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
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome
Drug: Renzapride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Renzapride in Women With Constipation-Predominant Irritable Bowel Syndrome (c-IBS)

Resource links provided by NLM:


Further study details as provided by Alizyme:

Primary Outcome Measures:
  • Number of months a patient is a Responder for overall relief of IBS symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1821
Study Start Date: December 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Renzapride
Placebo Renzapride 4 mg QD Renzapride 2 mg BID
Other Names:
  • ATL-1251
  • BRL-24924
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.
Drug: Renzapride
Placebo Renzapride 4 mg QD Renzapride 2 mg BID
Other Names:
  • ATL-1251
  • BRL-24924
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.
Drug: Renzapride
Placebo Renzapride 4 mg QD Renzapride 2 mg BID
Other Names:
  • ATL-1251
  • BRL-24924

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268879

Locations
United Kingdom
Alizyme
Cambridge, United Kingdom
Sponsors and Collaborators
Alizyme
Investigators
Principal Investigator: Anthony Lembo Beth Israel Deaconess Medical Centre, Boston
  More Information

No publications provided

Responsible Party: Research and Development Director, Alizyme
ClinicalTrials.gov Identifier: NCT00268879     History of Changes
Other Study ID Numbers: ATL1251/038/CL
Study First Received: December 22, 2005
Last Updated: February 13, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Alizyme:
Irritable bowel syndrome
Constipation-predominant irritable bowel syndrome

Additional relevant MeSH terms:
Constipation
Irritable Bowel Syndrome
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive
Renzapride
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin Agents
Serotonin Antagonists

ClinicalTrials.gov processed this record on October 22, 2014