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NCT00505778 · ClinicalTrials.gov registry record · Phase 3
A Comparison of Once a Day Dose Compared to 2 Doses/Day
A Phase 3 study of Ulcerative Colitis, sponsored by Warner Chilcott.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,027
- Enrollment target
- 20
- Study locations
NCT00505778: Completed Phase 3 study of Ulcerative Colitis, sponsored by Warner Chilcott.
NCT00505778 is a Phase 3 study of Ulcerative Colitis that has completed, run by Warner Chilcott. The registered enrollment target is 1,027 participants, below the 2,049-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00505778, a Phase 3 study of Ulcerative Colitis, has completed, sponsored by Warner Chilcott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,027 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to compare the efficacy in maintaining remission of ulcerative colitis between a once daily (QD) Asacol regimen and a divided, twice daily (BID) Asacol dosing regimen.
Primary Outcome
Remission defined as SCCAI \<5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).
Conditions Studied
Interventions
- DRUG Mesalamine Once-Daily
- DRUG Mesalamine Twice-Daily
Study Locations (20)
California
- Research Facility - Anaheim
- Research Facility - Beverly Hills
- Research Facility - Chico
- Research Facility - Encinitas
- Research Facility - Folsom
- Research Facility - La Mesa
- Research Facility - Lancaster
- Research Facility - Long Beach
- Research Facility - Los Angeles
- Research Facility - Los Angeles
Alabama
- Research Facility - Athens
- Research Facility - Birmingham
- Research Facility - Birmingham
- Research Facility - Dothan
Arizona
- Research Facility - Phoenix
- Research Facility - Scottsdale
- Research Facility - Tucson
- Research Facility - Tuscon
Arkansas
- Research Facility - Little Rock
- Research Facility - Lowell
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,027 participants |
| Start Date | 2007-07 |
| Est. Completion | 2009-07 |
| Phase | Phase 3 |
What the finished NCT00505778 record still lists
NCT00505778 is an interventional study that assigns participants to a tested intervention. Its 1,027 participants enrollment target places it among the larger protocols in the corpus, below the 2,049-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (50% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which Mesalamine Once-Daily is the first listed.
NCT00505778 names 20 study sites across 4 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT00505778 about?
NCT00505778 is a clinical study titled "A Comparison of Once a Day Dose Compared to 2 Doses/Day". The purpose of this study is to compare the efficacy in maintaining remission of ulcerative colitis between a once daily (QD) Asacol regimen and a divided, twice daily (BID) Asacol dosing regimen.
What is the current status of trial NCT00505778?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,027 participants. The study started on 2007-07. Estimated completion is 2009-07.
What conditions does trial NCT00505778 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT00505778?
The interventions under investigation include: Mesalamine Once-Daily (DRUG), Mesalamine Twice-Daily (DRUG).
Who is sponsoring clinical trial NCT00505778?
This trial is sponsored by Warner Chilcott, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00505778 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00505778's enrollment target sits among peer trials
1,027 10th of 122 higher than 113 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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