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 because the information has not been verified recently.
Verified June 2012 by Daewoong Pharmaceutical Co. LTD..
Recruitment status was  Recruiting
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
  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:


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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014