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

Intestinal Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01929044
• Other study ID #: 202.848
• Status: Completed
• Phase: Phase 3
• First received: August 22, 2013
• Last updated: February 10, 2016
• Start date: August 2013
• Est. completion date: February 2015

Study information

• Verified date: January 2016
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intestinal Diseases

Intervention

Drug:
• 654-II (anisodamine)
10mg injection
• Buscopan® (hyoscine butylbromide)
20mg injection

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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'.	Baseline and 10 minutes after the first injection	No
Secondary	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'.	Baseline and 30 minutes after the first injection	No
Secondary	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'.	Baseline and 60 minutes after the first injection	No
Secondary	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'.	Baseline and 120 minutes after the first injection	No
Secondary	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).	120 minutes after the first injection	No
Secondary	Proportion of Patients Who Need the Second Injection	Proportion of patients who need the second injection at 20 minutes after the first injection.	20 minutes after the first injection.	No

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