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

Launched by BOEHRINGER INGELHEIM · Aug 22, 2013

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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.