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

Daewoong Pharmaceutical

Status and phase: Unknown; Phase 4

Conditions: Irritable Bowel Syndrome

Treatments: Drug: Tiropramide HCl 100mg; Drug: Octylonium bromide 20mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01629212

DW-TRP001

Details and patient eligibility

About

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.

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

Tiropramide HCl

Experimental group

Treatment:

Drug: Tiropramide HCl 100mg

Octylonium bromide

Active Comparator group

Treatment:

Drug: Octylonium bromide 20mg