Condition category
Digestive System
Date applied
22/12/2005
Date assigned
24/01/2006
Last edited
15/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anthony Lembo

ORCID ID

Contact details

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

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

http://www.alizyme.com

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

Publication citations

Additional files

Editorial Notes