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Summary

Eligibility
for people ages 6–17
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

Summary

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

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

Details

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.

Keywords

Constipation - Functional Lubiprostone

Eligibility

You can join if…

Open to people ages 6–17

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Children's Hospital Los Angeles
    Los Angeles, California, 90027, United States
  • Loma Linda University Health Care
    Loma Linda, California, 92350, United States
  • WCCT Global
    Costa Mesa, California, 92626, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sucampo AG
ID
NCT02138136
Phase
Phase 3
Study Type
Interventional
Last Updated
May 1, 2017