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Completed

NCT Number: NCT01507922

Comparative Efficacy and Safety of Fenoverine

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.

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Key information

Conditions

Irritable Bowel Syndrome Abdominal Pain Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Korea University Ansan Hospital, Ansan, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fenoverine

Drug

Fenoverine 100mg three times a day for 8 weeks

Other names: Fexadin

Timebutine

Drug

Timebutine maleate 150mg three times a day for 8 weeks

Other names: Polybutin

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. subject's satisfaction with treatment

    Time frame: week 4, 8

    Subject's satisfaction with the treatment is measured using visual analog scale.

  4. 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.

Sponsors and collaborators

Lead sponsor

Bukwang Pharmaceutical

Industry

Registry information

Official study title

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

Acronym: FEN-401

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 11, 2012
Registry last updated
Dec 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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