A phase III multicentre, randomised, double blind, placebo controlled, parallel group study of renzapride in women with constipation predominant Irritable Bowel Syndrome (IBS)

ISRCTN ISRCTN75871030
DOI https://doi.org/10.1186/ISRCTN75871030
ClinicalTrials.gov number NCT00268879
Secondary identifying numbers ATL1251/038/CL
Submission date
22/12/2005
Registration date
24/01/2006
Last edited
28/01/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Anthony Lembo
Scientific

Beth Israel Deaconess Medical Centre
Boston
MA 02215
United States of America

Study information

Study designRandomised, double blind, placebo controlled, parallel group
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleClinical trial: renzapride treatment of women with irritable bowel syndrome and constipation – a double‐blind, randomized, placebo‐controlled, study
Study objectivesTo investigate whether renzapride will help alleviate the symptoms associated with constipation predominant irritable bowel syndrome
Ethics approval(s)Copernicus Group Institutional Review Board (IRB) on the 30/09/2005 (ref QUI1-05-131).
Health condition(s) or problem(s) studiedConstipation predominant irritable bowel syndrome
InterventionOral (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 typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Renzapride
Primary outcome measureNumber of months a patient is a responder for overall relief of IBS symptoms
Secondary outcome measuresNumber of months a patient is a responder for relief of abdominal pain/discomfort, bowel problems and bloating/abdominal distention
Overall study start date05/12/2005
Completion date31/01/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexFemale
Target number of participants1700 (This trial is no longer recruiting, and the completion date of this trial is estimated to be sometime during 1Q 2008).
Key inclusion criteria1. 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
Key exclusion criteria1. Patients who have predominant diarrhoea or alternating symptomatic IBS
2. Other gastrointestinal diseases that affect bowel transit
Date of first enrolment05/12/2005
Date of final enrolment31/01/2007

Locations

Countries of recruitment

  • Argentina
  • Canada
  • Chile
  • Colombia
  • United States of America

Study participating centre

Beth Israel Deaconess Medical Centre
Boston
MA 02215
United States of America

Sponsor information

Alizyme (UK)
Industry

Granta Park
Great Abington
Cambridge
CB1 6GX
United Kingdom

Phone +44 (0)1223 896000
Email Medical.Information@alizyme.co.uk
Website http://www.alizyme.com

Funders

Funder type

Industry

Alizyme (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2010 28/01/2019 Yes No

Editorial Notes

28/01/2019: Publication reference added