510
Participants
Start Date
January 27, 2012
Primary Completion Date
October 2, 2013
Study Completion Date
October 2, 2013
Budesonide MMX®
Oral tablet taken daily in the morning after breakfast.
Placebo
Matching budesonide MMX placebo oral tablet taken daily in the morning after breakfast.
5-ASA
"Acceptable oral 5-ASA medications to be received during the study include:~* Asacol®, Asacol® HD, Lialda®, Pentasa® (generic: mesalamine), minimum daily dose ≥2.4 grams (g)~* Azulfidine® (generic: sulfasalazine), minimum daily dose ≥4.0 g~* Dipentum® (generic: olsalazine), minimum daily dose ≥2.0 g~* Colazal®, Colazide® (generic: balsalazide), minimum daily dose ≥6.75 g"
Santarus Clinical Investigational Site 1031, New York
Santarus Clinical Investigational Site 1072, Great Neck
Santarus Clinical Investigational Site 1021, Cheektowaga
Santarus Clinical Investigational Site 1064, Lancaster
Santarus Clinical Investigational Site 1006, Sayre
Santarus Clinical Investigational Site 1044, Annapolis
Santarus Clinical Investigational Site 1038, Chesapeake
Santarus Clinical Investigational Site 1025, Christiansburg
Santarus Clinical Investigational Site 1073, Wilmington
Santarus Clinical Investigational Site 1050, Decatur
Santarus Clinical Investigational Site 1029, Port Orange
Santarus Clinical Investigational Site 1045, Jacksonville
Santarus Clinical Investigational Site 1024, Maitland
Santarus Clinical Investigational Site 1010, Winter Park
Santarus Clinical Investigational Site 1035, Boynton Beach
Santarus Clinical Investigational Site 1002, Zephyrhills
Santarus Clinical Investigational Site 1001, Largo
Santarus Clinical Investigational Site 1078, Cleveland
Santarus Clinical Investigational Site 1080, Cincinnati
Santarus Clinical Investigational Site 1082, Dayton
Santarus Clinical Investigational Site 1058, Indianapolis
Santarus Clinical Investigational Site 1016, Chesterfield
Santarus Clinical Investigational Site 1068, Ypsilanti
Santarus Clinical Investigational Site 1081, Novi
Santarus Clinical Investigational Site 1015, Wyoming
Santarus Clinical Investigational Site 1074, Rochester
Santarus Clinical Investigational Site 1065, Oak Lawn
Santarus Clinical Investigational Site 1075, Chicago
Santarus Clinical Investigational Site 1032, Shreveport
Santarus Clinical Investigational Site 1039, Houston
Santarus Clinical Investigational Site 1005, Pasadena
Santarus Clinical Investigational Site 1059, Austin
Santarus Clinical Investigational Site 1063, Littleton
Santarus Clinical Investigational Site 1014, Lancaster
Santarus Clinical Investigational Site 1071, Lakewood
Santarus Clinical Investigational Site 1003, San Diego
Santarus Clinical Investigational Site 1043, Anaheim
Santarus Clinical Investigational Site 1028, Bristol
Santarus Clinical Investigational Site 1061, Lebanon
Santarus Clinical Investigational Site 4003, Pleven
Santarus Clinical Investigational Site 4004, Plovdiv
Santarus Clinical Investigational Site 4009, Plovdiv
Santarus Clinical Investigational Site 4008, Rousse
Santarus Clinical Investigational Site 4001, Sofia
Santarus Clinical Investigational Site 4002, Sofia
Santarus Clinical Investigational Site 4005, Sofia
Santarus Clinical Investigational Site 4007, Sofia
Santarus Clinical Investigational Site 4010, Sofia
Santarus Clinical Investigational Site 4011, Sofia
Santarus Clinical Investigational Site 2008, Halifax
Santarus Clinical Investigational Site 2004, London
Santarus Clinical Investigational Site 2010, Ottawa
Santarus Clinical Investigational Site 2009, Montreal
Santarus Clinical Investigational Site 2007, Calgary
Santarus Clinical Investigational Site 2005, London
Santarus Clinical Investigational Site 2006, Québec
Santarus Clinical Investigational Site 3001, Hradec Králové
Santarus Clinical Investigational Site 3006, Hradec Králové
Santarus Clinical Investigational Site 3005, Labem
Santarus Clinical Investigational Site 3003, Olomouc
Santarus Clinical Investigational Site 3004, Prague
Santarus Clinical Investigational Site 3007, Prague
Santarus Clinical Investigational Site 3009, Prague
Santarus Clinical Investigational Site 3002, Tábor
Santarus Clinical Investigational Site 3010, Ústí nad Orlicí
Santarus Clinical Investigational Site 3011, Valašské Meziříčí
Santarus Clinical Investigational Site 8001, Tallinn
Santarus Clinical Investigational Site 5010, Békéscsaba
Santarus Clinical Investigational Site 5008, Budapest
Santarus Clinical Investigational Site 5009, Budapest
Santarus Clinical Investigational Site 5001, Debrecen
Santarus Clinical Investigational Site 5003, Gyula
Santarus Clinical Investigational Site 5004, Kaposvár
Santarus Clinical Investigational Site 5002, Miskolc
Santarus Clinical Investigational Site 5006, Mosonmagyaróvár
Santarus Clinical Investigational Site 5011, Pécs
Santarus Clinical Investigational Site 5005, Szeged
Santarus Clinical Investigational Site 5007, Vác
Santarus Clinical Investigational Site 8101, Riga
Santarus Clinical Investigational Site 8102, Riga
Santarus Clinical Investigational Site 8103, Riga
Santarus Clinical Investigational Site 8202, Kaunas
Santarus Clinical Investigational Site 8201, Vilnius
Santarus Clinical Investigational Site 8203, Vilnius
Santarus Clinical Investigational Site 6003, Elblag
Santarus Clinical Investigational Site 6001, Krakow
Santarus Clinical Investigational Site 6002, Sopot
Santarus Clinical Investigational Site 6006, Szczecin
Santarus Clinical Investigational Site 6004, Warsaw
Santarus Clinical Investigational Site 6008, Warsaw
Santarus Clinical Investigational Site 6005, Warszawy
Santarus Clinical Investigational Site 9016, Lipetsk
Santarus Clinical Investigational Site 9005, Moscow
Santarus Clinical Investigational Site 9010, Moscow
Santarus Clinical Investigational Site 9004, Nizhny Novgorod
Santarus Clinical Investigational Site 9003, Ryazan
Santarus Clinical Investigational Site 9001, Saint Petersburg
Santarus Clinical Investigational Site 9008, Saint Petersburg
Santarus Clinical Investigational Site 9013, Saint Petersburg
Santarus Clinical Investigational Site 9014, Saint Petersburg
Santarus Clinical Investigational Site 9009, Saratov
Santarus Clinical Investigational Site 9007, Stavropol
Santarus Clinical Investigational Site 9006, Ufa
Santarus Clinical Investigational Site 9017, Volgograd
Santarus Clinical Investigational Site 7010, Crimea
Santarus Clinical Investigational Site 7002, Donetsk
Santarus Clinical Investigational Site 7001, Kharkiv
Santarus Clinical Investigational Site 7004, Kharkiv
Santarus Clinical Investigational Site 7006, Kyiv
Santarus Clinical Investigational Site 7008, Kyiv
Santarus Clinical Investigational Site 7005, Vinnytsia
Santarus Clinical Investigational Site 2003, Winnipeg
Santarus Clinical Investigational Site 2002, Vaughan
Santarus Clinical Investigational Site 2001, Sherbrooke
Bausch Health Americas, Inc.
INDUSTRY