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Comparative Efficacy and Safety of Fenoverine (FEN-401)

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fenoverine
Timebutine
Sponsored by
Bukwang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Fenoverine, Irritable Bowel Syndrome, Abdominal pain, BSS

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Korea University Ansan Hospital
  • Hallym University Sacred Heart Hospital
  • Kangwon National University Hospital
  • Gachon University Gil Hospital
  • Inje University Seoul Paik Hospital
  • Korea University Anam Hospital
  • Korea University Guro Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fenoverine

Trimebutine

Arm Description

Fenoverine 100mg three times a day will be administered for 8 weeks.

Trimebutine maleate 150mg three times a day will be administered for 8 weeks.

Outcomes

Primary Outcome Measures

the proportion of subjects with improvement in abdominal pain or discomfort
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)
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
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
Subject's satisfaction with the treatment is measured using visual analog scale.
adverse event
Vital signs will be checked at each visit. Laboratory tests will be conducted at baseline and week 8, and at any time if necessary.

Full Information

First Posted
January 5, 2012
Last Updated
December 17, 2014
Sponsor
Bukwang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT01507922
Brief Title
Comparative Efficacy and Safety of Fenoverine
Acronym
FEN-401
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bukwang Pharmaceutical

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Fenoverine, Irritable Bowel Syndrome, Abdominal pain, BSS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fenoverine
Arm Type
Experimental
Arm Description
Fenoverine 100mg three times a day will be administered for 8 weeks.
Arm Title
Trimebutine
Arm Type
Active Comparator
Arm Description
Trimebutine maleate 150mg three times a day will be administered for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Fenoverine
Other Intervention Name(s)
Fexadin
Intervention Description
Fenoverine 100mg three times a day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Timebutine
Other Intervention Name(s)
Polybutin
Intervention Description
Timebutine maleate 150mg three times a day for 8 weeks
Primary Outcome Measure Information:
Title
the proportion of subjects with improvement in abdominal pain or discomfort
Description
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
Time Frame
week 8
Secondary Outcome Measure Information:
Title
BSS scores (each and total)
Description
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.
Time Frame
week 4, 8
Title
overall BSS score
Description
IBS symptom will be assessed overally by subjects at day 1, week 4, and week 8. The scores will be compared chronologically between groups.
Time Frame
Week 4, 8
Title
subject's satisfaction with treatment
Description
Subject's satisfaction with the treatment is measured using visual analog scale.
Time Frame
week 4, 8
Title
adverse event
Description
Vital signs will be checked at each visit. Laboratory tests will be conducted at baseline and week 8, and at any time if necessary.
Time Frame
at each visit or contact until 4 weeks after the last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoon Tae Jeen, Dr.
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Ansan Hospital
City
Ansan
Country
Korea, Republic of
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang
Country
Korea, Republic of
Facility Name
Kangwon National University Hospital
City
Chuncheon
Country
Korea, Republic of
Facility Name
Gachon University Gil Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Inje University Seoul Paik Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Comparative Efficacy and Safety of Fenoverine

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