Phase 3
N=606
Lubiprostone in Children With Functional Constipation
Constipation - Functional
Bottom Line
View on ClinicalTrials.gov: NCT02042183 ↗Enrolled (actual)
606
Serious AEs
3.0%
Results posted
Jul 2020
Primary outcome: Primary: Number of Participants Classified as Overall Responders at Week 12 — 76; 28 Participants — p=0.1609
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lubiprostone (Drug); Placebo (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Sucampo Pharma Americas, LLC
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Classified as Overall Responders at Week 12 |
76; 28 | 0.1609 |
| SECONDARY Mean Number of SBMs Observed Each Week for 12 Weeks |
1.40; 1.42; 2.65; 2.50; 2.68; 2.69 | — |
Summary
Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.
Eligibility Criteria
Inclusion Criteria
- Medically-confirmed diagnosis of Functional Constipation per Rome III Diagnostic Criteria for Childhood Functional Constipation
- At least 6 years of age but less than 18 years of age at the time of randomisation
- Only stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors are allowed if subject is taking antidepressants
Exclusion Criteria
- Any gastrointestinal (GI) condition, other than constipation and/or irritable bowel syndrome (IBS), affecting GI motility or defecation
- Untreated faecal impaction at the time of screening
- Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication
Data sourced from ClinicalTrials.gov (NCT02042183). 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.