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NCT01004185 · ClinicalTrials.gov registry record · Phase 3
Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis
A Phase 3 study, sponsored by Warner Chilcott.
- Terminated
- Registry status
- Phase 3
- Development phase
- 39
- Enrollment target
NCT01004185 is a Phase 3 study that was terminated before completion, run by Warner Chilcott. The registered enrollment target is 39 participants.
The verdict
NCT01004185, a Phase 3 study, was terminated before completion, sponsored by Warner Chilcott.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 39 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether low dose Asacol® (27 mg/kg - 71 mg/kg) and high dose Asacol® (53 mg/kg - 118 mg/kg) are safe and effective when dosed as 400 mg delayed-release tablets given twice daily for 26 weeks to children and adolescents for the maintenance of remission of ulcerative colitis.
Interventions
- DRUG Asacol 400 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2009-10 |
| Est. Completion | 2011-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01004185
The ClinicalTrials.gov registry entry for NCT01004185 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 39 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.
NCT01004185 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01004185 about?
NCT01004185 is a clinical study titled "Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis". The purpose of this study is to determine whether low dose Asacol® (27 mg/kg - 71 mg/kg) and high dose Asacol® (53 mg/kg - 118 mg/kg) are safe and effective when dosed as 400 mg delayed-release tablets given twice daily for 26 weeks to children and adolescents for the maintenance of remission of ulc...
What is the current status of trial NCT01004185?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 39 participants. The study started on 2009-10. Estimated completion is 2011-03.
What interventions are being tested in trial NCT01004185?
The interventions under investigation include: Asacol 400 mg (DRUG).
Who is sponsoring clinical trial NCT01004185?
This trial is sponsored by Warner Chilcott, which has 53 total clinical trials registered on ClinicalTrials.gov.
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