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Comparative Efficacy and Safety of Fenoverine (FEN-401)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01507922
Recruitment Status : Completed
First Posted : January 11, 2012
Last Update Posted : December 18, 2014
Sponsor:
Information provided by (Responsible Party):

January 5, 2012
January 11, 2012
December 18, 2014
December 2011
March 2013   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01507922 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Comparative Efficacy and Safety of Fenoverine
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.

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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Irritable Bowel Syndrome
  • Drug: Fenoverine
    Fenoverine 100mg three times a day for 8 weeks
    Other Name: Fexadin
  • Drug: Timebutine
    Timebutine maleate 150mg three times a day for 8 weeks
    Other Name: Polybutin
  • Experimental: Fenoverine
    Fenoverine 100mg three times a day will be administered for 8 weeks.
    Intervention: Drug: Fenoverine
  • Active Comparator: Trimebutine
    Trimebutine maleate 150mg three times a day will be administered for 8 weeks.
    Intervention: Drug: Timebutine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
186
June 2013
March 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01507922
FEN-401
No
Not Provided
Not Provided
Bukwang Pharmaceutical
Bukwang Pharmaceutical
Not Provided
Principal Investigator: Yoon Tae Jeen, Dr. Korea University Anam Hospital
Bukwang Pharmaceutical
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP