Comparative Efficacy and Safety of Fenoverine

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2013

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.

Interventions

  • Drug: Fenoverine
    • Fenoverine 100mg three times a day for 8 weeks
  • Drug: Timebutine
    • Timebutine maleate 150mg three times a day for 8 weeks

Arms, Groups and Cohorts

  • Experimental: Fenoverine
    • Fenoverine 100mg three times a day will be administered for 8 weeks.
  • Active Comparator: Trimebutine
    • Trimebutine maleate 150mg three times a day will be administered for 8 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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.
  • 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.
  • subject’s satisfaction with treatment
    • Time Frame: week 4, 8
    • Subject’s satisfaction with the treatment is measured using visual analog scale.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bukwang Pharmaceutical
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yoon Tae Jeen, Dr., Principal Investigator, Korea University Anam Hospital

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