NCT01116206

An Efficacy and Safety Study of Prucalopride in Participants With Chronic Constipation

A Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prucalopride (Resolor) Tablets in Participants With Chronic Constipation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 507 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy and safety of prucalopride to placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) in treatment of participants with chronic (very serious, life threatening) constipation (decreased number of or difficulty making bowel \[the intestine\] movements).

Detailed description

This is a randomized (study drug is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participants receives), placebo-controlled, multi-center (when more than 1 hospital or medical school team work on a medical research study) study with a parallel-group design (a medical research study comparing the response in 2 or more groups of participants receiving different treatments) study of prucalopride. This study consist of 3 phases: a 2 weeks drug-free screening or run in phase, a 12-week treatment phase and follow-up (post-treatment) phase performed 7 days following the last dose of study drug. The total duration of study will be approximately 15 to 20 weeks, including the run-in and post-treatment phases. During the run-in phase, participants will receive laxative (bisacodyl) as a rescue medication throughout the study, if they will not have bowel movement (BM) for 3 or more consecutive days. If participants will not be able to tolerate bisacodyl, an enema may be used in place of the bisacodyl. During the double-blind treatment phase, participants will be randomly assigned in a 1:1 ratio to 1 of 2 treatment groups to receive either 2 milligram (mg) prucalopride or matching placebo prucalopride for 12 weeks, orally once daily. Participants will be primarily assessed for spontaneous complete bowel movements (SCBMs) per week. Participant's safety and quality of life will be monitored throughout the study.

Conditions

• Constipation

Interventions

Type	Name	Description
DRUG	Prucalopride	2 mg tablet, orally once daily, for 12 weeks
DRUG	Placebo	1 tablet, orally once dailyfor 12 weeks

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2010-05-04
• Last updated: 2017-03-21

Locations

27 sites across 5 countries: Australia, China, South Korea, Taiwan, Thailand