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Completed Phase 3 Interventional Results available

Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission

ClinicalTrials.gov ID: NCT00326209

Public ClinicalTrials.gov record NCT00326209. 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 19, 2026, 1:43 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 Multicenter, Open-Label, Treatment Extension Trial to Evalaute the Long-Term Safety and Tolerability of Mesalamine Pellet Formulation

Brief summary

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

To evaluate the long-term safety and tolerability of encapsulated mesalamine Granules (eMG) (formerly referred to as Mesalamine Pellets \[MP\]) in participants with ulcerative colitis currently in remission.

Study identification

NCT ID
NCT00326209
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bausch Health Americas, Inc.
Industry
Enrollment
393 participants

Conditions and interventions

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 22, 2005 (Actual)
Primary completion
May 5, 2008 (Actual)
Completion
May 5, 2008 (Actual)
Last update posted
Nov 1, 2019

2005 – 2008

United States locations

U.S. sites
61
U.S. states
25
U.S. cities
57
Facility City State ZIP Site status
Birmingham Gastroenterology Associates Birmingham Alabama 35209 —
First Care Family Doctors South Fayetteville Arkansas 72701 —
Little Rock Diagnostic Clinic Little Rock Arkansas 72205 —
AGMG Clinical Research Anaheim California 92801 —
Lovelace Scientific Resources Beverly Hills California 90211 —
Digestive Liver Disease Specialists, Medical Group Garden Grove California 92840 —
Long Beach VA Medical Center Long Beach California 90822 —
Community Clinical Trials Orange California 92868 —
Rider Research Group San Francisco California 94117 —
John Jolley, M.D. San Rafael California 94901 —
Lovelace Scientific Resources Santa Ana California 92704 —
Santa Barbara Clinical Research Santa Barbara California 93108 —
Professionals for Clinical Research Littleton Colorado 80120 —
Connecticut Gastroenterology Institute Bristol Connecticut 06010 —
Clinical Research of Tampa Bay, Inc. Brooksville Florida 34613 —
Medical Research Unlimited Hialeah Florida 33013 —
Southern Clinical Research Consultants Hollywood Florida 33021 —
United Medical Research New Smyrna Beach Florida 32168 —
Venture Research Institute, LLC North Miami Beach Florida 33162 —
Penninsula Research, Inc. Ormond Beach Florida 32174 —
Advanced Gastroenterology Associates Palm Harbor Florida 34684 —
Lovelace Scientific Resources Sarasota Florida 34233 —
Advent Clinical Research Sarasota Florida 34239 —
Metabolic Research Institute, Inc. West Palm Beach Florida 33401 —
Consultative Gastroenterology Atlanta Georgia 30308 —
Digestive Care Associates Austell Georgia 30106 —
Center for Gastroenterology Decatur Georgia 30033 —
Gastroenterology Associates of Central Georgia Macon Georgia 31201 —
Northwest Gastroenterologists S.C. Arlington Heights Illinois 60005 —
Covenant Clinic Waterloo Iowa 50702 —
Cotton-O'Neil Digestive Health Center Topeka Kansas 66606 —
University of Louisville Louisville Kentucky 40202 —
Sinai Medical Office Building Baltimore Maryland 21215 —
Philip J. Beam Medical Center Hollywood Maryland 20636 —
Research Institute of Michigan, LLC Chesterfield Michigan 48047 —
Center for Digestive & Liver Diseases Mexico Missouri 65265 —
St. Louis Center for Clinical Research St Louis Missouri 63128 —
Shore Health Group Ocean City New Jersey 07712 —
Simon Lichtiger, M.D. New York New York 10128 —
VA Medical Center, Northport Northport New York 11768 —
VA Medical Center Syracuse New York 13210 —
Upstate Gastroenterology Associates, PC Troy New York 12180 —
LeBauer Research Associates, PA Greensboro North Carolina 27403 —
Bethany Medical Center High Point North Carolina 27262 —
Boice-Willis Clinic Rocky Mount North Carolina 27804 —
Consultants for Clinical Research, Inc. Cincinnati Ohio 45219 —
Avamar Center for Endoscopy Warren Ohio 44484 —
Oklahoma Gastroenterology Associates, LLC Tulsa Oklahoma 74104 —
Charleston Gastroenterology Specialists, LLC Charleston South Carolina 29414 —
Hillcrest Clinical Research, LLC Simpsonville South Carolina 29681 —
Medical Research Institute Nashville Tennessee 37205 —
NationsMed Clinical Research Houston Texas 77034 —
Clinical Trial Network Houston Texas 77074 —
Houston Digestive Disease Clinic Houston Texas 77090 —
Gastroenterology Associates of Tidewater Chesapeake Virginia 23320 —
New River Research Institute Christiansburg Virginia 24073 —
Seattle Gastroenterology Associates Seattle Washington 98133 —
Eastern Washington Clinical Research Center Spokane Washington 99204 —
Spokane Digestive Disease Center Spokane Washington 99204 —
Digestive Disease Research Center Tacoma Washington 98405 —
Center for Advanced Research Milwaukee Wisconsin 53215 —

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 NCT00326209, 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 Nov 1, 2019 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00326209 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →