Phase 3
N=419
Lubiprostone for Children With Constipation
Constipation - Functional
Bottom Line
View on ClinicalTrials.gov: NCT02138136 ↗Enrolled (actual)
419
Serious AEs
3.1%
Results posted
Jan 2020
Primary outcome: Primary: Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month — 2.66; 2.75; 2.70; 2.75 Weekly SBMs
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lubiprostone (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Sucampo Pharma Americas, LLC
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month |
2.66; 2.75; 2.70; 2.75; 2.74; 2.50 | — |
Summary
This study is for children with constipation.
Children who completed 3 months of treatment in the earlier study (NCT02042183):
* were invited to participate
* will receive lubiprostone for 9 more months
* will see if lubiprostone safely relieves their constipation if taken for a whole year
Eligibility Criteria
Inclusion Criteria
- Has completed the 3-month placebo-controlled study (NCT02042183)
- Will continue to abstain from taking concomitant medication (prescribed or over-the-counter) that affects gastrointestinal motility
Exclusion Criteria
- Has untreated faecal impaction at the time of rolling over into study
- Has significant change in medical status, newly diagnosed and uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, or other systemic disease
- Has demonstrated non-compliance with study protocol during the 3-month placebo-controlled study (NCT02042183)
Data sourced from ClinicalTrials.gov (NCT02138136). 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.