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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01629212
First Posted: June 27, 2012
Last Update Posted: June 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01629212


Contacts
Contact: Oh Young Lee, MD leeoy@hanyang.ac.kr

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

Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT01629212     History of Changes
Other Study ID Numbers: DW-TRP001
First Submitted: June 21, 2012
First Posted: June 27, 2012
Last Update Posted: June 27, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Bromides
Octylonium
Tiropramide
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents