Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis

PHASE3CompletedINTERVENTIONAL
Enrollment

386

Participants

Timeline

Start Date

September 30, 2000

Primary Completion Date

September 30, 2003

Study Completion Date

September 30, 2003

Conditions
Ulcerative Colitis
Interventions
DRUG

Asacol 800 mg (mesalamine)

tablets, 4.8 g/day for 6 weeks, 2 - 800 mg Asacol tablets and 2 placebo tablets 3 times daily

DRUG

Asacol 400 mg (mesalamine)

tablets, 2.4 g/day for 6 weeks, 2 - 400 mg Asacol tablets and 2 placebo tablets 3 times daily

Trial Locations (57)

10128

Research Site, New York

11021

Long Island Clinical Research Associates, Great Neck

11375

Research Site, Forest Hills

16602

Research Site, Altoona

17331

Research Site, Hanover

20815

Metropolitan Gastroenterology Group, Chevy Chase

21215

Research Site, Baltimore

21229

Digestive Disease Associates, Baltimore

21401

Digestive Disorders Associates, Annapolis

22031

Research Site, Fairfax

22401

Research Site, Fredericksburg

22902

Charlottesville Medical Research, Charlottesville

23226

Richmond GI Research, Richmond

27612

Research Site, Raleigh

28262

Carolinas Digestive Health Associates, Charlotte

28677

Research Site, Statesville

30067

Southeast Research Associates, Marietta

32789

Research Site, Maitland

33021

Center for GI Disorders, Hollywood

33540

Research Site, Zephyrhills

34684

Advanced Gastroenterology Associates, Palm Harbor

38305

Community Clinical Trials, Orange

Regional Research Institute, Jackson

43215

Research Site, Columbus

45219

Consultants for Clinical Research, Cincinnati

45267

Research Site, Cincinnati

45440

GI & Liver Consultants, Dayton

48202

Henry Ford Hospital, Detroit

53207

Wisconsin Center for Advanced Research, Milwaukee

55905

Mayo Clinic, Rochester

60637

University of Chicago Medical Center, Chicago

70001

GI Research, Metairie

71103

Louisiana Research Center, Shreveport

73190

Research Site, Oklahoma City

74135

Research Site, Tulsa

75246

Research Site, Dallas

76508

Research Site, Temple

77030

Research Site, Houston

77090

Houston Medical Research Associates, Houston

78705

Research Site, Austin

80002

Research Site, Arvada

80110

Research Site, Englewood

84405

Research Site, Ogden

85259

Mayo Clinic Scottsdale, Scottsdale

90067

Research Site, Los Angeles

92123

Sharp Rees-Stealy Medical Group, San Diego

92801

AGMG Clinical Research, Anaheim

92869

AGMG Clinical Research, Orange

95825

Research Site, Sacramento

97225

West Hills Gastroenterology Group, Portland

99207

Research Site, Spokane

06040

Center for Medical Research, LLC, Manchester

02115

Brigham & Women's Hospital, Boston

08844

PharmaTrials, Inc., Hillsborough

V7C 5L9

Research Site, Richmond

M5B 1W8

Research Site, Toronto

00935

University of Puerto Rico, School of Medicine, San Juan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Warner Chilcott

INDUSTRY

NCT00073021 - Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis | Biotech Hunter | Biotech Hunter