# 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

> **NCT00503243** · PHASE3 · COMPLETED · sponsor: **Shire** · enrollment: 280 (actual)

## Conditions studied

- Colitis, Ulcerative

## Interventions

- **DRUG:** Delayed and extended release mesalazine

## Key facts

- **NCT ID:** NCT00503243
- **Lead sponsor:** Shire
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2003-09-30
- **Primary completion:** 2005-01-17
- **Final completion:** 2005-01-17
- **Target enrollment:** 280 (ACTUAL)
- **Last updated:** 2021-06-11


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00503243

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT00503243. Licensed CC0.

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