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

Launched by SHIRE · Aug 25, 2011

Keywords

ClinConnect Summary

In this phase IV trial a total of 340 subjects (170 subjects per treatment group), with chronic constipation, are planned to be randomly assigned to double-blind treatment.

The trial duration for a subject can be 26 to 28 weeks in total, including a 2- to 4-week run-in phase followed by a 24-week double-blind treatment phase. The patient will complete an e-diary.

Adult subjects (≥18 to \<65 years of age) will take 2 mg prucalopride or matching placebo throughout the entire 24-week treatment period. Elderly subjects (≥65 years of age) will start at a dose of 1 mg prucalopride or matching p...

Gender

ALL

Eligibility 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.