Completed PHASE3 INTERVENTIONAL 2-arm NCT02042183

Lubiprostone in Children With Functional Constipation

A Multicentre, Randomised, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation

Sponsor: Sucampo AG

Conditions Constipation - Functional

Interventions Lubiprostone Placebo

Updated 11 times since 2017 Last updated: Jul 20, 2020 Started: Dec 13, 2013 Primary completion: Jul 27, 2016 Completion: Jul 27, 2016

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02042183, this PHASE3 trial focuses on Constipation - Functional and remains completed. Sponsored by Sucampo AG, it has been updated 11 times since 2013, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

11 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Dec 2021 — Jul 2024 [monthly]

Completed PHASE3
Jan 2021 — Dec 2021 [monthly]

Completed PHASE3

▶ Show 6 earlier versions

Aug 2020 — Jan 2021 [monthly]

Completed PHASE3
Jan 2020 — Aug 2020 [monthly]

Completed PHASE3
Jun 2018 — Jan 2020 [monthly]

Completed PHASE3
Apr 2018 — Jun 2018 [monthly]

Completed PHASE3
Feb 2017 — Apr 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Dec 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Sucampo AG
Sucampo Pharma Americas, LLC

Data source: Mallinckrodt

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Amarillo, United States , Amsterdam, Netherlands , Atlanta, United States , Austin, United States , Baltimore, United States , Baytown, United States , Beavercreek, United States , Bellevue, United States , Bialystok, Poland , Birmingham, United States and 93 more locations