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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00326209
The ClinicalTrials.gov registry entry for NCT00326209 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 393 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,054-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (81% lower). The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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