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

February 10, 2016 updated by: Boehringer Ingelheim

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) for the Treatment of Acute Gastric or Intestinal Spasm-like Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

299

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Baotou, China
        • 202.848.86016 Boehringer Ingelheim Investigational Site
      • Beijing, 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
      • Changchun, China
        • 202.848.86012 Boehringer Ingelheim Investigational Site
      • Changsha, China
        • 202.848.86020 Boehringer Ingelheim Investigational Site
      • Chenzhou, China
        • 202.848.86018 Boehringer Ingelheim Investigational Site
      • Chongqing, China
        • 202.848.86007 Boehringer Ingelheim Investigational Site
      • Chongqing, China
        • 202.848.86021 Boehringer Ingelheim Investigational Site
      • Guangzhou, China
        • 202.848.86006 Boehringer Ingelheim Investigational Site
      • Hangzhou, China
        • 202.848.86003 Boehringer Ingelheim Investigational Site
      • Huanggang, China
        • 202.848.86022 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 202.848.86001 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 202.848.86011 Boehringer Ingelheim Investigational Site
      • Shenyang, China
        • 202.848.86015 Boehringer Ingelheim Investigational Site
      • Shijiazhuang, China
        • 202.848.86014 Boehringer Ingelheim Investigational Site
      • Wenzhou, China
        • 202.848.86019 Boehringer Ingelheim Investigational Site
      • Wuhan, China
        • 202.848.86004 Boehringer Ingelheim Investigational Site
      • Wuhan, China
        • 202.848.86005 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Patients must sign and date an Informed Consent consistent with International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP) guidelines and local regulation prior to participation in the trial.
  2. Patients must agree to cooperate with all trial evaluations and perform all required tasks.
  3. Patients with acute gastric or intestinal spasm-like pain (without severe vomiting and surgical acute abdomen).
  4. Male or female patients aged 18 to 70 years.
  5. The pain intensity upon screening is at least point 6 on a 0-10 numerical rating scale (NRS).

Exclusion criteria:

  1. Patients with the following concomitant disease is not eligible for enrollment:

    • Painful gastric or intestinal spasm of organic origin such as Crohn's disease, ulcerative colitis, lactose intolerance, gastrointestinal perforation, suspected gastrointestinal perforation or peritoneal effusion.
    • Pain related with malignancy.
    • Patients with other severe pain states of organic origin.
    • Mechanical stenosis of the gastrointestinal tract ,megacolin.
    • Urinary retention associated with mechanical stenosis of urinary tract.
    • Narrow-angled glaucoma.
    • Tachyarrhythmia.
    • Myasthenia gravis.
    • Meulengracht-Gilbert syndrome.
    • Known depression or known mental illness, anxiety disturbance.

  2. Patients taking the following concomitant medication within 7 half-life of concomitant medication (the duration from taking concomitant medication to attending the trial is less than 7 half-life) are not eligible for enrollment:

    • Analgesics,
    • Spasmolytics,
    • Anticholinergics
    • Affecting gastrointestinal motility, such as propantheline, metoclopramide, cisapride, loperamide, diphenoxylate, opioid analgesics, antacids and other ulcer treatment
    • Regular administration of laxatives
    • Narcotics
    • Antidepressant treatment or treatment with psychoactive drugs
  3. Pregnancy and/or lactation or planned pregnancy;
  4. Known hypersensitivity to N-butylscopolammonium bromide
  5. Alcohol, or drug abuse.
  6. Simultaneous participating in another clinical trial, or discontinuing from another clinical trial before randomization (administration of study medication); moreover, in the case of screening failure or premature discontinuing from the trial, repeated enrollment is forbidden.
  7. Unwilling to or unable to complete the entire trial procedure according to the protocol.
  8. In investigator's opinion, the patient is not proper for the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Buscopan® (hyoscine butylbromide)
1st injection of Buscopan® solution 20mg, if necessary 2nd injection after 20min of the 1st injection
Drug: Buscopan® (hyoscine butylbromide)
20mg injection
Active Comparator: 654-II(anisodamine)
1st injection of 654-II solution 10mg, if necessary 2nd injection after 20min of the 1st injection
Drug: 654-II (anisodamine)
10mg injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PID From Pre-dose Baseline at 20 Minutes After First Injection.
Time Frame: 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'.
Baseline and 20 minutes after the first injection

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

August 22, 2013

First Submitted That Met QC Criteria

August 22, 2013

First Posted (Estimate)

August 27, 2013

Study Record Updates

Last Update Posted (Estimate)

March 8, 2016

Last Update Submitted That Met QC Criteria

February 10, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202.848

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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