Status:
COMPLETED
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Abdominal Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 t...
Eligibility Criteria
Inclusion
- Written Informed Consent given by the patient
- Male and female patients aging from 18 to 70
- 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
- The pain intensity score upon screening is at least 4 cm in VAS score
Exclusion
- 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
- Frequent vomiting that might have prevented adequate absorption of the active ingredient after the film-coated tablet was taken
- 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
- Pregnancy and/or lactation or planned pregnancy
- Known hypersensitivity to N-butylscopolammonium bromide
- Alcohol or drug abuse
- 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
- Unwilling to or unable to complete the entire trial procedure according to the protocol
- In investigator's opinion, the patient was not proper for the trial
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2009
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT02242305
Start Date
November 1 2008
End Date
July 20 2009
Last Update
July 27 2017
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