Predicting Response to Standardized Pediatric Colitis Therapy

PHASE4CompletedINTERVENTIONAL
Enrollment

431

Participants

Timeline

Start Date

July 10, 2012

Primary Completion Date

April 30, 2018

Study Completion Date

April 30, 2018

Conditions
Ulcerative Colitis
Interventions
DRUG

Mesalazine

Mesalazine (Pentasa) comes in 500mg capsules, and doses will need to be rounded to the nearest 500mg increment, with a maximum dose of 76 mg/kg/day. The average dose for the pediatric population will be approximately 70 mg/kg/day. Patients will be allowed to escalate to the final dose over 4 days to minimize side-effects such as headache.

DRUG

IV Corticosteroid

Treatment with IV Corticosteroid

DRUG

Oral Corticosteroids

Treatment with oral corticosteroids

OTHER

Additional Therapies

Anti-TNFα, Calcineurin inhibitor, Immunomodulator

PROCEDURE

Colectomy

Colectomy

Trial Locations (29)

10029

Mt Sinai Hospital, New York

10032

Morgan Stanley Children's Hospital, New York

11040

Cohen Children's Medical Center, New Hyde Park

13210

Golisano Children's Hospital SUNY Upstate Medical University, Syracuse

14222

Women and Children's Hospital of Buffalo, Buffalo

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

19104

Children's Hospital of Philadelphia, Philadelphia

21287

John Hopkins Children's Hospital, Baltimore

27599

University of North Carolina at Chapel HIll, Chapel Hill

30322

Emory Children's Center, Atlanta

32207

Nemours Children's Clinic, Jacksonville

37232

Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville

43205

Nationwide Children's Hospital, Columbus

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Riley Children's Hospital, Indianapolis

53226

Medical College of Wisconsin, Milwaukee

55454

University of Minnesota Medical Center, Minneapolis

75235

UT Southwestern, Dallas

84132

Primary Children's Medical Center (University of Utah), Salt Lake City

90095

UCLA Medical Center, Los Angeles

94143

University of California at San Francisco, San Francisco

06106

Connecticut Children's Medical Center, Hartford

60611-2605

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

02115

Children's Hospital of Boston, Boston

07962

Goryeb Children's Hospital / Atlantic Health, Morristown

02903

Hasbro Children's Hospital, Providence

B3k6r8

IWK Health Centre, Halifax

K1H8L1

Children's Hospital of Eastern Ontario, Ottawa

M5G1X8

Hospital for Sick Children, Toronto

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

Connecticut Children's Medical Center

OTHER

NCT01536535 - Predicting Response to Standardized Pediatric Colitis Therapy | Biotech Hunter | Biotech Hunter