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

Primary Purpose

Irritable Bowel Syndrome

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tiropramide HCl 100mg
Octylonium bromide 20mg
Sponsored by
Daewoong Pharmaceutical Co. LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Han Yang University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tiropramide HCl

Octylonium bromide

Arm Description

Outcomes

Primary Outcome Measures

Change of abdominal pain VAS scores from baseline to week 4

Secondary Outcome Measures

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

Full Information

First Posted
June 21, 2012
Last Updated
June 26, 2012
Sponsor
Daewoong Pharmaceutical Co. LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT01629212
Brief Title
Comparison of the Efficacy and Safety of Tiropramide and Octylonium in the Treatment of Irritable Bowel Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
February 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4

8. Arms, Groups, and Interventions

Arm Title
Tiropramide HCl
Arm Type
Experimental
Arm Title
Octylonium bromide
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tiropramide HCl 100mg
Intervention Type
Drug
Intervention Name(s)
Octylonium bromide 20mg
Primary Outcome Measure Information:
Title
Change of abdominal pain VAS scores from baseline to week 4
Secondary Outcome Measure Information:
Title
Change of abdominal pain VAS scores from baseline to week 2
Title
Change of abdominal discomfort VAS scores from baseline to week 2 and 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oh Young Lee, MD
Email
leeoy@hanyang.ac.kr
Facility Information:
Facility Name
Han Yang University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oh Young Lee
Email
leeoy@hanyang.ac.kr

12. IPD Sharing Statement

Learn more about this trial

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

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