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NCT00326209 · ClinicalTrials.gov registry record · Phase 3
Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission
A Phase 3 study of Ulcerative Colitis, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 3
- Development phase
- 393
- Enrollment target
- 20
- Study locations
NCT00326209: Completed Phase 3 study of Ulcerative Colitis, sponsored by Bausch Health Americas.
NCT00326209 is a Phase 3 study of Ulcerative Colitis that has completed, run by Bausch Health Americas. The registered enrollment target is 393 participants, below the 2,054-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00326209, a Phase 3 study of Ulcerative Colitis, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 393 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A TEAE was defined as any event with a start date occurring on or after treatment Day 1 or, if pre-existing, worsening after treatment Day 1. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth
Conditions Studied
Interventions
- DRUG Encapsulated Mesalamine Granules (eMG)
Study Locations (20)
California
- AGMG Clinical Research - Anaheim
- Lovelace Scientific Resources - Beverly Hills
- Digestive Liver Disease Specialists, Medical Group - Garden Grove
- Long Beach VA Medical Center - Long Beach
- Community Clinical Trials - Orange
- Rider Research Group - San Francisco
- John Jolley, M.D. - San Rafael
- Lovelace Scientific Resources - Santa Ana
- Santa Barbara Clinical Research - Santa Barbara
Florida
- Clinical Research of Tampa Bay, Inc. - Brooksville
- Medical Research Unlimited - Hialeah
- Southern Clinical Research Consultants - Hollywood
- United Medical Research - New Smyrna Beach
- Venture Research Institute, LLC - North Miami Beach
- Penninsula Research, Inc. - Ormond Beach
Arkansas
- First Care Family Doctors South - Fayetteville
- Little Rock Diagnostic Clinic - Little Rock
Alabama
- Birmingham Gastroenterology Associates - Birmingham
Colorado
- Professionals for Clinical Research - Littleton
Connecticut
- Connecticut Gastroenterology Institute - Bristol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 393 participants |
| Start Date | 2005-12-22 |
| Est. Completion | 2008-05-05 |
| Phase | Phase 3 |
What the finished NCT00326209 record still lists
NCT00326209 is an interventional study that assigns participants to a tested intervention. The registered 393 participants enrollment target is mid-sized for trials with a published cap, below the 2,054-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 1 intervention - of which Encapsulated Mesalamine Granules (eMG) is the first listed.
NCT00326209 names 20 study sites across 6 states, led by California, Florida, Arkansas.
Frequently Asked Questions
What is clinical trial NCT00326209 about?
NCT00326209 is a clinical study titled "Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission". 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.
What is the current status of trial NCT00326209?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 393 participants. The study started on 2005-12-22. Estimated completion is 2008-05-05.
What conditions does trial NCT00326209 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT00326209?
The interventions under investigation include: Encapsulated Mesalamine Granules (eMG) (DRUG).
Who is sponsoring clinical trial NCT00326209?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00326209 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ulcerative Colitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00326209's enrollment target sits among peer trials
393 27th of 122 higher than 96 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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