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Clinical trialNCT01536535CompletedPhase 4Interventional

Predicting Response to Standardized Pediatric Colitis Therapy

SponsorConnecticut Children's Medical CenterEnrollment431Ulcerative Colitis
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is a multi-center, open-label study to determine the safety and effectiveness (how well it works) of two standardized treatments called "mesalamine" (Pentasa®) and "prednisone" in children with newly diagnosed Ulcerative Colitis (UC). Standardized treatments are types of treatments agreed upon and used by many qualified doctors. The medications being used in this study are considered "standard of care". Currently the ways in which these medicines are used (doses, frequency of dosing) may vary from site to site. This study will determine response to a standardized way of giving these medicines. This study will also identify biomarkers for ulcerative colitis. Biomarkers are things that doctors can find in blood, stool, or bowel tissue that indicate how much inflammation there is in the bowel, how the inflammation is produced, and whether the inflammation is responding to treatment. Collecting response and remission (free of symptoms) information on these standardized treatments and the "biomarkers" can possibly help doctors create a model, or plan to know which children with UC may respond quickly, or which children may develop complications.

Investigators

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

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

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

Canada
  • Iwk Health Centre

    Halifax, Nova Scotia, Canada

  • Children'S Hospital of Eastern Ontario

    Ottawa, Ontario, Canada

  • Hospital for Sick Children

    Toronto, Ontario, Canada

United States
  • Ucla Medical Center

    Los Angeles, California, United States

  • University of California at San Francisco

    San Francisco, California, United States

  • Connecticut Children'S Medical Center

    Hartford, Connecticut, United States

  • Nemours Children'S Clinic

    Jacksonville, Florida, United States

  • Emory Children'S Center

    Atlanta, Georgia, United States

  • Ann & Robert H. Lurie Children'S Hospital of Chicago

    Chicago, Illinois, United States

  • Riley Children'S Hospital

    Indianapolis, Indiana, United States

  • John Hopkins Children'S Hospital

    Baltimore, Maryland, United States

  • Children'S Hospital of Boston

    Boston, Massachusetts, United States

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, United States

  • Goryeb Children'S Hospital / Atlantic Health

    Morristown, New Jersey, United States

  • Women and Children'S Hospital of Buffalo

    Buffalo, New York, United States

  • Cohen Children'S Medical Center

    New Hyde Park, New York, United States

  • Morgan Stanley Children'S Hospital

    New York, New York, United States

  • Mt Sinai Hospital

    New York, New York, United States

  • Golisano Children'S Hospital Suny Upstate Medical University

    Syracuse, New York, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, United States

  • Cincinnati Children'S Hospital Medical Center

    Cincinnati, Ohio, United States

  • Nationwide Children'S Hospital

    Columbus, Ohio, United States

  • Children'S Hospital of Philadelphia

    Philadelphia, Pennsylvania, United States

  • Children'S Hospital of Pittsburgh of Upmc

    Pittsburgh, Pennsylvania, United States

  • Hasbro Children'S Hospital

    Providence, Rhode Island, United States

  • Monroe Carell Jr. Children'S Hospital at Vanderbilt

    Nashville, Tennessee, United States

  • Ut Southwestern

    Dallas, Texas, United States

  • Primary Children'S Medical Center (university of Utah)

    Salt Lake City, Utah, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, United States

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.

IV CorticosteroidMesalamine →Oral Corticosteroids
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
10 Jul 2012
Primary completion
30 Apr 2018
Completion
30 Apr 2018
Last update posted
20 Sept 2019
Registered enrollment
431
Registry id
NCT01536535

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.