Evaluation of Long-term Prucalopride Treatment With Chronic Constipation in Subjects Aged ≥ 18 Years

• Status: Completed
• Trial end date: 2012-12-19
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to evaluate the long-term (24 weeks) efficacy of prucalopride versus placebo in subjects aged 18 years and older with chronic constipation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Prucalopride

Criteria

Inclusion Criteria:

1. Subject is a male or non-pregnant, non-breastfeeding female out-patient ≥18 years of age (no upper age limit).

2. Subject has a history of constipation. The subject reports an average of ≤2 SBM/week that result in a feeling of complete evacuation (SCBM).

3. Subject agrees to stop his/her current laxative treatment and is willing to use rescue medication according to the rescue rule [bisacodyl/enemas].

Exclusion Criteria:

1. Subjects in whom constipation is thought to be drug-induced

2. Subjects using any disallowed medication.

3. Subjects who previously used prucalopride.

4. Subjects suffering from secondary causes of chronic constipation.