NCT01424228

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

A Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Quality of Life, Safety and Tolerability of Long-term Treatment (24 Weeks) With Prucalopride in Subjects Aged ≥18 Years With Chronic Constipation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 364 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 placebo. In case of insufficient response the daily dose has to be increased to 2 mg (i.e. changed to 2 mg prucalopride or matching placebo).

Conditions

• Constipation

Interventions

Type	Name	Description
DRUG	placebo	Placebo matching tablet 2 mg once daily before breakfast for 24 weeks
DRUG	prucalopride	Prucalopride 2 mg daily before breakfast 1 mg for subjects \>65 years; in case of insufficient response 2 mg at week 2 or week 4

Timeline

• Start date: 2011-04-06
• Primary completion: 2012-12-19
• Completion: 2012-12-19
• First posted: 2011-08-26
• Last updated: 2021-06-11
• Results posted: 2014-04-02

Locations

60 sites across 9 countries: Belgium, Czechia, Hungary, Italy, Poland, Romania, Slovakia, Spain, Sweden