# Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476

> **NCT00545389** · PHASE2 · COMPLETED · sponsor: **Shire** · enrollment: 38 (actual)

## Conditions studied

- Colitis, Ulcerative

## Interventions

- **DRUG:** SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine

## Key facts

- **NCT ID:** NCT00545389
- **Lead sponsor:** Shire
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2003-02-10
- **Primary completion:** 2004-10-20
- **Final completion:** 2004-10-20
- **Target enrollment:** 38 (ACTUAL)
- **Last updated:** 2021-06-11


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00545389

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00545389, "Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476". Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/clinical/NCT00545389. Licensed CC0.

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