Clinical trial NCT01929044: Efficacy of Buscopan® in Comparison With 654-II (Anisodamine) in Acute Gastric or Intestinal Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intestinal Diseases
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-08-27
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: PID From Pre-dose Baseline at 20 Minutes After First Injection.
timeFrame: Baseline and 20 minutes after the first injection
Secondary outcomes:
measure: PID From Pre-dose Baseline at 10 Minutes After First Injection.
timeFrame: Baseline and 10 minutes after the first injection
measure: PID From Pre-dose Baseline at 30 Minutes After First Injection.
timeFrame: Baseline and 30 minutes after the first injection
measure: PID From Pre-dose Baseline at 60 Minutes After First Injection.
timeFrame: Baseline and 60 minutes after the first injection
measure: PID From Pre-dose Baseline at 120 Minutes After First Injection.
timeFrame: Baseline and 120 minutes after the first injection
measure: Global Assessment of Efficacy by the Patient at 120 Minutes After the First Injection
timeFrame: 120 minutes after the first injection
measure: Proportion of Patients Who Need the Second Injection
timeFrame: 20 minutes after the first injection.
Other outcomes:
Locations:
city: Baotou
country: China
facility: 202.848.86016 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 202.848.86008 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 202.848.86009 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 202.848.86010 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 202.848.86013 Boehringer Ingelheim Investigational Site
city: Changchun
country: China
facility: 202.848.86012 Boehringer Ingelheim Investigational Site
city: Changsha
country: China
facility: 202.848.86020 Boehringer Ingelheim Investigational Site
city: Chenzhou
country: China
facility: 202.848.86018 Boehringer Ingelheim Investigational Site
city: Chongqing
country: China
facility: 202.848.86007 Boehringer Ingelheim Investigational Site
city: Chongqing
country: China
facility: 202.848.86021 Boehringer Ingelheim Investigational Site
city: Guangzhou
country: China
facility: 202.848.86006 Boehringer Ingelheim Investigational Site
city: Hangzhou
country: China
facility: 202.848.86003 Boehringer Ingelheim Investigational Site
city: Huanggang
country: China
facility: 202.848.86022 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 202.848.86001 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 202.848.86011 Boehringer Ingelheim Investigational Site
city: Shenyang
country: China
facility: 202.848.86015 Boehringer Ingelheim Investigational Site
city: Shijiazhuang
country: China
facility: 202.848.86014 Boehringer Ingelheim Investigational Site
city: Wenzhou
country: China
facility: 202.848.86019 Boehringer Ingelheim Investigational Site
city: Wuhan
country: China
facility: 202.848.86004 Boehringer Ingelheim Investigational Site
city: Wuhan
country: China
facility: 202.848.86005 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: