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
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
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
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