A Study of Asacol Absorption, Metabolism and Excretion in Children and Adolescents With Ulcerative Colitis.

ClinicalTrials.gov ID: NCT00254618

Public ClinicalTrials.gov record NCT00254618. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 3, 2026, 2:30 AM EDT

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Official title

Study to Determine the Pharmacokinetics of Mesalamine Following Administration of 30, 60, and 90 mg/kg/Day as 400 mg Delayed-release Tablets Given Every 12 Hours for 28 Days to Children/Adolescents With Active Ulcerative Colitis.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT00254618
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 1
Lead sponsor: Warner Chilcott; Industry
Enrollment: 34 participants

Conditions and interventions

Conditions

Ulcerative Colitis

Interventions

mesalamine Drug

Drug

Eligibility (public fields only)

Age range: 5 Years to 17 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 30, 2005
Primary completion: May 31, 2008
Completion: May 31, 2008
Last update posted: Apr 16, 2013

2005 – 2008

United States locations

U.S. sites: 22
U.S. states: 15
U.S. cities: 22

Facility	City	State	ZIP	Site status
Research Site	Birmingham	Alabama	35203	—
Research Site	Mobile	Alabama	63304	—
Research Site	Costa Mesa	California	92626	—
Research Site	San Diego	California	92103	—
Research Site	San Francisco	California	94143	—
Research Site	Gainesville	Florida	32610	—
Research Site	Jacksonville	Florida	32207	—
Research Site	Park Ridge	Illinois	60068	—
Research Site	Baltimore	Maryland	21287	—
Research Site	Boston	Massachusetts	21114	—
Research Site	Detroit	Michigan	48236	—
Research Site	Omaha	Nebraska	68105	—
Research Site	Morristown	New Jersey	07962	—
Research Site	Buffalo	New York	14222	—
Research Site	Cincinnati	Ohio	45229	—
Research Site	Cleveland	Ohio	44106	—
Research Site	Portland	Oregon	97239	—
Research Site	Greenville	South Carolina	29615	—
Research Site	Dallas	Texas	75235	—
Research Site	Houston	Texas	77030	—
Research Site	Pasadena	Texas	77504	—
Research Site	Seattle	Washington	98105	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00254618, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Apr 16, 2013 · Synced Sep 3, 2026

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The complete protocol, eligibility criteria, and contact information for NCT00254618 live on ClinicalTrials.gov.

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