Long-Term Safety of Renzapride in Women With Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

Alizyme

Status and phase: Terminated; Phase 3

Conditions: Constipation-Predominant Irritable Bowel Syndrome

Treatments: Drug: Renzapride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00607971

ATL1251/052/CL

Details and patient eligibility

About

The main purpose of this study is to evaluate the long-term safety and tolerability of renzapride at a dose of 4 mg taken once daily for 12 months in women with constipation-predominant irritable bowel syndrome (IBS-C).

Full description

Since IBS is a chronic condition affecting patients over many years, it is anticipated that renzapride will be prescribed and used by patients on a daily basis for long periods of time. Hence the need to understand its long-term safety and tolerability in the target population. This study is open label and so all subjects will take renzapride and will know that they are taking it. Enrolment in to this study is restricted to subjects completing a 12-week, placebo-controlled study of the effectiveness of renzapride in providing relief from IBS-C (Study no. ATL1251/038/CL).

Enrollment: 939 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• completed 12 weeks treatment in the preceding pivotal study ATL1251/038/CL

Exclusion criteria

• Subjects who are pregnant or breastfeeding

Trial design

939 participants in 1 patient group

1

Experimental group

Description:

All subjects take two capsules (2x renzapride 2 mg) daily, from the day of enrolment until the scheduled visit at the end of Week 52

Treatment:

Drug: Renzapride