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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: Clinical Trial Phase 3 study, sponsored by Warner Chilcott.
NCT01004185 is a Phase 3 study that was terminated before completion, run by Warner Chilcott. The registered enrollment target is 39 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PUCAI Score (0-85, sum of scores for each): abdominal pain (0/5/10 - no pain/ignored/not ignored), rectal bleeding (0/10/20/30 - none, small amount \<50% of stools, small amount most stools, large amount \>50%), stool consistency (0/5/10 - formed, partially formed, completely formed), # stools/24 hrs. (0/5/10/15 - 0-2/3-5/6-8/\>8), nocturnal bowel/any diarrhea causing wakening (0/10 - no/yes), activity level (0/5/10 - no limitation/occ limitation, severe restrictions). Remission \<10, Mild 10-34
Interventions
- DRUG Asacol 400 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2009-10 |
| Est. Completion | 2011-03 |
| Phase | Phase 3 |
Why NCT01004185 stopped before completion
NCT01004185 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Asacol 400 mg is the first listed.
NCT01004185 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01004185's enrollment target sits among peer trials
39 1898th of 2000 higher than 101 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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