Phase 4
N=364
Evaluation of Long-term Prucalopride Treatment With Chronic Constipation in Subjects Aged ≥ 18 Years
Constipation
Bottom Line
View on ClinicalTrials.gov: NCT01424228 ↗Enrolled (actual)
364
Serious AEs
2.2%
Results posted
Apr 2014
Primary outcome: Primary: The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week Over the 24 Week Treatment Period — 20.7; 25.1 percentage of subjects — p=0.367
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- placebo (Drug); prucalopride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week Over the 24 Week Treatment Period |
20.7; 25.1 | 0.367 |
| SECONDARY Percentage of Subjects With an Increase of ≥1 Spontaneous Complete Bowel Movement (SCBM) Per Week Up to 24 Weeks |
42.0; 48.0 | — |
| SECONDARY Average Number of Spontaneous Complete Bowel Movements (SCBM) Per Week Up to 24 Weeks |
1.7; 2.1 | — |
| SECONDARY Change From Baseline in Spontaneous Complete Bowel Movements Per Week at Up to 24 Weeks |
1.3; 1.7 | — |
| SECONDARY Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week |
18.3; 32.2; 23.1; 34.5; 22.5; 32.2 | — |
| SECONDARY Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by 4-Week Treatment Period |
18.3; 26.9; 23.7; 25.7; 23.7; 29.2 | — |
| SECONDARY Change From Baseline in Average Consistency Per SCBM at Up to 24 Weeks |
-0.1; -0.1 | — |
| SECONDARY Change From Baseline in Percent SCBM With a Consistency of Normal and Hard/Very Hard at Up to 24 Weeks |
16.82; 25.71; -9.11; -13.82 | — |
| SECONDARY Change From Baseline in Straining Per SCBM at Up to 24 Weeks |
-0.44; -0.23 | — |
| SECONDARY Change From Baseline in Percent SCBM With No Straining and Severe/Very Severe Straining at Up to 24 Weeks |
11.14; 6.61; -9.85; -4.49 | — |
| SECONDARY Change From Baseline in Percent SBM With Sensation of Complete Evacuation at Up to 24 Weeks |
20.94; 24.22 | — |
| SECONDARY Time to First SCBM After Investigational Product Intake on Day 1 and Day 28 |
359.67; 100.83; 100.58; 81.78 | — |
| SECONDARY Change From Baseline in the Number of Bisacodyl Tablets Taken Per Week at Up to 24 Weeks |
-0.68; -0.97 | — |
| SECONDARY Change From Baseline in the Number of Days With Rescue Medication Taken Per Week at Up to 24 Weeks |
-0.42; -0.54 | — |
| SECONDARY Change From Baseline in the Patient Assessment of Constipation - Symptom (PAC-SYM) Questionnaire Score at Up to the Final On Treatment Assessment Value |
-0.68; -0.55 | — |
| SECONDARY Change From Baseline in the Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score at Up to the Final On Treatment Assessment Value |
-0.73; -0.67 | — |
| SECONDARY Change From Baseline in the Short Form-36 Health Survey (SF-36) Score at Up to the Final On Treatment Assessment Value |
3.786; 3.179; 3.331; 2.965 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01424228). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.