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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Intestinal Diseases

Intervention / Treatment
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* Drug: 654-II (anisodamine)
* Drug: Buscopan® (hyoscine butylbromide)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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. Patients must agree to cooperate with all trial evaluations and perform all required tasks. Patients with acute gastric or intestinal spasm-like pain (without severe vomiting and surgical acute abdomen). Male or female patients aged 18 to 70 years. The pain intensity upon screening is at least point 6 on a 0-10 numerical rating scale (NRS). Exclusion criteria: 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. 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 Pregnancy and/or lactation or planned pregnancy; Known hypersensitivity to N-butylscopolammonium bromide Alcohol, or drug abuse. 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. Unwilling to or unable to complete the entire trial procedure according to the protocol. In investigator's opinion, the patient is not proper for the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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. |