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

Phase 4

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: Tiropramide HCl 100mg; Drug: Octylonium bromide 20mg

• Registration Number: NCT01629212
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Status Verified: 2012-06
• Study First Submitted: 2012-06-21
• Study First Submitted QC: 2012-06-26
• Last Update Submitted: 2012-06-26
• Study First Posted: 2012-06-27
• Last Update Posted: 2012-06-27
• Primary Completion: 2013-02
• Study Completion: 2013-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tiropramide HCl	Tiropramide HCl 100mg	-
Octylonium bromide	Octylonium bromide 20mg	-

Primary Outcome Measures

Name	Time	Method
Change of abdominal pain VAS scores from baseline to week 4

Secondary Outcome Measures

Name	Time	Method
Change of abdominal pain VAS scores from baseline to week 2
Change of abdominal discomfort VAS scores from baseline to week 2 and 4

Trial Locations

Locations (1)

Han Yang University Hospital; 🇰🇷 Seoul, Korea, Republic of