Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Tablets for the Treatment of Occasional or Recurrent Episodes of Gastric or Intestinal Spasm-like Pain or Discomfort
Condition: Abdominal Pain
MeSH terms: Abdominal Pain
Intervention: Hyoscine Butylbromide - Tablet; Hyoscine Butylbromide - Capsule; Placebo
Intervention MeSH terms: Scopolamine; Butylscopolammonium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 302.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      In contrast with Hyoscine Butylbromide Capsule 10mg, Study is to evaluate the efficacy and
      safety of Hyoscine Butylbromide tablets 10 mg (20mg, 3 times daily, orally) over a period of
      3 days for the treatment of occasional or recurrent episodes of self-reported gastric or
      intestinal spasm-like pain or discomfort
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written Informed Consent given by the patient

          2. Male and female patients aging from 18 to 70

          3. Subjects with occasional or recurrent episodes of gastric or intestinal spasm-like
             pain, or discomfort, such as occur e.g. in irritable bowel syndrome, which has been
             present for at least 3 months

          4. The pain intensity score upon screening is at least 4 cm in VAS score

        Exclusion Criteria:

          1. Patients with the following concomitant disease were not eligible for enrolment

               -  Painful gastric or intestinal spasm of organic origin such as Crohn's disease,
                  ulcerative colitis, lactose intolerance, gastritis, ulcer. Exception:
                  diverticulitis and mild gastritis if dominant symptom was cramp pain, but
                  ineligible if heartburn or reflux were dominant symptoms

               -  Pain related with malignancy

               -  Patients with other severe pain states of organic origin

               -  Mechanical stenosis of the gastrointestinal tract, megacolon

               -  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. Frequent vomiting that might have prevented adequate absorption of the active
             ingredient after the film-coated tablet was taken

          3. Patients taking the following concomitant medication are not eligible for enrolment

               -  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

          4. Pregnancy and/or lactation or planned pregnancy

          5. Known hypersensitivity to N-butylscopolammonium bromide

          6. Alcohol or drug abuse

          7. 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
             enrolment is forbidden

          8. Unwilling to or unable to complete the entire trial procedure according to the
             protocol

          9. In investigator's opinion, the patient was not proper for the trial