Irritable Bowel Syndrome
Conditions
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.
Interventions
DRUGTiropramide HCl 100mg
DRUGOctylonium bromide 20mg
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of abdominal pain VAS scores from baseline to week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of abdominal pain VAS scores from baseline to week 2 | — |
| Change of abdominal discomfort VAS scores from baseline to week 2 and 4 | — |
Countries
South Korea
Contacts
Primary ContactOh Young Lee, MD
Outcome results
None listed