Study of COLAL-PRED to Treat Moderate to Severe Ulcerative Colitis

PHASE2CompletedINTERVENTIONAL
Enrollment

190

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

October 31, 2009

Study Completion Date

October 31, 2009

Conditions
Colitis, Ulcerative
Interventions
DRUG

Placebo

Placebo solid capsule dosage form administered orally once daily.

DRUG

COLAL-PRED

The study is a double-blinded and results have not been unblinded. Patients were randomized to one of four doses. A solid capsule dosage form was administered orally once daily at doses of 40 mg, 60 mg, 80 mg, or 120 mg.

Trial Locations (89)

11021

Prometheus Investigational Site #002, Great Neck

11570

Prometheus Investigational Site 043, Rockville Centre

11794

Prometheus Investigational Site 087, Stony Brook

14642

Prometheus Investigational Site #080, Brooklyn

Prometheus Investigational Site #079, Rochester

18840

Prometheus Investigational Site #034, Sayre

19106

Prometheus Investigational Site #030, Philadelphia

19107

Prometheus Investigational Site #038, Philadelphia

20707

Prometheus Investigational Site #035, Laurel

20815

Prometheus Investigational Site #016, Chevy Chase

21093

Prometheus Investigational Site #025, Lutherville

21742

Prometheus Investigational Site #046, Hagerstown

27834

Prometheus Investigational Site #047, Greenville

28207

Prometheus Investigational Site #013, Charlotte

28403

Prometheus Investigational Site #058, Wilmington

29414

Prometheus Investigational Site #045, Charleston

30342

Prometheus Investigational Site #005, Atlanta

Prometheus Investigational Site #044, Atlanta

32256

Prometheus Investigational Site #007, Jacksonville

32708

Prometheus Investigational Site #066, Winter Park

33021

Prometheus Investigational Site #076, Hollywood

33144

Prometheus Investigational Site #008, Miami

33904

Prometheus Investigational Site #023, Cape Coral

Prometheus Investigational Site #075, Cape Coral

34239

Prometheus Investigational Site #027, Sarasota

35233

Prometheus Investigational Site #059, Birmingham

35801

Prometheus Investigational Site #042, Huntsville

Prometheus Investigational Site #081, Huntsville

36116

Prometheus Investigational Site #033, Montgomery

37067

Prometheus Investigational Site #084, Franklin

37205

Prometheus Investigational Site #053, Nashville

38138

Prometheus Investigational Site #020, Germantown

38261

Prometheus Investigational Site #074, Union City

39202

Prometheus Investigational Site #021, Jackson

43215

Prometheus Investigational Site #069, Columbus

44060

Prometheus Investigational Site #055, Mentor

44145

Prometheus Investigational Site #094, Westlake

45415

Prometheus Investigational Site #070, Dayton

45440

Prometheus Investigational Site #064, Dayton

46016

Prometheus Investigational Site #059, Anderson

48047

Prometheus Investigational Site # 050, Chesterfield

48377

Prometheus Investigational Site #011, Novi

49519

Prometheus Investigational Site #072, Wyoming

52807

Prometheus Investigational Site #015, Davenport

55446

Prometheus Investigational Site #098, Plymouth

60005

Prometheus Investigational Site #010, Arlington Heights

60612

Prometheus Investigational Site 041, Chicago

60637

Prometheus Investigational Site # 001, Chicago

61602

Prometheus Investigational Site #089, Peoria

65265

Prometheus Investigational Site #019, Mexico

66606

Prometheus Investigational Site #051, Topeka

70005

Prometheus Investigational Site 092, New Orleans

70503

Prometheus Investigational Site #061, Lafayette

70809

Prometheus Investigational Site #039, Baton Rouge

71103

Prometheus Investigational Site 100, Shreveport

72205

Prometheus Investigational Site #065, Little Rock

72401

Prometheus Investigational Site #068, Jonesboro

72745

Prometheus Investigational Site #093, Lowell

74104

Prometheus Investigational Site #028, Tulsa

74135

Prometheus Investigational Site #049, Tulsa

75075

Prometheus Investigational Site #071, Plano

76201

Prometheus Investigational Site 101, Denton

77479

Prometheus Investigational Site #082, Sugar Land

78229

Prometheus Investigational Site #026, San Antonio

Prometheus Investigational Site #073, San Antonio

80026

Prometheus Investigational Site #097, Lafayette

80120

Prometheus Investigational Site #006, Littleton

80229

Prometheus Investigational SIte #036, Thornton

84405

Prometheus Investigational Site #012, Ogden

85260

Prometheus Investigational Site #067, Scottsdale

85710

Prometheus Investigational Site #090, Tucson

90404

Prometheus Investigational Site #052, Santa Monica

91790

Prometheus Investigational Site #086, West Covina

92117

Prometheus Investigational Site #022, San Diego

92262

Prometheus Investigational Site #060, Palm Springs

93637

Prometheus Investigational Site #057, Madera

93721

Prometheus Investigational Site 062, Fresno

94070

Prometheus Investigational Site #003, San Carlos

95661

Prometheus Investigational Site #095, Roseville

98195

Prometheus Investigational Site #040, Seattle

06518

Prometheus Investigational Site #031, Hamden

06106

Prometheus Investigational Site #083, Hartford

02115

Prometheus Investigational Site #037, Boston

02184

Prometheus Investigational Site #018, Braintree

01550

Prometheus Investigational Site #091, Southbridge

03756

Prometheus Investigational Site #017, Lebanon

07927

Prometheus Investigational Site #014, Cedar Knolls

08234

Prometheus Investigational Site #009, Egg Harbor

07712

Prometheus Investigational Site #063, Ocean City

Sponsors
All Listed Sponsors
lead

Prometheus Laboratories

INDUSTRY

NCT00676832 - Study of COLAL-PRED to Treat Moderate to Severe Ulcerative Colitis | Biotech Hunter | Biotech Hunter