Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00268879
Protocol/serial number
ATL1251/038/CL
Study information
Scientific title
Acronym
Study hypothesis
To investigate whether renzapride will help alleviate the symptoms associated with constipation predominant irritable bowel syndrome
Ethics approval
Copernicus Group Institutional Review Board (IRB) on the 30/09/2005 (ref QUI1-05-131).
Study design
Randomised, double blind, placebo controlled, parallel group
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Constipation predominant irritable bowel syndrome
Intervention
Oral (capsules), 4 mg renzapride once daily (OD), 2 mg renzapride twice daily (BD) or placebo, taken for 12 weeks with a 4-week safety follow-up period.
N.B. In the USA only, patients who completed the full 12 weeks of treatment were invited to enrol in a follow-on, open label, long-term safety study (ATL1251/052/CL) in which all patients took oral (capsules), 4 mg renzapride OD for up to 12 months; this study is ongoing and is due to report during 1H 2009.
Intervention type
Drug
Phase
Phase III
Drug names
Renzapride
Primary outcome measures
Number of months a patient is a responder for overall relief of IBS symptoms
Secondary outcome measures
Number of months a patient is a responder for relief of abdominal pain/discomfort, bowel problems and bloating/abdominal distention
Overall trial start date
05/12/2005
Overall trial end date
31/01/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Females, aged 18-65, with constipation predominant IBS as defined by the Rome II criteria
2. Colonoscopy or sigmoidoscopy in the previous 5 years showing no significant disease
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1700 (This trial is no longer recruiting, and the completion date of this trial is estimated to be sometime during 1Q 2008).
Participant exclusion criteria
1. Patients who have predominant diarrhoea or alternating symptomatic IBS
2. Other gastrointestinal diseases that affect bowel transit
Recruitment start date
05/12/2005
Recruitment end date
31/01/2007
Locations
Countries of recruitment
Argentina, Canada, Chile, Colombia, United States of America
Trial participating centre
Beth Israel Deaconess Medical Centre
Boston
MA 02215
United States of America
Sponsor information
Organisation
Alizyme (UK)
Sponsor details
Granta Park
Great Abington
Cambridge
CB1 6GX
United Kingdom
+44 (0)1223 896000
Medical.Information@alizyme.co.uk
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Alizyme (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary