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NCT00713310 · ClinicalTrials.gov registry record · Phase 3
Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis
A Phase 3 study, sponsored by Warner Chilcott.
- Completed
- Registry status
- Phase 3
- Development phase
- 83
- Enrollment target
NCT00713310: Completed Phase 3 study, sponsored by Warner Chilcott.
NCT00713310 is a Phase 3 study that has completed, run by Warner Chilcott. The registered enrollment target is 83 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00713310, a Phase 3 study, has completed, sponsored by Warner Chilcott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 83 participants
- Enrollment target
Study Summary
The overall objective of this study is to assess the safety and efficacy of high dose and low dose Asacol administered as 400 mg delayed-release tablets given every 12 hours for 6 weeks to children and adolescents with mildly-to-moderately active ulcerative colitis.
Primary Outcome
PUCAI 0-85, abdominal pain (no pain/0, pain ignored/5, pain not ignored/10), rectal bleeding (none/0, small \<50% stool/10, small with most stools/20, large \>50% stool/30), stool consistency (formed/0, partially/5, unformed/10), # per 24 hrs (0-2/0, 3-5/5, 6-8/10, \>8/15), nocturnal bowel movements (no/0, yes/10), activity level (no limitation/0, occasional limitation/5, severely restricted/10) Remission \<10, Mild 10-34, Moderate 35-64, Severe 65-85, Success score\<10 at Wk 6 (complete) or red
Interventions
- DRUG Asacol 400 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2008-12 |
| Est. Completion | 2011-03 |
| Phase | Phase 3 |
What the finished NCT00713310 record still lists
NCT00713310 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Asacol 400 mg is the first listed.
NCT00713310 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00713310 about?
NCT00713310 is a clinical study titled "Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis". The overall objective of this study is to assess the safety and efficacy of high dose and low dose Asacol administered as 400 mg delayed-release tablets given every 12 hours for 6 weeks to children and adolescents with mildly-to-moderately active ulcerative colitis.
What is the current status of trial NCT00713310?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 83 participants. The study started on 2008-12. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00713310?
The interventions under investigation include: Asacol 400 mg (DRUG).
Who is sponsoring clinical trial NCT00713310?
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 NCT00713310's enrollment target sits among peer trials
83 1751st of 2000 higher than 249 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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