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

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.

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.