Comparison of the Efficacy and Safety of Tiropramide and Octylonium in the Treatment of Irritable Bowel Syndrome

• Status: Unknown status
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to compare the Efficacy and Safety of Tiropramide HCl and Octylonium bromide in the Treatment of Irritable Bowel Syndrome.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.
• Treatments: Bromides; Octylonium; Tiropramide

Criteria

Inclusion Criteria:

1. Adult patients (aged 20-75 years)

2. Patients who had been suffered from IBS as defined by Rome III criteria

3. Patients who had abdominal pain at least 2 days/week, during the run-in period of 2 weeks

Exclusion Criteria:

1. Patients with known intolerance to tiropramide or octylonium

2. Patients with uncontrolled diabetes, uncontrolled hypertension or thyroid dysfunction

3. Patients who had the history of cancer [However, patients with cancer other than gastrointerstinal cancer, who have not recurr within 5 years after treatment were possible for enrollment]

4. Patients with hepatic or renal dysfunction

5. Patients with lactose intorelance