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

Irritable Bowel Syndrome Clinical Trial

Official title:

Comparative and Analytical Study for Effectiveness and Safety of Tiropramide HCl and Octylonium Bromide in the Treatment of Irritable Bowel Syndrome: Mullticenter, Randomized, Double Blind, Active Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01629212
• Other study ID #: DW-TRP001
• Status: Recruiting
• Phase: Phase 4
• First received: June 21, 2012
• Last updated: June 26, 2012
• Start date: December 2011
• Est. completion date: February 2013

Study information

• Verified date: June 2012
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: Oh Young Lee, MD
• Email: leeoy[@]hanyang.ac.kr
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Tiropramide HCl 100mg

• Octylonium bromide 20mg

Locations

Country	Name	City	State
Korea, Republic of	Han Yang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of abdominal pain VAS scores from baseline to week 4
Secondary	Change of abdominal pain VAS scores from baseline to week 2
Secondary	Change of abdominal discomfort VAS scores from baseline to week 2 and 4