Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)

PHASE3CompletedINTERVENTIONAL
Enrollment

510

Participants

Timeline

Start Date

January 27, 2012

Primary Completion Date

October 2, 2013

Study Completion Date

October 2, 2013

Conditions
Ulcerative Colitis
Interventions
DRUG

Budesonide MMX®

Oral tablet taken daily in the morning after breakfast.

DRUG

Placebo

Matching budesonide MMX placebo oral tablet taken daily in the morning after breakfast.

DRUG

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"

Trial Locations (114)

10028

Santarus Clinical Investigational Site 1031, New York

11023

Santarus Clinical Investigational Site 1072, Great Neck

14225

Santarus Clinical Investigational Site 1021, Cheektowaga

17604

Santarus Clinical Investigational Site 1064, Lancaster

18840

Santarus Clinical Investigational Site 1006, Sayre

21401

Santarus Clinical Investigational Site 1044, Annapolis

23320

Santarus Clinical Investigational Site 1038, Chesapeake

24073

Santarus Clinical Investigational Site 1025, Christiansburg

28403

Santarus Clinical Investigational Site 1073, Wilmington

30033

Santarus Clinical Investigational Site 1050, Decatur

32127

Santarus Clinical Investigational Site 1029, Port Orange

32256

Santarus Clinical Investigational Site 1045, Jacksonville

32751

Santarus Clinical Investigational Site 1024, Maitland

32789

Santarus Clinical Investigational Site 1010, Winter Park

33426

Santarus Clinical Investigational Site 1035, Boynton Beach

33613

Santarus Clinical Investigational Site 1002, Zephyrhills

33777

Santarus Clinical Investigational Site 1001, Largo

44195

Santarus Clinical Investigational Site 1078, Cleveland

45267

Santarus Clinical Investigational Site 1080, Cincinnati

45415

Santarus Clinical Investigational Site 1082, Dayton

46202

Santarus Clinical Investigational Site 1058, Indianapolis

48047

Santarus Clinical Investigational Site 1016, Chesterfield

48197

Santarus Clinical Investigational Site 1068, Ypsilanti

48377

Santarus Clinical Investigational Site 1081, Novi

49159

Santarus Clinical Investigational Site 1015, Wyoming

55905

Santarus Clinical Investigational Site 1074, Rochester

60453

Santarus Clinical Investigational Site 1065, Oak Lawn

60637

Santarus Clinical Investigational Site 1075, Chicago

71103

Santarus Clinical Investigational Site 1032, Shreveport

77030

Santarus Clinical Investigational Site 1039, Houston

77505

Santarus Clinical Investigational Site 1005, Pasadena

78705

Santarus Clinical Investigational Site 1059, Austin

80120

Santarus Clinical Investigational Site 1063, Littleton

84341

Santarus Clinical Investigational Site 1014, Lancaster

90712

Santarus Clinical Investigational Site 1071, Lakewood

92114

Santarus Clinical Investigational Site 1003, San Diego

92801

Santarus Clinical Investigational Site 1043, Anaheim

06010

Santarus Clinical Investigational Site 1028, Bristol

03756

Santarus Clinical Investigational Site 1061, Lebanon

Unknown

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

R3A1R9

Santarus Clinical Investigational Site 2003, Winnipeg

L4L4Y7

Santarus Clinical Investigational Site 2002, Vaughan

J1G2E8

Santarus Clinical Investigational Site 2001, Sherbrooke

All Listed Sponsors
lead

Bausch Health Americas, Inc.

INDUSTRY

NCT01532648 - Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA) | Biotech Hunter | Biotech Hunter