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NCT00254618 · ClinicalTrials.gov registry record · Phase 1
A Study of Asacol Absorption, Metabolism and Excretion in Children and Adolescents With Ulcerative Colitis.
A Phase 1 study, sponsored by Warner Chilcott.
- Terminated
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT00254618: Clinical Trial Phase 1 study, sponsored by Warner Chilcott.
NCT00254618 is a Phase 1 study that was terminated before completion, run by Warner Chilcott. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00254618, a Phase 1 study, was terminated before completion, sponsored by Warner Chilcott.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
The purpose of this randomized, open-label, parallel-group study is to determine how the body absorbs and eliminates mesalamine following administration of either 30 mg/kg/day, 60 mg/kg/day or 90 mg/kg/day as 400 mg delayed-release tablets given every 12 hours of 28 days to children and adolescents with active ulcerative colitis.
Interventions
- DRUG mesalamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2005-10 |
| Est. Completion | 2008-06 |
| Phase | Phase 1 |
Why NCT00254618 stopped before completion
NCT00254618 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 1 intervention - of which mesalamine is the first listed.
NCT00254618 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00254618 about?
NCT00254618 is a clinical study titled "A Study of Asacol Absorption, Metabolism and Excretion in Children and Adolescents With Ulcerative Colitis.". The purpose of this randomized, open-label, parallel-group study is to determine how the body absorbs and eliminates mesalamine following administration of either 30 mg/kg/day, 60 mg/kg/day or 90 mg/kg/day as 400 mg delayed-release tablets given every 12 hours of 28 days to children and adolescents ...
What is the current status of trial NCT00254618?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2005-10. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00254618?
The interventions under investigation include: mesalamine (DRUG).
Who is sponsoring clinical trial NCT00254618?
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 NCT00254618's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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