Investigation of the Safety and Efficacy of Renzapride in Constipation Predominant Irritable Bowel Syndrome (IBS)
NCT ID: NCT00268879
Last Updated: 2008-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1821 participants
INTERVENTIONAL
2005-12-31
2008-01-31
Brief Summary
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Detailed Description
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In this study female patients with constipation predominant IBS will receive one of two dosing regimens of renzapride or placebo for 12 weeks. Patients will record the severity of their symptoms throughout the study. The results will be analysed to see if those patients who received renzapride had greater relief of their symptoms than did the patients who received placebo.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Two capsules are taken by mouth each morning and each evening from the day of the randomization visit until the scheduled visit at the end of Week 12.
Renzapride
Placebo Renzapride 4 mg QD Renzapride 2 mg BID
2
Renzapride 4 mg QD. Two capsules are taken by mouth each morning and each evening from the day of the randomization visit until the scheduled visit at the end of Week 12.
Renzapride
Placebo Renzapride 4 mg QD Renzapride 2 mg BID
3
Renzapride 2 mg BID: Two capsules are taken by mouth each morning and each evening from the day of the randomization visit until the scheduled visit at the end of Week 12.
Renzapride
Placebo Renzapride 4 mg QD Renzapride 2 mg BID
Interventions
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Renzapride
Placebo Renzapride 4 mg QD Renzapride 2 mg BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Colonoscopy or sigmoidoscopy in previous 5 years showed no significant disease
Exclusion Criteria
* Other gastrointestinal diseases that affect bowel transit
18 Years
65 Years
FEMALE
No
Sponsors
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Alizyme
INDUSTRY
Responsible Party
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Alizyme
Principal Investigators
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Anthony Lembo
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Centre, Boston
Locations
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Alizyme
Cambridge, , United Kingdom
Countries
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Other Identifiers
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ATL1251/038/CL
Identifier Type: -
Identifier Source: org_study_id
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