Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years With Functional Constipation

Phase 3

Completed

• Conditions: Constipation - Functional
• Interventions: Drug: Lubiprostone

• Registration Number: NCT02766777
• Lead Sponsor: Sucampo Pharma Americas, LLC

Brief Summary

A study of the safety of lubiprostone in pediatric participants aged ≥ 6 Years to \< 18 years diagnosed with functional constipation.

Detailed Description

To assess the long-term safety and tolerability of oral lubiprostone 12 or 24mcg capsules dosed twice daily (BID) when administered orally for 24 weeks in pediatric participants with functional constipation. Evaluation of lubiprostone safety and tolerability is the primary objective in this study.

Study Timeline

• Study Start: 2016-04-12
• Study First Submitted: 2016-05-06
• Study First Submitted QC: 2016-05-06
• Study First Posted: 2016-05-10
• Primary Completion: 2016-11-04
• Study Completion: 2016-11-04
• Disposition First Submitted: 2018-03-22
• Disposition First Submitted QC: 2018-03-22
• Disposition First Posted: 2018-03-26
• Status Verified: 2020-05
• Results First Submitted: 2020-05-04
• Results First Submitted QC: 2020-05-04
• Last Update Submitted: 2020-05-04
• Results First Posted: 2020-05-15
• Last Update Posted: 2020-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lubiprostone	Lubiprostone	Participants received lubiprostone twice daily (BID). Participants received either lubiprostone 12 mcg BID, lubiprostone 24 mcg BID (dose based on participant's weight) up to 24 weeks.

Primary Outcome Measures

Name	Time	Method
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)	within 25 weeks	Adverse events with onset dates after the administration of the first dose of study medication or prior to the last day of treatment plus 7 days are considered treatment-emergent.

Trial Locations

Locations (13)

Northwest Arkansas Pediatric Clinic; 🇺🇸 Fayetteville, Arkansas, United States

Pioneer Clinical Research; 🇺🇸 Bellevue, Nebraska, United States

Methodist Medical Center; 🇺🇸 Peoria, Illinois, United States

Coastal Clinical Research; 🇺🇸 Charleston, South Carolina, United States

Cyn3rgy Research; 🇺🇸 Gresham, Oregon, United States

Bridgerland Clinical Research; 🇺🇸 Logan, Utah, United States

Pediatric Research of Charlottesville, LLC; 🇺🇸 Charlottesville, Virginia, United States

Wee Care Pediatrics; 🇺🇸 Syracuse, Utah, United States

PriMed Clinical Research; 🇺🇸 Beavercreek, Ohio, United States

Willis-Knighton Physician Network; 🇺🇸 Shreveport, Louisiana, United States

Spartanburg Medical Research; 🇺🇸 Spartanburg, South Carolina, United States

Coastal Pediatrics Associates - Mount Pleasant; 🇺🇸 Mount Pleasant, South Carolina, United States

3rd Coast Research Associates; 🇺🇸 Corpus Christi, Texas, United States