (Number)
Besifloxocin15
Erythromycin15

[back to top]

Evaluate Improvement of Bacterial Cultures With Two Different Topical Antibiotics

Compare improvement of microbial cultures (greater inhibition of bacterial growth) with the two antibiotics used to treat blepharitis (NCT01478256)
Timeframe: Three weeks

Interventionparticipants (Number)
Besifloxocin15
Erythromycin15

[back to top]

Area Under the Curve 0-4 Hours for Plasma Levodopa After Erythromycin Versus Placebo

Mean Area under the Curve 0-4 hours for plasma levodopa after erythromycin versus placebo. Plasma samples were collected at the following times post-levodopa dose: 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, and 240 minutes. (NCT02005029)
Timeframe: 2 weeks, between visits 2 and 3

Interventionng/mL*min (Mean)
Erythromycin123237
Placebo103584

[back to top]

Change in Dyskinesia

Mean total AIMS (Abnormal Involuntary Movements Scale) score after receiving erythromycin minus mean total AIMS score after receiving placebo. The AIMS test has a total of twelve items rating involuntary movements of various areas of the patient's body. Ten of the items are rated on a five-point scale of severity from 0-4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). Two of the items are not scored. Total score range is from 0 to 40. Higher scores represent more severe dyskinesia (a worse outcome). (NCT02005029)
Timeframe: 2 weeks, between visits 2 and 3

Interventionunits on a scale (Mean)
Erythromycin0.875
Placebo0.375

[back to top]

Comfortable 20 Feet Gait Speed (CGS)

Change in motor function as assessed by comfortable 20 feet gait speed (CGS) (NCT02005029)
Timeframe: 2 weeks, between visits 2 and 3

Interventionseconds (Mean)
Erythromycin4.26
Placebo4.10

[back to top]

Five Times Sit-to-stand Test

Change in motor function as measured by Five times sit-to-stand test. This test measures the total time to complete 5 repetitions of sit to stand. (NCT02005029)
Timeframe: 2 weeks, between visits 2 and 3

Interventionseconds (Mean)
Erythromycin11.09
Placebo10.09

[back to top]

Gastric Emptying Time

Mean gastric emptying time in minutes as measured by SmartPill (NCT02005029)
Timeframe: 2 weeks, between visits 2 and 3

Interventionminutes (Mean)
Erythromycin105
Placebo180

[back to top]

Mean Cmax of Plasma Levodopa After Erythromycin Versus Placebo

Mean Cmax of plasma levodopa after erythromycin versus placebo. Plasma samples were collected at the following times post-levodopa dose: 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, and 240 minutes. (NCT02005029)
Timeframe: 2 weeks, between visits 2 and 3

Interventionng/mL (Mean)
Erythromycin1267
Placebo1395

[back to top]

Timed up and go Test (TUAG) Comfortable Speed

Change in motor function as assessed by timed up and go test (comfortable speed). This test measures the total time to stand from a chair, walk 10 feet, and return to sitting. (NCT02005029)
Timeframe: 2 weeks, between visits 2 and 3

Interventionseconds (Mean)
Erythromycin8.67
Placebo8.26

[back to top]

Timed up and go Test (TUAG) Fast Speed

Change in motor function as assessed by timed up and go test (fast speed). This test measures the total time to stand from a chair, walk 10 feet, and return to sitting. (NCT02005029)
Timeframe: 2 weeks, between visits 2 and 3

Interventionseconds (Mean)
Erythromycin6.79
Placebo6.85

[back to top]

MDS-UPDRS Part 3 (Movement Disorders Society- Unified Parkinson's Disease Rating Scale)

Part 3 of this scale is a standardized physical assessment that quantifies the total burden of motor symptoms in Parkinson's disease patients. Each of the 18 items on the scale is rated from 0 (none, 1 (slight), 2 (mild), 3 (moderate) and 4 (severe). Scores range from 0-72. Higher scores represent a more severe burden of motor symptoms (a worse outcome). (NCT02005029)
Timeframe: 2 weeks, between visits 2 and 3

,
Interventionunits on a scale (Mean)
"Before or off levodopa""After or on levodopa"
Erythromycin30.7517.13
Placebo25.3716.50

[back to top]

9-hole Peg Test Right Hand

Change in motor function as assessed by 9-hole peg test for upper extremity manipulation/dexterity. This test measures the total time required to place and remove 9 holes in a pegboard. Each hand is tested separately. (NCT02005029)
Timeframe: 2 weeks, between visits 2 and 3

Interventionseconds (Mean)
Erythromycin25.36
Placebo25.80

[back to top]

9-hole Peg Test Left Hand

Change in motor function as assessed by 9-hole peg test for upper extremity manipulation/dexterity. This test measures the total time required to place and remove 9 holes in a pegboard. Each hand is tested separately. (NCT02005029)
Timeframe: 2 weeks, between visits 2 and 3

Interventionseconds (Mean)
Erythromycin29.36
Placebo27.33

[back to top]

Colonic Transit Time of Two Different Bowel Preparation Methods for PillCam CCE

Colonic transit time of two different bowel preparation was assessed from RAPID video in total and by segment (NCT02481219)
Timeframe: an expected average of 3 weeks from study procedure

Interventionhours (Median)
Bowel Preparation Regimen - Control2.8
Bowel Preparation Regimen-Test2.4

[back to top]

Comparing of Completion Rate of Capsule of Two Different Bowel Preparation Methods for PillCam CCE

Will be assessed from RAPID video in total and by segment (NCT02481219)
Timeframe: an expected average of 3 weeks from study procedure

Interventionpercentage of participants (Number)
Bowel Preparation Regimen -Control76.9
Bowel Preparation Regimen-Test90.9

[back to top]

Excretion Rate of Capsule Within 12 Hours of Two Different Bowel Preparation Methods for PillCam CCE

Will be assesses by applicable case report form (CRF) (NCT02481219)
Timeframe: an expected average of 3 weeks from study procedure

Interventionpercentage of participants (Number)
Bowel Preparation Regimen -Control80.4
Bowel Preparation Regimen-Test90.9

[back to top]

Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)

The primary endpoint is the bowel cleansing level, as determined by a standardized 4-point grading scale, assessed in total and by segment (cecum, ascending, transverse, descending/sigmoid, and rectum). (NCT02481219)
Timeframe: Within two weeks of study procedure

,
Interventionpercentage of particpants (Number)
Overall Excellent cleansingCecum Excellent cleansingAscending Excellent cleansingTransverse Excellent cleansingDescending Excellent cleansingRectum Excellent cleansingOverall Good cleansingCecum Good cleansingAscending Good cleansingTransverse Good cleansingDescending Good cleansingRectum Good cleansingOverall Fair cleansingCecum Fair cleansingAscending Fair cleansingTransverse Fair cleansingDescending Fair cleansingRectum Fair cleansingOverall Poor cleansingCecum Poor cleansingAscending Poor cleansingTransverse Poor cleansingDescending Poor cleansingRectum Poor cleansing
Bowel Preparation Regimen -Control6.814.012.210.69.5070.554.063.361.773.856.122.730.022.527.716.746.502.02.0002.4
Bowel Preparation Regimen-Test16.714.618.214.618.510.059.352.760.060.063.052.024.130.921.825.518.536.001.80002.0

[back to top]

Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE

Will be assessed from RAPID video in total and by segment (NCT02481219)
Timeframe: an expected average of 3 weeks from study procedure

,
Interventionpercentage of participants (Number)
Overall (any size)Cecum (any size)Ascending (any size)Transverse (any size)Descending (any size)rectum (any size)Overall (polyps ≥6mm)Cecum (polyps ≥6mm)Ascending (polyps ≥6mm)Transverse (polyps ≥6mm)Descending (polyps ≥6mm)Rectum (polyps ≥6mm)Overall (polyps ≥10mm)Cecum Overall (polyps ≥10mm)Ascending Overall (polyps ≥10mm)Transverse (polyps ≥10mm)Descending (polyps ≥10mm)Rectum (polyps ≥10mm)
Bowel Preparation Regimen -Control46.86.014.04.331.924.421.32.02.04.312.87.38.502.004.34.9
Bowel Preparation Regimen-Test58.214.69.17.329.132.036.412.73.67.316.46.014.67.33.61.83.62.0

[back to top]

Adverse Events Rate Between Two Different Bowel Preparation Methods for PillCam CCE

Will be assesses by applicable CRF (NCT02481219)
Timeframe: Adverse Events (AE) were collected starting from the screening visit and until 5-9 days following the PillCam procedure day.

Interventionpercentage of participants with >1 AE (Number)
Bowel Preparation Regimen -Control3.4
Bowel Preparation Regimen-Test19.4

[back to top]

Summary of Clinical Cure

Clinical cure was assessed using the latest efficacy evaluation conducted on Day 16 (+/- 4 days) post-randomization, and was defined as resolution of all presenting signs/symptoms of CABP (excluding cough), no development of new signs/symptoms of CABP, and no requirement for an additional antibiotic. (NCT02605122)
Timeframe: Short-term follow-up at 16 days (+/- 4 days)

Interventionpercentage of participants (Number)
Solithromycin60.0
Standard of Care68.4

[back to top]

Summary of Clinical Improvement

Clinical improvement was assessed using the latest efficacy evaluation conducted on last day of treatment (+48 hours), and was defined identically to the early clinical response. (NCT02605122)
Timeframe: Last day of Treatment (+48 hours)

Interventionpercentage of participants (Number)
Solithromycin64.5
Standard of Care81

[back to top]

Summary of Early Clinical Response

Early clinical response (ECR) was defined using the latest efficacy evaluation from Day 2 (if subject discharged prior to Day 2), Day3, or Day 4, and was defined as improvement in at least 1 presenting sign/symptom of CABP with no deterioration in any signs/symptoms of CABP and no requirement for an additional antibiotic. (NCT02605122)
Timeframe: During Treatment Days 3 to 4

Interventionpercentage of participants (Number)
Solithromycin66.7
Standard of Care46.7

[back to top]

Overview of Adverse Events By Treatment Arm

Summary of subjects experiencing Treatment Emergent Adverse Events (TEAE) through Day 16 visit and Treatment Emergent Serious Adverse Events (TESAE) through Day 28 visit (28 days +/- 4 days after randomization) (NCT02605122)
Timeframe: Up to 28 days post-treatment

,
InterventionParticipants (Count of Participants)
TEAETESAE
Solithromycin241
Standard of Care71

[back to top]

Apparent Elimination Rate Constant (Lambdaz) of Padsevonil for Multiple Doses in Plasma

lambdaz: The apparent elimination rate constant of padsevonil for multiple doses in plasma. Lambdaz was expressed in liters per hour (l/hour). (NCT03480243)
Timeframe: Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3)

Interventionlhour (Geometric Mean)
Padsevonil (Period 1) (PK-PPS)0.1049
Padsevonil (Period 2) (PK-PPS)0.1006
Padsevonil and Erythromycin (Period 3b) (PK-PPS)0.07975

[back to top]

Apparent Terminal Elimination Half-life at Steady-state (t1/2,ss) of Padsevonil for Multiple Doses in Plasma

t½,ss: The apparent terminal elimination half-life at steady-state of padsevonil for multiple doses in plasma. t1/2, ss was expressed in hours (h). (NCT03480243)
Timeframe: Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3)

Interventionhours (Median)
Padsevonil (Period 1) (PK-PPS)6.465
Padsevonil (Period 2) (PK-PPS)6.649
Padsevonil and Erythromycin (Period 3b) (PK-PPS)8.548

[back to top]

Apparent Total Clearance at Steady-state (CL/Fss) of Padsevonil for Multiple Doses in Plasma

CL/Fss: The apparent total clearance at steady-state of padsevonil for multiple doses in plasma. CL/Fss was expressed in milliliters per hour (mL/hour). (NCT03480243)
Timeframe: Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3)

InterventionmL/hour (Geometric Mean)
Padsevonil (Period 1) (PK-PPS)48810
Padsevonil (Period 2) (PK-PPS)43970
Padsevonil and Erythromycin (Period 3b) (PK-PPS)19710

[back to top]

Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours (AUC(0-12)) of Padsevonil for Single Dose

AUC(0-12): The area under the plasma concentration-time curve from time zero to 12 hours of padsevonil for single dose . AUC(0-12) was expressed in hours times nanograms per milliliter (hours*ng/mL). (NCT03480243)
Timeframe: Predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1, 12, and 26

Interventionhours*ng/mL (Geometric Mean)
Padsevonil (Period 1) (PK-PPS)1428
Padsevonil (Period 2) (PK-PPS)1571
Padsevonil and Erythromycin (Period 3b) (PK-PPS)2576

[back to top]

Area Under the Plasma Concentration-time Curve Over a Dosing Interval (12 Hours) (AUCtau) of Padsevonil for Multiple Doses

AUCtau: The area under the plasma concentration-time curve over a dosing interval (12 hours) of padsevonil for multiple doses. AUC(tau) was expressed in hours times nanograms per millilitre (hours*ng/mL). (NCT03480243)
Timeframe: Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3)

Interventionhours*ng/mL (Geometric Mean)
Padsevonil (Period 1) (PK-PPS)2049
Padsevonil (Period 2) (PK-PPS)2274
Padsevonil and Erythromycin (Period 3b) (PK-PPS)5073

[back to top]

Maximum Observed Plasma Concentration (Cmax) of Padsevonil for Single Dose

Cmax: The maximum observed plasma concentration of padsevonil for single dose . Cmax was expressed in nanograms per milliliter (ng/mL). (NCT03480243)
Timeframe: Predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1, 12, and 26

Interventionng/mL (Geometric Mean)
Padsevonil (Period 1) (PK-PPS)366.6
Padsevonil (Period 2) (PK-PPS)385.3
Padsevonil and Erythromycin (Period 3b) (PK-PPS)697.4

[back to top]

Maximum Observed Steady-state Plasma Concentration (Cmax, ss) of Padsevonil for Multiple Doses

Cmax, ss: The maximum observed steady-state plasma concentration of padsevonil for multiple doses. Cmax, ss was expressed in nanograms per millilitre (ng/mL). (NCT03480243)
Timeframe: Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3)

Interventionng/mL (Geometric Mean)
Padsevonil (Period 1) (PK-PPS)475.0
Padsevonil (Period 2) (PK-PPS)473.9
Padsevonil and Erythromycin (Period 3b) (PK-PPS)1010

[back to top]

Minimum Observed Plasma Concentration (Cmin) of Padsevonil for Single Dose

Cmin: The minimum observed plasma concentration of padsevonil for single dose. Cmin was expressed in nanograms per millilitre (ng/mL). (NCT03480243)
Timeframe: Blood samples were taken at specific time points from pre-dose to 12 hours post first dose of Padsevonil for each Treatment Period

Interventionng/mL (Geometric Mean)
Padsevonil (Period 1) (PK-PPS)2.857
Padsevonil (Period 2) (PK-PPS)5.643
Padsevonil and Erythromycin (Period 3b) (PK-PPS)4.286

[back to top]

Percentage of Participants Experiencing Treatment-Emergent Non-serious Adverse Events (AEs) During the Study

Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of UP0057 IMP, or events in which severity worsened on or after the date of first dose of UP0057 study medication. (NCT03480243)
Timeframe: From beginning of the first Treatment Period (Day 1) to the Safety Follow-up Visit (up to 48 days )

Interventionpercentage of participants (Number)
Padsevonil (Period 1+2) (FAS)100
Erythromycin (Period 3a) (FAS)11.1
Padsevonil and Erythromycin (Period 3b) (FAS)96.3
Erythromycin (Period 3c) (FAS)19.2

[back to top]

Formation Clearance (CLform) of Padsevonil Metabolites (1, 2, and 3) in the Urine for Multiple Doses

CLform: The formation clearance of padsevonil metabolites (1, 2, and 3) in the urine for multiple doses. CLform was expressed in milliliters per hour (mL/hour). (NCT03480243)
Timeframe: Urine samples were taken 0 to 12 hours, 12 to 24 hours,and 24 to 48 hours post last PSL dose during Treatment Period 1 and 2; 0 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours post last dose of PSL during Treatment Period 3

,,
InterventionmL/h (Geometric Mean)
Metabolite 1Metabolite 2Metabolite 3
Padsevonil (Period 1) (PK-PPS)295.3733125150
Padsevonil (Period 2) (PK-PPS)294.6662220890
Padsevonil and Erythromycin (Period 3b) (PK-PPS)166.4259311170

[back to top]

Cumulative Amount (Ae) of Padsevonil and Metabolites (1, 2, and 3) Excreted Into the Urine for Single Dose

Ae: The cumulative amount of padsevonil and its metabolites (1, 2, and 3) excreted into the urine for single dose. Ae was expressed in milligrams (mg). (NCT03480243)
Timeframe: Urine samples were taken 0 to 12 hours post first dose of Padsevonil during each Treatment Period

,,
Interventionmilligrams (Geometric Mean)
PadsevonilMetabolite 1Metabolite 2Metabolite 3
Padsevonil (Period 1) (PK-PPS)0.039140.210110.5329.11
Padsevonil (Period 2) (PK-PPS)0.040540.23339.42327.44
Padsevonil and Erythromycin (Period 3b) (PK-PPS)0.049870.23099.76426.09

[back to top]

Cumulative Amount (Ae) of Padsevonil and Metabolites (1, 2, and 3) Excreted Into the Urine for Multiple Doses

Ae: The cumulative amount of padsevonil and its metabolites (1, 2, and 3) excreted into the urine for multiple doses. Ae was expressed in milligrams (mg). (NCT03480243)
Timeframe: Urine samples were taken 0 to 12 hours, 12 to 24 hours,and 24 to 48 hours post last PSL dose during Treatment Period 1 and 2; 0 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours post last dose of PSL during Treatment Period 3

,,
Interventionmilligrams (Geometric Mean)
PadsevonilMetabolite 1Metabolite 2Metabolite 3
Padsevonil (Period 1) (PK-PPS)0.058250.618815.0370.83
Padsevonil (Period 2) (PK-PPS)0.057410.665715.0765.30
Padsevonil and Erythromycin (Period 3b) (PK-PPS)0.12740.879713.6781.36

[back to top]

Area Under the Plasma Concentration-time Curve Over a Dosing Interval (12 Hours) (AUCtau) of Padsevonil Metabolites (1 and 2) for Multiple Doses

AUCtau: The area under the plasma concentration-time curve over a dosing interval (12 hours) of padsevonil metabolites (1 and 2) for multiple doses. AUCtau was expressed in hours times nanograms per milliliter (hours*ng/mL). (NCT03480243)
Timeframe: Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3)

,,
Interventionhours*ng/mL (Geometric Mean)
Metabolite 1Metabolite 2
Padsevonil (Period 1) (PK-PPS)1748775.1
Padsevonil (Period 2) (PK-PPS)1993813.1
Padsevonil and Erythromycin (Period 3b) (PK-PPS)2625799.0

[back to top]

Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours (AUC(0-12)) of Padsevonil Metabolites (1 and 2) for Single Dose

AUC(0-12): The area under the plasma concentration-time curve from time zero to 12 hours of padsevonil metabolites (1 and 2) for single dose. AUC(0-12) was expressed in hours times nanograms per milliliter (hours*ng/mL). (NCT03480243)
Timeframe: Blood samples were taken at specific time points from pre-dose to 12 hours post first dose of Padsevonil for each Treatment Period

,,
Interventionhours*ng/mL (Geometric Mean)
Metabolite 1Metabolite 2
Padsevonil (Period 1) (PK-PPS)828.3596.5
Padsevonil (Period 2) (PK-PPS)824.3534.4
Padsevonil and Erythromycin (Period 3b) (PK-PPS)905.6599.5

[back to top]

Time of Maximum Plasma Concentration (Tmax) of Padsevonil for Single Dose

Tmax: The time of maximum plasma concentration of padsevonil for single dose. Tmax was expressed in hours (h). (NCT03480243)
Timeframe: Blood samples were taken at specific time points from pre-dose to 12 hours post first dose of Padsevonil for each Treatment Period

Interventionhours (Median)
Padsevonil (Period 1) (PK-PPS)3.000
Padsevonil (Period 2) (PK-PPS)1.500
Padsevonil and Erythromycin (Period 3b) (PK-PPS)1.500

[back to top]

Time of Maximum Plasma Concentration (Tmax) of Padsevonil for Multiple Doses

Tmax: The time of maximum plasma concentration of padsevonil for multiple doses. Tmax was expressed in hours (h). (NCT03480243)
Timeframe: Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3)

Interventionhours (Median)
Padsevonil (Period 1) (PK-PPS)1.750
Padsevonil (Period 2) (PK-PPS)1.500
Padsevonil and Erythromycin (Period 3b) (PK-PPS)2.000

[back to top]

Predose Observed Plasma Concentration (Ctrough) of Padsevonil for Multiple Doses

Ctrough: The predose observed plasma concentration of padsevonil for multiple doses. Ctrough was expressed in nanograms per millilitre (ng/mL). (NCT03480243)
Timeframe: Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3)

Interventionng/mL (Geometric Mean)
Padsevonil (Period 1) (PK-PPS)57.03
Padsevonil (Period 2) (PK-PPS)68.57
Padsevonil and Erythromycin (Period 3b) (PK-PPS)182.6

[back to top]

Renal Clearance (CLr) of Padsevonil and Metabolites (1 and 2) for Single Dose in Urine

CLr: The renal clearance of padsevonil and its metabolites (1 and 2) for single dose in urine. CLr was expressed in milliliters per hour (mL/hour). (NCT03480243)
Timeframe: Urine samples were taken 0 to 12 hours post first dose of Padsevonil during each Treatment Period

,,
InterventionmL/hour (Geometric Mean)
PadsevonilMetabolite 1Metabolite 2
Padsevonil (Period 1) (PK-PPS)27.40253.717640
Padsevonil (Period 2) (PK-PPS)25.80283.017630
Padsevonil and Erythromycin (Period 3b) (PK-PPS)19.36255.016290

[back to top]

Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) During the Study

"An SAE is any untoward medical occurrence that at any dose:~Results in death~Is life-threatening~Requires in patient hospitalization or prolongation of existing hospitalization~Is a congenital anomaly or birth defect~Is an infection that requires treatment parenteral antibiotics~Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above." (NCT03480243)
Timeframe: From beginning of the first Treatment Period (Day 1) to the Safety Follow-up Visit (up to 48 days )

Interventionpercentage of participants (Number)
Padsevonil (Period 1+2) (FAS)0
Erythromycin (Period 3a) (FAS)0
Padsevonil and Erythromycin (Period 3b) (FAS)0
Erythromycin (Period 3c) (FAS)0

[back to top]

Renal Clearance (CLr) of Padsevonil and Metabolites (1 and 2) for Multiple Doses in Urine

CLr: The renal clearance of padsevonil and its metabolites (1 and 2) for multiple doses in urine. CLr was expressed in milliliters per hour (mL/hour). (NCT03480243)
Timeframe: Urine samples were taken 0 to 12 hours, 12 to 24 hours,and 24 to 48 hours post last PSL dose during Treatment Period 1 and 2; 0 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours post last dose of PSL during Treatment Period 3

,,
InterventionmL/hours (Geometric Mean)
PadsevonilMetabolite 1Metabolite 2
Padsevonil (Period 1) (PK-PPS)28.43335.019390
Padsevonil (Period 2) (PK-PPS)25.24325.418530
Padsevonil and Erythromycin (Period 3b) (PK-PPS)25.12311.416470

[back to top]

Metabolite-to-parent Ratio for Cmax of Padsevonil Metabolites (1 and 2) in Plasma

Metabolite-to-parent ratio calculated as: Cmax of padsevonil metabolites (1 and 2) divided by Cmax of padsevonil following a single dose in plasma. Metabolite-to-parent ratio for Cmax was expressed as ratio. (NCT03480243)
Timeframe: Blood samples were taken at specific time points from pre-dose to 12 hours post dose of Padsevonil for each Treatment Period

,,
Interventionratio (Geometric Mean)
Metabolite 1Metabolite 2
Padsevonil (Period 1) (PK-PPS)0.45440.3015
Padsevonil (Period 2) (PK-PPS)0.41190.2452
Padsevonil and Erythromycin (Period 3b) (PK-PPS)0.27170.1552

[back to top]

Metabolite-to-parent Ratio for AUCtau of Padsevonil Metabolites (1 and 2) in Plasma

Metabolite-to-parent ratio calculated as: AUCtau of padsevonil metabolites (1 and 2) divided by AUCtau of padsevonil following multiple dosing in plasma. Metabolite-to-parent ratio for AUCtau was expressed as ratio. (NCT03480243)
Timeframe: Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3)

,,
Interventionratio (Geometric Mean)
Metabolite 1Metabolite 2
Padsevonil (Period 1) (PK-PPS)0.85330.3783
Padsevonil (Period 2) (PK-PPS)0.87660.3576
Padsevonil and Erythromycin (Period 3b) (PK-PPS)0.51740.1575

[back to top]

Metabolite-to-parent Ratio for AUC(0-12) of Padsevonil Metabolites (1 and 2) in Plasma

Metabolite-to-parent ratio calculated as: AUC(0-12)of padsevonil metabolites (1 and 2) divided by AUC(0-12) of padsevonil following a single dose in plasma. Metabolite-to-parent ratio for AUC(0-12) was expressed as ratio. (NCT03480243)
Timeframe: Blood samples were taken at specific time points from pre-dose to 12 hours post first dose of Padsevonil for each Treatment Period

,,
Interventionratio (Geometric Mean)
Metabolite 1Metabolite 2
Padsevonil (Period 1) (PK-PPS)0.57990.4176
Padsevonil (Period 2) (PK-PPS)0.52460.3401
Padsevonil and Erythromycin (Period 3b) (PK-PPS)0.35150.2327

[back to top]

Maximum Observed Steady-state Plasma Concentration (Cmax, ss) of Padsevonil Metabolites (1 and 2) for Multiple Doses

Cmax, ss: The maximum observed steady-state plasma concentration of padsevonil metabolites (1 and 2) for multiple doses. Cmax, ss was expressed in nanograms per millilitre (ng/mL). (NCT03480243)
Timeframe: Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3)

,,
Interventionng/mL (Geometric Mean)
Metabolite 1Metabolite 2
Padsevonil (Period 1) (PK-PPS)232.3118.6
Padsevonil (Period 2) (PK-PPS)258.3113.3
Padsevonil and Erythromycin (Period 3b) (PK-PPS)310.3101.8

[back to top]

Maximum Observed Plasma Concentration (Cmax) of Padsevonil Metabolites (1 and 2) for Single Dose

Cmax: The maximum plasma concentration of padsevonil metabolites (1 and 2) for single dose. Cmax was expressed in nanograms per milliliter (ng/mL). (NCT03480243)
Timeframe: Blood samples were taken at specific time points from pre-dose to 12 hours post first dose of Padsevonil for each Treatment Period

,,
Interventionng/mL (Geometric Mean)
Metabolite 1Metabolite 2
Padsevonil (Period 1) (PK-PPS)166.6110.5
Padsevonil (Period 2) (PK-PPS)158.794.47
Padsevonil and Erythromycin (Period 3b) (PK-PPS)189.5108.3

[back to top]

Fraction (fe) of Padsevonil and Metabolites (1, 2, and 3) Excreted Into the Urine for Single Dose

fe: The fraction of padsevonil or metabolites (1, 2, and 3) excreted into the urine for single dose. fe was expressed in percentage (%). (NCT03480243)
Timeframe: Urine samples were taken 0 to 12 hours post first dose of Padsevonil during each Treatment Period

,,
Interventionpercentage excreted (Geometric Mean)
PadsevonilMetabolite 1Metabolite 2Metabolite 3
Padsevonil (Period 1) (PK-PPS)0.039140.217010.5221.17
Padsevonil (Period 2) (PK-PPS)0.040540.24109.41919.96
Padsevonil and Erythromycin (Period 3b) (PK-PPS)0.049870.23859.76018.98

[back to top]

Fraction (fe) of Padsevonil and Metabolites (1, 2, and 3) Excreted Into the Urine for Multiple Doses

fe: The fraction of padsevonil and its metabolites (1, 2, and 3) excreted into the urine for multiple doses. fe was expressed in percentage (%). (NCT03480243)
Timeframe: Urine samples were taken 0 to 12 hours, 12 to 24 hours,and 24 to 48 hours post last PSL dose during Treatment Period 1 and 2; 0 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours post last dose of PSL during Treatment Period 3

,,
Interventionpercentage excreted (Geometric Mean)
PadsevonilMetabolite 1Metabolite 2Metabolite 3
Padsevonil (Period 1) (PK-PPS)0.058250.604915.0251.52
Padsevonil (Period 2) (PK-PPS)0.057410.670015.0647.50
Padsevonil and Erythromycin (Period 3b) (PK-PPS)0.12740.844313.1556.69

[back to top]

Formation Clearance (CLform) of Padsevonil Metabolites (1, 2, and 3) in the Urine for Single Dose

CLform: The formation clearance of padsevonil metabolites (1, 2, and 3) in the urine for single dose. CLform was expressed in milliliters per hour (mL/hour). (NCT03480243)
Timeframe: Urine samples were taken 0 to 12 hours post first dose of Padsevonil during each Treatment Period

,,
InterventionmL/hour (Geometric Mean)
Metabolite 1Metabolite 2Metabolite 3
Padsevonil (Period 1) (PK-PPS)151.9736514820
Padsevonil (Period 2) (PK-PPS)153.4599412700
Padsevonil and Erythromycin (Period 3b) (PK-PPS)92.5937887367

[back to top]