Completed PHASE3 INTERVENTIONAL 2-arm NCT00713310

Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis

Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8 g/Day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents With Mildly-to-Moderately Active Ulcerative Colitis

Sponsor: Warner Chilcott

Conditions Ulcerative Colitis

Interventions Asacol 400 mg

Updated 7 times since 2017 Last updated: Apr 3, 2012 Started: Dec 31, 2008 Primary completion: Mar 31, 2011 Completion: Mar 31, 2011

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

This PHASE3 trial investigates Ulcerative Colitis and is currently completed. Warner Chilcott leads this study, which shows 7 recorded versions since 2008 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

7 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Dec 2008

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Warner Chilcott

Data source: Warner Chilcott

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

Study Locations

Bialystok, Poland , Birmingham, United States , Boston, United States , Bucharest, Romania , Buffalo, United States , Bydgoszcz, Poland , Chattanooga, United States , Fort Worth, United States , Gainesville, United States , Halifax, Canada and 30 more locations