Overview

This trial is active, not recruiting.

Condition constipation - functional
Treatment lubiprostone
Phase phase 3
Sponsor Sucampo AG
Collaborator Sucampo Pharma Americas, LLC
Start date March 2014
End date May 2017
Trial size 420 participants
Trial identifier NCT02138136, SAG/0211PFC-11S1

Summary

A study of the long-term safety and efficacy of Lubiprostone in subjects aged ≥ 6 to < 18 years diagnosed with Functional Constipation

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Lubiprostone 12 or 24 mcg twice daily (BID)
lubiprostone Amitiza®
12 or 24 mcg capsules twice daily (BID) for 9 months

Primary Outcomes

Measure
Evaluation of incidence of adverse events (AEs)
time frame: Across 9-month treatment period
Evaluation of changes in clinical laboratory parameters
time frame: Across 9-month treatment period
Evaluation of changes in physical examination
time frame: Across 9-month treatment period
Evaluation of changes in vital sign measurements
time frame: Across 9-month treatment period
Assessment of bone mineral density and bone mineral content
time frame: Across 9-month treatment period

Secondary Outcomes

Measure
Changes from baseline in bowel movement (BM) and spontaneous bowel movement (SBM) frequency rate
time frame: Monthly for up to 9 months
Changes from baseline in stool consistency of SBMs.
time frame: Monthly for up to 9 months
Monthly SBM Response
time frame: Monthly for up to 9 months
Treatment effectiveness rating
time frame: Monthly for up to 9 months
Overall Health-related quality of life (PedsQL™)
time frame: Monthly for up to 9 months
Change from baseline in incontinence episodes frequency
time frame: Monthly for up to 9 months
Change from baseline in the production of large diameter stool
time frame: Monthly for up to 9 months
Change from baseline in frequency of faecal impaction
time frame: Monthly for up to 9 months
Change from baseline in proportion of BMs and SBMs in toilet overall
time frame: Monthly for up to 9 months
Change from baseline in frequency of retentive posturing or excessive volitional stool retention
time frame: Monthly for up to 9 months
Changes from baseline in straining associated with SBMs.
time frame: Monthly for up to 9 months
Changes from baseline in abdominal pain associated with SBMs.
time frame: Monthly for up to 9 months
Changes from baseline in constipation severity.
time frame: Monthly for up to 9 months

Eligibility Criteria

Male or female participants from 6 years up to 17 years old.

Inclusion Criteria: - Completed 12 weeks of blinded treatment in the SAG/0211PFC-1131 study. - Continue to abstain from taking concomitant medication (prescribed or over-the-counter) that affects gastrointestinal motility. Exclusion Criteria: - Untreated faecal impaction at the time of rolling over into study. - Significant change in medical status, newly diagnosed and uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, or other systemic disease. - Demonstrated non-compliance with study protocol during the SAG/0211PFC-1131 study.

Additional Information

Official title A Multicentre, Long-term Safety, Efficacy, and Pharmacokinetics Study of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation
Principal investigator Carlo Di Lorenzo, MD
Description The purpose of this study is to assess the long-term safety, efficacy, and pharmacokinetics of oral lubiprostone 12 or 24 mcg capsules dosed twice daily (BID) when administered orally for 36 weeks in paediatric subjects with functional constipation.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Sucampo Pharma Americas, LLC.