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

This study is currently recruiting participants.

Verified June 2012 by Daewoong Pharmaceutical Co. LTD.

Sponsor:

Information provided by (Responsible Party):

Daewoong Pharmaceutical Co. LTD.

ClinicalTrials.gov Identifier:

NCT01629212

First received: June 21, 2012

Last updated: June 26, 2012

Last verified: June 2012

History of Changes

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

Resource links provided by NLM:

MedlinePlus related topics: Abdominal Pain

U.S. FDA Resources

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

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:	NCT01629212 History of Changes
Other Study ID Numbers:	DW-TRP001
Study First Received:	June 21, 2012
Last Updated:	June 26, 2012
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:

Colonic Diseases, Functional
Irritable Bowel Syndrome
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Bromides
Octylonium
Tiropramide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Gastrointestinal Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 16, 2013

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