| December 22, 2005 |
| February 13, 2008 |
| December 2005 |
| January 2008 (final data collection date for primary outcome measure) |
| Number of months a patient is a Responder for overall relief of IBS symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] |
| Number of months a patient is a Responder for overall relief of IBS symptoms |
| Complete list of historical versions of study NCT00268879 on ClinicalTrials.gov Archive Site |
| Number of months a patient is a Responder for relief of abdominal pain/discomfort, bowel problems, and bloating/abdominal distention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] |
| Number of months a patient is a Responder for relief of abdominal pain/discomfort, bowel problems, and bloating/abdominal distention |
| |
| Investigation of the Safety and Efficacy of Renzapride in Constipation Predominant Irritable Bowel Syndrome (IBS) |
| A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Renzapride in Women With Constipation-Predominant Irritable Bowel Syndrome (c-IBS) |
The purpose of the study is to investigate whether renzapride will help alleviate the symptoms associated with constipation predominant irritable bowel syndrome in female patients. |
Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by recurrent symptoms of abdominal pain/discomfort accompanied by disturbed bowel function.
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. |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Irritable Bowel Syndrome |
| Drug: Renzapride |
- Placebo Comparator: 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.
- Experimental: 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.
- Experimental: 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.
|
| |
| |
| Completed |
| 1821 |
| January 2008 |
| January 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Females with constipation predominant IBS as defined by the Rome II criteria
- Colonoscopy or sigmoidoscopy in previous 5 years showed no significant disease
Exclusion Criteria:
- Patients who have diarrhoea predominant or alternating symptom IBS
- Other gastrointestinal diseases that affect bowel transit
|
| Female |
| 18 Years to 65 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United Kingdom |
| |
| NCT00268879 |
| Research and Development Director, Alizyme |
| ATL1251/038/CL |
| Alizyme |
|
| Principal Investigator: |
Anthony Lembo |
Beth Israel Deaconess Medical Centre, Boston |
|
|
| Alizyme |
| February 2008 |
