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

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.