Study of the Safety and Efficacy of Zoenasa® Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis

PHASE2UnknownINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

April 30, 2014

Conditions
Ulcerative ColitisLeft-sided Ulcerative ColitisDistal Ulcerative Colitis
Interventions
DRUG

Zoenasa-1:4

Zoenasa Rectal Gel (4.0g mesalamine \[5-ASA\], 1.0g N-acetylcysteine \[NAC\]; 60ml)

DRUG

Mesalamine Enema

Mesalamine Rectal Suspension Enema (4.0g mesalamine \[5-ASA\], 60ml)

Trial Locations (45)

10028

Research Associates of New York, New York

11021

Long Island Clinical Research Associates, Great Neck

15213

University of Pittsburgh, Pittsburgh

23502

Digestive & Liver Disease Specialists, Norfolk

24073

New River Valley Research Institute, Christiansburg

27403

LeBauer Research Associates, P.A., Greensboro

28036

Carolina Digestive Health Associates, Davidson

28801

Asheville Gastroenterology Associates, P.A., Asheville

30033

The Atlanta Center for Gastroenterology, Decatur

30309

Digestive Healthcare of Georgia, Atlanta

30606

Tri-County Research, Athens

31405

St. Josephs Candler Health System, Savannah

32605

Digestive Disease Associates, Gainesville

32789

Shafran Gastroenterology, Winter Park

33016

Digestive Medical Associates, Hialeah

33021

The Center for Gastrointestinal Disorders, Hollywood

33156

Miami Gastroenterology Consultants P.A., Miami

33186

South Medical Research Group, Miami

34102

Gastroenterology of Naples, Naples

34684

Advanced Gastroenterology Associates, Palm Harbor

35209

Birmingham Gastroenterology Associates, Birmingham

36305

Digestive Health Specialists of the Southeast, Dothan

38138

Gastro One, Germantown

Memphis Gastroenterology Group, Germantown

39202

GI Associates and Endoscopy Center, Jackson

45219

Greater Cincinnati Gastroenterology, Cincinnati

48047

Clinical Research Institute of Michigan, LLC, Chesterfield

48072

Dr. Jason Bozdin, M.D., Berkley

48418

Gregory Cammel, MD PLC, Wyoming

52807

Gastrointestinal Clinic of Quad Cities, Davenport

53215

Wisconsin Center for Advanced Research, Milwaukee

60004

NCH Medical Group, Arlington Heights

67203

Professional Research Network of Kansas, Wichita

70006

Clinical Trials Management of Louisiana, Metairie

73071

Central Sooner Research, Norman

73104

Oklahoma Foundation for Digestive Research, Oklahoma City

74104

Options Health Research, Tulsa

74135

Gastroenterology United Tulsa, Tulsa

75075

Digestive Health Associates of Texas, Plano

75216

Dallas VA Medical Center, Dallas

77090

Houston Digestive Disease Clinic, Houston

80214

Rocky Mountain Gastroenterology, Lakewood

84405

Advanced Research Institute, South Ogden

98101

Digestive Disease Institute, Seattle

98405

Franciscan Research Center, Tacoma

Sponsors
All Listed Sponsors
lead

Altheus Therapeutics, Inc.

INDUSTRY

NCT01586533 - Study of the Safety and Efficacy of Zoenasa® Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis | Biotech Hunter | Biotech Hunter