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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00545103
The ClinicalTrials.gov registry entry for NCT00545103 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 592 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 25,162-participant average among 8 other Diverticulitis trials with a reported enrollment target (98% lower). The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.