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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 is a Phase 3 study that has completed, run by Warner Chilcott. The registered enrollment target is 83 participants.
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.
Interventions
- DRUG Asacol 400 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2008-12 |
| Est. Completion | 2011-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00713310
The ClinicalTrials.gov registry entry for NCT00713310 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Warner Chilcott, which has 53 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Asacol 400 mg is the first listed.
NCT00713310 reports 0 study locations.
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.
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