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NCT00269438 · ClinicalTrials.gov registry record · Phase 3
New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis
A Phase 3 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 3
- Development phase
- 225
- Enrollment target
NCT00269438: Completed Phase 3 study, sponsored by Bausch Health Americas.
NCT00269438 is a Phase 3 study that has completed, run by Bausch Health Americas. The registered enrollment target is 225 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00269438, a Phase 3 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 225 participants
- Enrollment target
Study Summary
The purpose of this study is to establish the efficacy and safety of a new tablet formulation and dosing regimen of balsalazide disodium dosed twice daily in achieving clinical improvement in subjects with mildly to moderately active ulcerative colitis after 8 weeks of therapy.
Interventions
- DRUG 5 ASA, enemas, suppositories, corticosteroids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2005-12 |
| Est. Completion | 2007-06 |
| Phase | Phase 3 |
What the finished NCT00269438 record still lists
NCT00269438 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 1 intervention - of which 5 ASA, enemas, suppositories, corticosteroids is the first listed.
NCT00269438 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00269438 about?
NCT00269438 is a clinical study titled "New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis". The purpose of this study is to establish the efficacy and safety of a new tablet formulation and dosing regimen of balsalazide disodium dosed twice daily in achieving clinical improvement in subjects with mildly to moderately active ulcerative colitis after 8 weeks of therapy.
What is the current status of trial NCT00269438?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 225 participants. The study started on 2005-12. Estimated completion is 2007-06.
What interventions are being tested in trial NCT00269438?
The interventions under investigation include: 5 ASA, enemas, suppositories, corticosteroids (DRUG).
Who is sponsoring clinical trial NCT00269438?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00269438's enrollment target sits among peer trials
225 1311th of 2000 higher than 684 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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