Clinical trialNCT00713310CompletedPhase 3Interventional

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

SponsorWarner ChilcottEnrollment83Ulcerative Colitis

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Preston M Dunnmon, MD
Procter and Gamble
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

42 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

Research Facility
Halifax, Nova Scotia, Canada
Research Facility
Hamilton, Ontario, Canada
Research Facility
London, Ontario, Canada
Research Facility
Ottawa, Ontario, Canada
Research Facility
Montreal, Quebec, Canada

Croatia

Research Site
Rijeka, Croatia, Croatia
Research Site
Zagreb, Croatia, Croatia

Poland

Research Site
Bialystok, Poland, Poland
Research Site
Bydgoszcz, Poland, Poland
Research Site
Krakow, Poland, Poland
Research Site
Lodz, Poland, Poland
Research Site
Warsazawa, Poland, Poland
Research Site
Wroclaw, Poland, Poland

Romania

Research Site
Bucharest, Romania, Romania
Research Site
Bucharest, Romania, Romania
Research Site
Iași, Romania, Romania

United States

Research Facility
Birmingham, Alabama, United States
Research Facility
Phoenix, Arizona, United States
Research Facility
Loma Linda, California, United States
Research Facility
San Diego, California, United States
Research Facility
San Francisco, California, United States
Research Facility
San Francisco, California, United States
Research Facility
Washington D.C., District of Columbia, United States
Research Facility
Gainesville, Florida, United States
Research Facility
Park Ridge, Illinois, United States
Research Facility
Louisville, Kentucky, United States
Research Facility
Boston, Massachusetts, United States
Research Facility
Worcester, Massachusetts, United States
Research Facility
Kansas City, Missouri, United States
Research Facility
Omaha, Nebraska, United States
Research Facility
Mays Landing, New Jersey, United States
Research Facility
Buffalo, New York, United States
Research Facility
New Hyde Park, New York, United States
Research Facility
Youngstown, Ohio, United States
Research Facility
Portland, Oregon, United States
Research Facility
Chattanooga, Tennessee, United States
Research Facility
Knoxville, Tennessee, United States
Research Facility
Fort Worth, Texas, United States
Research Facility
Houston, Texas, United States
Research Facility
San Antonio, Texas, United States

2 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Asacol 400 mg

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Dec 2008
Primary completion: 31 Mar 2011
Completion: 31 Mar 2011
Last update posted: 5 Apr 2012
Registered enrollment: 83
Registry id: NCT00713310

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.