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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01507922 |
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Date of registration:
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05/01/2012 |
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Primary sponsor: |
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Public title:
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Comparative Efficacy and Safety of Fenoverine
FEN-401 |
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Scientific title:
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Comparative Efficacy and Safety of Fenoverine and Trimebutine Maleate in Irritable Bowel Syndrome; A Randomized Double-blind Parallel Multi-center Phase IV Trial |
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Date of first enrolment:
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December 2011 |
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Target sample size:
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186 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01507922 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Hyunju Oh, Dr. |
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Address:
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Telephone:
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82-2-828-8070 |
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Email:
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hjoh@bukwang.co.kr |
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Affiliation:
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Name:
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Yoon Tae Jeen, Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Korea University Anam Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Irritable Bowel Syndrome
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Intervention(s)
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Drug: Fenoverine
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Drug: Timebutine
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Primary Outcome(s)
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the proportion of subjects with improvement in abdominal pain or discomfort
[Time Frame: week 8]
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Secondary Outcome(s)
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adverse event
[Time Frame: at each visit or contact until 4 weeks after the last dose]
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BSS scores (each and total)
[Time Frame: week 4, 8]
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overall BSS score
[Time Frame: Week 4, 8]
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subject's satisfaction with treatment
[Time Frame: week 4, 8]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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