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

NCT ID: NCT02242305

Last Updated: 2017-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 302 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-01
• Study Completion Date: 2009-07-20

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 treatment of occasional or recurrent episodes of self-reported gastric or intestinal spasm-like pain or discomfort

Conditions

Abdominal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hyoscine Butylbromide - Tablet

Group Type: EXPERIMENTAL

Hyoscine Butylbromide - Tablet

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Hyoscine Butylbromide - Capsule

Group Type: ACTIVE_COMPARATOR

Hyoscine Butylbromide - Capsule

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Interventions

Hyoscine Butylbromide - Tablet

Intervention Type: DRUG

Hyoscine Butylbromide - Capsule

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

202.838

Identifier Type: -

Identifier Source: org_study_id