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| Sponsor: | 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 |
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, Arizona | |
| Phoenix, Arizona, United States, 85006 | |
| Phoenix, Arizona, United States, 85012 | |
| United States, Arkansas | |
| Rogers, Arkansas, United States, 72756 | |
| United States, California | |
| Burbank, California, United States, 91505 | |
| Modesto, California, United States, 95350 | |
| Los Angeles, California, United States, 90073 | |
| Los Angeles, California, United States, 90089 | |
| Newport Beach, California, United States, 92663 | |
| Sacramento, California, United States, 95817 | |
| San Diego, California, United States, 92103 | |
| Los Angeles, California, United States, 90095 | |
| United States, Colorado | |
| Denver, Colorado, United States, 80218-1191 | |
| Denver, Colorado, United States, 80210 | |
| Denver, Colorado, United States, 80262 | |
| Denver, Colorado, United States, 80204 | |
| United States, Delaware | |
| Newark, Delaware, United States, 19718 | |
| United States, Florida | |
| Bay Pines, Florida, United States, 33744 | |
| Jacksonville, Florida, United States, 32207 | |
| Zephyrhills, Florida, United States, 33542 | |
| Tampa, Florida, United States, 33607 | |
| Brooksville, Florida, United States, 34613 | |
| Brandon, Florida, United States, 33511 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30309 | |
| Ft. Gordon, Georgia, United States, 30905 | |
| Savannah, Georgia, United States, 31405 | |
| United States, Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Illinois | |
| Maywood, Illinois, United States, 60153 | |
| Chicago, Illinois, United States, 60634 | |
| North Chicago, Illinois, United States, 60064 | |
| Hines, Illinois, United States, 60141 | |
| Decatur, Illinois, United States, 62526 | |
| United States, Indiana | |
| Lafayette, Indiana, United States, 47904 | |
| Muncie, Indiana, United States, 47303 | |
| Anderson, Indiana, United States, 46011 | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| Des Moines, Iowa, United States, 50302 | |
| Clive, Iowa, United States, 50325 | |
| Des Moines, Iowa, United States, 50309 | |
| Dubuque, Iowa, United States, 52002 | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kentucky | |
| Louisville, Kentucky, United States, 40202 | |
| Louisville, Kentucky, United States, 40206-1499 | |
| Bowling Green, Kentucky, United States, 42101 | |
| United States, Louisiana | |
| New Orleans, Louisiana, United States, 70115 | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Maryland | |
| Hagerstown, Maryland, United States, 21740 | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Worcester, Massachusetts, United States, 01608-1320 | |
| Boston, Massachusetts, United States, 02114 | |
| Boston, Massachusetts, United States, 02115 | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| Muskegon, Michigan, United States, 49444 | |
| Detroit, Michigan, United States, 48202 | |
| Detroit, Michigan, United States, 48201 | |
| United States, Minnesota | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Mississippi | |
| Ocean Springs, Mississippi, United States, 39564 | |
| United States, Missouri | |
| Everton, Missouri, United States, 65646 | |
| Kansas City, Missouri, United States, 64111 | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Montana | |
| Butte, Montana, United States, 59701 | |
| Missoula, Montana, United States, 59802 | |
| United States, New Hampshire | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New Jersey | |
| Trenton, New Jersey, United States, 08629 | |
| Cedar Knolls, New Jersey, United States, 07927 | |
| Neptune, New Jersey, United States, 07753 | |
| Newark, New Jersey, United States, 07103 | |
| United States, New York | |
| New Hyde Park, New York, United States, 11040 | |
| Albany, New York, United States, 12208 | |
| Syracuse, New York, United States, 13210 | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Greenville, North Carolina, United States, 27834 | |
| Raleigh, North Carolina, United States, 27612 | |
| Asheville, North Carolina, United States, 28801 | |
| United States, North Dakota | |
| Fargo, North Dakota, United States, 58122 | |
| United States, Ohio | |
| Akron, Ohio, United States, 44304 | |
| Toledo, Ohio, United States, 43608 | |
| Centerville, Ohio, United States, 45459 | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19141 | |
| Lancaster, Pennsylvania, United States, 17602 | |
| Allentown, Pennsylvania, United States, 18102 | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Pittsburgh, Pennsylvania, United States, 15261 | |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| Doylestown, Pennsylvania, United States, 18901 | |
| United States, South Carolina | |
| Charleston, South Carolina, United States, 29401 | |
| Greenville, South Carolina, United States, 29605 | |
| United States, South Dakota | |
| Rapid City, South Dakota, United States, 57701 | |
| United States, Tennessee | |
| Hermitage, Tennessee, United States, 37076 | |
| United States, Texas | |
| Tyler, Texas, United States, 75702 | |
| Houston, Texas, United States, 77030 | |
| United States, Vermont | |
| Burlington, Vermont, United States, 05403 | |
| United States, Virginia | |
| Richmond, Virginia, United States, 23298 | |
| Danville, Virginia, United States, 24541 | |
| Richmond, Virginia, United States, 23249 | |
| Winchester, Virginia, United States, 22601 | |
| United States, Washington | |
| Tacoma, Washington, United States, 98431 | |
| United States, Wisconsin | |
| Marshfield, Wisconsin, United States, 54449 | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Eau Claire, Wisconsin, United States, 54710 | |
| Canada, Alberta | |
| Calgary, Alberta, Canada, T2N 2T9 | |
| Edmonton, Alberta, Canada, T5H 3V9 | |
| Canada, British Columbia | |
| Victoria, British Columbia, Canada, V8R 1J8 | |
| Kelowna, British Columbia, Canada, V1V 1Y5 | |
| Kelowna, British Columbia, Canada, V1Y 1T2 & V1Y3G8 | |
| Vancouver, British Columbia, Canada, V5Z 3J5 | |
| Canada, Manitoba | |
| Winnipeg, Manitoba, Canada, R3A 1R9 | |
| Winnipeg, Manitoba, Canada, R3C 0N2 | |
| Canada, New Brunswick | |
| Moncton, New Brunswick, Canada, E1C 6Z8 | |
| Saint John, New Brunswick, Canada, E2K 4L2 | |
| Canada, Nova Scotia | |
| Halifax, Nova Scotia, Canada, B3H 2Y9 | |
| Canada, Ontario | |
| Windsor, Ontario, Canada, N8X 3V6 | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Toronto, Ontario, Canada, M3N 2V6 | |
| Scarborough, Ontario, Canada, M1E 4B9 | |
| Toronto, Ontario, Canada, M5G 1X5 | |
| Toronto, Ontario, Canada, M2K 1E1 | |
| Ajax, Ontario, Canada, L1S 2J5 | |
| London, Ontario, Canada, N6A 4G5 | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Peterborough, Ontario, Canada, K9J 7B3 | |
| Windsor, Ontario, Canada, N9A 1E1 | |
| Toronto, Ontario, Canada, M5G 2M9 & M5G 1X5 | |
| Thunder Bay, Ontario, Canada, P7B 6V1 | |
| Hamilton, Ontario, Canada, L8N 4A6 | |
| Guelph, Ontario, Canada, N1E 4J4 | |
| Kingston, Ontario, Canada, K7L 3N6 | |
| Canada, Quebec | |
| Chicoutimi, Quebec, Canada, G7H 5H6 | |
| Trois Rivieres, Quebec, Canada, G9A 1Y1 | |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Levis, Quebec, Canada, G6V 3Z1 | |
| Quebec City, Quebec, Canada, G1L 3L5 | |
| Sainte Foy, Quebec, Canada, G1V 4G2 | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| St-Hyacinthe, Quebec, Canada, J2S 4Y8 | |
| St. Charles Borromee, Quebec, Canada, J6E 2C3 | |
| Green Field Park, Quebec, Canada, J4V 2H1 | |
| Montreal, Quebec, Canada, H3A 1A1 | |
| Quebec City, Quebec, Canada, G1R 2J6 | |
| Canada, Saskatchewan | |
| Saskatoon, Saskatchewan, Canada, S7K 1J5 | |
| Puerto Rico | |
| San Juan, Puerto Rico, 00935 | |
| Study Director: | Medical Monitor | Genzyme |
More Information
| Responsible Party: | Genzyme Corporation ( Medical Monitor ) |
| Study ID Numbers: | GD3-170-301 |
| Study First Received: | March 25, 2005 |
| Last Updated: | July 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00106509 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Clostridium Enterocolitis Pseudomembranous Colitis Clostridium difficile-associated diarrhea C. difficile CDAD |
|
Bacterial Infections Anti-Infective Agents Metronidazole Antiprotozoal Agents Diarrhea Signs and Symptoms, Digestive Gastrointestinal Diseases Physiological Effects of Drugs Colonic Diseases Enterocolitis, Pseudomembranous Intestinal Diseases Enterocolitis |
Pharmacologic Actions Anti-Bacterial Agents Signs and Symptoms Antiparasitic Agents Gram-Positive Bacterial Infections Digestive System Diseases Radiation-Sensitizing Agents Therapeutic Uses Vancomycin Gastroenteritis Clostridium Infections Colitis |
