At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 364 enrolled
Drug / intervention
placebo +1 moredrug
Likely dose
placebo 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating placebo and prucalopride for Constipation. Completed, enrolled 364 participants across 60 sites in 9 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConstipation
CountriesBelgium, Czechia, Hungary, Italy, Poland, Romania, Slovakia, Spain, Sweden
Collaborators--
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2011
First PostedAug 2011
Primary CompletionDec 2012
TodayJul 2026
First PostedAug 26, 2011
Enrollment StartApr 6, 2011
Primary CompletionDec 19, 2012
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 14.8 years ago
Interventions
placebodrug
Placebo matching tablet 2 mg once daily before breakfast for 24 weeks
prucalopridedrug
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