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

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Abdominal Pain

Treatments: Drug: Placebo; Drug: Hyoscine Butylbromide - Capsule; Drug: Hyoscine Butylbromide - Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02242305

202.838

Details and patient eligibility

About

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

Enrollment: 302 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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302 participants in 2 patient groups

Hyoscine Butylbromide - Tablet

Experimental group

Treatment:

Drug: Placebo

Drug: Hyoscine Butylbromide - Tablet

Hyoscine Butylbromide - Capsule

Active Comparator group

Treatment:

Drug: Placebo

Drug: Hyoscine Butylbromide - Capsule