Clinical TrialID 1600

Efficacy of Buscopan® in Comparison With 654-II (Anisodamine) in Acute Gastric or Intestinal Pain

NCT01929044

Intestinal Diseases

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Record Fields

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Clinical Trial Id
1600
Evidence Id
1600
Core Evidence Id
1600
Source Clinical Trial Id
1574
Herb2 Clinical Trial Id
HBCT001574
Nct Id
NCT01929044
Title
Efficacy of Buscopan® in Comparison With 654-II (Anisodamine) in Acute Gastric or Intestinal Pain
Status
Completed
Phase
Phase 3
Study Result
Yes
Study Condition
Intestinal Diseases
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Intervention
DRUG: 654-II (anisodamine)|DRUG: Buscopan® (hyoscine butylbromide)
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Double
Intervention Purpose
Treatment
Gender
All
Age
Adult, Older_Adult
Enrollment
299
Outcome Measure
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'., Baseline and 20 minutes after the first injection
Sponsor Collaborator
Boehringer Ingelheim
Funded By
INDUSTRY
Location
202.848.86016 Boehringer Ingelheim Investigational Site, Baotou, China|202.848.86008 Boehringer Ingelheim Investigational Site, Beijing, China|202.848.86009 Boehringer Ingelheim Investigational Site, Beijing, China|202.848.86010 Boehringer Ingelheim Investigational Site, Beijing, China|202.848.86013 Boehringer Ingelheim Investigational Site, Beijing, China|202.848.86012 Boehringer Ingelheim Investigational Site, Changchun, China|202.848.86020 Boehringer Ingelheim Investigational Site, Changsha, China|202.848.86018 Boehringer Ingelheim Investigational Site, Chenzhou, China|202.848.86007 Boehringer Ingelheim Investigational Site, Chongqing, China|202.848.86021 Boehringer Ingelheim Investigational Site, Chongqing, China|202.848.86006 Boehringer Ingelheim Investigational Site, Guangzhou, China|202.848.86003 Boehringer Ingelheim Investigational Site, Hangzhou, China|202.848.86022 Boehringer Ingelheim Investigational Site, Huanggang, China|202.848.86001 Boehringer Ingelheim Investigational Site, Shanghai, China|202.848.86011 Boehringer Ingelheim Investigational Site, Shanghai, China|202.848.86015 Boehringer Ingelheim Investigational Site, Shenyang, China|202.848.86014 Boehringer Ingelheim Investigational Site, Shijiazhuang, China|202.848.86019 Boehringer Ingelheim Investigational Site, Wenzhou, China|202.848.86004 Boehringer Ingelheim Investigational Site, Wuhan, China|202.848.86005 Boehringer Ingelheim Investigational Site, Wuhan, China
Other Id
202.848
Start Date
2013-08
Primary Completion Date
2015-02
Completion Date
2015-02
First Posted
2013-08-27
Results First Posted
2016-03-08
Last Update Posted
2016-03-08
Study Document
Study Url
https://clinicaltrials.gov/study/NCT01929044
Title Cn
Title En
Efficacy of Buscopan® in Comparison With 654-II (Anisodamine) in Acute Gastric or Intestinal Pain
Bilingual Status
semi_complete