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 (NCT) | NCT00268879 |
| Protocol serial number | ATL1251/038/CL |
| Sponsor | Alizyme (UK) |
| Funder | Alizyme (UK) |
- 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
Scientific
Beth Israel Deaconess Medical Centre
Boston
MA 02215
United States of America
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double blind, placebo controlled, parallel group |
| Secondary study design | Randomised controlled trial |
| Scientific title | Clinical trial: renzapride treatment of women with irritable bowel syndrome and constipation – a double‐blind, randomized, placebo‐controlled, study |
| Study objectives | To 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) studied | 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 / device / biological / vaccine name(s) | Renzapride |
| Primary outcome measure(s) |
Number of months a patient is a responder for overall relief of IBS symptoms |
| Key secondary outcome measure(s) |
Number of months a patient is a responder for relief of abdominal pain/discomfort, bowel problems and bloating/abdominal distention |
| Completion date | 31/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Female |
| Target sample size at registration | 1700 |
| Key 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 |
| Key exclusion criteria | 1. Patients who have predominant diarrhoea or alternating symptomatic IBS 2. Other gastrointestinal diseases that affect bowel transit |
| Date of first enrolment | 05/12/2005 |
| Date of final enrolment | 31/01/2007 |
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
MA 02215
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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
