Evaluation of Prucalopride in Male Subjects With Chronic Constipation.
This is a multi-centre, randomised, parallel-group, double-blind, placebo-controlled phase III trial to evaluate the efficacy of prucalopride versus placebo over 12 weeks of treatment in male subjects with chronic constipation.
Furthermore the safety, tolerability, effect on quality of life and effect on symptoms of prucalopride will be assessed.
Male Subjects With Chronic Constipation
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A 12-week, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Quality of Life, Safety and Tolerability of Prucalopride in Male Subjects With Chronic Constipation|
- Efficacy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To evaluate the efficacy of prucalopride versus placebo in male subjects with chronic constipation.
The primary endpoint is defined as the proportion (%) of subjects with an average of ≥3 SCBM/week over the entire treatment period.
- Safety and Tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Evaluation of safety parameters by measuring adverse events, safety, blood and urine samples, ECGs, vital signs and physical examinations.
- Quality of Life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Quality of life will be evaluated using the Patient Assessment of Constipation-Quality of Life questionnaire.
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Group I
2 or 1 mg placebo
Active Comparator: Group II
prucalopride 1 mg or 2 mg
2 mg for subjects >18 to <65 years;
1 mg for subjects >65 years; in case of insufficient response 2 mg at week 2 or week 4
No Intervention: ALL
2-week run-in period
In this phase III trial subjects will be screened and enter a 2-week run-in period (or a 3-week run-in period if the subject is using agents that influence bowel habit) during which the presence of constipation will be confirmed [the subject will complete an electronic daily diary (e-diary)]. At the start of run-in, all existing laxative medication will be withdrawn and subjects will be instructed not to change their diet or lifestyle during the trial. Subjects will be allowed to take a laxative [Dulcolax (bisacodyl)] as rescue medication during the trial, but only if they have not had a bowel movement (BM) for 3 or more consecutive days. An enema can only be used after unsuccessful use of Dulcolax (bisacodyl). No Dulcolax (bisacodyl) should be taken or enemas used between 48 hours before and 48 hours after the first intake of study medication.
After the run-in subjects will be randomly assigned to placebo or prucalopride in an equal ratio (1:1) if the subject fulfils the constipation criteria for inclusion. Randomisation will be stratified by country and by the average number of complete bowel movements (CBM) during run-in: 0 CBM/week and >0 CBM/week.
Adult subjects (i.e. subjects ≥18 to <65 years of age) will take 2 mg prucalopride or matching placebo once daily before breakfast during the entire 12-week treatment period. Elderly subjects (i.e. subjects ≥65 years of age) will start at a dose of 1 mg prucalopride or matching placebo once daily before breakfast. In case of insufficient response, defined as an average of <3 spontaneous complete bowel movements (SCBM)/week during the preceding 2 weeks of treatment (i.e. since the previous visit) at Week 2 or Week 4, the daily dose has to be increased to 2 mg (or matching placebo). Once the dose is increased to 2 mg once daily the subject will stay on this dose for the remainder of the trial. After Week 4 (Visit 4) no changes in dose are allowed anymore.