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

Alizyme

Status and phase: Completed; Phase 3

Conditions: Irritable Bowel Syndrome

Treatments: Drug: Renzapride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00268879

ATL1251/038/CL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,821 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,821 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

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.

Treatment:

Drug: Renzapride

2

Experimental group

Description:

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.

Treatment:

Drug: Renzapride

3

Experimental group

Description:

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.

Treatment:

Drug: Renzapride