107
Participants
Start Date
December 12, 2014
Primary Completion Date
November 28, 2018
Study Completion Date
November 28, 2018
MMX Mesalamine/Mesalazine (Low Dose)
Once daily, tablets - the amount depends on the participants weight; 900 milligram per day (mg/day) for participants weighing 18 kg to less than or equal to (\<=) 23 kilograms (kg); 1200 mg/day for participants weighing greater than (\>) 23 kg to \<= 35 kg; 1800 mg/day for participants weighing \> 35 kg to \<= 50 kg; 2400 mg/day for participants weighing \> 50 kg to \<= 90 kg.
MMX Mesalamine/Mesalazine (High Dose)
Once daily, tablets - the amount depends on the participants weight;1800 mg/day for participants weighing 18 kg to \<= 23 kg; 2400 mg/day for participants weighing \> 23 kg to \<= 35 kg; 3600 mg/day for participants weighing \> 35 kg to \<= 50 kg; 4800 mg/day for participants weighing \> 50 kg to \<= 90 kg.
Baz Megyei Korhaz Es Egyetemi Oktatokorhaz, Miskolc
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhaz, Nyíregyháza
Penn State Milton S. Hershey Medical Center, Hershey
University of Maryland Children's Hospital, Baltimore
John Hopkins, Baltimore
Carilion Medical Center, Roanoke
Rambam Health Corporation, Haifa
Schneider Medical Centre, Petah Tikva
University of Minnesota Children's Hospital, Minneapolis
Mayo Clinic Gastroenterology, Rochester
Texas Digestive Disease Consultants, Southlake
Soroka Medical Center, Beersheba
Shaare Zedek Medical Center, Jerusalem
Massachusetts General Hospital, Boston
Newton Wellesley Hospital, Newton
University of Alberta Pediatric Gastroenterology & Nutrition, Edmonton
Szent Janos Korhaz És Észak-budai Egyesitett Korha, Budapest
Bekes Megyei Pandy Kalman Korhaz, Gyula
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Szeged
Uniwersytecki Dzieciecy Szpital Kliniczny im. Ludwika Zamenhofa, Bialystok
Klinika Pediatrii Gastroenterologii I Zywienia, Krakow
Klinika Gastroenterologii I Pediatrii, Lodz
Wojewodzki Specjalistyczny Szpital Dzieciecy, Olsztyn
Gabinet Lekarski-Bartosz Korczowski, Rzeszów
Oddzial Gastroenterologii I Hepatologii, Warsaw
Uniwersytecki Szpital Kliniczny We Wrocławiu, Wroclaw
Detská fakultná nemocnica s poliklinikou, Banská Bystrica
University Children's Hospital, Bratislava
Univerzitna Nemocnica Martin, Martin
Alder Hey Children's Hospital, Liverpool
Barts Health NHS Trust, Royal London Hospital, London
King's College Hospital, London
Great Ormond Street Hospital, London
Lead Sponsor
Shire
INDUSTRY