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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 is a Phase 1 study that was terminated before completion, run by Warner Chilcott. The registered enrollment target is 34 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00254618
The ClinicalTrials.gov registry entry for NCT00254618 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 34 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 mesalamine is the first listed.
NCT00254618 reports 0 study locations.
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.
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