Comparison of the Efficacy and Safety of Tiropramide and Octylonium in the Treatment of Irritable Bowel Syndrome
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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 21, 2012
CompletedFirst Posted
Study publicly available on registry
June 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedJune 27, 2012
June 1, 2012
1.2 years
June 21, 2012
June 26, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Change of abdominal pain VAS scores from baseline to week 4
Secondary Outcomes (2)
Change of abdominal pain VAS scores from baseline to week 2
Change of abdominal discomfort VAS scores from baseline to week 2 and 4
Study Arms (2)
Tiropramide HCl
EXPERIMENTALOctylonium bromide
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Adult patients (aged 20-75 years)
- Patients who had been suffered from IBS as defined by Rome III criteria
- Patients who had abdominal pain at least 2 days/week, during the run-in period of 2 weeks
You may not qualify if:
- Patients with known intolerance to tiropramide or octylonium
- Patients with uncontrolled diabetes, uncontrolled hypertension or thyroid dysfunction
- Patients who had the history of cancer \[However, patients with cancer other than gastrointerstinal cancer, who have not recurr within 5 years after treatment were possible for enrollment\]
- Patients with hepatic or renal dysfunction
- Patients with lactose intorelance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Han Yang University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2012
First Posted
June 27, 2012
Study Start
December 1, 2011
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
June 27, 2012
Record last verified: 2012-06