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Completed Phase 4 Interventional Results available

Strategies in Maintenance for Patients Receiving Long-term Therapy (S.I.M.P.L.E.) With MMX (Multi-Matrix System) Mesalamine for Ulcerative Colitis (UC)

ClinicalTrials.gov ID: NCT00446849

Public ClinicalTrials.gov record NCT00446849. 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 Oct 24, 2026, 1:47 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 IV, Multi-center, Open-label Study to Assess Clinical Recurrence Related to Compliance With Treatment With MMX Mesalamine 2.4g/Day Given Once Daily for the Maintenance of Quiescent Ulcerative Colitis (UC)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

To evaluate the percentage of subjects with clinical recurrence of UC at 6 months using MMX mesalamine once daily.

Study identification

NCT ID
NCT00446849
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Shire
Industry
Enrollment
290 participants

Conditions and interventions

Interventions

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
May 1, 2007 (Actual)
Primary completion
Aug 17, 2009 (Actual)
Completion
Aug 17, 2009 (Actual)
Last update posted
Jun 14, 2021

2007 – 2009

United States locations

U.S. sites
62
U.S. states
29
U.S. cities
56
Facility City State ZIP Site status
Birmingham Gastroenterology Assoc. Birmingham Alabama 35209 —
Clopton Clinic Jonesboro Arkansas 72401 —
VA Medical Center - Long Beach Long Beach California 90822 —
Sharp Rees-Stealy Medical Group San Diego California 92101 —
Clinical Applications Laboratories, Inc. San Diego California 92103 —
South Denver Gastroenterology, P.C. Englewood Colorado 80113 —
The Center for GI Medicine of Fairfield & Westchester, P.C. Greenwich Connecticut 06830 —
Medical Research Center of Connecticut, LLC Hamden Connecticut 06518 —
Connecticut Gastroenterology Associates New Haven Connecticut 06510 —
Walter Reed Army Medical Center Washington D.C. District of Columbia 20307 —
Advanced Digestive Care, PA Clearwater Florida 33756 —
Southern Clinical Research Consultants Hollywood Florida 33021 —
Borland-Groover Clinic Jacksonville Florida 32256 —
United Medical Research New Smyrna Beach Florida 32168 —
Advanced Gastroenterology Associates Palm Harbor Florida 34684 —
Soapstone Ctr. for Clin. Rsrch Decatur Georgia 30034 —
Gastroenterology Assoc./Cen.GA Macon Georgia 31201 —
NW GA Gastroenterology Marietta Georgia 30060 —
Midwest Clinical Research Associates Moline Illinois 61265 —
Accelovance Peoria Illinois 61602 —
Rockford Gastroenterology Associates Rockford Illinois 61107 —
Indiana University Hospital Indianapolis Indiana 46202 —
Gastrointestinal Clinic of Quad Cities Davenport Iowa 52807 —
University of Iowa Hospital and Clinics Iowa City Iowa 52242 —
GI Associates Overland Park Kansas 66212 —
Louisiana Research Center, LLC Shreveport Louisiana 71103 —
Digestive Disorders Associates Research Division Annapolis Maryland 21401 —
Maryland Clinical Trials Annapolis Maryland 21401 —
Maryland Digestive Disease Research, LLC Laurel Maryland 20707 —
Center for Digestive Health Troy Michigan 48098 —
Mayo Clinic Rochester Rochester Minnesota 55905 —
Center for Digestive and Liver Diseases Mexico Missouri 65265 —
Clinical Research Group of Montana, PLLC Bozeman Montana 59718 —
Marlboro Gastroenterology Manalapan New Jersey 07726 —
Western Suffolk Gastroenterology Associates, LLP Bay Shore New York 11706 —
Long Island Clinical Research Associates, LLP Long Island City New York 11021 —
North Shore University Hospital Manhasset New York 11030 —
Winthrop University Hospital Mineola New York 11501 —
Digestive Medicine of Long Island New Hyde Park New York 11042 —
Mount Sinai and Metropolitan Hospital New York New York 10128 —
Upstate Gastroentrology Associates Troy New York 12180 —
Peters Medical Research High Point North Carolina 27262 —
East Carolina Gastroenterology Jacksonville North Carolina 28546 —
Gastroenterology Associates Beachwood Ohio 44122 —
Consultants for Clinical Research, Inc. Cincinnati Ohio 45219 —
Digestive Health Network Cincinnati Ohio 45220 —
Gastro Consultants of Greater Cincinnati Cincinnati Ohio 45242 —
Gild Consultants, P.C. Dayton Ohio 45415 —
Central Sooner Research Norman Oklahoma 73069 —
Guthrie Clinic Sayre Pennsylvania 18840 —
ClinSearch Chattanooga Tennessee 37404 —
Gastroenterology of Midsouth Germantown Tennessee 38138 —
Holston Medical Group Kingsport Tennessee 37660 —
Houston Endoscopy & Research Center Houston Texas 77024 —
Gastroenterology Clinic of San Antonio San Antonio Texas 78229 —
Gastroenterology Associates of Tidewater Chesapeake Virginia 23320 —
New River Valley Research Christiansburg Virginia 24073 —
Inland Empire Gastroenterology, P.S. Spokane Washington 99204 —
Spokane Digestive Disease Center, P.S. Spokane Washington 99204 —
Wisconsin Center for Advanced Research Milwaukee Wisconsin 53215 —
Aurora Sinai Medical Center Milwaukee Wisconsin 53233 —
Aurora Health Center- Waukesha Waukesha Wisconsin 53186 —

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

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00446849, 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 14, 2021 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00446849 live on ClinicalTrials.gov.

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