Irritable Bowel SyndromePhase 4FEN-401NCT01507922
Comparative Efficacy and Safety of Fenoverine
A Phase 4 study testing Fenoverine and Timebutine in people with Irritable Bowel Syndrome, run by Bukwang Pharmaceutical at 7 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Fenoverine and Timebutine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 7 sitesSouth Korea
- Study dates
- Dec 2011to Jun 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Korea University Ansan Hospital
Ansan
Hallym University Sacred Heart Hospital
Anyang
Kangwon National University Hospital
Chuncheon
Gachon University Gil Hospital
Incheon
Inje University Seoul Paik Hospital
Seoul
Korea University Anam Hospital
Seoul
Korea University Guro Hospital
Seoul
About this study
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
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.
Read the 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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Fenoverine, Timebutine
- Keywords
- Fenoverine, Irritable Bowel Syndrome, Abdominal pain, BSS
- Medical subject headings
- Irritable Bowel Syndrome, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenoverineDrug
Also called Fexadin
Fenoverine 100mg three times a day for 8 weeks
TimebutineDrug
Also called Polybutin
Timebutine maleate 150mg three times a day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Fenoverine | Experimental | Fenoverine 100mg three times a day will be administered for 8 weeks. Receives: Drug: Fenoverine |
| Trimebutine | Active comparator | Trimebutine maleate 150mg three times a day will be administered for 8 weeks. Receives: Drug: Timebutine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: week 8
Secondary outcomes (4)
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.
Measured: week 4, 8
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.
Measured: Week 4, 8
subject's satisfaction with treatment
Subject's satisfaction with the treatment is measured using visual analog scale.
Measured: week 4, 8
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.
Measured: at each visit or contact until 4 weeks after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionMar 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bukwang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoon Tae Jeen, Dr., Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507922
- Sponsor's protocol ID
- FEN-401
- Acronym
- FEN-401
- Status last verified
- Dec 2014
- First submitted
- 5 Jan 2012
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01507922
- Acronym / sponsor ID
- FEN-401 / FEN-401
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Fenoverine, Irritable Bowel Syndrome, Abdominal pain, BSS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 11 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fenoverine | Experimental | Drug: FenoverineFenoverine 100mg three times a day will be administered for 8 weeks. |
| Trimebutine | Active comparator | Drug: TimebutineTrimebutine maleate 150mg three times a day will be administered for 8 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FenoverineAlso: FexadinFenoverine 100mg three times a day for 8 weeks | Drug | Fenoverine |
| TimebutineAlso: PolybutinTimebutine maleate 150mg three times a day for 8 weeks | Drug | Trimebutine |
Primary outcome
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
4 secondary outcomes
BSS scores (each and total)
Time frame: week 4, 8
overall BSS score
Time frame: Week 4, 8
subject's satisfaction with treatment
Time frame: week 4, 8
adverse event
Time frame: at each visit or contact until 4 weeks after the last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoon Tae Jeen, Dr. principal investigator
Korea University Anam Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fenoverine and Timebutine in people with Irritable Bowel Syndrome, run by Bukwang Pharmaceutical at 7 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of subjects with improvement in abdominal pain or discomfort (time frame: week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2014.