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NCT00073021 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis
A Phase 3 study, sponsored by Warner Chilcott.
- Completed
- Registry status
- Phase 3
- Development phase
- 386
- Enrollment target
NCT00073021: Completed Phase 3 study, sponsored by Warner Chilcott.
NCT00073021 is a Phase 3 study that has completed, run by Warner Chilcott. The registered enrollment target is 386 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00073021, a Phase 3 study, has completed, sponsored by Warner Chilcott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 386 participants
- Enrollment target
Study Summary
This study is a prospective clinical study to evaluate the safety and efficacy of two different doses of Asacol for the treatment of moderately active ulcerative colitis. In addition, a new tablet formulation will be evaluated at one of the two doses.
Primary Outcome
Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment \[stool frequency, rectal bleeding, PFA, sigmoidoscopy\] and no worsening in any other clinical assessments)
Interventions
- DRUG Asacol 800 mg (mesalamine)
- DRUG Asacol 400 mg (mesalamine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 386 participants |
| Start Date | 2000-09 |
| Est. Completion | 2003-09 |
| Phase | Phase 3 |
What the finished NCT00073021 record still lists
NCT00073021 is an interventional study that assigns participants to a tested intervention. The registered 386 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 (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Asacol 800 mg (mesalamine) is the first listed.
NCT00073021 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00073021 about?
NCT00073021 is a clinical study titled "Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis". This study is a prospective clinical study to evaluate the safety and efficacy of two different doses of Asacol for the treatment of moderately active ulcerative colitis. In addition, a new tablet formulation will be evaluated at one of the two doses.
What is the current status of trial NCT00073021?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 386 participants. The study started on 2000-09. Estimated completion is 2003-09.
What interventions are being tested in trial NCT00073021?
The interventions under investigation include: Asacol 800 mg (mesalamine) (DRUG), Asacol 400 mg (mesalamine) (DRUG).
Who is sponsoring clinical trial NCT00073021?
This trial is sponsored by Warner Chilcott, which has 53 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00073021's enrollment target sits among peer trials
386 973rd of 2000 higher than 1,026 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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