Comparative Efficacy and Safety of Fenoverine (FEN-401)

December 17, 2014 updated by: Bukwang Pharmaceutical

Comparative Efficacy and Safety of Fenoverine and Trimebutine Maleate in Irritable Bowel Syndrome; A Randomized Double-blind Parallel Multi-center Phase IV Trial

It is a randomized double-blind parallel phase IV study to compare Fenoverine and Trimebutine maleate in the efficacy and safety.

Study Hypothesis: Fenoverine is non-inferior to Trimebutine maleate in its efficacy and safety.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For subjects with IBS, Fenoverine and Trimebutine will be administered orally for 8 weeks; Fenoverine 100mg capsule three times a day and Trimebutine 150mg tablet three times a day. Because one is capsule and the other is tablet, double dummy design will be used. Efficacy is evaluated at the end of 8 weeks and safety will be followed for 4 more weeks after the end of the scheduled medication.

Study Type

Interventional

Enrollment (Anticipated)

186

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Ansan, Korea, Republic of
        • Korea University Ansan Hospital
      • Anyang, Korea, Republic of
        • Hallym University Sacred Heart Hospital
      • Chuncheon, Korea, Republic of
        • Kangwon National University Hospital
      • Incheon, Korea, Republic of
        • Gachon University Gil Hospital
      • Seoul, Korea, Republic of
        • Inje University Seoul Paik Hospital
      • Seoul, Korea, Republic of
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of
        • Korea University Anam Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older and 60 years of age or younger
  • Diagnosed as irritable bowel syndrome using Rome III Criteria
  • Female subjects of child-bearing potential are confirmed to have a negative urine beta-hCG test within 7 days prior to administration of initial dose of investigational products.
  • Female subjects of child-bearing potential must agree to use contraceptive measures during study period.

Exclusion Criteria:

  • Known allergy or hypersensitivity to investigational products or components of the formulation
  • Past or current diagnosis of chronic liver disease (e.g., liver cirrhosis, acute hepatitis, alcoholic hepatitis, chronic alcohol abuse and HCC)
  • Past or current diagnosis of Myopathy
  • Subject with serious renal disease
  • Known medical condition assessed by investigators as inappropriate for the study
  • Continuous use of NSAIDS, analgesics, steroids, or other immunosuppressants.
  • Continuous use of HMG-CoA reductase inhibitors or fibrates to lower blood lipid level
  • Pregnant, lactating, or planning to be pregnant women
  • Evidence of abuse of drugs or alcohol within 6 months prior to screening
  • Participation in other clinical trials within 3 months prior to enrollment or elapse of less than 5 half lives of previous investigational product after last dose of it.
  • Unable to submit informed consent or comply with the requirements of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fenoverine
Fenoverine 100mg three times a day will be administered for 8 weeks.
Drug: Fenoverine
Fenoverine 100mg three times a day for 8 weeks
Other Names:
  • Fexadin
Active Comparator: Trimebutine
Trimebutine maleate 150mg three times a day will be administered for 8 weeks.
Drug: Timebutine
Timebutine maleate 150mg three times a day for 8 weeks
Other Names:
  • Polybutin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the proportion of subjects with improvement in abdominal pain or discomfort
Time Frame: week 8
the proportion of subjects who experienced more than 30% improvement in abdominal pain or discomfort score with visual analog scale at week 8 compared to baseline
week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BSS scores (each and total)
Time Frame: week 4, 8
BSS score will be checked for four IBS symptoms; abdominal pain or discomfort, bloating, constipation, diarrhea. The scores will be compared for its chronological changes between trial groups. Total BSS score will be the sum of the scores of four symptoms measured.
week 4, 8
overall BSS score
Time Frame: Week 4, 8
IBS symptom will be assessed overally by subjects at day 1, week 4, and week 8. The scores will be compared chronologically between groups.
Week 4, 8
subject's satisfaction with treatment
Time Frame: week 4, 8
Subject's satisfaction with the treatment is measured using visual analog scale.
week 4, 8
adverse event
Time Frame: at each visit or contact until 4 weeks after the last dose
Vital signs will be checked at each visit. Laboratory tests will be conducted at baseline and week 8, and at any time if necessary.
at each visit or contact until 4 weeks after the last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bukwang Pharmaceutical

Investigators

  • Principal Investigator: Yoon Tae Jeen, Dr., Korea University Anam Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

January 5, 2012

First Submitted That Met QC Criteria

January 8, 2012

First Posted (Estimate)

January 11, 2012

Study Record Updates

Last Update Posted (Estimate)

December 18, 2014

Last Update Submitted That Met QC Criteria

December 17, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FEN-401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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