Comparative Efficacy and Safety of Fenoverine - Full Text View

Purpose

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.

Condition	Intervention	Phase
Irritable Bowel Syndrome	Drug: Fenoverine Drug: Timebutine	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Comparative Efficacy and Safety of Fenoverine and Trimebutine Maleate in Irritable Bowel Syndrome; A Randomized Double-blind Parallel Multi-center Phase IV Trial

Resource links provided by NLM:

MedlinePlus related topics: Abdominal Pain

U.S. FDA Resources

Further study details as provided by Bukwang Pharmaceutical:

Primary Outcome Measures:

the proportion of subjects with improvement in abdominal pain or discomfort [ Time Frame: week 8 ] [ Designated as safety issue: No ]
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 Outcome Measures:

BSS scores (each and total) [ Time Frame: week 4, 8 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
Vital signs will be checked at each visit. Laboratory tests will be conducted at baseline and week 8, and at any time if necessary.

Estimated Enrollment:	186
Study Start Date:	December 2011
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: Polybutin

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507922

Contacts

Contact: Hyunju Oh, Dr.

82-2-828-8070

hjoh@bukwang.co.kr

Locations

Korea, Republic of
Korea University Ansan Hospital	Recruiting
Ansan, Korea, Republic of
Hallym University Sacred Heart Hospital	Recruiting
Anyang, Korea, Republic of
Kangwon National University Hospital	Not yet recruiting
Chuncheon, Korea, Republic of
Gachon University Gil Hospital	Recruiting
Incheon, Korea, Republic of
Korea University Guro Hospital	Recruiting
Seoul, Korea, Republic of
Korea University Anam Hospital	Recruiting
Seoul, Korea, Republic of
Inje University Seoul Paik Hospital	Recruiting
Seoul, Korea, Republic of

Sponsors and Collaborators

Bukwang Pharmaceutical

Investigators

Principal Investigator:

Yoon Tae Jeen, Dr.

Korea University Anam Hospital

More Information

No publications provided

Responsible Party:	Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:	NCT01507922 History of Changes
Other Study ID Numbers:	FEN-401
Study First Received:	January 5, 2012
Last Updated:	July 24, 2012
Health Authority:	Korea: Food and Drug Administration Korea: Institutional Review Board

Keywords provided by Bukwang Pharmaceutical:

Fenoverine
Irritable Bowel Syndrome
Abdominal pain
BSS

Additional relevant MeSH terms:

Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Maleic acid
Trimebutine
Fenoverine

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013

Comparative Efficacy and Safety of Fenoverine (FEN-401)