Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years W… (NCT02766777) | Clinical Trial Compass
CompletedPhase 3
Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years With Functional Constipation
United States87 participantsStarted 2016-04-12
Plain-language summary
A study of the safety of lubiprostone in pediatric participants aged ≥ 6 Years to \< 18 years diagnosed with functional constipation.
Who can participate
Age range6 Years – 17 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)