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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 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 280 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00503243
The ClinicalTrials.gov registry entry for NCT00503243 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 280 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Delayed and extended release mesalazine is the first listed.
NCT00503243 reports 0 study locations.
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.
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