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

Phase 3

Completed

• Conditions: Intestinal Diseases
• Interventions: Drug: Buscopan® (hyoscine butylbromide); Drug: 654-II (anisodamine)

• Registration Number: NCT01929044
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The aim of the study is to assess the efficacy of Buscopan® (hyoscine butylbromide) in comparison to 654-II (anisodamine)in acute gastric or intestinal spasm-like pain.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-22
• Study First Submitted QC: 2013-08-22
• Study First Posted: 2013-08-27
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2016-01
• Results First Submitted: 2016-02-10
• Results First Submitted QC: 2016-02-10
• Last Update Submitted: 2016-02-10
• Results First Posted: 2016-03-08
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 299

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buscopan® (hyoscine butylbromide)	Buscopan® (hyoscine butylbromide)	1st injection of Buscopan® solution 20mg, if necessary 2nd injection after 20min of the 1st injection
654-II(anisodamine)	654-II (anisodamine)	1st injection of 654-II solution 10mg, if necessary 2nd injection after 20min of the 1st injection

Primary Outcome Measures

Name	Time	Method
PID From Pre-dose Baseline at 20 Minutes After First Injection.	Baseline and 20 minutes after the 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'.

Secondary Outcome Measures

Name	Time	Method
PID From Pre-dose Baseline at 10 Minutes After First Injection.	Baseline and 10 minutes after the 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'.
Global Assessment of Efficacy by the Patient at 120 Minutes After the First Injection	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).
Proportion of Patients Who Need the Second Injection	20 minutes after the first injection.	Proportion of patients who need the second injection at 20 minutes after the first injection.
PID From Pre-dose Baseline at 30 Minutes After First Injection.	Baseline and 30 minutes after the 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'.
PID From Pre-dose Baseline at 60 Minutes After First Injection.	Baseline and 60 minutes after the 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'.
PID From Pre-dose Baseline at 120 Minutes After First Injection.	Baseline and 120 minutes after the 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'.

Trial Locations

Locations (20)

202.848.86013 Boehringer Ingelheim Investigational Site; 🇨🇳 Beijing, China

202.848.86020 Boehringer Ingelheim Investigational Site; 🇨🇳 Changsha, China

202.848.86007 Boehringer Ingelheim Investigational Site; 🇨🇳 Chongqing, China

202.848.86011 Boehringer Ingelheim Investigational Site; 🇨🇳 Shanghai, China

202.848.86015 Boehringer Ingelheim Investigational Site; 🇨🇳 Shenyang, China

202.848.86009 Boehringer Ingelheim Investigational Site; 🇨🇳 Beijing, China

202.848.86006 Boehringer Ingelheim Investigational Site; 🇨🇳 Guangzhou, China

202.848.86014 Boehringer Ingelheim Investigational Site; 🇨🇳 Shijiazhuang, China

202.848.86016 Boehringer Ingelheim Investigational Site; 🇨🇳 Baotou, China

202.848.86022 Boehringer Ingelheim Investigational Site; 🇨🇳 Huanggang, China

202.848.86004 Boehringer Ingelheim Investigational Site; 🇨🇳 Wuhan, China

202.848.86010 Boehringer Ingelheim Investigational Site; 🇨🇳 Beijing, China

202.848.86012 Boehringer Ingelheim Investigational Site; 🇨🇳 Changchun, China

202.848.86021 Boehringer Ingelheim Investigational Site; 🇨🇳 Chongqing, China

202.848.86003 Boehringer Ingelheim Investigational Site; 🇨🇳 Hangzhou, China

202.848.86008 Boehringer Ingelheim Investigational Site; 🇨🇳 Beijing, China

202.848.86018 Boehringer Ingelheim Investigational Site; 🇨🇳 Chenzhou, China

202.848.86005 Boehringer Ingelheim Investigational Site; 🇨🇳 Wuhan, China

202.848.86001 Boehringer Ingelheim Investigational Site; 🇨🇳 Shanghai, China

202.848.86019 Boehringer Ingelheim Investigational Site; 🇨🇳 Wenzhou, China