Investigation of the Safety and Efficacy of Renzapride in Constipation Predominant Irritable Bowel Syndrome (IBS)

This study has been completed.
Sponsor:
Information provided by:
Alizyme
ClinicalTrials.gov Identifier:
NCT00268879
First received: December 22, 2005
Last updated: February 13, 2008
Last verified: February 2008

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
Not Provided
Not Provided
 
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Irritable Bowel Syndrome
Drug: Renzapride
Placebo Renzapride 4 mg QD Renzapride 2 mg BID
Other Names:
  • ATL-1251
  • BRL-24924
  • Placebo Comparator: 1
    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.
    Intervention: Drug: Renzapride
  • Experimental: 2
    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.
    Intervention: Drug: Renzapride
  • Experimental: 3
    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.
    Intervention: Drug: Renzapride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
ATL1251/038/CL
Yes
Research and Development Director, Alizyme
Alizyme
Not Provided
Principal Investigator: Anthony Lembo Beth Israel Deaconess Medical Centre, Boston
Alizyme
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP