Page last updated: 2024-12-08

butylscopolammonium bromide

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

Description

Butylscopolammonium Bromide: Antimuscarinic quaternary ammonium derivative of scopolamine used to treat cramps in gastrointestinal, urinary, uterine, and biliary tracts, and to facilitate radiologic visualization of the gastrointestinal tract. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID6852391
CHEMBL ID1256901
CHEBI ID32123
SCHEMBL ID25291
MeSH IDM0003107

Synonyms (113)

Synonym
MLS002153372
(-)-scopolamine n-butyl bromide
MLS000069755 ,
smr000058795
(1r,2r,4s,5s,7s)-9-butyl-7-{[(2s)-3-hydroxy-2-phenylpropanoyl]oxy}-9-methyl-3-oxa-9-azoniatricyclo[3.3.1.0~2,4~]nonane bromide
butylscopolammonium bromide
(-)-scopolamine n-butyl bromide, >=98% (tlc), powder
149-64-4
n-butylscopolammonium bromide
scopolamine n-butyl bromide
buscolysine
buscapine
scobutyl
scopolamine butobromide
stilbron
n-butylscopolaminium bromide
1-alpha-h,5-alpha-h-tropanium, 8-butyl-6-beta,7-beta-epoxy-3-alpha-hydroxy-, bromide, (-)-tropate
hyoscine butobromide
scopolan
hyoscine butyl bromide
amisepan
hyoscine-n-butyl bromide
buscol
3-oxa-9-azoniatricyclo(3.3.1.02,4)nonane, 9-butyl-7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9-methyl-, bromide, (7(s)-(1alpha,2beta,4beta,5alpha,7beta))-
monospan
sporamin
butylscopolamine bromide [jan]
buscolamin
joscine
scopolamine butyl bromide
donopon
butylhyoscine
scopolamine bromobutylate
hyoscine butylbromide
n-butylhyoscine bromide
butylmin
n-butylhyoscinium bromide
tirantil
scopolamine n-n-butylbromide
hyoscin-n-butylbromid [german]
n-butylscopolamine bromide
buscapina
scobron
buscolysin
scobro
scobutil
einecs 205-744-1
sparicon
hyoscin-n-butyl bromide
buscopan
scoburen
CHEMBL1256901
scopolamine butylbromide
scopolamine n-butylbromide
stibron
dtxsid1022718 ,
tox21_112031
cas-149-64-4
dtxcid102718
HMS2235K20
AKOS016009548
unii-0gh9jx37c8
hyoscin-n-butylbromid
0gh9jx37c8 ,
(-)-n-butylscopolamine bromide
(-)-scopolamine butylbromide
hyoscine butylbromide [who-dd]
hyoscine butylbromide [mart.]
scopolamine butylbromide [jan]
hyoscine butylbromide [ep monograph]
butylscopolamine bromide [green book]
3-oxa-9-azoniatricyclo(3.3.1.0 sup(2,4))nonane, 9-butyl-7-((2s)-3-hydroxy-1-oxo-2-phenylpropoxy)-9-methyl-, bromide (1:1),(1.alpha.,2.beta.,4.beta.,5.alpha.,7.beta.)-
n-butylscopolammonium bromide [mi]
CCG-208412
HY-N0340
CS-3142
SCHEMBL25291
tox21_112031_1
NCGC00186628-02
MLS006013629
smr004705104
AC-34139
OPERA_ID_556
mfcd00078561
scopolamine (butylbromide)
SR-01000759230-3
scopinal
hyoscin butobromide
hyocimax
(2r,4s,5s,7s)-9-butyl-7-{[(2s)-3-hydroxy-2-phenylpropanoyl]oxy}-9-methyl-3-oxa-9-azoniatricyclo[3.3.1.0(2,4)]nonane bromide
buscogast
CHEBI:32123 ,
spasler-p
antipan
hybrocare
buskolamin
spasmin
hyoscine butylbromide, european pharmacopoeia (ep) reference standard
butylscopolamin
J-008603
HMS3714I19
hyoscine butylbromide, british pharmacopoeia (bp) reference standard
F17660
hyoscine butylbromide; (-)-scopolamine butylbromide; butylscopolamine bromide
HMS3884J15
A884250
AKOS037515799
[(1s,2s,4r,5r)-9-butyl-9-methyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonan-7-yl] (2s)-3-hydroxy-2-phenylpropanoate;bromide
EN300-7394481
(1r,2r,4s,5s,7r)-9-butyl-7-{[(2s)-3-hydroxy-2-phenylpropanoyl]oxy}-9-methyl-3-oxa-9-azatricyclo[3.3.1.0,2,4]nonan-9-ium bromide
AS-78017
PD087140
(-)-scopolamine-n-butylbromide

Research Excerpts

Toxicity

A combination of butylscopolammonium bromide and metamizole sodium may be useful to ameliorate the adverse effects of imidocarb dipropionate in horses.

ExcerptReferenceRelevance
" exerts an adequate spasmolytic effect and is a safe drug without troublesome side effects."( Action and side effects of small doses of buscopan in gastroduodenal radiography. A prospective study in 300 patients.
Dommerholt, O; Hüpscher, DN, 1984
)
0.27
" Only three adverse effects of light intensity were found without needing treatment, related to the manifestations of gastralgia and sleepiness."( [Analgesic-antispasmodic effect and safety of lysine clonixinate and L-hyoscinbutylbromide in the treatment of dysmenorrhea].
de la Jara Díaz, J; Hernández Bueno, JA; Llorens Torres, F; Sedeño Cruz, F, 1998
)
0.3
"To evaluate the ability of atropine sulfate, butylscopolammonium bromide combined with metamizole sodium, and flunixin meglumine to ameliorate the clinical adverse effects of imidocarb dipropionate in horses."( Evaluation of the use of atropine sulfate, a combination of butylscopolammonium bromide and metamizole sodium, and flunixin meglumine to ameliorate clinical adverse effects of imidocarb dipropionate in horses.
Abutarbush, SM; Al-Majali, AM; Alfaqeeh, SM; Mustafa, G; Qura'n, L, 2013
)
0.39
"Imidocarb dipropionate use in the control group was associated with serious adverse effects including signs of abdominal pain (4/7 horses) and diarrhea (2/7)."( Evaluation of the use of atropine sulfate, a combination of butylscopolammonium bromide and metamizole sodium, and flunixin meglumine to ameliorate clinical adverse effects of imidocarb dipropionate in horses.
Abutarbush, SM; Al-Majali, AM; Alfaqeeh, SM; Mustafa, G; Qura'n, L, 2013
)
0.39
"A combination of butylscopolammonium bromide and metamizole sodium may be useful to ameliorate the adverse effects of imidocarb dipropionate in horses, although group size was small and significant differences from the control group were not found."( Evaluation of the use of atropine sulfate, a combination of butylscopolammonium bromide and metamizole sodium, and flunixin meglumine to ameliorate clinical adverse effects of imidocarb dipropionate in horses.
Abutarbush, SM; Al-Majali, AM; Alfaqeeh, SM; Mustafa, G; Qura'n, L, 2013
)
0.39
" The percentage of patients with at least one adverse event was lower in the HBB group than in the anisodamine group (13."( Comparison of efficacy and safety of hyoscine butylbromide versus anisodamine for acute gastric or intestinal spasm-like pain: A randomized, double-blinded, multicenter Phase III trial.
Du, YQ; Guo, XZ; Hou, XH; Jiang, F; Li, ZS; Wang, RQ; Xu, H; Zeng, Y; Zhu, CP, 2017
)
0.46
" Both drugs were safe and well tolerated."( Comparison of efficacy and safety of hyoscine butylbromide versus anisodamine for acute gastric or intestinal spasm-like pain: A randomized, double-blinded, multicenter Phase III trial.
Du, YQ; Guo, XZ; Hou, XH; Jiang, F; Li, ZS; Wang, RQ; Xu, H; Zeng, Y; Zhu, CP, 2017
)
0.46
" Hemodynamic changes, adverse events, and discomfort levels of patients were similar between the two groups."( Antiperistaltic effect and safety of L-menthol for esophagogastroduodenoscopy in the elderly with contraindication to hyoscine-N-butylbromide.
Chen, LK; Chen, PH; Hou, MC; Huang, YH; Lin, MH; Peng, LN; Yang, TC, 2022
)
0.72

Pharmacokinetics

ExcerptReferenceRelevance
" However, there were no significant differences in pharmacokinetic parameters including T(max), cumulative urinary excretion rates of CTIZ and cumulative urinary excretion rates of pivaloylcarnitine for 12 h after the dosing between the pretreated and control groups."( Effects of gastrointestinal stimulant and suppressant pretreatment on the pharmacokinetics of AS-924, a novel ester-type cephem antibiotic.
Kano, T; Kitamura, T; Mori, N; Sakai, A; Shimada, J; Sugihara, T; Yamaji, S; Yanagawa, A; Yano, K, 2001
)
0.31
"The influence of synthetic drugs prescribed for peptic ulcer on the pharmacokinetic fate of glycyrrhizin (GL) from Shaoyao-Gancao-tang (SGT, a traditional Chinese formulation, Shakuyaku-Kanzo-to in Japanese) was investigated in rats."( The influence of commonly prescribed synthetic drugs for peptic ulcer on the pharmacokinetic fate of glycyrrhizin from Shaoyao-Gancao-tang.
Akao, T; He, JX; Nishino, T; Tani, T, 2001
)
0.31
" There was some, but very limited, absorption of butylscopolamine, with rapid elimination from plasma with a mean half-life of 2 hr."( The pharmacokinetics of orally administered butylscopolamine in greyhound dogs.
Colgan, S; Gower, S; Hudson, S; Morris, T; Paine, SW; Pittorino, M; Viljanto, M, 2018
)
0.48

Bioavailability

ExcerptReferenceRelevance
" Thanks to their typical physico-chemical characteristics, they are poorly absorbed by the systemic circulation and generally remain in the gastrointestinal tract where they exert the muscle relaxant activity by a local activity."( Quaternary ammonium derivatives as spasmolytics for irritable bowel syndrome.
Evangelista, S, 2004
)
0.32
" The bioavailability of hyoscine butylbromide, estimated from renal excretion, was generally <1%."( Hyoscine butylbromide: a review of its use in the treatment of abdominal cramping and pain.
Tytgat, GN, 2007
)
0.34
" These differences in the disintegration and drug dissolution might cause differences in the bioavailability of the drug."( [Comparison in dissolution behavior of ethical and over-the counter scopolamine butylbromide].
Kagawa, Y; Miyazaki, Y; Suzuki, I; Uchino, T, 2011
)
0.37
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51

Dosage Studied

ExcerptRelevanceReference
" The drug led to successful results in 77 to 85 per cent of patients in the dosage used (40 mg), the intravenous route proving the most efficient."( Hyoscine-N-butylbromide (Buscopan) as a duodenal relaxant in tubeless duodenography.
Ayre-Smith, G, 1976
)
0.26
" Depending on the dosage the effect of stimulation can be diminished or abolished by atropine as well as by Buscopan."( [Cholinergic contraction of the dog urinary bladder by electrical stimulation of the n. pelvicus and the ligamenta lateralia nerves and its affection by atropine and scopolaminebutylbromide (author's transl)].
Bauer, R; Wick, H, 1976
)
0.26
" Pupillary reaction is little affected by either dosage, and the pupil diameters at the end of the reaction are only slightly greater after the injection of either dosage than after placebo injection."( The effect of anticholinergic drugs on the inner eye muscles.
Bleichert, A; Mehlfeld, G, 1986
)
0.27
"Heart-rate responses to intravenous hyoscine butylbromide, atropine and physiological saline in cumulative dosage regimens have been recorded in six healthy subjects."( Dose-response relationships of intravenous hyoscine butylbromide and atropine sulphate on heart rate in healthy volunteers.
Grainger, SL; Smith, SE, 1983
)
0.27
" However, there were no significant differences in pharmacokinetic parameters including T(max), cumulative urinary excretion rates of CTIZ and cumulative urinary excretion rates of pivaloylcarnitine for 12 h after the dosing between the pretreated and control groups."( Effects of gastrointestinal stimulant and suppressant pretreatment on the pharmacokinetics of AS-924, a novel ester-type cephem antibiotic.
Kano, T; Kitamura, T; Mori, N; Sakai, A; Shimada, J; Sugihara, T; Yamaji, S; Yanagawa, A; Yano, K, 2001
)
0.31
" The number of pain episodes, analgesic dosage and the number of days of spontaneous passage of the calculi through the ureter were also recorded."( Efficacy of three different alpha 1-adrenergic blockers and hyoscine N-butylbromide for distal ureteral stones.
Canat, L; Caskurlu, T; Gurbuz, MC; Kilic, M; Polat, H,
)
0.13
" We recorded patient characteristics, hemodynamic profiles, effect-site propofol concentration upon LOC, total propofol dosage for colonoscopy, and colonoscopy outcomes."( The hemodynamic effect of an intravenous antispasmodic on propofol requirements during colonoscopy: A randomized clinical trial.
Chen, JP; Chung, KC; Hu, WH; Hung, KC; Juang, SE; Lee, KC; Lu, HF; Pao, YY; Tan, PH, 2014
)
0.4
"261) nor total propofol dosage required for colonoscopy (3."( The hemodynamic effect of an intravenous antispasmodic on propofol requirements during colonoscopy: A randomized clinical trial.
Chen, JP; Chung, KC; Hu, WH; Hung, KC; Juang, SE; Lee, KC; Lu, HF; Pao, YY; Tan, PH, 2014
)
0.4
"The hemodynamic responses to intravenous Buscopan neither affected the effect-site propofol concentration needed to induce LOC, nor the total propofol dosage required for colonoscopy in this study."( The hemodynamic effect of an intravenous antispasmodic on propofol requirements during colonoscopy: A randomized clinical trial.
Chen, JP; Chung, KC; Hu, WH; Hung, KC; Juang, SE; Lee, KC; Lu, HF; Pao, YY; Tan, PH, 2014
)
0.4
"The aim of this study is to assess the current situation in out of hospital pain management in Germany regarding the substances, indications, dosage and the delegation of the use of analgesics to emergency medical service (EMS) staff."( Application of analgesics in emergency services in Germany: a survey of the medical directors.
Scharonow, M; Scharonow, O; Vilcane, S; Weilbach, C, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Protein Targets (8)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Chain A, Beta-lactamaseEscherichia coli K-12Potency6.30960.044717.8581100.0000AID485341
USP1 protein, partialHomo sapiens (human)Potency8.91250.031637.5844354.8130AID743255
nuclear receptor subfamily 1, group I, member 3Homo sapiens (human)Potency2.98490.001022.650876.6163AID1224838
cytochrome P450 2D6Homo sapiens (human)Potency2.75400.00108.379861.1304AID1645840
IDH1Homo sapiens (human)Potency16.36010.005210.865235.4813AID686970
chromobox protein homolog 1Homo sapiens (human)Potency89.12510.006026.168889.1251AID540317
gemininHomo sapiens (human)Potency1.99530.004611.374133.4983AID624297
lamin isoform A-delta10Homo sapiens (human)Potency0.00890.891312.067628.1838AID1487
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Bioassays (80)

Assay IDTitleYearJournalArticle
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1508629Cell Viability qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
AID1508628Confirmatory 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.
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.
AID1508627Counterscreen qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: GLuc-NoTag assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
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.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
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.
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.
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.
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.
AID496827Antimicrobial activity against Leishmania amazonensis2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496826Antimicrobial activity against Entamoeba histolytica2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496825Antimicrobial activity against Leishmania mexicana2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID79530Inhibitory effect on the response of isolated ileum to acetylcholine (anti-ACh activity) in guinea pig was determined1982Journal of medicinal chemistry, Oct, Volume: 25, Issue:10
Synthesis and spasmolytic activities of 2-(1,2-benzisoxazol-3-yl)-3-[[omega-(dialkylamino)alkoxy]phenyl]acrylonitriles.
AID496820Antimicrobial activity against Trypanosoma brucei2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID409954Inhibition of mouse brain MAOA2008Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21
Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
AID496829Antimicrobial activity against Leishmania infantum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496830Antimicrobial activity against Leishmania major2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID133063Percent inhibition of the charcoal meal transfer in mice(100 mg/kg).1982Journal of medicinal chemistry, Oct, Volume: 25, Issue:10
Synthesis and spasmolytic activities of 2-(1,2-benzisoxazol-3-yl)-3-[[omega-(dialkylamino)alkoxy]phenyl]acrylonitriles.
AID496832Antimicrobial activity against Trypanosoma brucei rhodesiense2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496831Antimicrobial activity against Cryptosporidium parvum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496817Antimicrobial activity against Trypanosoma cruzi2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID697852Inhibition of electric eel AChE at 2 mg/ml by Ellman's method2012Bioorganic & medicinal chemistry, Nov-15, Volume: 20, Issue:22
Exploration of natural compounds as sources of new bifunctional scaffolds targeting cholinesterases and beta amyloid aggregation: the case of chelerythrine.
AID496828Antimicrobial activity against Leishmania donovani2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496818Antimicrobial activity against Trypanosoma brucei brucei2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496821Antimicrobial activity against Leishmania2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496819Antimicrobial activity against Plasmodium falciparum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496824Antimicrobial activity against Toxoplasma gondii2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496823Antimicrobial activity against Trichomonas vaginalis2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID497005Antimicrobial activity against Pneumocystis carinii2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID521220Inhibition of neurosphere proliferation of mouse neural precursor cells by MTT assay2007Nature chemical biology, May, Volume: 3, Issue:5
Chemical genetics reveals a complex functional ground state of neural stem cells.
AID697853Inhibition of horse BChE at 2 mg/ml by Ellman's method2012Bioorganic & medicinal chemistry, Nov-15, Volume: 20, Issue:22
Exploration of natural compounds as sources of new bifunctional scaffolds targeting cholinesterases and beta amyloid aggregation: the case of chelerythrine.
AID79532Inhibitory effect on the response of isolated ileum to transmural electrical stimulation in guinea pig (anti-TMS activity) was determined1982Journal of medicinal chemistry, Oct, Volume: 25, Issue:10
Synthesis and spasmolytic activities of 2-(1,2-benzisoxazol-3-yl)-3-[[omega-(dialkylamino)alkoxy]phenyl]acrylonitriles.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
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 (643)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990242 (37.64)18.7374
1990's107 (16.64)18.2507
2000's132 (20.53)29.6817
2010's119 (18.51)24.3611
2020's43 (6.69)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials165 (23.74%)5.53%
Reviews31 (4.46%)6.00%
Case Studies43 (6.19%)4.05%
Observational5 (0.72%)0.25%
Other451 (64.89%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (93)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide: Randomized Double Blind Placebo Controlled Trial [NCT04682860]Phase 450 participants (Actual)Interventional2021-09-08Completed
Open-label, Dose-escalating, Non-randomized, Single-Center Study to Determine the Safety and Pharmacokinetic Profiles of Scopolamine in Healthy Volunteers [NCT03874130]Phase 1130 participants (Anticipated)Interventional2018-08-01Recruiting
A Double-blind Randomized Placebo Controlled Comparison of Scopolamine With Cinnarizin for Prevention of Simulator Sickness [NCT01198106]100 participants (Anticipated)Interventional2009-09-30Recruiting
Use of Buscopan in Patients Undergoing IVF/Intracytoplasmic Sperm Injection Treatment With High and Low Uterine Contraction Frequency Prior to Embryo Transfer: A Prospective Double-blinded Randomized Controlled Trial [NCT04751084]1,039 participants (Anticipated)Interventional2020-05-30Recruiting
A Randomized, Double-Blind, Sponsor Unblinded, Placebo- And Positive- Controlled Study To Evaluate The Effects Of Single Oral Administrations Of PF-04995274, Alone Or In Combination With Donepezil, On Scopolamine-Induced Deficits In Psychomotor And Cognit [NCT01345864]Phase 188 participants (Actual)Interventional2011-05-31Terminated(stopped due to See termination reason in detailed description.)
Efficacy and Safety of Hyoscine-n-butylbromide for the Alleviation of Early Catheter-related Bladder Discomfort After Elective Cesarean Delivery: a Randomized Controlled Trial [NCT03513250]92 participants (Actual)Interventional2018-05-30Completed
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety, Efficacy and Pharmacokinetics of DPI-386 Nasal Gel for the Prevention and Treatment of Nausea Associated With Motion Sickness in Senior Subjects With Open-Label Follow-Up [NCT03988530]Phase 398 participants (Actual)Interventional2019-06-07Completed
A Five-Period, Placebo-Controlled, Crossover Study to Evaluate the Effect of Donepezil and MK-3134 on Reversal of Cognitive Impairment Associated With a Single-Dose of Scopolamine. [NCT01181310]Phase 131 participants (Actual)Interventional2007-06-30Completed
Absolute Bioavailability/Pharmacokinetic and Residual Drug Analysis of the Transderm Scōp System in Healthy Adults [NCT03029650]Phase 426 participants (Actual)Interventional2016-11-30Completed
A Randomized, Double-Blind, Sponsor Unblinded, Placebo-Controlled, 5-Period Crossover, Phase 1b Study To Evaluate The Effects Of Single Oral Administration of TAK-071 On Scopolamine-Induced Cognitive Impairment In Healthy Subjects [NCT02918266]Phase 118 participants (Actual)Interventional2016-11-21Terminated(stopped due to Terminated prematurely due to indication change.)
Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy [NCT03435003]Phase 4104 participants (Actual)Interventional2017-08-28Completed
National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Escócia Association in the Treatment of Acute Pain [NCT04666701]Phase 20 participants (Actual)Interventional2023-02-28Withdrawn(stopped due to Strategy review)
Is the Application of Scopolamine Patch With or Without Intra-operative Acupressure Point P6 Stimulation More Effective Than Intra-operative Acupressure Point P6 Stimulation Alone? [NCT02960113]Phase 4240 participants (Actual)Interventional2016-05-31Completed
Assessment of Cholinergic and Cognitive Function Using Pharmacologic ASL-Perfusion MRI [NCT01379001]60 participants (Actual)Interventional2008-07-31Completed
Development of a Diagnostic Tool for Alzheimer's Disease [NCT02273895]29 participants (Actual)Interventional2004-04-30Completed
Cholinergic Modulation of Cognition and Emotion in Mood Disorders: Functional Neuroimaging Studies [NCT00055575]Phase 2197 participants (Actual)Interventional2003-02-27Terminated
The Use of Propofol/Ketamine Anesthesia With Bispectral Monitoring (PKA-BIS) Versus Inhalational Anesthetics in Rhytidoplasty - A Prospective, Double-blinded, Randomized Comparison Study [NCT02410460]30 participants (Actual)Interventional2013-09-30Completed
Celecoxib Versus Hyoscine Butyl-bromide in Reducing Pain Perception During Copper T380A Intrauterine Device Insertion: a Randomized Double-blind Controlled Trial [NCT03499743]105 participants (Actual)Interventional2018-04-20Completed
A Single Center, Single-dose, Double-blind, Randomized, Two Period Crossover, Two Stage Design to Determine Bioequivalence of Two Formulations Containing Hyoscine Butylbromide 10mg Sugar Coated Tablets, Under Fasting Conditions [NCT02516098]Phase 156 participants (Actual)Interventional2015-10-31Completed
Observational Prospective Cohort Study to Evaluate the Incidence of Adverse Events (AE), Risk Factors, and Drug Utilization Patterns Related to Treatment With BUSCAPINA COMPOSITUM N From March to December 2016 in Patients From Metropolitan Lima [NCT02910167]360 participants (Actual)Observational2016-10-15Completed
Buscopan® Plus, Buscopan®, Paracetamol and Placebo: Double-blind Randomized Group Comparison to Investigate the Efficacy and Tolerability of the Film-coated Tablets in Patients With Painful Gastric or Intestinal Spasms [NCT02229786]Phase 21,637 participants (Actual)Interventional1998-02-28Completed
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of Defender Pharmaceuticals Inc, (DPI)-386 Nasal Gel on Ocean-Going Vessels for the Prevention and Treatment of Nausea Associated With Motion Sickness [NCT03920644]Phase 3320 participants (Anticipated)Interventional2019-04-30Recruiting
A Double-blind, Controlled, Randomized Study Comparing Escitalopram Combined With Scopolamine or Escitalopram in Patients With Major Depressive Disorder [NCT03131050]Phase 466 participants (Actual)Interventional2017-03-15Completed
The Safety and Efficacy of Naltrexone and Scopolamine Utilized in Combination in the Treatment of Major Depression: A Double Blinded, Randomized, Controlled Pilot Study [NCT03386448]Phase 414 participants (Actual)Interventional2018-01-01Completed
A Randomized, Double-Blind, Sponsor Unblinded, Placebo Controlled, 5-Way, Crossover Study To Evaluate The Effects Of Single Oral Administrations of PF-05212377 (SAM-760), A 5-HT6 Antagonist, On Scopolamine Induced Deficits In Psychomotor And Cognitive Fun [NCT01213355]Phase 138 participants (Actual)Interventional2011-04-30Completed
Assessment of Analgesic Efficacy and Safety of Intravenous Hyoscine-N-Butylbromide in Patients With Abdominal Colic Associated With Acute Gastroenteritis; a Randomized, Double-blind, Placebo Controlled Study [NCT02508142]Phase 4126 participants (Anticipated)Interventional2015-07-31Recruiting
A Randomised Double-Blinded Placebo-Controlled Trial to Assess the Efficacy and Safety of Scopolamine Compared to Placebo in Individuals With Bipolar Disorder Who Are Experiencing a Depressive Episode [NCT04211961]Phase 250 participants (Anticipated)Interventional2021-03-23Recruiting
A Randomised Trial for Postoperative Pain After Rectal Misoprostol or Rectal Hyoscine Administration [NCT03359655]120 participants (Actual)Interventional2018-06-11Completed
A Randomised, Double-blind, Placebo-controlled Study to Assess Pharmacokinetics, Safety and Tolerability of Single Rising Oral Doses (20 mg, 60 mg, 100 mg, 200 mg and 400 mg) and Multiple Rising Oral Doses (3 x 20 mg, 3 x 60 mg and 3 x 100 mg Per Day) of [NCT02261077]Phase 160 participants (Actual)Interventional2007-05-31Completed
Efficacy and Safety of Hyoscine N Butyl Bromide on the Augmentation of Labor: a Double-Blind, Placebo - Controlled Trial [NCT02098889]Phase 4382 participants (Actual)Interventional2012-05-31Completed
Effect of Buscopan on Gastrointestinal Imaging Quality With Probe-based Confocal Laser Endomicroscopy [NCT02725398]150 participants (Anticipated)Interventional2013-12-31Recruiting
A Randomized, Double-Blind Placebo-Controlled Phase 3 Study of the Safety, Pharmacokinetics, and Efficacy of DPI 386 Nasal Gel for the Prevention of Nausea Associated With Motion Sickness [NCT04219982]Phase 2/Phase 323 participants (Actual)Interventional2018-06-29Terminated(stopped due to Failure to meet enrollment)
A Clinical Analysis of Scopolamine Hydrobromide in Probe-based Confocal Laser Endomicroscopy for Gastroendoscopy Examination [NCT02811341]Phase 1122 participants (Actual)Interventional2014-08-31Completed
Prophylactic Use of Iv Hyoscine Butylbromide for Prevention of Bradycardia During Cesarean Section Under Spinal Anaesthesia. a Randomized Controlled Trial [NCT04069078]Phase 4173 participants (Actual)Interventional2019-10-10Completed
Efficacy of Mefenamic Acid and Hyoscine for Pain Relief During Saline Infusion Sonohysterography in Infertile Women. A Double Blind Randomized Controlled Trial [NCT01060696]138 participants (Anticipated)Interventional2009-01-31Active, not recruiting
The Antidepressant Efficacy of the Anticholinergic Scopolamine [NCT00369915]Phase 217 participants (Actual)Interventional2006-08-31Terminated
A Feasibility Study of Glycopyrrolate in Comparison to Hyoscine Hydrobromide and Placebo in the Treatment of Hypersalivation Induced by Clozapine [NCT02613494]Phase 1/Phase 229 participants (Actual)Interventional2016-01-25Completed
[NCT00646061]Phase 10 participants Interventional2007-11-30Completed
Hyoscine Hydrobromide (Buscopan) Versus Acetaminophen for Acute Abdominal Pain in Children: A Randomized Controlled Trial [NCT02582307]Phase 3236 participants (Actual)Interventional2017-03-20Completed
Toward a Computationally-Informed, Personalized Treatment for Hallucinations [NCT04366518]Early Phase 135 participants (Anticipated)Interventional2021-07-15Recruiting
A Randomized Double Blinded Placebo-controlled Trial to Compare the Effect of Hyoscine-N-butyl Bromide (HBB) or Celecoxib Administered Alone Versus in Combination to Reduce Pain in Patients Undergoing Office Hysteroscopy. [NCT05911126]180 participants (Anticipated)Interventional2023-06-13Not yet recruiting
Study the Effect of Intravenous Hyoscine Butylbromide Injection on the Duration and Progress of First Stage Labour in High Risk Women [NCT03055390]Phase 4300 participants (Actual)Interventional2017-02-11Completed
A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of DPI-386 Nasal Gel on Ocean Going Vessels for the Prevention and Treatment of Nausea Associated With Motion Sickness [NCT03986905]Phase 3300 participants (Actual)Interventional2019-04-26Completed
Randomized Clinical Trial of Oral Hyoscine Butyl Bromide With Cervical Lidocaine Cream in Reducing Pain During Hysterosalpingography [NCT02710305]Phase 2140 participants (Actual)Interventional2016-04-30Completed
Randomized Clinical Trial of Oral Hyoscine Butyl Bromide in Reducing Pain During HSG [NCT02709603]Phase 4200 participants (Actual)Interventional2016-03-31Completed
Cholinergic Decontextualization of Exposure Therapy for Anxiety [NCT01900301]Phase 160 participants (Actual)Interventional2013-08-31Completed
Effect of Hyoscine- Bromide on Duration of the First Stage of Labor [NCT06056869]60 participants (Anticipated)Interventional2023-09-27Recruiting
Nebulizer Delivery of Intranasal Scopolamine [NCT04999449]Phase 130 participants (Anticipated)Interventional2022-01-24Recruiting
Randomized Clinical Trial of Oral Hyoscine Butyl Bromide Versus Diclofenac Potassium in Reducing Pain During Office Hysteroscopy [NCT02714699]Phase 2/Phase 3129 participants (Actual)Interventional2016-10-31Completed
A Randomized Controlled Trial of 2 Different Methods for Pain Relief During Intrauterine Device Insertion [NCT02714231]Phase 4100 participants (Actual)Interventional2016-03-31Completed
BUSCLAB - A Double Blind Randomized Placebo-Controlled Trial Investigating the Effect of Intravenous Butylscopolamine Bromide to Prevent Slow Progress in Labor [NCT03961165]Phase 3250 participants (Actual)Interventional2019-05-25Completed
[NCT02839213]Phase 2400 participants (Actual)Interventional2015-10-31Completed
A Randomized, Single-center, Crossover, Comparative Bioavailability and Adhesion Performance Study, Comparing Single Administrations of a New Scopolamine Transdermal Delivery System Formulation to the Currently Established Reference Transdermal Delivery S [NCT02839135]Phase 1128 participants (Actual)Interventional2016-05-13Completed
Use of Hyoscine Butyl Bromide for Management of Prolonged Labor in Nulliparous Women, A Randomized Controlled Trial [NCT01854073]Phase 3500 participants (Anticipated)Interventional2014-02-28Recruiting
A Randomized, Double-blind, Placebo-controlled, Single-dose, 6-Period Crossover Study to Evaluate the Effects of BPN14770 on Scopolamine-induced Cognitive Impairment in Healthy Volunteers [NCT03030105]Phase 138 participants (Actual)Interventional2017-01-31Completed
Effects of Transdermal Scopolamine on Occupational Performance [NCT00374478]Phase 233 participants Interventional2005-04-30Completed
INtervention for Cognitive Reserve Enhancement in Delaying the Onset of Alzheimer's Symptomatic Expression: The INCREASE Study [NCT02849639]Early Phase 190 participants (Actual)Interventional2017-04-04Completed
A Randomized, Double-blind Comparison of Oral Aprepitant Alone vs Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting [NCT00717054]115 participants (Actual)Interventional2008-02-29Completed
The Effect of Hyoscine Butyl Bromide on the First Stage of Labor in Term Pregnancies [NCT00409890]Phase 2120 participants Interventional2005-06-30Completed
Hyoscine Butyl-bromide Versus Ondansetron for Nausea and Vomiting During Cesarean Section Under Spinal Anesthesia: A Randomized Clinical Trial [NCT04785118]Phase 4165 participants (Actual)Interventional2021-10-01Completed
The Effects of Preoperative Scopolamine Patch Application on the Postoperative Nausea and Vomiting in Microvascular Decompression Surgery [NCT02968082]Phase 460 participants (Anticipated)Interventional2016-11-30Not yet recruiting
A Randomized, Double-blind Comparison of Oral Aprepitant Alone Versus Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting [NCT00659737]115 participants (Actual)Interventional2008-04-30Completed
Behavioral and Pharmacological Manipulation of Time Cell Activity in the Human Mesial Temporal Lobe [NCT05594017]Early Phase 160 participants (Anticipated)Interventional2019-08-01Recruiting
4FMFES Positron Emission Tomography (PET) for Detection of Newly-diagnosed ER+ Endometrial and Ovarian Cancers [NCT04823065]Phase 1/Phase 272 participants (Anticipated)Interventional2018-09-01Recruiting
Does Hyoscine N-butylbromide Administered During Colonoscopy Increase the Polyp Detection Rate? a Randomized, Single Center, Double Blind, Placebo-controlled Study [NCT01609855]Phase 4400 participants (Anticipated)Interventional2012-01-31Recruiting
Whole-body Diffusion MRI for Staging, Response Prediction and Detecting Tumor Recurrence in Patients With Ovarian Cancer [NCT01657747]350 participants (Actual)Interventional2011-11-30Completed
A Pilot Study of the Use of IV Scopolamine to Augment the Efficacy of Electroconvulsive Therapy (ECT) [NCT01312844]Phase 27 participants (Actual)Interventional2010-04-30Terminated(stopped due to This was an inpatient study, but PI left inpatient service at MGH)
Patient-controlled Sedation With Propofol Versus Combined Sedation During Bronchoscopy - a Randomized Controlled Trial [NCT03357393]150 participants (Actual)Interventional2016-04-04Completed
A Double-blind Randomized Placebo-controlled Four-arm Trial to Assess the Efficacy of Oral Bicarbonate and Intravenous Butylscopolamine Bromide to Facilitate Spontaneous (Non-operative) Delivery in Pregnant Female Participants With Induction of Labor [NCT05719467]Phase 33,000 participants (Anticipated)Interventional2023-01-03Recruiting
Effect of Intravenous Hyoscine Butylbromide Injection on the Course and Duration of First Stage of Labour in Primigavidae [NCT02824679]Phase 4200 participants (Actual)Interventional2015-07-31Completed
A Randomised Control Study: The Effect of Hyoscine-N-butylbromide (HBB, Buscopan) in Augmented Labour Among Primigravidae [NCT04349722]Phase 4110 participants (Actual)Interventional2019-12-01Completed
A Randomized, Controlled Trial of Adding Intravenous Pantoprazole to Conventional Treatment for the Immediate Relief of Dyspeptic Pain [NCT01281501]Phase 487 participants (Actual)Interventional2011-01-31Completed
Combination of Anticholinergic and Glutamatergic Effects in Treatment-resistant Major Depressive Disorder. A Pilot Study [NCT01613820]0 participants (Actual)Interventional2015-09-30Withdrawn(stopped due to Lack of funding)
A Randomized, Double-blind, Independent 3rd Party Unblind, Active-controlled, Parallel-group, Multi-center Trial, in Contrast With Anisodamine (654-II), 10mg, to Evaluate the Efficacy and Safety of Buscopan® Solution for Injection, 20mg (Intramuscularly) [NCT01929044]Phase 3299 participants (Actual)Interventional2013-08-31Completed
A Randomized, Double-blind, Double-dummy, Active-controlled, Parallel-group, Multi-center Trial, in Contrast With Hyoscine Butylbromide Capsule 10mg, to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Tablets 10 mg (20mg, 3 Times Daily, Orally) [NCT02242305]Phase 3302 participants (Actual)Interventional2008-11-01Completed
Pharmacokinetic and Efficacy Profile of Low-Dose Intranasal Scopolamine Spray for Motion Sickness [NCT02155309]Phase 2/Phase 363 participants (Actual)Interventional2014-06-30Terminated(stopped due to Business reason)
Effect Of Intravenous Hyoscine -N-Butyl Bromide In Management Of Prolonged Labor In Nulliparous [NCT03430362]100 participants (Actual)Interventional2018-03-02Completed
A Randomized, Double-Blind, Placebo Controlled, 4-Period, Cross-Over Study to Evaluate the Effects of Single Oral Administrations of Roflumilast in Combination With Donepezil on Reversing Scopolamine (Hyoscine) Induced Deficits in Psychomotor and Cognitiv [NCT02051335]Phase 127 participants (Actual)Interventional2014-01-31Completed
Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis [NCT02625181]27,034 participants (Actual)Interventional2016-07-31Completed
Reclassifying Constipation Using Magnetic Resonance Imaging Combined With High Resolution Manometry: A Validation Study And Double-Blind Crossover Trial [NCT03226145]120 participants (Anticipated)Interventional2017-07-20Recruiting
A Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Study To Evaluated The Safety, Tolerability, and Pharmacokinetics Of Intramuscular Administration Of Scopolamine Hydrobromide Trihydrate, Injection [NCT04314713]Phase 132 participants (Actual)Interventional2020-06-02Terminated(stopped due to DSMB decision due to adverse events)
A Double-blind, Placebo-controlled, Randomized, Parallel Group Study of the Efficacy and Safety of Oral Doses of 20 mg Hyoscine Butylbromide When Used On-demand up to 7 Episodes Over a Period of 6 Weeks for the Treatment of Occasional Episodes of Self-rep [NCT02242292]Phase 2527 participants (Actual)Interventional2006-04-30Completed
A National, Multicenter, Randomized, Double-blind, Double-dummy, Phase III, Crossover Study to Assess the Efficacy and Safety of CDE100 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea. [NCT05640232]Phase 3238 participants (Anticipated)Interventional2023-09-30Not yet recruiting
A Trial to Evaluate Target Occupancy of Scopolamine at the Muscarinic M1 Receptor [NCT06014385]Phase 16 participants (Anticipated)Interventional2024-01-31Not yet recruiting
Relative Bioavailability Study to Investigate and to Compare Two Different Formulations of Hyoscine Butylbromide, Following Oral Administration in Healthy Male and Female Volunteers (an Open-label, Randomised, Single Dose, Two-way Crossover, Phase I Study [NCT01734902]Phase 130 participants (Actual)Interventional2012-11-01Completed
Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During ERCP: a Prospective, Multicenter Randomized Controlled Trial [NCT00731198]Phase 3650 participants (Actual)Interventional2008-08-31Completed
The Safety and Effectiveness of Cholinergic Receptor Block Therapy in the Treatment of Amyotrophic Lateral Sclerosis [NCT04391361]Phase 230 participants (Anticipated)Interventional2020-11-01Not yet recruiting
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of DPI-386 Nasal Gel Under Military Operational Conditions for the Prevention of Nausea Associated With Motion Sickness [NCT04272255]Phase 3300 participants (Anticipated)Interventional2019-04-22Recruiting
Cholinergic Correlates of Impaired Cognitive Ability in HIV-Associated Neurocognitive Disorders [NCT03244488]22 participants (Actual)Observational2015-12-31Completed
A Novel Usage of Transdermal Scopolamine in Reducing Narcotic Usage in Outpatient Hand Surgery [NCT04008264]74 participants (Actual)Observational2019-06-25Completed
Multimodal Analgesia Effect on Post Surgical Patient [NCT04240626]Phase 460 participants (Anticipated)Interventional2021-01-20Recruiting
Hyoscine Butylbromide Effect on Duration of Labor in Nulliparous Women: A Randomized, Double Blind, Controlled Trial [NCT03441217]218 participants (Actual)Interventional2019-07-12Completed
Optimizing the Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance [NCT05886660]Phase 230 participants (Anticipated)Interventional2022-01-21Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00369915 (2) [back to overview]Change in Depression Severity
NCT00369915 (2) [back to overview]Hamilton Anxiety Rating Scale
NCT00659737 (1) [back to overview]Number of Participants With Postoperative Nausea and Vomiting
NCT00717054 (4) [back to overview]Need for Antiemetic Medication
NCT00717054 (4) [back to overview]Number of Participants With Nausea and Vomiting
NCT00717054 (4) [back to overview]Number of Participants With Nausea and Vomiting in PACU
NCT00717054 (4) [back to overview]Total Vomiting
NCT00731198 (1) [back to overview]The Grades of the Number of Duodenal Contractions
NCT01281501 (4) [back to overview]Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment
NCT01281501 (4) [back to overview]Number of Participants That Have Overall Satisfaction on the Treatment
NCT01281501 (4) [back to overview]"Number of Participants in the Predefined Responders"
NCT01281501 (4) [back to overview]"Number of Participants in the Predefined Non-responders"
NCT01312844 (9) [back to overview]The Mean Levels of Physiological Measures of ECT (Blood Pressure)
NCT01312844 (9) [back to overview]Number of ECT Treatments Received to Achieve Response/Remission
NCT01312844 (9) [back to overview]Time to Response for Patients Receiving ECT
NCT01312844 (9) [back to overview]The Mean Number of Moderate to Severe Side Effects
NCT01312844 (9) [back to overview]The Mean Levels of Physiological Measures of ECT (Seizure Duration)
NCT01312844 (9) [back to overview]The Mean Levels of Physiological Measures of ECT (Energy Needed)
NCT01312844 (9) [back to overview]The Mean Levels of Physiological Measures of ECT (Heart Rate)
NCT01312844 (9) [back to overview]Change in Ham D 17 Scores
NCT01312844 (9) [back to overview]Number of ECT Treatments Withheld Due to Cognitive Impairment
NCT01734902 (3) [back to overview]Maximum Measured Concentration of the Hyoscine Butylbromide in Plasma (Cmax)
NCT01734902 (3) [back to overview]Area Under the Concentration-time Curve of the Hyoscine Butylbromide in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
NCT01734902 (3) [back to overview]Area Under the Concentration-time Curve of the Hyoscine Butylbromide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞ )
NCT01929044 (7) [back to overview]PID From Pre-dose Baseline at 120 Minutes After First Injection.
NCT01929044 (7) [back to overview]PID From Pre-dose Baseline at 10 Minutes After First Injection.
NCT01929044 (7) [back to overview]Global Assessment of Efficacy by the Patient at 120 Minutes After the First Injection
NCT01929044 (7) [back to overview]Proportion of Patients Who Need the Second Injection
NCT01929044 (7) [back to overview]PID From Pre-dose Baseline at 60 Minutes After First Injection.
NCT01929044 (7) [back to overview]PID From Pre-dose Baseline at 30 Minutes After First Injection.
NCT01929044 (7) [back to overview]PID From Pre-dose Baseline at 20 Minutes After First Injection.
NCT02051335 (11) [back to overview]Change From Baseline in the Verbal Recall Memory (VRM) Total Number of Correct Responses for Delayed Recall at 1 Hour After Scopolamine Administration
NCT02051335 (11) [back to overview]Change From Baseline in the Verbal Recall Memory (VRM) Total Number of Correct Responses for Immediate Recall at 1 Hour After Scopolamine Administration
NCT02051335 (11) [back to overview]Percentage of Participants Who Experience at Least 1 Treatment Emergent Adverse Event (TEAE)
NCT02051335 (11) [back to overview]Percentage of Participants With Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post-Dose
NCT02051335 (11) [back to overview]Change From Baseline in the Paired Associates Learning (PAL) Total Number of Errors Adjusted at All Time-points Assessed After Scopolamine Administration
NCT02051335 (11) [back to overview]Change From Baseline in the Rapid Visual Information Processing (RVP) Median Latency at All Time-points Assessed After Scopolamine Administration
NCT02051335 (11) [back to overview]Change From Baseline in the Spatial Working Memory (SWM) Total Number of Between Errors at the 10-Box Stage and the 12-Box Stage at All Time-points Assessed After Scopolamine Administration
NCT02051335 (11) [back to overview]Change From Baseline in the Verbal Recall Memory (VRM) Total Number of Correct Responses for Immediate and Delayed Recall at 2 and 4 Hours After Scopolamine Administration
NCT02051335 (11) [back to overview]Percentage of Participants With Markedly Abnormal Safety Laboratory Tests
NCT02051335 (11) [back to overview]Percentage of Participants With Markedly Abnormal Vital Sign Measurements at Least Once Post-dose
NCT02051335 (11) [back to overview]Change From Baseline in the Rapid Visual Information Processing (RVP) A Prime Signal Detection at All Time-points Assessed After Scopolamine Administration
NCT02155309 (1) [back to overview]Efficacy: Number of Head Movements During Rotation
NCT02242305 (7) [back to overview]Number of Patients With Adverse Events
NCT02242305 (7) [back to overview]Global Assessment of Efficacy by Patient on 4-point Scale
NCT02242305 (7) [back to overview]Global Assessment of Tolerability by Investigator on a 4-point Scale
NCT02242305 (7) [back to overview]Change of the Pain Frequency Assessed on 4-stage Verbal Rating Scale (VRS)
NCT02242305 (7) [back to overview]Change of the Mean Pain Intensity Score Measured on a Visual Analogue Scale (VAS) Within 3 Days (and Within 1 Day) - ANCOVA
NCT02242305 (7) [back to overview]Percentage of Event for Time to Therapeutic Effect
NCT02242305 (7) [back to overview]Number of Subjects With Clinical Relevant Abnormalities for Laboratory, Vital Signs, ElectroCardioGram (ECG) and Physical Examination
NCT02516098 (4) [back to overview]Area Under the Curve, for the Test Product, to the Time of the Maximum Concentration of the Reference Product and the Test Product (AUCReftmax)
NCT02516098 (4) [back to overview]Maximum Observed Plasma Concentration of Hyoscine Butylbromide (Cmax)
NCT02516098 (4) [back to overview]Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC0-∞).
NCT02516098 (4) [back to overview]AUC Time Zero to Times of Last Quantifiable Concentration (AUC 0-t)
NCT02625181 (4) [back to overview]PONV Incidence: Number of Participants With Postoperative Nausea and Vomiting
NCT02625181 (4) [back to overview]The Number of Prophylactic Interventions for PONV
NCT02625181 (4) [back to overview]Time to Discharge From the Postanesthesia Care Unit (PACU)
NCT02625181 (4) [back to overview]Adherence to PONV Guidelines
NCT02849639 (5) [back to overview]Trail Making Test B With the Scopolamine Patch
NCT02849639 (5) [back to overview]Cognitive Reserve: California Verbal Learning Test
NCT02849639 (5) [back to overview]Cognitive Reserve: Montreal Cognitive Assessment
NCT02849639 (5) [back to overview]Medication Appropriateness Index
NCT02849639 (5) [back to overview]Perceived Health Status
NCT02910167 (5) [back to overview]Percentage of Patients With an Incidence of Adverse Event (AE) Associated to Potential Liver Damage During the Clinical Evaluation of Patients
NCT02910167 (5) [back to overview]Percentage of Patients With Different Transaminase Levels Found by the Doctor During the Clinical Evaluation of Patients With Symptoms Related to Potential Liver Damage.
NCT02910167 (5) [back to overview]Percentage of Patients With Different Variables Related to the Occurrence of Increase of Transaminases in Patients Under Treatment With Buscapina Compositum N
NCT02910167 (5) [back to overview]Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima
NCT02910167 (5) [back to overview]Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment
NCT02918266 (10) [back to overview]Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Electrocardiogram (ECG) at Least Once Postdose
NCT02918266 (10) [back to overview]T1/2z: Terminal Disposition Phase Elimination Half-Life in Plasma for TAK-071
NCT02918266 (10) [back to overview]Tmax: Time to Reach the Maximum Observed Plasma Concentration(Cmax) for TAK-071
NCT02918266 (10) [back to overview]Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Postdose
NCT02918266 (10) [back to overview]Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)
NCT02918266 (10) [back to overview]AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-071
NCT02918266 (10) [back to overview]AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Postdose for TAK-071
NCT02918266 (10) [back to overview]AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-071
NCT02918266 (10) [back to overview]Cmax: Maximum Observed Plasma Concentration for TAK-071
NCT02918266 (10) [back to overview]Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Postdose
NCT02960113 (11) [back to overview]Number of Patients With Vomiting After the Administration of the Regional Anesthesia Medications
NCT02960113 (11) [back to overview]Level of Nausea Upon Arrival to the Post-operative Recovery Room
NCT02960113 (11) [back to overview]Level of Nausea After the Administration of the Regional Anesthesia Medications
NCT02960113 (11) [back to overview]Level of Nausea After Replacement of the Uterus
NCT02960113 (11) [back to overview]Number of Patients With Nausea
NCT02960113 (11) [back to overview]Number of Patients With Vomiting Upon Arrival to the Post-operative Recovery Room
NCT02960113 (11) [back to overview]Level of Nausea After Eversion of the Uterus
NCT02960113 (11) [back to overview]Satisfaction With Intraoperative Antiemetic Treatment
NCT02960113 (11) [back to overview]Number of Patients With Vomiting After Replacement of the Uterus
NCT02960113 (11) [back to overview]Number of Patients With Vomiting After Eversion of the Uterus
NCT02960113 (11) [back to overview]Number of Patients With Vomiting
NCT03029650 (7) [back to overview]Determination of Area Under the Serum Concentration-time Curve (AUC)
NCT03029650 (7) [back to overview]Measurement of Elimination Rate Constant of Scopolamine (Kel)
NCT03029650 (7) [back to overview]Measurement of Maximum Serum Concentration of Scopolamine (Cmax)
NCT03029650 (7) [back to overview]Measurement of Time of Maximum Serum Scopolamine Concentration (Tmax)
NCT03029650 (7) [back to overview]Residual Drug Analysis in Worn TDDS
NCT03029650 (7) [back to overview]Measurement of Volume of Scopolamine Distribution (V)
NCT03029650 (7) [back to overview]Assessment of Scopolamine Clearance (CL)
NCT03357393 (7) [back to overview]Patients' Satisfaction Using a Likert-type Scale
NCT03357393 (7) [back to overview]Number of Participants With Interventions Performed
NCT03357393 (7) [back to overview]Assessment of Self-rated Patient Questionaries' Using S-PSR
NCT03357393 (7) [back to overview]Discharge Assessment Using PADSS After 2 Hours Number of Patients Reaching PADSS Score 10 After 2 Hours
NCT03357393 (7) [back to overview]Level of Sedation Using the Observer's Assessment of Alertness/Sedation (OAA/S) Scale
NCT03357393 (7) [back to overview]Quality of Recovery (QoR-23)
NCT03357393 (7) [back to overview]Bronchoscopist Evaluation Using a Likert-type Scale
NCT03386448 (1) [back to overview]Response to Medications as Assessed by Change in Score on Modified MDRS Scale From Baseline to End of Study Period

Change in Depression Severity

The Montgomery-Asberg Depression Rating Scale (MADRS) has a range of scores from 0 to 60 where the highest values indicate the most depression. (NCT00369915)
Timeframe: Outcome measures obtained at each of 12 sessions

,
Interventionunits on a scale (Mean)
Block 1 - Session 1Block 1 - Session 2Block 1 - Session 3Block 1 - Session 4Block 1 - Session 5Block 1 - Session 6Block 2 - Session 1Block 2 - Session 2Block 2 - Session 3Block 2 - Session 4Block 2 - Session 5Block 2 - Session 6
Plac/Scop29.526.524.519.519.320.823.318.019.81816.315.5
Scop/Plac30.529.831.027.027.828.527.523.820.017.316.820.3

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Hamilton Anxiety Rating Scale

The Hamilton Anxiety Rating Scale (HARS) has a range of scores from 0 to 56 where the highest values indicate the most anxiety. (NCT00369915)
Timeframe: Each of 12 sessions.

,
Interventionunits on a scale (Mean)
Block 1 - Session 1Block 1 - Session 2Block 1 - Session 3Block 1 - Session 4Block 1 - Session 5Block 1 - Session 6Block 2 - Session 1Block 2 - Session 2Block 2 - Session 3Block 2 - Session 4Block 2 - Session 5Block 2 - Session 6
Plac/Scop17.016.814.514.312.817.814.813.314.310.59.811.8
Scop/Plac20.314.514.313.012.011.513.512.013.314.310.311.8

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Number of Participants With Postoperative Nausea and Vomiting

(NCT00659737)
Timeframe: 0-24 hours

Interventionparticipants (Number)
Aprepitant and Placebo Transdermal Patch28
Aprepitant and Scopolamine Transdermal Patch34

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Need for Antiemetic Medication

(NCT00717054)
Timeframe: 24 hours postoperatively

Interventionparticipants (Number)
Aprepitant and Scopolamine Group23
Aprepitant and Scopolamine Placebo Group21

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Number of Participants With Nausea and Vomiting

(NCT00717054)
Timeframe: 24 hours postoperatively

Interventionparticipants (Number)
Aprepitant and Scopolamine Group24
Aprepitant and Placebo Scopolamine Group29

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Number of Participants With Nausea and Vomiting in PACU

(NCT00717054)
Timeframe: Postoperatively, up to 2 hours

Interventionparticipants (Number)
Aprepitant and Scopolamine Group35
Aprepitant and Placebo Scopolamine Group39

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Total Vomiting

(NCT00717054)
Timeframe: 24 hours postoperatively

Interventionparticipants (Number)
Aprepitant and Scopolamine Group5
Aprepitant and Scopolamine Placebo Group2

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The Grades of the Number of Duodenal Contractions

a duodenal motility grade was determined as follows: 0 = no motility; 1 = less than five contractions/minute; 2 = 5 to 10/minute; 3 = 11 to 15/minute; 4 = continuous. (NCT00731198)
Timeframe: Intra-procedure

Interventionscores on a scale (Mean)
Experimental1.13
Active Comparator1.17

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Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment

"Post-treatment VAS will be consecutively measured every 15 minutes until 1 hour after treatment. Minimal and maximal VAS score of every measurement is 0 to 100 millimeters. VAS scores at 1 hour after treatment were the primary outcome measurement. The patients who had <50% decrement between pre- and 1-hour post-treatment VAS or post-treatment scores > 40 millimeters were defined as Non-responders(worse outcome). In the same way, those who had ≥ 50% decrement between pre- and 1-hour post-treatment VAS and post-treatment scores≤ 40 millimeters were defined as Responders (good outcome)." (NCT01281501)
Timeframe: 1 hour after treatment

Interventionmillimeter (Mean)
Conventional17
Pantoprazole19

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Number of Participants That Have Overall Satisfaction on the Treatment

The satisfaction will be assessed by a simple, self-reported yes/no question. (NCT01281501)
Timeframe: 1 hour after treatment

Interventionparticipants (Number)
Conventional34
Pantoprazole34

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"Number of Participants in the Predefined Responders"

"Responders define the participants who have ≥ 50% decrease in post-treatment pain scores compared with the pre-treatment evaluation and also have the post-treatment scores ≤ 40 at the end of the study." (NCT01281501)
Timeframe: pretreatment and 1 hour after treatment

Interventionparticipants (Number)
Conventional36
Pantoprazole32

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"Number of Participants in the Predefined Non-responders"

"Non-responders defined the participants who had < 50% decrease in post-treatment VAS compared with pre-treatment evaluation or post-treatment scores > 40 at the end of the study." (NCT01281501)
Timeframe: pretreatment and 1 hour after treatment

Interventionparticipants (Number)
Conventional8
Pantoprazole11

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The Mean Levels of Physiological Measures of ECT (Blood Pressure)

Blood pressure was taken immediately post ECT administration at each ECT visit. We averaged Blood pressure for each participant at each ECT administration. The reported mean refers to the average among all participants in each group. (NCT01312844)
Timeframe: Duration of ECT treatment (usually 2 weeks)

,
InterventionmmHg (Mean)
Systolic blood pressure immediately post ECTDiastolic Blood Pressure Immediately Post ECT
Placebo131.0578.80
Scopolamine170.3587.41

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Number of ECT Treatments Received to Achieve Response/Remission

The number of ECT treatments needed to achieve response (defined as a HAM D score less than half of baseline) and remission (defined as a HAM D score of less than 8). If patients HAM D score rose above these markers at any point in the study, they were not considered as responding or remitting.The HAM D 17 measures severity of depression with 52 being most severe and 0 being no depression. (NCT01312844)
Timeframe: Duration of ECTtreatment (usually 2 weeks)

,
Intervention# of ECT administrations (Mean)
# of ECT administrations to response# of ECT administrations to remission
Placebo2.506.50
Scopolamine2.3310.00

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Time to Response for Patients Receiving ECT

The number of days between baseline HAM D score and HAM D score showing response (defined as a HAM D score less than half of baseline). If patients HAM D score rose above this marker at any point in the study, they were not considered as responding.The HAM D 17 measures severity of depression with 52 being most severe and 0 being no depression. . (NCT01312844)
Timeframe: Duration of ECT treatment (usually 2 weeks)

Interventiondays (Mean)
Scopolamine8.33
Placebo5.00

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The Mean Number of Moderate to Severe Side Effects

The mean number of adverse events classified as moderate to severe. (NCT01312844)
Timeframe: Duration of ECT treatment (usually 2 weeks)

Interventionnumber of side effects (Mean)
Scopolamine.75
Placebo0

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The Mean Levels of Physiological Measures of ECT (Seizure Duration)

Mean duration in seconds of the seizure induced by ECT for each participant at each ECT administration they received.The reported mean refers to the average among all participants in each group. (NCT01312844)
Timeframe: Duration of ECT treatment (usually 2 weeks)

Interventionseconds (Mean)
Scopolamine30.25
Placebo31.89

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The Mean Levels of Physiological Measures of ECT (Energy Needed)

Mean energy needed to induce the seizure for each participant at each ECT administration they received. The reported mean refers to the average among all participants in each group. (NCT01312844)
Timeframe: Duration of ECT treatment (usually 2 weeks)

Interventionjoules (Mean)
Scopolamine73.83
Placebo67.06

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The Mean Levels of Physiological Measures of ECT (Heart Rate)

Heart rate was taken immediately post ECT administration at each ECT visit. We averaged heart rate for each participant at each ECT administration. The reported mean refers to the average among all participants in each group. (NCT01312844)
Timeframe: Duration of ECT treatment (usually 2 weeks)

InterventionBeats per minute (Mean)
Scopolamine69.24
Placebo86.20

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Change in Ham D 17 Scores

Change in Ham D 17 scores measured by the difference between baseline HAM D score and HAM D score at last ECT administration. The HAM D 17 measures severity of depression with 52 being most severe and 0 being no depression. A negative change score refers to a decrease in HAM D score, while a positive change score would refer to an increase in HAM D score. (NCT01312844)
Timeframe: At the time of ECT completion (about 2 weeks)

Interventionunits on a scale (Mean)
Scopolamine-17.50
Placebo-14.00

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Number of ECT Treatments Withheld Due to Cognitive Impairment

The number of ECT treatments withheld during the course of the study due to cognitive impairment. In these cases, the participant would still be enrolled in the study but have a reduced # of ECTs. This outcome measure does not include patients who withdrew from the study. (NCT01312844)
Timeframe: Duration of ECT treatment (usually 2 weeks)

InterventionECT Treatments withheld (Mean)
Scopolamine0
Placebo0

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Maximum Measured Concentration of the Hyoscine Butylbromide in Plasma (Cmax)

Cmax, maximum measured concentration of the hyoscine butylbromide in plasma. (NCT01734902)
Timeframe: Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.

InterventionPicogram/millilitre [pg/mL] (Geometric Mean)
Hyoscine Butylbromide Drops (T)70.3
Buscopan® Tablet (R)77.1

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Area Under the Concentration-time Curve of the Hyoscine Butylbromide in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

AUC0-tz, area under the concentration-time curve of the hyoscine butylbromide in plasma over the time interval from 0 to the last quantifiable data point (NCT01734902)
Timeframe: Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.

InterventionPicogram*hour/millilitre [pg*h/mL] (Geometric Mean)
Hyoscine Butylbromide Drops (T)564.0
Buscopan® Tablet (R)608.0

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Area Under the Concentration-time Curve of the Hyoscine Butylbromide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞ )

AUC0-∞, area under the concentration-time curve of the hyoscine butylbromide in plasma over the time interval from 0 extrapolated to infinity (NCT01734902)
Timeframe: Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.

InterventionPicogram*hour/millilitre [pg*h/mL] (Geometric Mean)
Hyoscine Butylbromide Drops (T)623.0
Buscopan® Tablet (R)668.0

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PID From Pre-dose Baseline at 120 Minutes After First Injection.

Pain intensity difference (PID) from pre-dose baseline at 120 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = 'no pain' to 10 = 'worst pain possible'. (NCT01929044)
Timeframe: Baseline and 120 minutes after the first injection

InterventionUnits on a scale (Least Squares Mean)
Buscopan® (Hyoscine Butylbromide)-6.46
654-II (Anisodamine)-6.01

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PID From Pre-dose Baseline at 10 Minutes After First Injection.

Pain intensity difference (PID) from pre-dose baseline at 10 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = 'no pain' to 10 = 'worst pain possible'. (NCT01929044)
Timeframe: Baseline and 10 minutes after the first injection

InterventionUnits on a scale (Least Squares Mean)
Buscopan® (Hyoscine Butylbromide)-2.64
654-II (Anisodamine)-2.33

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Global Assessment of Efficacy by the Patient at 120 Minutes After the First Injection

"Global assessment of efficacy by the patient. The patient was to assess the efficacy at 120 min after the first injection using a 4-point rating scale by answering the question: How would you rate the effect of the study medication for relieving your acute gastric or intestinal spasm-like pain? (0 = poor; 1 = fair; 2 = good; 3 = very good)." (NCT01929044)
Timeframe: 120 minutes after the first injection

,
InterventionPercentage of Patients (Number)
Very GoodGoodFairPoor
654-II (Anisodamine)22.044.129.14.7
Buscopan® (Hyoscine Butylbromide)22.559.218.30.0

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Proportion of Patients Who Need the Second Injection

Proportion of patients who need the second injection at 20 minutes after the first injection. (NCT01929044)
Timeframe: 20 minutes after the first injection.

InterventionPercentage of Patients (Number)
Buscopan® (Hyoscine Butylbromide)24.6
654-II (Anisodamine)33.9

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PID From Pre-dose Baseline at 60 Minutes After First Injection.

Pain intensity difference (PID) from pre-dose baseline at 60 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = 'no pain' to 10 = 'worst pain possible'. (NCT01929044)
Timeframe: Baseline and 60 minutes after the first injection

InterventionUnits on a scale (Least Squares Mean)
Buscopan® (Hyoscine Butylbromide)-5.96
654-II (Anisodamine)-5.51

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PID From Pre-dose Baseline at 30 Minutes After First Injection.

Pain intensity difference (PID) from pre-dose baseline at 30 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = 'no pain' to 10 = 'worst pain possible'. (NCT01929044)
Timeframe: Baseline and 30 minutes after the first injection

InterventionUnits on a scale (Least Squares Mean)
Buscopan® (Hyoscine Butylbromide)-5.14
654-II (Anisodamine)-4.74

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PID From Pre-dose Baseline at 20 Minutes After First Injection.

Pain intensity difference (PID) from pre-dose baseline at 20 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = 'no pain' to 10 = 'worst pain possible'. (NCT01929044)
Timeframe: Baseline and 20 minutes after the first injection

InterventionUnits on a scale (Least Squares Mean)
Buscopan® (Hyoscine Butylbromide)-4.09
654-II (Anisodamine)-3.66

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Change From Baseline in the Verbal Recall Memory (VRM) Total Number of Correct Responses for Delayed Recall at 1 Hour After Scopolamine Administration

VRM measures the ability to encode and subsequently retrieve verbal information. This task begins with the first presentation phase in which 18 words are shown in turn on the screen. The participant is then asked to recall as many words as possible during the first immediate recall phase. The same 18 words are then shown in a second presentation phase which is followed by a second immediate recall phase. After a delay of approximately 20-30 minutes, a delayed recall stage is completed. The possible range of correct responses is 0 (worst) to 18 (best). Higher number of correct responses in the test indicates a better outcome. A negative change from baseline indicates a worsening of the score. (NCT02051335)
Timeframe: Baseline and 1 hour after scopolamine administration on Day 1 of each treatment period. Baseline is defined as the assessment 1 hour before roflumilast/donepezil administration (3 hours before scopolamine administration).

Interventioncorrect responses (Mean)
A: Placebo-6.7
B: Donepezil 10 mg-7.0
C: Roflumilast Dose A-7.4
D: Roflumilast Dose A + Donepezil 10 mg-6.6

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Change From Baseline in the Verbal Recall Memory (VRM) Total Number of Correct Responses for Immediate Recall at 1 Hour After Scopolamine Administration

VRM measures the ability to encode and subsequently retrieve verbal information. This task begins with the first presentation phase in which 18 words are shown in turn on the screen. The participant is then asked to recall as many words as possible during the first immediate recall phase. The possible range of correct responses is 0 (worst) to 18 (best). Higher number of correct responses in the test indicates a better outcome. A negative change from baseline indicates a worsening of the score. (NCT02051335)
Timeframe: Baseline and 1 hour after scopolamine administration on Day 1 of each treatment period.

Interventioncorrect responses (Mean)
A: Placebo-9.8
B: Donepezil 10 mg-7.7
C: Roflumilast Dose A-10.6
D: Roflumilast Dose A + Donepezil 10 mg-7.7

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Percentage of Participants Who Experience at Least 1 Treatment Emergent Adverse Event (TEAE)

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as any adverse event, regardless of relationship to study drug that occurs or worsens after the first dose of study drug and no more than 14 days after the last dose of study drug. (NCT02051335)
Timeframe: Day 1 up to Day 95

Interventionpercentage of participants (Number)
A: Placebo30.4
B: Donepezil 10 mg65.2
C: Roflumilast Dose A24.0
D: Roflumilast Dose A + Donepezil 10 mg51.9

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Percentage of Participants With Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post-Dose

The percentage of participants who meet markedly abnormal criteria specified by the protocol and statistical analysis plan=abnormal clinically significant. (NCT02051335)
Timeframe: Day 1 up to Day 95

Interventionpercentage of participants (Number)
A: Placebo0
B: Donepezil 10 mg0
C: Roflumilast Dose A0
D: Roflumilast Dose A + Donepezil 10 mg0

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Change From Baseline in the Paired Associates Learning (PAL) Total Number of Errors Adjusted at All Time-points Assessed After Scopolamine Administration

PAL assesses visuospatial associative learning and memory. Boxes are displayed on the screen and open in a randomised order to reveal a number of patterns. The patterns are then displayed in the middle of the screen, one at a time, and the participant must touch the box where the pattern was originally located. If the participant makes an error, the patterns are re-presented to remind the participant of their locations. If the participant has not responded correctly within six attempts, ie, one presentation and five re-presentations, the task is terminated. As the task progresses the difficulty level increases with the number of patterns to be remembered. For participants who fail to complete all levels, an adjusted total is calculated that takes into account errors predicted in the stages that were not attempted. The possible range for total errors is 0 (best) to 91 (worst). Fewer number of errors in the test indicates a better outcome. (NCT02051335)
Timeframe: Baseline and at 1, 2 and 4 hours after scopolamine administration on Day 1 of each treatment period.

,,,
Interventionerrors (Mean)
1 hour post Scopolamine2 hours post Scopolamine4 hours post Scopolamine
A: Placebo8.03.02.3
B: Donepezil 10 mg11.53.07.7
C: Roflumilast Dose A1.6-0.70.2
D: Roflumilast Dose A + Donepezil 10 mg7.52.93.1

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Change From Baseline in the Rapid Visual Information Processing (RVP) Median Latency at All Time-points Assessed After Scopolamine Administration

"RVP is a task of continuous performance and visual sustained attention. The task consists of a 2-minute practice stage and a 7-minute assessed stage. There is a white box in the centre of the screen in which single digits from 2 to 9 appear one at a time in a pseudo-random order at a rate of 100 digits per minute. Participants must detect target sequences of digits (2-4-6, 3-5-7, and 4-6-8) and touch a button when they see the last digit of a target sequence. Nine target sequences appear every 100 numbers. Assessment will be based on a median latency. The possible range for RVP median latency is 100 (worst) to 1900 (best). Higher number in the test indicates a better outcome. Median latency is a measure captured by computerized test measure and given as one time value (between 100 and 1900). The mean of these values is presented." (NCT02051335)
Timeframe: Baseline and at 1, 2 and 4 hours after scopolamine administration on Day 1 of each treatment period.

,,,
Interventionmsec (Mean)
1 hour post Scopolamine2 hours post Scopolamine4 hours post Scopolamine
A: Placebo10.6310.8313.13
B: Donepezil 10 mg-7.35-4.89-5.39
C: Roflumilast Dose A5.6210.623.90
D: Roflumilast Dose A + Donepezil 10 mg2.590.13-8.98

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Change From Baseline in the Spatial Working Memory (SWM) Total Number of Between Errors at the 10-Box Stage and the 12-Box Stage at All Time-points Assessed After Scopolamine Administration

SWM assesses the ability to retain spatial information and manipulate it in working memory. In this task, colored boxes are shown on the screen, and participants must search for blue tokens by touching the colored boxes to open them. When the blue token has been found the participant has to place the token in the black column ('home') on the right-hand side of the screen by touching this area. The participant must not return to a box where a token has previously been found. The task becomes more difficult as the number of boxes increases (one trial at each of 6-box and 8-box stages; three trials at each of 10-box and 12-box stages). Between Errors is the total number of times the participant revisits a box in which a token has previously been found in the same problem. The possible range of errors is 0 (best) to 1040 (worst). Lower number of errors in the test indicates a better outcome. (NCT02051335)
Timeframe: Baseline and at 1, 2 and 4 hours after scopolamine administration on Day 1 of each treatment period.

,,,
Interventionerrors (Mean)
1 hour post Scopolamine2 hours post Scopolamine4 hours post Scopolamine
A: Placebo23.828.431.1
B: Donepezil 10 mg25.713.419.7
C: Roflumilast Dose A31.729.632.8
D: Roflumilast Dose A + Donepezil 10 mg16.518.27.7

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Change From Baseline in the Verbal Recall Memory (VRM) Total Number of Correct Responses for Immediate and Delayed Recall at 2 and 4 Hours After Scopolamine Administration

VRM measures the ability to encode and subsequently retrieve verbal information. This task begins with the first presentation phase in which 18 words are shown in turn on the screen. The participant is then asked to recall as many words as possible during the first immediate recall phase. The same 18 words are then shown in a second presentation phase which is followed by a second immediate recall phase. After a delay of approximately 20-30 minutes, a delayed recall stage is completed. The possible range of correct responses is 0 (worst) to 18 (best). Higher number of correct responses in the test indicates a better outcome. A negative change from baseline indicates a worsening of the score. (NCT02051335)
Timeframe: Baseline and 2 and 4 hours after scopolamine administration on Day 1 of each treatment period.

,,,
Interventioncorrect responses (Mean)
Immediate Recall: 2 hours post ScopolamineImmediate Recall: 4 hours post ScopolamineDelayed Recall: 2 hours post ScopolamineDelayed Recall: 4 hours post Scopolamine
A: Placebo-10.1-8.3-6.3-5.5
B: Donepezil 10 mg-7.3-7.6-5.6-5.6
C: Roflumilast Dose A-9.9-7.9-6.8-5.9
D: Roflumilast Dose A + Donepezil 10 mg-6.5-6.1-5.9-5.3

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Percentage of Participants With Markedly Abnormal Safety Laboratory Tests

The percentage of participants with any markedly abnormal standard safety laboratory values, including hematology, serum chemistries, and urinalysis. LLN=lower limit of normal. ULN=upper limit of normal. (NCT02051335)
Timeframe: Day 1 up to Day 95

,,,
Interventionpercentage of participants (Number)
Hematocrit <0.8 x LLN (n=22,23,25,27)Hematocrit >1.2 x ULN (n=22,23,25,27)Hemoglobin <0.8 x LLN (n=22,23,25,27)Hemoglobin >1.2 x ULN (n=22,23,25,27)Platelet Count <75 x 10^3/μL (n=22,23,25,27)Platelet Count >600 x 10^3/μL (n=22,23,25,27)Red Blood Cells <0.8 x LLN (n=22,23,25,27)Red Blood Cells >1.2 x ULN (n=22,23,25,27)White Blood Cells <0.5 x LLN (n=22,23,25,27)White Blood Cells >1.5 x ULN (n=22,23,25,27)Alanine Aminotransferase >3 x ULNAlbumin <2.5 g/dLAlkaline Phosphatase >3 x ULNAspartate Aminotransferase >3xULNBlood Urea Nitrogen >10.7 mmol/LCalcium <1.75 mmol/LCalcium >2.88 mmol/LCreatine Kinase >5 x ULNCreatinine >2.0 mg/dLGamma Glutamyl Transpeptidase >3xULNPotassium <3.0 mmol/LPotassium >6.0 mmol/LSodium <130 mmol/LSodium >150 mmol/LTotal Bilirubin >2.0 mg/dLTotal Protein <0.8 x LLNTotal Protein >1.2 x ULN
A: Placebo000000000000000000000000000
B: Donepezil 10 mg000000000000000000000000000
C: Roflumilast Dose A000000000000000000000000000
D: Roflumilast Dose A + Donepezil 10 mg000000000000000000000000000

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Percentage of Participants With Markedly Abnormal Vital Sign Measurements at Least Once Post-dose

The percentage of participants who meet markedly abnormal criteria for vital signs, including oral body temperature, respiration rate, pulse, and resting blood pressure and after standing. (NCT02051335)
Timeframe: Day 1 up to Day 95

,,,
Interventionpercentage of participants (Number)
Pulse <50 bpmPulse >120 bpmSystolic Blood Pressure <85 mmHgSystolic Blood Pressure >180 mmHgDiastolic Blood Pressure <50 mmHgDiastolic Blood Pressure >110 mmHg
A: Placebo26.100000
B: Donepezil 10 mg21.70008.70
C: Roflumilast Dose A28.000000
D: Roflumilast Dose A + Donepezil 10 mg33.300011.10

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Change From Baseline in the Rapid Visual Information Processing (RVP) A Prime Signal Detection at All Time-points Assessed After Scopolamine Administration

RVP is a task of continuous performance and visual sustained attention. The task consists of a 2-minute practice stage and a 7-minute assessed stage. There is a white box in the centre of the screen in which single digits from 2 to 9 appear one at a time in a pseudo-random order at a rate of 100 digits per minute. Participants must detect target sequences of digits (2-4-6, 3-5-7, and 4-6-8) and touch a button when they see the last digit of a target sequence. Nine target sequences appear every 100 numbers. A prime (A') is a signal detection measure that reflects target sensitivity regardless of the participant's tendency, or bias, to respond. Detection sensitivity for RVP A' prime: 0 to 1. Lower numbers in the test indicates worsening in the performance. (NCT02051335)
Timeframe: Baseline and at 1, 2 and 4 hours after scopolamine administration on Day 1 of each treatment period.

,,,
Interventionunitless (Mean)
1 hour post Scopolamine2 hours post Scopolamine4 hours post Scopolamine
A: Placebo-0.0184-0.0297-0.0201
B: Donepezil 10 mg-0.0107-0.0151-0.0106
C: Roflumilast Dose A-0.0290-0.0315-0.0227
D: Roflumilast Dose A + Donepezil 10 mg-0.0157-0.0282-0.0114

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Efficacy: Number of Head Movements During Rotation

During rotation, efficacy is measured by the number of head movements subjects are able to make (12 per minute). While seated yaw-axis rotating, a pre-recorded computerized voice informed subjects to make paced head tilts of 30 ̊ to the right and left at a rate of 0.125 Hz (right, center, left, and back to center over 16 seconds). (NCT02155309)
Timeframe: 40 min

InterventionNumber of head tilts (Mean)
Head Tilts: Scopolamine ConditionHead Tilts: Placebo Condition
Efficacy: Scopolamine and Placebo (Crossover, Double-blind)222.5191.7

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Number of Patients With Adverse Events

The endpoint presents number of patients with Adverse Events (AEs). Subjects were required to report spontaneously any AEs as well as the time of onset, end and intensity of these events. Specific questions were asked wherever required or useful to more precisely describe an AE. An Adverse Event was termed serious when one of the following applied: death, directly lifethreatening, continuous or severe impairment, in-patient treatment or prolonging of hospitalization, congenital deformity and other similar medical criteria. (NCT02242305)
Timeframe: Up to 3 days.

,
InterventionParticipants (Number)
Subjects with AESubjects with treatment related AESubjects with Serious Adverse Event (SAE)AE leading to discontinuation from treatmentSubjects with AE: MildSubjects with AE: ModerateSubjects with AE: Severe
Hyoscine Butylbromide - Capsule105001000
Hyoscine Butylbromide - Tablet105011000

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Global Assessment of Efficacy by Patient on 4-point Scale

The endpoint presents global assessment of efficacy: by the patient after 3 days of treatment using a 4-point rating scale (good, satisfactory, not satisfactory, and bad). (NCT02242305)
Timeframe: Post 3 days of treatment.

,
InterventionParticipants (Number)
GoodSatisfactoryNot satisfactoryBad
Hyoscine Butylbromide - Capsule3576300
Hyoscine Butylbromide - Tablet3569372

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Global Assessment of Tolerability by Investigator on a 4-point Scale

The endpoint presents global assessment of tolerability by subject on a 4-point scale. Global assessment of tolerability regarding all episodes treated by the subject after 3 days of treatment (good, satisfactory, not satisfactory, bad). (NCT02242305)
Timeframe: Day 3.

,
InterventionParticipants (Number)
GoodSatisfactoryNot satisfactoryBad
Hyoscine Butylbromide - Capsule4772220
Hyoscine Butylbromide - Tablet5172211

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Change of the Pain Frequency Assessed on 4-stage Verbal Rating Scale (VRS)

"The endpoint presents frequency improvement, change of the pain frequency from baseline pain frequency for each of Day 1 - 3. Baseline pain frequency meant the pain frequency before randomization on visit 1. VRS score of Day 3 change from baseline was calculated. A retrospective assessment was entered by the patient in the patient diary, again once daily in the evening, of the pain frequency over the preceding 24 hour period. This was based on a 4-stage Verbal Rating Scale (VRS) with the following scores to the question: How many times have the spasm-like pains occurred today? 0 = not at all, 1 = 1-2 times, 2 = 3-5 times, 3 = more than 5 times." (NCT02242305)
Timeframe: Up to 3 days.

,
InterventionUnits on a scale (Mean)
Day 1-BaselineDay 3-Baseline
Hyoscine Butylbromide - Capsule-0.2-0.8
Hyoscine Butylbromide - Tablet-0.4-1.0

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Change of the Mean Pain Intensity Score Measured on a Visual Analogue Scale (VAS) Within 3 Days (and Within 1 Day) - ANCOVA

"The endpoint presents change of the mean Visual Analogue Scale (VAS) of pain intensity score, recorded daily by the patient in the evening in his/her patient diary describing pain intensity during the previous 24 hours, from the baseline pain intensity. The baseline pain intensity was the pain intensity of first episode on Day 1 after randomization before taking study medication. The mean VAS pain intensity score was calculated for the 3-day treatment period. A VAS for describing the pain intensity was used (VAS: maximum score of 10 cm, the score from 0 - 10 cm reaching from no pain to the most severe pain imaginable)." (NCT02242305)
Timeframe: 3 days (1 day)

,
InterventionUnits on a scale (Number)
Within 3 daysWithin 1 day
Hyoscine Butylbromide - Capsule-2.45-2.31
Hyoscine Butylbromide - Tablet-2.48-2.36

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Percentage of Event for Time to Therapeutic Effect

This outcome measure presents percentage of event for time to therapeutic effect defined as the time that the first VAS reduction occurred. (NCT02242305)
Timeframe: From time of the first dose to the time that the first VAS reduction occurred, up to 180 minutes after the first dose on Day 1.

InterventionPercentage of event (Number)
Hyoscine Butylbromide - Tablet93.6
Hyoscine Butylbromide - Capsule92.1

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Number of Subjects With Clinical Relevant Abnormalities for Laboratory, Vital Signs, ElectroCardioGram (ECG) and Physical Examination

Number of patients with findings in clinical relevant abnormalities for laboratory, vital signs, ElectroCardioGram (ECG) and physical examination. Relevant findings or worsening of baseline conditions were reported as Adverse Events (AEs). (NCT02242305)
Timeframe: Up to 3 days.

,
InterventionParticipants (Number)
Urinary White Bllood Cell count abnormalitiesUrinary Red Blood Cell count abnormalitiesUrinary albumin abnormalitiesWhite Blood Cell count abnormalitiesPlatelet count abnormalities
Hyoscine Butylbromide - Capsule21111
Hyoscine Butylbromide - Tablet42100

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Area Under the Curve, for the Test Product, to the Time of the Maximum Concentration of the Reference Product and the Test Product (AUCReftmax)

Area under the concentration-time curve of hyoscine butylbromide to the time of the maximum concentration of hyoscine butylbromide of the reference product (Buscopan®). This was calculated both for test and reference products. (NCT02516098)
Timeframe: Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter

Interventionh*pg/mL (Geometric Mean)
Buscopan® (REF)187
Buscapina® (T)170

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Maximum Observed Plasma Concentration of Hyoscine Butylbromide (Cmax)

The maximum measured concentration of hyoscine butylbromide in plasma. (NCT02516098)
Timeframe: Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter

Interventionpicogram (pg)/millilitre (mL) (Geometric Mean)
Buscopan® (REF)91
Buscapina® (T)80

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Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC0-∞).

The area under the concentration-time curve of hyoscine butylbromide in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). (NCT02516098)
Timeframe: Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter

Interventionh*pg/mL (Geometric Mean)
Buscopan® (REF)847
Buscapina® (T)760

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AUC Time Zero to Times of Last Quantifiable Concentration (AUC 0-t)

Area under the concentration-time curve of hyoscine butylbromide in plasma over the time interval from 0 to the last quantifiable data point (AUC0-t). (NCT02516098)
Timeframe: Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter

Interventionhour (h)*pg/mL (Geometric Mean)
Buscopan® (REF)807
Buscapina® (T)725

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PONV Incidence: Number of Participants With Postoperative Nausea and Vomiting

The occurrence of PONV, as defined by the administration of antiemetics in the PACU between admission to PACU and discharge from PACU. (NCT02625181)
Timeframe: PACU recovery period

InterventionParticipants (Count of Participants)
Baseline Measurement139
CDS Email Recommendations1323
CDS Email + Real TIme Recommenations1343

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The Number of Prophylactic Interventions for PONV

the absolute number of prophylactic interventions applied between the admission of the patient in the holding room until admission to the PACU. (NCT02625181)
Timeframe: A specific time frame on the day of surgery: from the start of admission at the holding room to the end of the anesthetic case

Interventionprophylactic antiemetics administered (Mean)
Baseline Measurement2.196
CDS Email Recommendations2.176
CDS Email + Real TIme Recommenations2.129

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Time to Discharge From the Postanesthesia Care Unit (PACU)

This is the number of minutes from admission to the PACU until discharge, assessed up to 2 days (NCT02625181)
Timeframe: A specific time frame on the day of surgery: from the start of admission to the PACU to discharge from the PACU

Interventionminutes (Mean)
Baseline Measurement266
CDS Email Recommendations264
CDS Email + Real TIme Recommenations266

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Adherence to PONV Guidelines

PONV guideline adherence: percentage of patients who received the exact number of prophylactic interventions for PONV that were recommended by the decision support. (NCT02625181)
Timeframe: A specific time frame on the day of surgery: the start of admission at the holding room to the end of the anesthetic case

InterventionParticipants (Count of Participants)
Baseline Measurement666
CDS Email Recommendations5260
CDS Email + Real TIme Recommenations5863

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Trail Making Test B With the Scopolamine Patch

End of study for Trail Making Test B with the scopolamine patch. The mean and standard used to compute the TMTB z-scores were taken from a sample of cognitively intact older adult research volunteers (Weintraub et al. 2009; mean = 90.3, SD = 50) (22). Z-scores were then multiplied by -1 to facilitate interpretation, since higher TMTB scores are worse. For the z-score, we converted time in seconds to units of standard deviations from a mean of 0, where 0 represents the mean performance of cognitively intact (normal) older adult research volunteers enrolled in longitudinal studies at Alzheimer's Disease Research Centers in the United States. Scores that are at least 1.5 standard deviations below the mean are indicative of potential cognitive impairment. (NCT02849639)
Timeframe: baseline to end of study, an average of 1 year

Interventionz-scores (Least Squares Mean)
Placebo-0.1
Medication Therapy Management (MTM)0.03

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Cognitive Reserve: California Verbal Learning Test

"Change from baseline to end of study for California Verbal Learning test. Z scores (higher scores are better; Z score = 0 corresponds mean CVLT score for cognitively normal older adults; typical neuropsych interpretation of z scores is that -1.5 indicates impaired performance on that test) are adjusted for age and sex and are based on the normative population used to develop norms for CVLT-II; individuals sampled to create the normative data were tested cross-sectionally, demographically matched to the most recent U.S. Censuses, and screened for self-reported neurological, psychiatric, or debilitating medical illnesses. Delis, D. C., Kramer, J. H., Kaplan, E., & Ober, B. A. (1987-2000). California Verbal Learning Test--Second Edition (CVLT -II) [Database record]. APA PsycTests.~https://doi.org/10.1037/t15072-000" (NCT02849639)
Timeframe: change from baseline to end of study, an average of 1 year

Interventionz-score (Least Squares Mean)
Placebo-0.10
Medication Therapy Management (MTM)-0.083

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Cognitive Reserve: Montreal Cognitive Assessment

Change from baseline to end of study for Montreal Cognitive Assessment. Z score is based on the NACC cognitively normal population (https://files.alz.washington.edu/documentation/weintraub-2018-v3.pdf), Z score = 0 corresponds mean MoCA score for cognitively normal older adults; higher Z scores are better; typical neuropsych interpretation of z scores is that -1.5 indicates impaired performance on that test. (NCT02849639)
Timeframe: change from baseline to end of study, an average of 1 year

Interventionz-score (Least Squares Mean)
Placebo-0.15
Medication Therapy Management (MTM)-0.31

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Medication Appropriateness Index

"Change from baseline to end of study. The Medication Appropriateness Index (MAI) rates medications as appropriate, marginally appropriate, or inappropriate based on ten criteria. All medications reported by study participants were evaluated by the study team and assigned a medication-specific MAI. As an outcome measure, the total MAI was obtained by adding the medication specific MAIs for all medications reported by the participant. Minimum score for one medication is 0 (appropriate) and the maximum is 18 (inappropriate for all criteria). Total MAI depends on the number of medications taken by participant. A decrease in MAI from baseline to end of study indicates improvement in medication appropriateness." (NCT02849639)
Timeframe: change from baseline to end of study, an average of 1 year

Interventionunits on a scale (Least Squares Mean)
Placebo11.2
Medication Therapy Management (MTM)9.4

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Perceived Health Status

Change from baseline to end of study for Short Form Health Survey (SF-36). T scores have a mean of 50 and SD of 10; higher scores are better; mean = 50 represents expected mean in general US adult population, with no available clinically relevant thresholds . (NCT02849639)
Timeframe: change from baseline to end of study, an average of 1 year

Interventiont-score (Least Squares Mean)
Placebo41.4
Medication Therapy Management (MTM)41.2

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Percentage of Patients With an Incidence of Adverse Event (AE) Associated to Potential Liver Damage During the Clinical Evaluation of Patients

Percentage of patients with an incidence of Adverse Event (AE) associated to potential liver damage during the clinical evaluation of patients. (NCT02910167)
Timeframe: From the initial dose of study drug until end of the follow up period, up to 113 days

InterventionPercentage of Patients (Number)
Buscapina Compositum N0.0

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Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima

Percentage of patients with different drug utilization patterns of Buscapina Compositum N in patients in Metropolitan Lima. (NCT02910167)
Timeframe: From the initial dose of study drug until end of the follow up period, up to 113 days

InterventionPercentage of Patients (Number)
Patient took the medication with liquids (Yes)Patient took the medication with liquids (No)Type of liquid used (Water)Type of liquid used (Juice)Type of liquid used (Other)Amount of liquid used (A straw/sip)Amount of liquid used (1/4 cup)Amount of liquid used (1/2 cup)Amount of liquid used (A full cup)Amount of liquid used (More than a cup)Storage of medicine (In a dry and fresh location)Storage of medicine (In a hot location)Storage of medicine (In the refrigerator)Storage of medicine (Other)Reason - Not taking medicine (No symptoms anymore)Reason - Not taking medicine (Forgot it)Reason - Not taking medicine (Had no time)Reason - Not taking medicine (Other)Reason - Not taking medicine (No answer)
Buscapina Compositum N100.00.094.782.90.33.833.044.718.198.00.30.01.851.423.45.612.27.5

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Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment

Percentage of patients per adverse event preferred term in patients who developed any adverse event during treatment with Buscapina Compositum N. (NCT02910167)
Timeframe: From the initial dose of study drug until end of the follow up period, up to 113 days

InterventionPercentage of Patients (Number)
Abdominal pain (upper)DiarrhoeaNauseaConstipationAbdominal PainDizzinessSomnolenceCoughUrine color abnormalHeadache + nauseaNausea + constipationFlatulence + constipationPolydipsia + abdominal pain (upper)
Buscapina Compositum N0.30.30.30.30.30.31.20.30.30.30.30.30.3

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Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Electrocardiogram (ECG) at Least Once Postdose

(NCT02918266)
Timeframe: Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1

Interventionpercentage of participants (Number)
Part 1: TAK-071 80 mg + Scopolamine 0.5 mg16.7
Part 2: Treatment A0
Part 2: Treatment B50.0
Part 2: Treatment C0
Part 2: Treatment D0
Part 2: Treatment E50.0

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T1/2z: Terminal Disposition Phase Elimination Half-Life in Plasma for TAK-071

(NCT02918266)
Timeframe: Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose

Interventionhours (Mean)
Part 1: TAK-071 80 mg + Scopolamine 0.5 mg47.02

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Tmax: Time to Reach the Maximum Observed Plasma Concentration(Cmax) for TAK-071

(NCT02918266)
Timeframe: Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose

Interventionhours (Median)
Part 1: TAK-071 80 mg + Scopolamine 0.5 mg30.00

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Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Postdose

(NCT02918266)
Timeframe: Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1

,,,,,
Interventionpercentage of participants (Number)
Diastolic Blood Pressure (mmHg)/Supine <50 mmHgPulse rate/supine: <50 beats per minuteTemperature: <35.6 CelsiusTemperature: >37.7 Celsius
Part 1: TAK-071 80 mg + Scopolamine 0.5 mg033.3016.7
Part 2: Treatment A033.300
Part 2: Treatment B050.000
Part 2: Treatment C0033.30
Part 2: Treatment D0000
Part 2: Treatment E050.000

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Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)

(NCT02918266)
Timeframe: Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1

Interventionpercentage of participants (Number)
Scopolamine 0.5 mg SC + TAK-071 80 mg66.7
Part 2: Treatment A66.7
Part 2: Treatment B100.0
Part 2: Treatment C100.0
Part 2: Treatment D100.0
Part 2: Treatment E100.0

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AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-071

(NCT02918266)
Timeframe: Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose

Interventionh*ng/mL (Geometric Mean)
Part 1: TAK-071 80 mg + Scopolamine 0.5 mg94100

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AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Postdose for TAK-071

(NCT02918266)
Timeframe: Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 24 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 24 hours) post-scopolamine dose

Interventionh*ng/mL (Geometric Mean)
Part 1: TAK-071 80 mg + Scopolamine 0.5 mg19330

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AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-071

(NCT02918266)
Timeframe: Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose

Interventionhour*nanogram per milliliter (h*ng/mL) (Geometric Mean)
Part 1: TAK-071 80 mg + Scopolamine 0.5 mg82010

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Cmax: Maximum Observed Plasma Concentration for TAK-071

(NCT02918266)
Timeframe: Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose

Interventionnanogram per milliliter (ng/mL) (Geometric Mean)
Part 1: TAK-071 80 mg + Scopolamine 0.5 mg1066

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Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Postdose

(NCT02918266)
Timeframe: Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1

Interventionpercentage of participants (Number)
Scopolamine 0.5 mg SC + TAK-071 80 mg0
Part 2: Treatment A0
Part 2: Treatment B0
Part 2: Treatment C0
Part 2: Treatment D0
Part 2: Treatment E0

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Number of Patients With Vomiting After the Administration of the Regional Anesthesia Medications

Objective assessments of whether or not the patients have vomited at this point in the surgical procedure will be done. The investigators will analyze if there is a statistically significant difference between the number of patients that vomit in each group. (NCT02960113)
Timeframe: After the administration of the regional anesthesia medications until eversion of the uterus

InterventionParticipants (Count of Participants)
Scopolamine Patch20
Acupressure Point P615
Scopolamine Patch + Acupressure Point P620

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Level of Nausea Upon Arrival to the Post-operative Recovery Room

Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) upon arrival to the post-operative recovery room. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea. (NCT02960113)
Timeframe: 15 minutes after replacement of the uterus to arrival at post-anaesthesia care unit

Interventionunits on a scale (Mean)
Scopolamine Patch0.18
Acupressure Point P60.25
Scopolamine Patch + Acupressure Point P60.23

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Level of Nausea After the Administration of the Regional Anesthesia Medications

Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) after the administration of the regional anesthesia medications. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea. (NCT02960113)
Timeframe: From administration of anaesthesia until eversion of uterus

Interventionunits on a scale (Mean)
Scopolamine Patch2.71
Acupressure Point P62.57
Scopolamine Patch + Acupressure Point P62.84

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Level of Nausea After Replacement of the Uterus

Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) after replacement of the uterus. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea. (NCT02960113)
Timeframe: After replacement of the uterus and to the next 15 minutes

Interventionunits on a scale (Mean)
Scopolamine Patch2.19
Acupressure Point P62.19
Scopolamine Patch + Acupressure Point P62.51

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Number of Patients With Nausea

The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea at any point during the surgical procedure in each group. (NCT02960113)
Timeframe: Throughout the entire surgical procedure

InterventionParticipants (Count of Participants)
Scopolamine Patch40
Acupressure Point P639
Scopolamine Patch + Acupressure Point P646

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Number of Patients With Vomiting Upon Arrival to the Post-operative Recovery Room

Objective assessments of whether or not the patients have vomited at this point in the surgical procedure will be done. The investigators will analyze if there is a statistically significant difference between the number of patients that vomit in each group. (NCT02960113)
Timeframe: From 15 minutes after replacement of the uterus until arrival at the post-anaesthesia care unit

InterventionParticipants (Count of Participants)
Scopolamine Patch1
Acupressure Point P61
Scopolamine Patch + Acupressure Point P64

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Level of Nausea After Eversion of the Uterus

Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) after eversion of the uterus. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea. (NCT02960113)
Timeframe: After eversion of the uterus until replacement of the uterus

Interventionunits on a scale (Mean)
Scopolamine Patch1.28
Acupressure Point P61.09
Scopolamine Patch + Acupressure Point P61.40

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Satisfaction With Intraoperative Antiemetic Treatment

Patients are asked their nausea and vomiting treatment satisfaction (0 = Not Satisfied, 10 = Extremely Satisfied). Patients are also asked their overall satisfaction with the procedure (0 = Not Satisfied, 10 = Extremely Satisfied). (NCT02960113)
Timeframe: Throughout the surgical procedure

Interventionunits on a scale (Mean)
Scopolamine Patch9.29
Acupressure Point P68.96
Scopolamine Patch + Acupressure Point P69.59

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Number of Patients With Vomiting After Replacement of the Uterus

Objective assessments of whether or not the patients have vomited at this point in the surgical procedure will be done. The investigators will analyze if there is a statistically significant difference between the number of patients that vomit in each group. (NCT02960113)
Timeframe: After replacement of the uterus and for next 15 minutes

InterventionParticipants (Count of Participants)
Scopolamine Patch10
Acupressure Point P615
Scopolamine Patch + Acupressure Point P612

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Number of Patients With Vomiting After Eversion of the Uterus

Objective assessments of whether or not the patients have vomited at this point in the surgical procedure will be done. The investigators will analyze if there is a statistically significant difference between the number of patients that vomit in each group. (NCT02960113)
Timeframe: After eversion of to replacement of the uterus

InterventionParticipants (Count of Participants)
Scopolamine Patch8
Acupressure Point P66
Scopolamine Patch + Acupressure Point P69

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Number of Patients With Vomiting

The investigators will perform objective assessments of whether or not the patients have vomited during the procedure. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group. (NCT02960113)
Timeframe: Throughout the surgical procedure

InterventionParticipants (Count of Participants)
Scopolamine Patch24
Acupressure Point P625
Scopolamine Patch + Acupressure Point P631

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Determination of Area Under the Serum Concentration-time Curve (AUC)

(NCT03029650)
Timeframe: Measured at time points:1,2,3,4,5,6,8,10,12,24,36,48,60,72,73,74,78,84,96,108,120 hours during Intervention: Transderm Scop® and at time points: 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12,24,36, and 48 hours during Intervention: scopolamine HBr

Interventionng*hr/ml (Mean)
Transderm Scop®8.01
Intravenous Scopolamine Hydrobromide2.6

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Measurement of Elimination Rate Constant of Scopolamine (Kel)

(NCT03029650)
Timeframe: Measured at time points: 73,74,78,84,96,108,120 hours during Intervention: Transderm Scop® and at time points: pre-dose, 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12 hours during Intervention: scopolamine HBr

Intervention1/hr (Mean)
Transderm Scop®0.06
Intravenous Scopolamine Hydrobromide0.23

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Measurement of Maximum Serum Concentration of Scopolamine (Cmax)

(NCT03029650)
Timeframe: Measured at time points: pre-dose, 1,2,3,4,5,6,8,10,12,24,36,48,60, and 72 hours during Intervention: Transderm Scop® and at time points: pre-dose, 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12 hours during Intervention: scopolamine HBr

Interventionng/ml (Mean)
Transderm Scop®0.14
Intravenous Scopolamine Hydrobromide2.63

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Measurement of Time of Maximum Serum Scopolamine Concentration (Tmax)

(NCT03029650)
Timeframe: Measured at time points: pre-dose, 1,2,3,4,5,6,8,10,12,24,36,48,60, and 72 hours during Intervention: Transderm Scop® and at time points: pre-dose, 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12 hours during Intervention: scopolamine HBr

Interventionhr (Mean)
Transderm Scop®9.65
Intravenous Scopolamine Hydrobromide0.04

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Residual Drug Analysis in Worn TDDS

This will be done in the TDDS after its removal to estimate total amount of absorbed scopolamine. (NCT03029650)
Timeframe: 3 - 6 months

Intervention% residual drug recovery (Mean)
Transderm Scop®34.4

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Measurement of Volume of Scopolamine Distribution (V)

This measure is only analyzed for the IV scopolamine HBr arm of the study. (NCT03029650)
Timeframe: Measured at time points: 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12,24,36,48 hours during Intervention: scopolamine HBr

InterventionL (Mean)
Intravenous Scopolamine Hydrobromide488.3

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Assessment of Scopolamine Clearance (CL)

This will be done only after the IV is administered to estimate the rate of removal of scopolamine from the body. Will not be measured during patch arm. (NCT03029650)
Timeframe: Measured at time points: 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12,24,36,48 hours during Intervention: scopolamine HBr

InterventionL/hr (Mean)
Intervention: IV Scopolamine Hydrobromide164.4

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Patients' Satisfaction Using a Likert-type Scale

overall satisfaction with the procedure using the Likert-type scale (1. Very dissatisfied, 2. Dissatisfied, 3. Neither satisfied nor dissatisfied, 4. Satisfied, 5. Very satisfied). The patient may comment any cause which made the satisfaction score high or low and if the patient would like to receive the same method of sedation during a future bronchoscopy. (NCT03357393)
Timeframe: After patient has recovered after bronchoscopy and before discharge home, estimated period of time 0-24 hours.

Interventionunits on a scale (Median)
Midazolam and Morphine-scopolamine5
PCS (Propofol) With Morphine-scopolamine5
PCS (Propofol) With Glycopyrronium Bromide5

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Number of Participants With Interventions Performed

Number of participants with interventions performed to maintain cardiovascular (if atropine or ephidrine has been given) and respiratory stability (if assisted ventilation, chin lift or painful stimulation has been performed). Assesed every five minutes during the procedure. (NCT03357393)
Timeframe: From procedure start until end of procedure (extraction of bronchoscope), estimated period of time 0-60 minutes.

InterventionParticipants (Count of Participants)
Midazolam and Morphine-scopolamine1
PCS (Propofol) With Morphine-scopolamine4
PCS (Propofol) With Glycopyrronium Bromide3

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Assessment of Self-rated Patient Questionaries' Using S-PSR

"Post-discharge Surgical Recovery Scale (S-PSR) The modified Swedish version S-PSR is based on the Post-discharge Surgical Recovery Scale and is a 14-item questionnaire to assess the recovery post-discharge regarding the patients' health status and activity (see further appendix 2). Each item is rated using a semantic differential scale and the total sum is multiplied by 100. The possible range is 10-100, with higher score indicating a more favourable postoperative recovery." (NCT03357393)
Timeframe: The assessment is done by the patient at home (or at ward if pro-longed hospital stay is necessary) in the evening on the day of bronchoscopy. It takes approximately 2 minutes to complete the questionnaire.

Interventionunits on a scale (Median)
Midazolam and Morphine-scopolamine55
PCS (Propofol) With Morphine-scopolamine56
PCS (Propofol) With Glycopyrronium Bromide54

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Discharge Assessment Using PADSS After 2 Hours Number of Patients Reaching PADSS Score 10 After 2 Hours

Post Anaesthetic Discharge Scoring System (PADSS).A measurement of the PADSS score is done by pulmonary nurse every 15 min after bronchoscopy is finished (when bronchoscope is removed) for 2 hours. The PADSS is used to clinically assess if the patient is ready to be discharged after anaesthesia/sedation and consist of five criteria: vital signs, ambulation, nausea and/or vomiting, pain and surgical bleeding. Each criterion is given a score ranging from 0 to 2. Only patients who achieve a total score of 10 are considered ready for discharge after 2 hours. (NCT03357393)
Timeframe: 2 hours after bronchoscopy is finished

InterventionParticipants (Count of Participants)
Midazolam and Morphine-scopolamine19
PCS (Propofol) With Morphine-scopolamine30
PCS (Propofol) With Glycopyrronium Bromide45

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Level of Sedation Using the Observer's Assessment of Alertness/Sedation (OAA/S) Scale

"Level of sedation is assessed every 5th minute during the procedure by the nurse anaesthetist using The Observer's Assessment of Alertness/Sedation (OAA/S) scale whereby a higher score represent a lighter sedation. Below is the scale descriped, Observation/score:~Responds readily to name spoken in normal tone/5 Lethargic response to name spoken in normal tone/4 Responds only after name is called loudly and/or repeatedly/3 Responds only after mild prodding or shaking/2 Does not respond to mild prodding or shaking/1" (NCT03357393)
Timeframe: Assessement are done every 5th minute from procedure start until end of procedure (extraction of bronchoscope), estimated period of time 0-60 minutes.

Interventionunits on a scale (Median)
Midazolam and Morphine-scopolamine3
PCS (Propofol) With Morphine-scopolamine2
PCS (Propofol) With Glycopyrronium Bromide2

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Quality of Recovery (QoR-23)

"Modified version of Quality of Recovery (QoR-23) Minimum value 23. Maximum value 115. A higher score indicate a better quality of recovery.~The questionnaire Quality of Recovery (QoR-23) is a 23 item questionnaire to assess recovery after day surgery regarding the patients' emotional state, physical comfort and physical independence (see further appendix 4). Each item is rated on a five-point scale (1-5) and the scores are summed." (NCT03357393)
Timeframe: The assessment is done by the patient at home (or at ward if pro-longed hospital stay is necessary) in the morning the day after bronchoscopy. It takes less than 1 minute to complete the assessment.

Interventionscore on a scale (Median)
Midazolam and Morphine-scopolamine100
PCS (Propofol) With Morphine-scopolamine102
PCS (Propofol) With Glycopyrronium Bromide100

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Bronchoscopist Evaluation Using a Likert-type Scale

the bronchoscopist assess their perception of cough, bronchial secretion respectively circumstances for a smooth performance of the bronchoscopy of procedure using the Likert-type scale (1. Very dissatisfied, 2. Dissatisfied, 3. Neither satisfied nor dissatisfied, 4. Satisfied, 5. Very satisfied). (NCT03357393)
Timeframe: Directly after completion of the procedure.

Interventionunits on a scale (Median)
Midazolam and Morphine-scopolamine5
PCS (Propofol) With Morphine-scopolamine4
PCS (Propofol) With Glycopyrronium Bromide4

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Response to Medications as Assessed by Change in Score on Modified MDRS Scale From Baseline to End of Study Period

The Montgomery-Asberg (MADRS) depression scale will be utilized throughout the study. The scale is scored 0-60, 0 signifying no depression symptoms and 60 signifying very severe depression. A diagnosis of depression will be given to a participant in this study for a MADRS score of 20 or greater. A clinical response to medication will be noted when a participant has a 25% or greater decrease in MADRS score during the trial. (NCT03386448)
Timeframe: Baseline and 4 weeks

Interventionunits on a scale (Mean)
Control(Placebo)3.5
Active(Scopolamine and Naltrexone)12.5

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