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NCT00486031 · ClinicalTrials.gov registry record · Phase 3
Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study
A Phase 3 study of Ulcerative Colitis and Inflammatory Bowel Disease, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 3
- Development phase
- 443
- Enrollment target
- 20
- Study locations
NCT00486031 is a Phase 3 study of Ulcerative Colitis and Inflammatory Bowel Disease that has completed, run by Bausch Health Americas. The registered enrollment target is 443 participants, below the 2,054-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 7 states.
The verdict
NCT00486031, a Phase 3 study of Ulcerative Colitis and Inflammatory Bowel Disease, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 443 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of the study is to evaluate the long-term safety and tolerability of treatment with balsalazide disodium tablets in subjects who are in remission from ulcerative colitis or who have mildly to moderately active UC.
Conditions Studied
Interventions
- DRUG Balsalazide Disodium
Study Locations (20)
Florida
- Clinical Trials Management of Boca Raton - Boca Raton
- Research Consultants Group - Hialeah
- Horizon Institute for Clinical Research - Hollywood
- Mark Lamet, M.D. - Hollywood
- Southern Clinical Research Consultants - Hollywood
- A+ Research - Miami
- United Medical Research - New Smyrna Beach
California
- AGMG Clinical Research Institute - Anaheim
- Discovery Clinical Research, Inc. - Encinitas
- Digestive and Liver Disease Specialists - Garden Grove
- West Gastroenterology Medical Group - Los Angeles
- Community Clinical Trials - Orange
- Sharp Rees-Stealy Medical - San Diego
Colorado
- Rocky Mountain Gastroenterology - Lakewood
- Arapahoe Gastrroenterology, PC - Littleton
- South Denver Gastroenterology - Lone Tree
Alabama
- Birmingham Gastroenterology Associates, PC - Birmingham
Arizona
- Premeire Pharmaceutical Research - Tempe
Arkansas
- Medical Services of NWA - Fayetteville
Connecticut
- Connecticut Gastroenterology Institute - Bristol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 443 participants |
| Start Date | 2006-10 |
| Est. Completion | 2008-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00486031
The ClinicalTrials.gov registry entry for NCT00486031 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 443 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 (78% lower). The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 1 intervention - of which Balsalazide Disodium is the first listed.
NCT00486031 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT00486031 about?
NCT00486031 is a clinical study titled "Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study". The objective of the study is to evaluate the long-term safety and tolerability of treatment with balsalazide disodium tablets in subjects who are in remission from ulcerative colitis or who have mildly to moderately active UC.
What is the current status of trial NCT00486031?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 443 participants. The study started on 2006-10. Estimated completion is 2008-12.
What conditions does trial NCT00486031 study?
This clinical trial studies the following conditions: Ulcerative Colitis, Inflammatory Bowel Disease.
What interventions are being tested in trial NCT00486031?
The interventions under investigation include: Balsalazide Disodium (DRUG).
Who is sponsoring clinical trial NCT00486031?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00486031 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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