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

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-likepain, or discomfort, such as occur e.g. in irritable bowel syndrome, which has beenpresent 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, butineligible 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 activeingredient 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 ulcertreatment

• 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 anotherclinical trial before randomization (administration of study medication); moreover, inthe case of screening failure or premature discontinuing from the trial, repeatedenrolment is forbidden

8. Unwilling to or unable to complete the entire trial procedure according to theprotocol

9. In investigator's opinion, the patient was not proper for the trial