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NCT00577473 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)
A Phase 3 study, sponsored by Warner Chilcott.
- Completed
- Registry status
- Phase 3
- Development phase
- 301
- Enrollment target
NCT00577473: Completed Phase 3 study, sponsored by Warner Chilcott.
NCT00577473 is a Phase 3 study that has completed, run by Warner Chilcott. The registered enrollment target is 301 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00577473, a Phase 3 study, has completed, sponsored by Warner Chilcott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 301 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) versus Asacol 2.4 g/day (400 mg tablet
Primary Outcome
Treatment Success - complete or partial response; Complete = complete resolution of clinical assessments (stool frequency, rectal bleeding, PFA \[patient's functional assessment\], sigmoidoscopy) and PGA (physician global assessment) = 0, Partial = improvement from baseline PGA score and improvement in at least 1 of the clinical assessments \[decrease of at least 1 on scale\] and no worsening \[no score increases\] of remaining clinical assessments. Each clinical assessment graded using scale 0/
Interventions
- DRUG mesalamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 301 participants |
| Start Date | 2001-02 |
| Est. Completion | 2003-02 |
| Phase | Phase 3 |
What the finished NCT00577473 record still lists
NCT00577473 is an interventional study that assigns participants to a tested intervention. The registered 301 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 (61% lower).
The record links to 0 conditions, and to 1 intervention - of which mesalamine is the first listed.
NCT00577473 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00577473 about?
NCT00577473 is a clinical study titled "Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)". The purpose of this study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) versus Asacol 2.4 g/day (400 mg tablet
What is the current status of trial NCT00577473?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 301 participants. The study started on 2001-02. Estimated completion is 2003-02.
What interventions are being tested in trial NCT00577473?
The interventions under investigation include: mesalamine (DRUG).
Who is sponsoring clinical trial NCT00577473?
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 NCT00577473's enrollment target sits among peer trials
301 1121st of 2000 higher than 879 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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