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| Sponsor: | 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Mobile, Alabama, United States, 36617 | |
| United States, Arizona | |
| Tucson, Arizona, United States, 85724 | |
| Phoenix, Arizona, United States, 85006 | |
| United States, Arkansas | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Sacramento, California, United States, 95816 | |
| United States, Delaware | |
| Newark, Delaware, United States, 19718 | |
| United States, Florida | |
| Naples, Florida, United States, 34102 | |
| Orlando, Florida, United States, 32806 | |
| Bay Pines, Florida, United States, 33744 | |
| Brandon, Florida, United States, 33511 | |
| Hollywood, Florida, United States, 33021 | |
| United States, Georgia | |
| Columbus, Georgia, United States, 31902 | |
| Austell, Georgia, United States, 30106 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60611 | |
| North Chicago, Illinois, United States, 60064 | |
| Maywood, Illinois, United States, 60153 | |
| United States, Indiana | |
| Columbus, Indiana, United States, 47203 | |
| United States, Iowa | |
| Des Moines, Iowa, United States, 50309 | |
| Des Moines, Iowa, United States, 50314 | |
| United States, Kansas | |
| Wichita, Kansas, United States, 67214 | |
| United States, Kentucky | |
| Lexington, Kentucky, United States, 40536-0084 | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Louisiana | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Baltimore, Maryland, United States, 21215 | |
| Chevy Chase, Maryland, United States, 20815 | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States, 02111 | |
| West Roxbury, Massachusetts, United States, 02132 | |
| Braintree, Massachusetts, United States, 02185 | |
| United States, Missouri | |
| St. Louis, Missouri, United States, 63110 | |
| Springfield, Missouri, United States, 65807 | |
| United States, New Jersey | |
| Stratford, New Jersey, United States, 08084 | |
| United States, New York | |
| Buffalo, New York, United States, 14215 | |
| New York, New York, United States, 10032 | |
| Syracuse, New York, United States, 13210 | |
| New York, New York, United States, 10010 | |
| Manhasset, New York, United States, 11030 | |
| Jamaica, New York, United States, 11432 | |
| United States, North Carolina | |
| Charlotte, North Carolina, United States, 28203 | |
| Asheville, North Carolina, United States, 28801 | |
| United States, North Dakota | |
| Fargo, North Dakota, United States, 58122 | |
| United States, Ohio | |
| Columbus, Ohio, United States, 43215 | |
| Toledo, Ohio, United States, 43608 | |
| United States, Oklahoma | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Philadelphia, Pennsylvania, United States, 19102 | |
| Philadelphia, Pennsylvania, United States, 19129 | |
| Hershey, Pennsylvania, United States, 17033 | |
| Pittsburgh, Pennsylvania, United States, 15261 | |
| Upland, Pennsylvania, United States, 19013 | |
| Allentown, Pennsylvania, United States, 18105 | |
| United States, South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| Memphis, Tennessee, United States, 38104 | |
| Clarksville, Tennessee, United States, 37043 | |
| United States, Texas | |
| Temple, Texas, United States, 76508 | |
| United States, Virginia | |
| Richmond, Virginia, United States, 23294 | |
| Falls Church, Virginia, United States, 22042 | |
| Richmond, Virginia, United States, 23249 | |
| United States, Washington | |
| Seattle, Washington, United States, 98104 | |
| Canada | |
| Quebec, Canada, G1R 2J6 and G1L 3L5 | |
| Canada, Alberta | |
| Calgary, Alberta, Canada, T2N 1T9 | |
| Canada, British Columbia | |
| Vancouver, British Columbia, Canada, V5Z 3J5 | |
| Vancouver, British Columbia, Canada, V6Z 1Y6 | |
| Canada, Manitoba | |
| Winnipeg, Manitoba, Canada, R3A 1R9 | |
| Canada, New Brunswick | |
| Moncton, New Brunswick, Canada, E1C 6Z8 | |
| Canada, Ontario | |
| Windsor, Ontario, Canada, N9A 1C9 | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Canada, Quebec | |
| Chicoutimi, Quebec, Canada, G7H 5H6 | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Trois-Rivieres, Quebec, Canada, G9A 1Y1 | |
| Puerto Rico | |
| Hato Rey, Puerto Rico, 00918 | |
| United Kingdom | |
| Glasgow, United Kingdom, G21 3UR | |
| Leeds, United Kingdom, LS1 3EX | |
| Leicester, United Kingdom, LE1 5WW | |
| Birmingham, United Kingdom, B95SS | |
| Cambridge, United Kingdom, CB2 2QQ | |
| Birmingham, United Kingdom, B18 7QH | |
| Hull, United Kingdom, HU3 2JZ | |
| Newport, United Kingdom, NP20 2UB | |
| London, United Kingdom, W1N 8AA | |
| Wolverhampton, United Kingdom, WV10 0QP | |
| Edinburgh, United Kingdom, EH4 2XU | |
| Taunton, United Kingdom, TA1 5DA | |
| Nottingham, United Kingdom, NG7 2UH | |
| Shrewsbury, United Kingdom, SY3 8XQ | |
| London, United Kingdom, N19 5LW | |
| London, United Kingdom, SW17 0QT | |
| United Kingdom, Cardiff | |
| Heath Park, Cardiff, United Kingdom, CF4 4XW | |
| Penlan Rd, Cardiff, United Kingdom, CF64 2XX | |
| United Kingdom, Keighley | |
| Steeton, Keighley, United Kingdom, BD20 6TD | |
| United Kingdom, Lancashire | |
| Bury, Lancashire, United Kingdom, BL9 7TD | |
| United Kingdom, London | |
| Chelsea, London, United Kingdom, SW10 9NH | |
| South Kensington, London, United Kingdom, SW7 2AZ | |
| United Kingdom, Newcastle-upon-Tyne | |
| High Heaton, Newcastle-upon-Tyne, United Kingdom, NE7 7DN | |
| United Kingdom, Northampton | |
| Cliftonville, Northampton, United Kingdom, NN1 5BD | |
| United Kingdom, Preston | |
| Fulwood, Preston, United Kingdom, PR7 1PP | |
| United Kingdom, Stirling | |
| Livilands, Stirling, United Kingdom, FK8 2AU | |
| United Kingdom, Swansea | |
| Morriston, Swansea, United Kingdom, SA6 6NL | |
| Study Director: | Medical Monitor | Genzyme |
More Information
| Responsible Party: | Genzyme Corporation ( Medical Monitor ) |
| Study ID Numbers: | GTC-80-203, GT1105 |
| Study First Received: | April 24, 2002 |
| Last Updated: | July 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00034294 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
C. difficile-associated diarrhea CDAD Clostridium difficile-Associated Diarrhea Clostridium enterocolitis antibiotic-associated diarrhea |
clostridium difficile colitis infectious diarrhea chronic diarrhea antibiotic-associated colitis |
|
Bacterial Infections Anti-Infective Agents Diarrhea Signs and Symptoms, Digestive Gastrointestinal Diseases Colonic Diseases Enterocolitis, Pseudomembranous Intestinal Diseases Enterocolitis Pharmacologic Actions |
Anti-Bacterial Agents Signs and Symptoms Gram-Positive Bacterial Infections Digestive System Diseases Therapeutic Uses Vancomycin Gastroenteritis Clostridium Infections Colitis |
