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NCT00545740 · ClinicalTrials.gov registry record · Phase 3
Prevention of Recurrence of Diverticulitis
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 590
- Enrollment target
NCT00545740: Completed Phase 3 study, sponsored by Shire.
NCT00545740 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 590 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00545740, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 590 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.
Primary Outcome
Recurrence of diverticulitis is defined as the presence of each and all of the following 3 items: 1) abdominal pain, 2) a 15% increase in white blood cell count from baseline, 3) bowel wall thickening (\>5 mm) and/or fat stranding as evidenced by spiral computerized axial tomography (CT) scan; OR surgical intervention for diverticular disease. Withdrawals are considered as recurrences.
Interventions
- DRUG Placebo
- DRUG SPD476 (1.2g)
- DRUG SPD476 (2.4 g)
- DRUG SPD476 (4.8 g)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 590 participants |
| Start Date | 2007-11-28 |
| Est. Completion | 2012-03-05 |
| Phase | Phase 3 |
What the finished NCT00545740 record still lists
NCT00545740 is an interventional study that assigns participants to a tested intervention. The registered 590 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 (24% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00545740 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00545740 about?
NCT00545740 is a clinical study titled "Prevention of Recurrence of Diverticulitis". The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.
What is the current status of trial NCT00545740?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 590 participants. The study started on 2007-11-28. Estimated completion is 2012-03-05.
What interventions are being tested in trial NCT00545740?
The interventions under investigation include: Placebo (DRUG), SPD476 (1.2g) (DRUG), SPD476 (2.4 g) (DRUG), SPD476 (4.8 g) (DRUG).
Who is sponsoring clinical trial NCT00545740?
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 NCT00545740's enrollment target sits among peer trials
590 643rd of 2000 higher than 1,356 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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