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NCT00545103 · ClinicalTrials.gov registry record · Phase 3
Prevention of Recurrence of Diverticulitis
A Phase 3 study of Diverticulitis, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 592
- Enrollment target
- 20
- Study locations
NCT00545103: Completed Phase 3 study of Diverticulitis, sponsored by Shire.
NCT00545103 is a Phase 3 study of Diverticulitis that has completed, run by Shire. The registered enrollment target is 592 participants, below the 25,162-participant average among 8 other Diverticulitis trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00545103, a Phase 3 study of Diverticulitis, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 592 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SPD476, MMX™ mesalazine, 1.2g extended release tablet
- DRUG SPD476, MMX™ mesalazine, 2.4g extended release tablet
- DRUG SPD476, MMX™ mesalazine, 4.8g extended release tablet
Study Locations (20)
California
- Digestive and Liver Disease Specialists - Garden Grove
- High Desert Gastroenterology, Inc. - Lancaster
- VA Long Beach Healthcare System - Long Beach
- CA Physicians Research Alliance - Oceanside
- Digestive Care Medical Center - San Carlos
- Rider Research Group - San Francisco
- Huntington Medical Foundation - San Marino
Florida
- Madeleine DuPree, MD - Boynton Beach
- Palmetto Research LLC - Hialeah
- Mark Lamet, MD - Hollywood
- Digestive Disease Consultants - Maitland
- University of Miami Miller School of Medicine - Miami
Alabama
- Birmingham Gastroenterology Associates, PC - Birmingham
- Alabama Clinical Therapeutics, LLC - Birmingham
- Medical Affiliated Research Center, Inc - Huntsville
- Alabama Digestive Disorders Center, PC - Huntsville
Colorado
- Clinical Research of the Rockies - Lafayette
- Arapahoe Gastroenterology, PC - Littleton
Arizona
- Genova Clinical Research - Tucson
Connecticut
- Litchfield County Gastroenterology Associates, LLC - Torrington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 592 participants |
| Start Date | 2007-12-06 |
| Est. Completion | 2011-11-28 |
| Phase | Phase 3 |
What the finished NCT00545103 record still lists
NCT00545103 is an interventional study that assigns participants to a tested intervention. The registered 592 participants enrollment target is mid-sized for trials with a published cap, below the 25,162-participant average among 8 other Diverticulitis trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Diverticulitis appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT00545103 names 20 study sites across 6 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT00545103 about?
NCT00545103 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 NCT00545103?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 592 participants. The study started on 2007-12-06. Estimated completion is 2011-11-28.
What conditions does trial NCT00545103 study?
This clinical trial studies the following conditions: Diverticulitis.
What interventions are being tested in trial NCT00545103?
The interventions under investigation include: Placebo (DRUG), SPD476, MMX™ mesalazine, 1.2g extended release tablet (DRUG), SPD476, MMX™ mesalazine, 2.4g extended release tablet (DRUG), SPD476, MMX™ mesalazine, 4.8g extended release tablet (DRUG).
Who is sponsoring clinical trial NCT00545103?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00545103 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00545103's enrollment target sits among peer trials
592 3rd of 8 higher than 6 of 8 other Diverticulitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diverticulitis 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.
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