Completed PHASE3 INTERVENTIONAL NCT00503243

Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis

A Phase III, Randomized, Multi-Centre, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) Versus SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis

Sponsor: Shire

Conditions Colitis, Ulcerative

Interventions Delayed and extended release mesalazine

Updated 6 times since 2017 Last updated: Jun 8, 2021 Started: Sep 30, 2003 Primary completion: Jan 17, 2005 Completion: Jan 17, 2005

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

Listed as NCT00503243, this PHASE3 trial focuses on Colitis, Ulcerative and remains completed. Sponsored by Shire, it has been updated 6 times since 2003, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

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

Sep 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

• Philadelphia, United States