Phase 3
N=215
Prucalopride in Pediatric Subjects With Functional Constipation
Functional Constipation
Bottom Line
View on ClinicalTrials.gov: NCT01330381 ↗Enrolled (actual)
215
Serious AEs
2.9%
Results posted
Feb 2014
Primary outcome: Primary: Percent of Responders in the Last Four Weeks of the Double-Blind Treatment Period — 17.0; 17.8 percentage of subjects — p=0.9002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- prucalopride (Drug); Placebo (Drug); PEG 4000 (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Responders in the Last Four Weeks of the Double-Blind Treatment Period |
17.0; 17.8 | 0.9002 |
| SECONDARY Percent of Subjects With Bowel Frequency of 3 or More Spontaneous Bowel Movements (SBM) Per Week in the Last Four Weeks of the Double-Blind Treatment Period |
29.2; 35.5 | 0.3520 |
| SECONDARY Percent of Subjects With Fecal Incontinence Episodes of 1 or Less Per 2 Weeks in the Last Four Weeks of the Double-Blind Treatment Period |
43.0; 43.0 | 0.5228 |
| SECONDARY Number of Retentive Posturing or Excessive Volitional Stool Retention in the Double-Blind Treatment Period |
1.1; 1.2 | — |
| SECONDARY Painful Bowel Movements Score in the Double-Blind Treatment Period |
1.3; 1.7 | — |
| SECONDARY Stool Consistency Per SBM Score in Children Without Diapers in the Double-Blind Treatment Period |
3.8; 3.6 | — |
| SECONDARY Stool Consistency Per SBM Score in Children With Diapers in the Double-Blind Treatment Period |
2.1; 2.0 | — |
| SECONDARY Large Diameter Stools in the Double-Blind Treatment Period |
1.7; 1.7 | — |
| SECONDARY Abdominal Pain Score in Double-Blind Treatment Period |
0.9; 1.1 | — |
| SECONDARY Frequency of Toilet Training in the Double-Blind Treatment Period |
4.9; 5.1 | — |
| SECONDARY Number of Rescue Medications Taken in the Double-Blind Treatment Period |
1.2; 1.3 | — |
| SECONDARY Time to First SBM in the Double-Blind Treatment Period |
67.00; 99.75 | 0.377 |
| SECONDARY Number of SBM Per Week in the Double-Blind Treatment Period |
2.3; 2.1 | — |
| SECONDARY Change From Baseline in the Number of SBM Per Week Over the 8 Week Double Blind Treatment Period |
1.5; 1.0 | — |
| SECONDARY Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Double-Blind Treatment Period |
15.5; 5.6; 21.4; 18.7; 19.4; 27.1 | 0.1599 |
| SECONDARY Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Open-Label Treatment Period |
24.7; 46.2; 17.5; 16.1; 17.5; 9.7 | 0.0003 sig |
| SECONDARY Efficacy of Treatment for Final On Treatment Assessment in Double-Blind Treatment Period |
33.0; 32.7; 14.6; 18.7; 15.5; 25.2 | 0.4647 |
| SECONDARY Efficacy of Treatment for Final On Treatment Assessment in Open-Label Treatment Period |
29.9; 15.1; 10.3; 5.4; 20.6; 11.8 | <0.0001 sig |
| SECONDARY Convenience of Treatment for Final On Treatment Assessment in Open-Label Treatment Period |
16.5; 15.6; 1.0; 2.2; 0.0; 5.6 | 0.3044 |
Summary
To evaluate the efficacy of prucalopride compared to placebo for the treatment of functional constipation in a paediatric population, aged ≥ 6 months to < 18 years. A 16-week open-label comparator (PEG) controlled part will follow, to document safety and tolerability up to 24 weeks.
Eligibility Criteria
Main Inclusion Criteria:
- Boys and girls, aged ≥ 6 months and < 18 years.
- Subjects with a confirmed diagnosis of functional constipation as defined by the Rome III criteria.
Main Exclusion Criteria:
- Children with underlying GI abnormalities and causes for defecation disorders.
- Constipation is thought to be drug-induced.
- Subjects suffering from secondary causes of chronic constipation.
Data sourced from ClinicalTrials.gov (NCT01330381). 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.