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Completed Phase 3 Interventional Results available

Prevention of Recurrence of Diverticulitis

ClinicalTrials.gov ID: NCT00545103

Public ClinicalTrials.gov record NCT00545103. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 23, 2026, 6:18 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III, Randomised, Double-Blind, Dose-Response, Stratified, Placebo-Controlled Study Evaluating the Safety and Efficacy of SPD476 Versus Placebo Over 104 Weeks in the Prevention of Recurrence of Diverticulitis.

Study identification

NCT ID
NCT00545103
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Shire
Industry
Enrollment
592 participants

Conditions and interventions

Conditions

Interventions

  • 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
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 5, 2007
Primary completion
Nov 27, 2011
Completion
Nov 27, 2011
Last update posted
Jun 10, 2021

2007 – 2011

United States locations

U.S. sites
59
U.S. states
23
U.S. cities
55
Facility City State ZIP Site status
Birmingham Gastroenterology Associates, PC Birmingham Alabama 35209
Alabama Clinical Therapeutics, LLC Birmingham Alabama 35235
Medical Affiliated Research Center, Inc Huntsville Alabama 35801
Alabama Digestive Disorders Center, PC Huntsville Alabama 35802
Genova Clinical Research Tucson Arizona 85741
Digestive and Liver Disease Specialists Garden Grove California 92840
High Desert Gastroenterology, Inc. Lancaster California 93534
VA Long Beach Healthcare System Long Beach California 90822
CA Physicians Research Alliance Oceanside California 92083
Digestive Care Medical Center San Carlos California 94070
Rider Research Group San Francisco California 94117
Huntington Medical Foundation San Marino California 91108
Clinical Research of the Rockies Lafayette Colorado 80026
Arapahoe Gastroenterology, PC Littleton Colorado 80120
Litchfield County Gastroenterology Associates, LLC Torrington Connecticut 06790
Madeleine DuPree, MD Boynton Beach Florida 33426
Palmetto Research LLC Hialeah Florida 33016
Mark Lamet, MD Hollywood Florida 33021
Digestive Disease Consultants Maitland Florida 32751
University of Miami Miller School of Medicine Miami Florida 33136
University of Miami Miami Florida 33136
Miami Research Associates Miami Florida 33143
United Medical Research New Smyrna Beach Florida 32168
West Wind'r Research & Development Tampa Florida 33607
Atlanta Gastroenterology Associates Marietta Georgia 30067
Gastrointestinal Clinical of Quad Cities Davenport Iowa 52807
Sunflower Medical Group Mission Kansas 66202
Kansas Medical Clinic Topeka Kansas 66606
Gastroenterology Associates, LLC Baton Rouge Louisiana 70809
Louisiana Research Center, LLC Shreveport Louisiana 71103
Maryland Clinical Trials Annapolis Maryland 21401
Chevy Chase Clinical Research Chevy Chase Maryland 20815
Mid Atlantic Medical Research Centers Hollywood Maryland 20636
Charm City Research, LLC Lutherville Maryland 21093
Shah Associates, LLC Prince Frederick Maryland 20678
Clinical Research Institute of Michigan, LLC Chesterfield Michigan 48047
Center for Digestive Health Troy Michigan 48098
Gastrointestinal Associates, PA Jackson Mississippi 39202
Center for Digestive & Liver Diseases, Inc Mexico Missouri 65265
Sundance Clinical Research St Louis Missouri 63141
The Gastroenterology Group of South Jersey Vineland New Jersey 08360
NY Center for Clinical Research Lake Success New York 11042
Concorde Medical Group New York New York 10016
Cumberland Research Associates Fayetteville North Carolina 28304
LeBauer Research Associates, PA Greensboro North Carolina 27403
Wake Research Associates Raleigh North Carolina 27612
Digestive Health Specialists Winston-Salem North Carolina 27103
Consultants for Clinical Research Cincinnati Ohio 45219
Digestive Specialists Inc. Dayton Ohio 45415
AMH Feasterville Family Health Care Center Feasterville Pennsylvania 19053
Digestive Disorders Center Pittsburgh Pennsylvania 15213
Clinsearch, LLC Chattanooga Tennessee 37404
Memphis Gastroenterology Group, PC Germantown Tennessee 38138
Houston Endoscopy and Research Center Houston Texas 77024
Hidalgo Clinical Research San Antonio Texas 78215
Physician Research Options Murray Utah 84070
Granite Peaks Gastroenterology Sandy City Utah 84094
Northwest Gastroenerology Associates Bellevue Washington 98004
Seattle Gastroenterology Associates Seattle Washington 98133

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 72 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00545103, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 10, 2021 · Synced Jul 23, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00545103 live on ClinicalTrials.gov.

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