Page last updated: 2024-12-10

scopolamine

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators
FloraRankFlora DefinitionFamilyFamily Definition
DaturagenusA plant genus of the family SOLANACEAE. Members contain TROPANES. The common name of trumpet flower is also sometimes used for GELSEMIUM.[MeSH]SolanaceaeA plant family of the order SOLANALES, class MAGNOLIOPSIDA. Among the most noted are POTATOES; TOMATOES; CAPSICUM (green and red peppers); TOBACCO; and BELLADONNA.[MeSH]
SolanaceaefamilyA plant family of the order SOLANALES, class MAGNOLIOPSIDA. Among the most noted are POTATOES; TOMATOES; CAPSICUM (green and red peppers); TOBACCO; and BELLADONNA.[MeSH]SolanaceaeA plant family of the order SOLANALES, class MAGNOLIOPSIDA. Among the most noted are POTATOES; TOMATOES; CAPSICUM (green and red peppers); TOBACCO; and BELLADONNA.[MeSH]

Cross-References

ID SourceID
PubMed CID3000322
CHEMBL ID569713
CHEMBL ID3084722
CHEMBL ID1906925
CHEBI ID16794
CHEBI ID93572
SCHEMBL ID16226
SCHEMBL ID22393238
MeSH IDM0553271

Synonyms (120)

Synonym
beldavrin
(-)-hyoscine hydrobromide
hyosol
hyoscine bromide
tranaxine
scopolamine bromide
isoscopil
scopamin
l-scopolamine-hydrobromide
scopolaminium bromide
euscopol
scopolammonium bromide
l-hyoscine hydrobromide
(-)-scopolamine bromide
kwells
AC-968
hsdb 4074
(+)-hyoscine
SEE ,
einecs 200-090-3
3-oxa-9-azatricyclo(3.3.1.0(sup 2,4))nonan-7-ol, 9-methyl-, tropate (ester)
atroquin
skopolamin
l-scopolamine
transderm scop
benzeneacetic acid, alpha-(hydroxymethyl)-, (1alpha,2beta,4beta,5alpha,7beta)-9-methyl-3-oxa-9-azatricyclo(3.3.1.02,4)non-7-yl ester, (alphas)-
tropic acid, ester with scopine
6beta,7beta-epoxy-3alpha-tropanyl s-(-)-tropate
atrochin
6beta,7beta-epoxy-1alpha,5alpha-tropan-3alpha-ol
3-oxa-9-azatricyclo(3.3.1.o(sup 2,4))nonan-7-ol, 9-methyl-, tropate (ester)
benzeneacetic acid, alpha-(hydroxymethyl)-, 9-methyl-3-oxa-9-azatricyclo(3.3.1.02,4)non-7-yl ester, (7(s)-(1alpha,2beta,4beta,5alpha,7beta))-
epoxytropine tropate
tropic acid, 9-methyl-3-oxa-9-azatricyclo(3.3.1.0(sup 2,4))non-7-yl ester
scopolamine hcl
AB00429689-30
AB00429689-31
BRD-K89923877-003-02-4
(1r,2r,4s,5s,7s)-9-methyl-3-oxa-9-azatricyclo[3.3.1.0^{2,4}]nonan-7-yl (2s)-3-hydroxy-2-phenylpropanoate
gtpl330
scopoderm
levo-duboisine
6,7-epoxytropine tropate
(1r,2r,4s,5s,7s)-9-methyl-3-oxa-9-azatricyclo[3.3.1.0(2,4)]non-7-yl (2s)-3-hydroxy-2-phenylpropanoate
(1s,3s,5r,6r,7s)-6,7-epoxytropan-3-yl (2s)-3-hydroxy-2-phenylpropanoate
6-beta,7-beta-epoxy-3-alpha-tropanyl s-(-)-tropate
scopine (-)-tropate
(-)-scopolamine
alpha-(hydroxymethyl)benzeneacetic acid 9-methyl-3-oxa-9-azatricyclo(3.3.1.0(2.4))non-7-yl ester
CHEBI:16794 ,
(1r,2r,4s,5s,7s)-9-methyl-3-oxa-9-azatricyclo[3.3.1.0~2,4~]non-7-yl (2s)-3-hydroxy-2-phenylpropanoate
BPBIO1_001049
BSPBIO_000953
PRESTWICK3_000877
1alphah,5alphah-tropan-3alpha-ol, 6beta,7beta-epoxy-, (-)-tropate (ester)
tropane alkaloid
scopine tropate
hyoscine
[7(s)-(1.alpha.,2.beta.,4.beta.,5.alpha.,7.beta.)]-.alpha.-(hydroxymethyl)benzeneacetic acid 9-methyl-3-oxa-9-azatricyclo-[3.3.1.0^2,4]non-7-yl ester
(methyl[?]yl) (2s)-3-hydroxy-2-phenyl-propanoate
AB00429689
(-)-hyoscine
DB00747
SMP1_000270
NCGC00024357-04
NCGC00024357-05
scopace
boro-scopol
(1r,2r,4s,5s,7s)-9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]non-7-yl (2r)-3-hydroxy-2-phenylpropanoate
(1r,2r,4s,5s,7s)-9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl (2s)-3-hydroxy-2-phenylpropanoate
HMS2090N13
dl48g20x8x ,
unii-dl48g20x8x
hydrobromicum, scopolaminum
ec 200-090-3
CHEMBL569713
S9326
hyosceine
scop
transcop
benzeneacetic acid, .alpha.-(hydroxymethyl)-, 9-methyl-3-oxa-9-azatricyclo(3.3.1.02,4)non-7-yl ester, (7(s)-(1.alpha.,2.beta.,4.beta.,5.alpha.,7.beta.))-
hyoscine [who-dd]
scopolamine [hsdb]
scopolamine [orange book]
(1r,2r,4s,5s,7s)-9-methyl-3-oxa-9-azatricyclo(3.3.1.02,4)non-7-yl (2s)-3-hydroxy-2-phenylpropanoate
6.beta.,7.beta.-epoxy-1.alpha.h,5.alpha.h-tropan-3.alpha.-ol (-)-tropate (ester)
scopolamine [usp impurity]
scopolamine [mi]
benzeneacetic acid, .alpha.(hydroxymethyl)-,(1.alpha.,2.beta.,4.beta.,5.alpha.,7.beta.)-9-methyl-3-oxa-9-azatricyclo(3.3.1.02,4)non-7-yl ester, (.alpha.s)-
hyoscine [ep impurity]
hyoscine [ep monograph]
hyoscine [mart.]
scopolamine [vandf]
atropine sulfate impurity f [ep impurity]
SCHEMBL16226
CHEMBL3084722 ,
CHEMBL1906925
AB00429689_32
SCHEMBL22393238
DTXSID6023573 ,
AKOS025402477
CHEBI:93572
CS-6609
HY-N0296
s-(-)-tropate
(1r,2r,4s,5s,7s)-9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl (s)-3-hydroxy-2-phenylpropanoate
(-)-scopolamin (hyoscine)
Q337188
Q27165268
lsm-4015
STECJAGHUSJQJN-USLFZFAMSA-N
bdbm50263508
HMS3886L22
CCG-267504
[(1r,2r,4s,5s)-9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl] (2s)-3-hydroxy-2-phenylpropanoate
scopolamine 100 microg/ml in acetonitrile
scopolamine dried down 100 microg/ml
(1r,2r,4s,5s,7r)-9-methyl-3-oxa-9-azatricyclo[3.3.1.0,nonan-7-yl (2s)-3-hydroxy-2-phenylpropanoate
EN300-1718536
(1r,2r,4s,5s,7r)-9-methyl-3-oxa-9-azatricyclo[3.3.1.0,2,4]nonan-7-yl (2s)-3-hydroxy-2-phenylpropanoate
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (1)

ClassDescription
3-hydroxy carboxylic acidAny hydroxy carboxylic acid which contains a hydroxy group located beta- to the carboxylic acid group.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (4)

PathwayProteinsCompounds
superpathway of hyoscyamine and scopolamine biosynthesis434
hyoscyamine and scopolamine biosynthesis422
tropane alkaloids biosynthesis028
superpathway of hyoscyamine (atropine) and scopolamine biosynthesis039
superpathway of hyoscyamine and scopolamine biosynthesis441
hyoscyamine and scopolamine biosynthesis423

Protein Targets (2)

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Bile salt export pumpHomo sapiens (human)IC50 (µMol)1,000.00000.11007.190310.0000AID1449628
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (22)

Processvia Protein(s)Taxonomy
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (8)

Processvia Protein(s)Taxonomy
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (12)

Processvia Protein(s)Taxonomy
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (12)

Assay IDTitleYearJournalArticle
AID1417128Antileishmanial activity against Leishmania amazonensis MHOM/BR/77/LTB 0016 amastigotes infected in mouse peritoneal macrophages after 72 hrs by staining-based assay2018European journal of medicinal chemistry, Sep-05, Volume: 157Natural products as inhibitors of Leishmania major dihydroorotate dehydrogenase.
AID1417094Inhibition of recombinant oligo-histidine-tagged Leishmania major DHODH expressed in Escherichia coli BL21(DE3) cells using DHO as substrate measured after 60 secs2018European journal of medicinal chemistry, Sep-05, Volume: 157Natural products as inhibitors of Leishmania major dihydroorotate dehydrogenase.
AID1417127Antileishmanial activity against Leishmania amazonensis MHOM/BR/77/LTB 0016 promastigotes after 72 hrs by MTT assay2018European journal of medicinal chemistry, Sep-05, Volume: 157Natural products as inhibitors of Leishmania major dihydroorotate dehydrogenase.
AID1574990Antagonist activity at muscarinic acetylcholine receptor in superfused rat striatal slices assessed as inhibition of oxotremorine-induced [3H]DA release at 1 uM preincubated for 35 mins in presence of [3H]DA followed by oxotremorine addition and measured 2019Bioorganic & medicinal chemistry letters, 02-01, Volume: 29, Issue:3
Muscarinic agonist, (±)-quinuclidin-3-yl-(4-fluorophenethyl)(phenyl)carbamate: High affinity, but low subtype selectivity for human M
AID1417129Antitrypanosomal activity against Trypanosoma brucei TC221 trypomastigotes after 24 hrs by Alamar Blue assay2018European journal of medicinal chemistry, Sep-05, Volume: 157Natural products as inhibitors of Leishmania major dihydroorotate dehydrogenase.
AID1574991Antagonist activity at muscarinic acetylcholine receptor in superfused rat striatal slices assessed as inhibition of oxotremorine-induced [3H]DA release at 10 uM preincubated for 35 mins in presence of [3H]DA followed by oxotremorine addition and measured2019Bioorganic & medicinal chemistry letters, 02-01, Volume: 29, Issue:3
Muscarinic agonist, (±)-quinuclidin-3-yl-(4-fluorophenethyl)(phenyl)carbamate: High affinity, but low subtype selectivity for human M
AID1345326Human M2 receptor (Acetylcholine receptors (muscarinic))2001AAPS pharmSci, , Volume: 3, Issue:4
Receptor binding studies of soft anticholinergic agents.
AID1345465Human M4 receptor (Acetylcholine receptors (muscarinic))2001AAPS pharmSci, , Volume: 3, Issue:4
Receptor binding studies of soft anticholinergic agents.
AID1345343Human M3 receptor (Acetylcholine receptors (muscarinic))2001AAPS pharmSci, , Volume: 3, Issue:4
Receptor binding studies of soft anticholinergic agents.
AID1345286Human M1 receptor (Acetylcholine receptors (muscarinic))2001AAPS pharmSci, , Volume: 3, Issue:4
Receptor binding studies of soft anticholinergic agents.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
AID1449628Inhibition of human BSEP expressed in baculovirus transfected fall armyworm Sf21 cell membranes vesicles assessed as reduction in ATP-dependent [3H]-taurocholate transport into vesicles incubated for 5 mins by Topcount based rapid filtration method2012Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 40, Issue:12
Mitigating the inhibition of human bile salt export pump by drugs: opportunities provided by physicochemical property modulation, in silico modeling, and structural modification.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (5)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's1 (20.00)29.6817
2010's4 (80.00)24.3611
2020's0 (0.00)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 83.88

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

MetricThis Compound (vs All)
Research Demand Index83.88 (24.57)
Research Supply Index1.79 (2.92)
Research Growth Index5.08 (4.65)
Search Engine Demand Index192.96 (26.88)
Search Engine Supply Index2.75 (0.95)

This Compound (83.88)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials0 (0.00%)5.53%
Reviews0 (0.00%)6.00%
Case Studies0 (0.00%)4.05%
Observational0 (0.00%)0.25%
Other5 (100.00%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (100)

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
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
Randomized, Masked, Placebo-controlled Clinical Trial to Evaluate the Effects of a Single Intravenous Dose of Hyoscine Bromide on the Duration and Pain in Latent and Active Labor [NCT02103166]Phase 4180 participants (Anticipated)Interventional2014-04-30Suspended(stopped due to Conditions of recruitment changed)
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
Phase I Study Characterizing Effects of Hallucinogens and Other Drugs on Mood and Performance [NCT02033707]Phase 120 participants (Actual)Interventional2014-04-30Completed
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 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 [NCT04184115]Phase 3102 participants (Actual)Interventional2019-06-09Completed
Efficacy of Intravenous Hyoscine ButylBromide as an Analgesic During the First Stage of Labor: A Randomized Controlled Trial [NCT02557087]Phase 2104 participants (Anticipated)Interventional2015-09-30Not yet recruiting
A Randomised Trial for Postoperative Pain After Rectal Misoprostol or Rectal Hyoscine Administration [NCT03359655]120 participants (Actual)Interventional2018-06-11Completed
The Safety and Efficacy of the Enhanced Recovery After Surgery(ERAS) Applied on Cardiac Surgery With Cardiopulmonary Bypass: a Single Center, Randomized, Controlled Clinical Study [NCT02479581]Phase 2226 participants (Actual)Interventional2015-07-31Completed
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
Nebulizer Delivery of Intranasal Scopolamine [NCT04999449]Phase 130 participants (Anticipated)Interventional2022-01-24Recruiting
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
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
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
Effect of Hyoscine- Bromide on Duration of the First Stage of Labor [NCT06056869]60 participants (Anticipated)Interventional2023-09-27Recruiting
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
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of DPI-386 Nasal Gel for the Prevention of Nausea and Vomiting Associated With Motion [NCT05548270]Phase 3503 participants (Actual)Interventional2022-08-23Completed
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
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
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)
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
Optimizing the Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance. Motion Sickness Countermeasures Field Test [NCT05852730]Phase 280 participants (Anticipated)Interventional2021-08-10Recruiting
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
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
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
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
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
Behavioral and Pharmacological Manipulation of Time Cell Activity in the Human Mesial Temporal Lobe [NCT05594017]Early Phase 160 participants (Anticipated)Interventional2019-08-01Recruiting
Principal Investigator [NCT01644838]Phase 2/Phase 393 participants (Actual)Interventional2010-08-31Completed
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
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
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 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
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
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
Short-term Effects of Lumbar Spine Manipulation Versus Pharmacological Therapy in Young Women With Primary Dysmenorrhea: a Randomized Controlled Trial. [NCT04866355]42 participants (Actual)Interventional2021-02-28Completed
Motion Sickness Medications and Vestibular Time Constant [NCT03270839]Phase 480 participants (Anticipated)Interventional2017-06-01Recruiting
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of DPI-386 Nasal Gel for the Prevention of Nausea and Vomiting Associated With Motion [NCT04947423]Phase 3140 participants (Actual)Interventional2021-06-14Completed
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 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
A Prospective Evaluation of an Anesthesia Protocol to Reduce Post-operative and Post-discharge Nausea and Vomiting in a High Risk Orthognathic Surgery Population [NCT01592708]233 participants (Actual)Interventional2012-06-30Completed
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
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
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
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)
[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]Number of Participants That Have Overall Satisfaction on the Treatment
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 in the Predefined Non-responders"
NCT01281501 (4) [back to overview]"Number of Participants in the Predefined Responders"
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 (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]Change in Ham D 17 Scores
NCT01312844 (9) [back to overview]Number of ECT Treatments Withheld Due to Cognitive Impairment
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)
NCT01592708 (5) [back to overview]Post-operative Vomiting
NCT01592708 (5) [back to overview]Post-operative Nausea
NCT01592708 (5) [back to overview]Post-discharge Vomiting
NCT01592708 (5) [back to overview]Post-discharge Nausea
NCT01592708 (5) [back to overview]Hospital Length of Stay
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]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.
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.
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
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)
NCT02155309 (1) [back to overview]Efficacy: Number of Head Movements During Rotation
NCT02242305 (7) [back to overview]Number of Subjects With Clinical Relevant Abnormalities for Laboratory, Vital Signs, ElectroCardioGram (ECG) and Physical Examination
NCT02242305 (7) [back to overview]Percentage of Event for Time to Therapeutic Effect
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]Change of the Pain Frequency Assessed on 4-stage Verbal Rating Scale (VRS)
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]Number of Patients With Adverse Events
NCT02516098 (4) [back to overview]AUC Time Zero to Times of Last Quantifiable Concentration (AUC 0-t)
NCT02516098 (4) [back to overview]Maximum Observed Plasma Concentration of Hyoscine Butylbromide (Cmax)
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]Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC0-∞).
NCT02625181 (4) [back to overview]Time to Discharge From the Postanesthesia Care Unit (PACU)
NCT02625181 (4) [back to overview]The Number of Prophylactic Interventions for PONV
NCT02625181 (4) [back to overview]PONV Incidence: Number of Participants With Postoperative Nausea and Vomiting
NCT02625181 (4) [back to overview]Adherence to PONV Guidelines
NCT02849639 (5) [back to overview]Perceived Health Status
NCT02849639 (5) [back to overview]Medication Appropriateness Index
NCT02849639 (5) [back to overview]Cognitive Reserve: Montreal Cognitive Assessment
NCT02849639 (5) [back to overview]Cognitive Reserve: California Verbal Learning Test
NCT02849639 (5) [back to overview]Trail Making Test B With the Scopolamine Patch
NCT02910167 (5) [back to overview]Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment
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 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 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 Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima
NCT02918266 (10) [back to overview]Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests 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]Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Postdose
NCT02918266 (10) [back to overview]Tmax: Time to Reach the Maximum Observed Plasma Concentration(Cmax) for TAK-071
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]Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Electrocardiogram (ECG) at Least Once Postdose
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 Experienced at Least One Treatment-emergent Adverse Event (TEAE)
NCT02960113 (11) [back to overview]Level of Nausea After Replacement of the Uterus
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
NCT02960113 (11) [back to overview]Number of Patients With Nausea
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]Number of Patients With Vomiting After the Administration of the Regional Anesthesia Medications
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]Measurement of Volume of Scopolamine Distribution (V)
NCT03029650 (7) [back to overview]Residual Drug Analysis in Worn TDDS
NCT03029650 (7) [back to overview]Assessment of Scopolamine Clearance (CL)
NCT03357393 (7) [back to overview]Assessment of Self-rated Patient Questionaries' Using S-PSR
NCT03357393 (7) [back to overview]Bronchoscopist Evaluation Using a Likert-type Scale
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]Number of Participants With Interventions Performed
NCT03357393 (7) [back to overview]Level of Sedation Using the Observer's Assessment of Alertness/Sedation (OAA/S) Scale
NCT03357393 (7) [back to overview]Patients' Satisfaction Using a Likert-type Scale
NCT03357393 (7) [back to overview]Quality of Recovery (QoR-23)
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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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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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 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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"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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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 (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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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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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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Post-operative Vomiting

(NCT01592708)
Timeframe: End of surgery to discharge from hospital

Interventionpercentage of subjects with POV (Number)
Intervention Cohort11
Comparison Cohort28

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Post-operative Nausea

End of surgery time determined by anesthesia portion of the medical record. PONV to be assessed by review of surgeons' and nurses' notes in the medical record as well as through review of patient diaries. Vomiting constitutes a safety issue and, as such, associated adverse events will be noted. (NCT01592708)
Timeframe: End of surgery to discharge from hospital

Interventionpercentage of subjects with PON (Number)
Intervention Cohort24
Comparison Cohort70

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Post-discharge Vomiting

(NCT01592708)
Timeframe: 1 week post discharge

Interventionpercentage of subjects with PDV (Number)
Intervention Cohort22
Comparison Cohort29

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Post-discharge Nausea

To be assessed based on patient diary completed daily for 1 week following discharge to home from the hospital (NCT01592708)
Timeframe: 1 week from discharge from hospital

Interventionpercentage of subjects with PDN (Number)
Intervention Cohort72
Comparison Cohort60

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Hospital Length of Stay

Anesthesia start time determined from anesthesia portion of the medical record. Time at which discharge order was placed will serve as time of discharge. (NCT01592708)
Timeframe: Anesthesia start time to placement of hospital discharge order - average 26 - 28 hours

Interventionhours (Median)
Intervention Cohort26.4
Comparison Cohort28.2

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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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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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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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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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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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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 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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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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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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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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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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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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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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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 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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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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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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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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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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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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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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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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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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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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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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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 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 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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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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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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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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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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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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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 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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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 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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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