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Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study
NCT00486031 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 443 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch Health Americas, which has 55 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00486031 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00486031?
The interventions under investigation include: Balsalazide Disodium (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00486031?
This trial is sponsored by Bausch Health Americas, which has 55 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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