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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: Completed Phase 3 study of Ulcerative Colitis and Inflammatory Bowel Disease, sponsored by Bausch Health Americas.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Incidence of treatment emergent adverse events
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 |
What the finished NCT00486031 record still lists
NCT00486031 is an interventional study that assigns participants to a tested intervention. The registered 443 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 (78% lower).
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 names 20 study sites across 7 states, led by 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.
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 NCT00486031's enrollment target sits among peer trials
443 25th of 122 higher than 98 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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