GTC-80-203; GT1105: A Study of GT160-246 Versus Vancomycin in Patients with Clostridium Difficile-Associated Diarrhea

This study has been completed.

Sponsored By:	Genzyme
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00034294

Purpose

Approximately 300 patients will be entered into this study taking place throughout the United States, Canada and the United Kingdom. This study aims to determine if an investigational drug is safe and effective for treating the symptoms of C. difficile-associated diarrhea and lowering the risk of repeat episodes of diarrhea. 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 10 weeks.

Condition	Intervention	Phase
Clostridium difficile-Associated Diarrhea Clostridium Enterocolitis Clostridium Difficile Diarrhea Antibiotic-Associated Colitis Antibiotic-Associated Diarrhea	Drug: GT160-246	Phase II

Study Type: Interventional

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

Official Title: A Randomized, Double-Blind Study of GT160-246 Versus Vancomycin in Patients with C. Difficile-Associated Diarrhea

Further Study Details:

Total Enrollment: 300

Study Start: 2002-02

Eligibility

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

Criteria

Be at least 18 years old.

Have active mild to moderate C. difficile- Associated Diarrhea (CDAD).

Be able to tolerate oral medication.

Not be pregnant or breast-feeding.

Sign and date an informed consent form.

Location Information

Alabama
Mobile, Alabama, 36617, United States

Arizona
Tucson, Arizona, 85724, United States
Phoenix, Arizona, 85006, United States

Arkansas
Little Rock, Arkansas, 72205, United States

California
Davis, Sacramento, California, 95816, United States

Delaware
Newark, Delaware, 19718, United States

Florida
Naples, Florida, 34102, United States
Orlando, Florida, 32806, United States
Bay Pines, Florida, 33744, United States
Brandon, Florida, 33511, United States
Hollywood, Florida, 33021, United States

Georgia
Columbus, Georgia, 31902, United States
Austell, Georgia, 30106, United States

Illinois
Chicago, Illinois, 60611, United States
North Chicago, Illinois, 60064, United States
Maywood, Illinois, 60153, United States

Indiana
Columbus, Indiana, 47203, United States

Iowa
Des Moines, Iowa, 50309, United States
Des Moines, Iowa, 50314, United States

Kansas
Wichita, Kansas, 67214, United States

Kentucky
Lexington, Kentucky, 40536-0084, United States
Louisville, Kentucky, 40202, United States

Louisiana
New Orleans, Louisiana, 70112, United States

Maryland
Baltimore, Maryland, 21215, United States
Chevy Chase, Maryland, 20815, United States

Massachusetts
Boston, Massachusetts, 02111, United States
West Roxbury, Massachusetts, 02132, United States
Braintree, Massachusetts, 02185, United States

Missouri
St. Louis, Missouri, 63110, United States
Springfield, Missouri, 65807, United States

New Jersey
Stratford, New Jersey, 08084, United States

New York
Buffalo, New York, 14215, United States
New York, New York, 10032, United States
Syracuse, New York, 13210, United States
New York, New York, 10010, United States
Manhasset, New York, 11030, United States
Jamaica, New York, 11432, United States

North Carolina
Charlotte, North Carolina, 28203, United States
Asheville, North Carolina, 28801, United States

North Dakota
Fargo, North Dakota, 58122, United States

Ohio
Columbus, Ohio, 43215, United States
Toledo, Ohio, 43608, United States

Oklahoma
Oklahoma City, Oklahoma, 73104, United States

Pennsylvania
Philadelphia, Pennsylvania, 19140, United States
Allentown, Pennsylvania, 18105, United States
Philadelphia, Pennsylvania, 19129, United States
Hershey, Pennsylvania, 17033, United States
Pittsburgh, Pennsylvania, 15261, United States
Upland, Pennsylvania, 19013, United States
Philadelphia, Pennsylvania, 19102, United States

South Carolina
Charleston, South Carolina, 29425, United States

Tennessee
Memphis, Tennessee, 38104, United States
Clarksville, Tennessee, 37043, United States

Texas
Temple, Texas, 76508, United States

Virginia
Richmond, Virginia, 23249, United States
Falls Church, Virginia, 22042, United States
Richmond, Virginia, 23294, United States

Washington
Seattle, Washington, 98104, United States

Canada
Calgary, Alberta, T2N 1T9, Canada
Chicoutimi, Quebec, G7H 5H6, Canada
Moncton, New Brunswick, E1C 6Z8, Canada
Montreal, Quebec, H2L 4M1, Canada
Montreal, Quebec, H3T 1E2, Canada
Montreal, Quebec, H1T 2M4, Canada
Montreal, Quebec, H2L 4M1, Canada

Ottawa, Ontario, K1H 8L6, Canada
Quebec, G1R 2J6 and G1L 3L5, Canada
Quebec, G9A 1Y1, Canada
Vancouver, British Columbia, V5Z 3J5, Canada
Vancouver, British Columbia, V6Z 1Y6, Canada
Windsor, Ontario, N9A 1C9, Canada
Winnipeg, Manitoba, R3A 1R9, Canada

Puerto Rico
Hato Rey, 00918, Puerto Rico

United Kingdom
Birmingham, B18 7QH, United Kingdom
Birmingham, B95SS, United Kingdom
Cambridge, CB2 2QQ, United Kingdom
Cardiff, CF4 4XW, United Kingdom
Cardiff, CF64 2XX, United Kingdom
Edinburgh, EH4 2XU, United Kingdom
Glasgow, G21 3UR, United Kingdom
Hull, HU3 2JZ, United Kingdom
Keighley, BD20 6TD, United Kingdom
Lancashire, BL9 7TD, United Kingdom
Leeds, LS1 3EX, United Kingdom
Leicester, LE1 5WW, United Kingdom
London, N19 5LW, United Kingdom
London, SW10 9NH, United Kingdom
London, SW17 0QT, United Kingdom
London, SW7 2AZ, United Kingdom
London, W1N 8AA, United Kingdom
Newcastle-upon-Tyne, NE7 7DN, United Kingdom
Newport, NP20 2UB, United Kingdom
Northampton, NN1 5BD, United Kingdom
Nottingham, NG7 2UH, United Kingdom
Preston, PR7 1PP, United Kingdom
Shrewsbury, SY3 8XQ, United Kingdom
Stirling, FK8 2AU, United Kingdom
Swansea, SA6 6NL, United Kingdom
Taunton, TA1 5DA, United Kingdom
Wolverhampton, WV10 0QP, United Kingdom

More Information

Study ID Numbers: GTC-80-203; GT1105
ClinicalTrials.gov Identifier: NCT00034294
Health Authority: United States: Food and Drug Administration