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NCT00503243 · ClinicalTrials.gov registry record · Phase 3
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 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 280
- Enrollment target
NCT00503243: Completed Phase 3 study, sponsored by Shire.
NCT00503243 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 280 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00503243, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 280 participants
- Enrollment target
Study Summary
The aim of this study was to investigate the safety and efficacy of SPD476 2.4 g/day given twice daily (\[BID\] ie 1.2 g/day BID) and SPD476 4.8g/day given QD compared to placebo in subjects with acute, mild to moderate ulcerative colitis.
Interventions
- DRUG Delayed and extended release mesalazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2003-09-30 |
| Est. Completion | 2005-01-17 |
| Phase | Phase 3 |
What the finished NCT00503243 record still lists
NCT00503243 is an interventional study that assigns participants to a tested intervention. The registered 280 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 1 intervention - of which Delayed and extended release mesalazine is the first listed.
NCT00503243 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00503243 about?
NCT00503243 is a clinical study titled "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". The aim of this study was to investigate the safety and efficacy of SPD476 2.4 g/day given twice daily (\[BID\] ie 1.2 g/day BID) and SPD476 4.8g/day given QD compared to placebo in subjects with acute, mild to moderate ulcerative colitis.
What is the current status of trial NCT00503243?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 280 participants. The study started on 2003-09-30. Estimated completion is 2005-01-17.
What interventions are being tested in trial NCT00503243?
The interventions under investigation include: Delayed and extended release mesalazine (DRUG).
Who is sponsoring clinical trial NCT00503243?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00503243's enrollment target sits among peer trials
280 1195th of 2000 higher than 802 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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