Phase 3
Completed N=87
Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years With Functional Constipation
Constipation - Functional
Source: ClinicalTrials.gov NCT02766777 ↗
Enrolled (actual)
87
Serious AEs
2.3%
Results posted
May 2020
Primary outcomePrimary: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) — 47 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
A study of the safety of lubiprostone in pediatric participants aged ≥ 6 Years to < 18 years diagnosed with functional constipation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) |
47 | — |
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 participant is taking antidepressants
Exclusion Criteria
- Any gastrointestinal (GI) condition, other than constipation, 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 (NCT02766777). 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. Informational only — not medical advice.