Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis

PHASE1CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

October 8, 2010

Primary Completion Date

June 27, 2013

Study Completion Date

June 27, 2013

Conditions
Ulcerative Colitis
Interventions
DRUG

MMX Mesalamine

30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.

DRUG

MMX Mesalamine

60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.

DRUG

MMX Mesalamine

100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.

Trial Locations (19)

3052

Royal Children's Hospital Melbourne, Parkville

21201

University of Maryland Medical Center for Children, Baltimore

55905

Mayo Clinic, Rochester

72202

Arkansas Children's Hospital, Little Rock

92801

Advanced Clinical Research Institute, Anaheim

94143

University of California, San Francisco, San Francisco

06106

Connecticut Children's Medical Center, Hartford

30-663

Klinika Pediatrii Gastroenterologii i Zywienia, Uniwersytecki Szpital Dzieciecy w Krakowie, Wieliczka

281/289

Klinika Gastroenterolofii Pediatrii, Instytut Centrum Zdrowia Matki Polki, Lodz

20-093

Klinika Pediatrii Dzieciecy Szpital Kliniczny im prof Antoniego Gebali, Lublin

35-301

Kliniczny Oddzial Pediatrii z Pododdzialem Neurologii Dzieciecej Szpital Wojewodzki, Rzeszów

04-730

Oddzial Gastroenterologii i Hepatologii, Instytut Pomnik-Centrum Zdrowia Dziecka, Warsaw

036 01

Univerzitna nemocnica Martin, Martin

974 09

DFNsP Banska Bystrica, Banská Bystrica

824 02

Gastroenterologicka ambulancia, Bratislava

L12 2AP

Alder Hey Children's NHS Foundation Trust, Liverpool

E1 1BB

Barts Health NHS Trust/Royal London Hospital, London

WC1N 3JH

Somers Clinical Research Facility/Great Ormond Street Hospital, London

SO16 6YD

Southampton General Hospital, Southampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY