Completed PHASE3 INTERVENTIONAL NCT00548574

Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis

A Phase III, Randomized, Multi-Centre, Double-blind, Double Dummy, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to ASACOL 0.8g Three Times Daily, in Subjects With Mild to Moderate Ulcerative Colitis

Sponsor: Shire

Conditions Ulcerative Colitis

Interventions Mesalazine SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine

Updated 6 times since 2017 Last updated: Jun 8, 2021 Started: Dec 4, 2003 Primary completion: Oct 20, 2004 Completion: Oct 20, 2004

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. Shire leads this study, which shows 6 recorded versions since 2003 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Sep 2021 — Jul 2024 [monthly]

Completed PHASE3
Jan 2021 — Sep 2021 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 1 earlier version

Jan 2017 — Jun 2018 [monthly]

Completed PHASE3

First recorded

Dec 2003

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Shire

Data source: Takeda

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

Study Locations

• Bonheiden, Belgium