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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Daewoong Pharmaceutical Co. LTD..
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD. Identifier:
First received: June 21, 2012
Last updated: June 26, 2012
Last verified: June 2012
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.

Condition Intervention Phase
Irritable Bowel Syndrome
Drug: Tiropramide HCl 100mg
Drug: Octylonium bromide 20mg
Phase 4

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Further study details as provided by Daewoong Pharmaceutical Co. LTD.:

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

Study Start Date: December 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tiropramide HCl Drug: Tiropramide HCl 100mg
Active Comparator: Octylonium bromide Drug: Octylonium bromide 20mg


Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01629212

Contact: Oh Young Lee, MD

Korea, Republic of
Han Yang University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Oh Young Lee   
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
  More Information

Responsible Party: Daewoong Pharmaceutical Co. LTD. Identifier: NCT01629212     History of Changes
Other Study ID Numbers: DW-TRP001
Study First Received: June 21, 2012
Last Updated: June 26, 2012

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents processed this record on May 23, 2017