Status:
COMPLETED
Evaluation of Long-term Prucalopride Treatment With Chronic Constipation in Subjects Aged ≥ 18 Years
Lead Sponsor:
Shire
Conditions:
Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 s...
Eligibility Criteria
Inclusion
- Subject is a male or non-pregnant, non-breastfeeding female out-patient ≥18 years of age (no upper age limit).
- Subject has a history of constipation. The subject reports an average of ≤2 SBM/week that result in a feeling of complete evacuation (SCBM).
- Subject agrees to stop his/her current laxative treatment and is willing to use rescue medication according to the rescue rule \[bisacodyl/enemas\].
Exclusion
- Subjects in whom constipation is thought to be drug-induced
- Subjects using any disallowed medication.
- Subjects who previously used prucalopride.
- Subjects suffering from secondary causes of chronic constipation.
Key Trial Info
Start Date :
April 6 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2012
Estimated Enrollment :
364 Patients enrolled
Trial Details
Trial ID
NCT01424228
Start Date
April 6 2011
End Date
December 19 2012
Last Update
June 11 2021
Active Locations (60)
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1
Universitaire Ziekenhuizen Leuven
Leuven, Flemish Brabant, Belgium, 3000
2
Cliniques Universitaires St. Luc
Brussels, Belgium, 1200
3
Huisartspraktijk Jaak Mortelmans
Ham, Belgium, 3945
4
Centre Hospitalier Universitaire Sart Tilman Liège
Liège, Belgium, 4000