Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis

ClinicalTrials.gov ID: NCT00713310

Public ClinicalTrials.gov record NCT00713310. 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 Oct 21, 2026, 1:08 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8 g/Day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents With Mildly-to-Moderately Active Ulcerative Colitis

Brief summary

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

The overall objective of this study is to assess the safety and efficacy of high dose and low dose Asacol administered as 400 mg delayed-release tablets given every 12 hours for 6 weeks to children and adolescents with mildly-to-moderately active ulcerative colitis.

Study identification

NCT ID: NCT00713310
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Warner Chilcott; Industry
Enrollment: 83 participants

Conditions and interventions

Conditions

Ulcerative Colitis

Interventions

Asacol 400 mg 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: Dec 2008 (Type not available)
Primary completion: Mar 2011 (Actual)
Completion: Mar 2011 (Actual)
Last update posted: Apr 5, 2012

2008 – 2011

United States locations

U.S. sites: 26
U.S. states: 18
U.S. cities: 25

Facility	City	State	ZIP	Site status
Research Facility	Birmingham	Alabama	35233	—
Research Facility	Phoenix	Arizona	85016	—
Research Facility	Loma Linda	California	92354	—
Research Facility	San Diego	California	92123	—
Research Facility	San Francisco	California	94118	—
Research Facility	San Francisco	California	94143	—
Research Facility	Washington D.C.	District of Columbia	20010	—
Research Facility	Gainesville	Florida	32610	—
Research Facility	Park Ridge	Illinois	60068	—
Research Facility	Louisville	Kentucky	40202	—
Research Facility	Boston	Massachusetts	02114	—
Research Facility	Worcester	Massachusetts	01655	—
Research Facility	Kansas City	Missouri	64108	—
Research Facility	Omaha	Nebraska	68015	—
Research Facility	Mays Landing	New Jersey	08330	—
Research Facility	Buffalo	New York	14222	—
Research Facility	New Hyde Park	New York	11040	—
Research Facility	Youngstown	Ohio	44514	—
Research Facility	Portland	Oregon	97239-3098	—
Research Facility	Chattanooga	Tennessee	37404	—
Research Facility	Knoxville	Tennessee	37916	—
Research Facility	Fort Worth	Texas	76104	—
Research Facility	Houston	Texas	77030	—
Research Facility	San Antonio	Texas	78229	—
Research Facility	Norfolk	Virginia	23507	—
Research Facility	Huntington	West Virginia	25701	—

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

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00713310, 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 5, 2012 · Synced Oct 21, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00713310 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →