Efficacy of Buscopan® in Comparison With 654-II (Anisodamine) in Acute Gastric or Intestinal Pain
Condition: Intestinal Diseases
MeSH terms: Intestinal Diseases
Intervention: 654-II (anisodamine); Buscopan® (hyoscine butylbromide)
Intervention description: 10mg injection; 20mg injection
Intervention MeSH terms: Anisodamine; Scopolamine; Butylscopolammonium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 299.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

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.
    

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.