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||Drug: Placebo Drug: Prucalopride||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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|
- The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week [ Time Frame: Over 12 week treatment period ]Spontaneous Bowel Movements defined as a bowel movement that is not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.
- Percentage of Subjects With an Average Weekly Frequency of at Least 3 SCBM Per Week and an Increase of ≥ 1 SCBM Per Week for ≥ 75% of the 12-week Treatment Period and ≥ 75% of the Last Third of the 12-week Treatment Period [ Time Frame: Over 12 week treatment period ]
- Percentage of Subjects With an Increase of at Least 1 SCBM Per Week [ Time Frame: Over 12 week treatment period ]
- SCBM Per Week [ Time Frame: Over 12 week treatment period ]
- Percent SBM With a Consistency of Normal and Hard/Very Hard [ Time Frame: Over 12 week treatment period ]Consistency measured using the 7-point Bristol scale where 1-2 indicate constipation (=hard/very hard), 3-4 are ideal stools (=normal), and 5-7 tending toward diarrhea.
- Percent SCBM With No Straining and Severe/Very Severe Straining [ Time Frame: Over 12 week treatment period ]Straining was evaluated on a 5-point scale (0=none, 1=mild, 2=moderate, 3=severe, or 4=very severe)
- Percent SBM With Sensation of Complete Evacuation [ Time Frame: Over 12 week treatment period ]
- Time to First SCBM After Investigational Product Intake on Day 1 [ Time Frame: Day 1 ]
- Bisacodyl Tablets Taken Per Week [ Time Frame: Over 12 week treatment period ]
- Days With Rescue Medication Taken Per Week [ Time Frame: Over 12 week treatment period ]
- Percent of Subjects With an Improvement of ≥ 1 Point on the Patient Assessment of Constipation - Symptom (PAC-SYM) Questionnaire Total Score at Final On Treatment Assessment [ Time Frame: Over 12 week treatment period ]The PAC-SYM is a validated 12-item questionnaire for the evaluation of severity of symptoms of constipation in subjects with constipation. Items are rated on a 5-point Likert scale: 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe. Total score ranges from 0 to 48. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-SYM total score was considered clinically meaningful.
- Percent of Subjects With an Improvement of ≥ 1 Point on the Patient Assessment of Constipation - Quality of Life (PAC-QOL) Total Score at Final On Treatment Assessment [ Time Frame: Over 12 week treatment period ]The PAC-QOL is a validated 28-item questionnaire for the evaluation of quality of life in subjects with constipation. Items are rated on a 5-point Likert scale: 0=not at all/none of the time, 1=a little bit/a little bit of the time, 2=moderately/some of the time, 3=quite a bit/most of the time, 4=extremely/all of the time. Total score ranges from 0-112. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-QOL total score was considered clinically meaningful.
- Percent of Subjects on the Subject Global Evaluation on Severity of Constipation Score Rating Constipation as Severe to Very Severe at Final On-Treatment Assessment [ Time Frame: Over 12 week treatment period ]Subject was asked to rate the severity of his constipation using a 5-point Likert scale: 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe
- Percent of Subjects on the Subject Global Evaluation on Efficacy of Treatment Score Rating Treatment as Quite a Bit to Extremely Effective at Final On-Treatment Assessment [ Time Frame: Over 12 week treatment period ]
The subject was asked to rate his global evaluation of the efficacy of treatment using the following 5-point scale:
0=not at all effective
- a little bit effective
- moderately effective
- quite a bit effective
- extremely effective.
|Study Start Date:||September 2010|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Placebo matched to Prucalopride tablet orally once daily.
Active Comparator: Prucalopride
1 milligram (mg) or 2 mg
Prucalopride 2 mg tablet orally once daily for subjects greater than or equal to (≥) 18 to less than (<) 65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01147926
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