GD3-170-301: A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C.Difficile - Associated Diarrhea

This study is currently recruiting patients.

Sponsored By:	Genzyme
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00106509

Purpose

Approximately 520 patients will be entered into this study taking place throughout the US and Canada. This study aims to determine if an investigational drug is safe and effective for treating symptoms of C. difficile-associated diarrhea (CDAD) and lowering the risk of repeat episodes of CDAD. The investigational drug will be evaluated in comparison to current standard antibiotic treatment, so all patients will receive active medication. All study related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is approximately 6 weeks

Condition	Intervention	Phase
Clostridium Enterocolitis Pseudomembranous Colitis	Drug: tolevamer potassium-sodium (GT267-004)	Phase III

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Randomized, Double-Blind Study of GT267-004 Versus Vancomycin, and GT267-004 Versus Metronidazole, in Patients With C.Difficile - Associated Diarrhea

Further Study Details: 

Primary Outcomes: Resolution of diarrhea

Secondary Outcomes: Time to resolution of diarrhea; Recurrence rate; Number of stools; Average stool consistency; Treatment success

Expected Total Enrollment: 520

Study start: March 2005

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

18 years of age

The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea

Less than or equal to 48 hours of treatment with metronidazole, vancomycin or other antibacterial therapy specific for CDAD

Baseline serum potassium > 3.0 mmol (meq)/L

Patient considered sufficiently stable clinically to likely complete a 6 week study period

Location and Contact Information

Arizona
Phoenix, Arizona, 85006, United States
Phoenix, Arizona, 85012, United States

Arkansas
Rogers, Arkansas, 72756, United States

California
Burbank, California, 91505, United States
Newport Beach, California, 92663, United States
Los Angeles, California, 90073, United States
Los Angeles, California, 90089, United States
Modesto, California, 95350, United States
Sacramento, California, 95817, United States
San Diego, California, 92103, United States
Los Angeles, California, 90095, United States

Colorado
Denver, Colorado, 80218-1191, United States
Denver, Colorado, 80210, United States
Denver, Colorado, 80262, United States
Denver, Colorado, 80204, United States

Delaware
Newark, Delaware, 19718, United States

Florida
Bay Pines, Florida, 33744, United States
Jacksonville, Florida, 32207, United States
Zephyrhills, Florida, 33542, United States
Tampa, Florida, 33607, United States
Brooksville, Florida, 34613, United States
Brandon, Florida, 33511, United States

Georgia
Atlanta, Georgia, 30309, United States
Ft. Gordon, Georgia, 30905, United States
Savannah, Georgia, 31405, United States

Hawaii
Honolulu, Hawaii, 96813, United States
Honolulu, Hawaii, 96813, United States

Illinois
Maywood, Illinois, 60153, United States
Chicago, Illinois, 60634, United States
North Chicago, Illinois, 60064, United States
Hines, Illinois, 60141, United States
Decatur, Illinois, 62526, United States

Indiana
Lafayette, Indiana, 47904, United States
Muncie, Indiana, 47303, United States
Anderson, Indiana, 46011, United States
Indianapolis, Indiana, 46202, United States

Iowa
Des Moines, Iowa, 50302, United States
Clive, Iowa, 50325, United States
Des Moines, Iowa, 50309, United States
Dubuque, Iowa, 52002, United States
Iowa City, Iowa, 52242, United States

Kentucky
Louisville, Kentucky, 40202, United States
Louisville, Kentucky, 40206-1499, United States
Bowling Green, Kentucky, 42101, United States

Louisiana
New Orleans, Louisiana, 70115, United States
New Orleans, Louisiana, 70121, United States

Maryland
Hagerstown, Maryland, 21740, United States
Baltimore, Maryland, 21201, United States

Massachusetts
Worcester, Massachusetts, 01608-1320, United States
Boston, Massachusetts, 02114, United States
Boston, Massachusetts, 02115, United States
Worcester, Massachusetts, 01655, United States

Michigan
Muskegon, Michigan, 49444, United States
Detroit, Michigan, 48202, United States
Detroit, Michigan, 48201, United States

Minnesota
Rochester, Minnesota, 55905, United States

Mississippi
Ocean Springs, Mississippi, 39564, United States

Missouri
Everton, Missouri, 65646, United States
Kansas City, Missouri, 64111, United States
St. Louis, Missouri, 63110, United States

Montana
Butte, Montana, 59701, United States
Missoula, Montana, 59802, United States

New Hampshire
Lebanon, New Hampshire, 03756, United States

New Jersey
Trenton, New Jersey, 08629, United States
Cedar Knolls, New Jersey, 07927, United States
Neptune, New Jersey, 07753, United States
Newark, New Jersey, 07103, United States

New York
New Hyde Park, New York, 11040, United States
Albany, New York, 12208, United States
Syracuse, New York, 13210, United States
New York, New York, 10016, United States

North Carolina
Greenville, North Carolina, 27834, United States
Raleigh, North Carolina, 27612, United States
Asheville, North Carolina, 28801, United States

North Dakota
Fargo, North Dakota, 58122, United States

Ohio
Akron, Ohio, 44304, United States
Toledo, Ohio, 43608, United States
Centerville, Ohio, 45459, United States

Pennsylvania
Philadelphia, Pennsylvania, 19141, United States
Lancaster, Pennsylvania, 17602, United States
Allentown, Pennsylvania, 18102, United States
Philadelphia, Pennsylvania, 19140, United States
Pittsburgh, Pennsylvania, 15261, United States
Pittsburgh, Pennsylvania, 15212, United States
Doylestown, Pennsylvania, 18901, United States

South Carolina
Charleston, South Carolina, 29401, United States
Greenville, South Carolina, 29605, United States

South Dakota
Rapid City, South Dakota, 57701, United States

Tennessee
Hermitage, Tennessee, 37076, United States

Texas
Tyler, Texas, 75702, United States
Houston, Texas, 77030, United States

Vermont
Burlington, Vermont, 05403, United States

Virginia
Richmond, Virginia, 23298, United States
Danville, Virginia, 24541, United States
Richmond, Virginia, 23249, United States
Winchester, Virginia, 22601, United States

Washington
Tacoma, Washington, 98431, United States

Wisconsin
Marshfield, Wisconsin, 54449, United States
Milwaukee, Wisconsin, 53226, United States
Eau Claire, Wisconsin, 54710, United States

Canada, Alberta
Calgary, Alberta, T2N 2T9, Canada
Edmonton, Alberta, T5H 3V9, Canada

Canada, British Columbia
Vancouver, British Columbia, V5Z 3J5, Canada
Kelowna, British Columbia, V1V 1Y5, Canada
Kelowna, British Columbia, V1Y 1T2 & V1Y3G8, Canada
Victoria, British Columbia, V8R 1J8, Canada

Canada, Manitoba
Winnipeg, Manitoba, R3A 1R9, Canada
Winnipeg, Manitoba, R3C 0N2, Canada

Canada, New Brunswick
Moncton, New Brunswick, E1C 6Z8, Canada
Saint John, New Brunswick, E2K 4L2, Canada

Canada, Nova Scotia
Halifax, Nova Scotia, B3H 2Y9, Canada

Canada, Ontario
Windsor, Ontario, N8X 3V6, Canada
Ottawa, Ontario, K1H 8L6, Canada
Toronto, Ontario, M3N 2V6, Canada
Scarborough, Ontario, M1E 4B9, Canada
Thunder Bay, Ontario, P7B 6V1, Canada
Toronto, Ontario, M2K 1E1, Canada
Ajax, Ontario, L1S 2J5, Canada
London, Ontario, N6A 4G5, Canada
Toronto, Ontario, M4N 3M5, Canada
Peterborough, Ontario, K9J 7B3, Canada
Windsor, Ontario, N9A 1E1, Canada
Toronto, Ontario, M5G 2M9 & M5G 1X5, Canada
Toronto, Ontario, M5G 1X5, Canada
Hamilton, Ontario, L8N 4A6, Canada
Guelph, Ontario, N1E 4J4, Canada
Kingston, Ontario, K7L 3N6, Canada

Canada, Quebec
Chicoutimi, Quebec, G7H 5H6, Canada
Trois Rivieres, Quebec, G9A 1Y1, Canada
Sainte Foy, Quebec, G1V 4G2, Canada
Levis, Quebec, G6V 3Z1, Canada
Quebec City, Quebec, G1L 3L5, Canada
Montreal, Quebec, H3G 1A4, Canada
Montreal, Quebec, H1T 2M4, Canada
St-Hyacinthe, Quebec, J2S 4Y8, Canada
St. Charles Borromee, Quebec, J6E 2C3, Canada
Green Field Park, Quebec, J4V 2H1, Canada
Montreal, Quebec, H3A 1A1, Canada
Quebec City, Quebec, G1R 2J6, Canada

Canada, Saskatchewan
Saskatoon, Saskatchewan, S7K 1J5, Canada

Puerto Rico
San Juan, 00935, Puerto Rico

More Information

Study ID Numbers: GD3-170-301
ClinicalTrials.gov Identifier: NCT00106509
Health Authority: United States: Food and Drug Administration