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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tolevamer potassium-sodium (GT267-004) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of diarrhea |
| Measure | Description | Time Frame |
|---|---|---|
| Time to resolution of diarrhea | ||
| Recurrence rate | ||
| Number of stools |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85006 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24799326 | Derived | Johnson S, Louie TJ, Gerding DN, Cornely OA, Chasan-Taber S, Fitts D, Gelone SP, Broom C, Davidson DM; Polymer Alternative for CDI Treatment (PACT) investigators. Vancomycin, metronidazole, or tolevamer for Clostridium difficile infection: results from two multinational, randomized, controlled trials. Clin Infect Dis. 2014 Aug 1;59(3):345-54. doi: 10.1093/cid/ciu313. Epub 2014 May 5. |
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| Average stool consistency |
| Treatment success |
| Phoenix |
| Arizona |
| 85012 |
| United States |
| Rogers | Arkansas | 72756 | United States |
| Burbank | California | 91505 | United States |
| Los Angeles | California | 90073 | United States |
| Los Angeles | California | 90089 | United States |
| Los Angeles | California | 90095 | United States |
| Modesto | California | 95350 | United States |
| Newport Beach | California | 92663 | United States |
| Sacramento | California | 95817 | United States |
| San Diego | California | 92103 | United States |
| Denver | Colorado | 80204 | United States |
| Denver | Colorado | 80210 | United States |
| Denver | Colorado | 80218-1191 | United States |
| Denver | Colorado | 80262 | United States |
| Newark | Delaware | 19718 | United States |
| Bay Pines | Florida | 33744 | United States |
| Brandon | Florida | 33511 | United States |
| Brooksville | Florida | 34613 | United States |
| Jacksonville | Florida | 32207 | United States |
| Tampa | Florida | 33607 | United States |
| Zephyrhills | Florida | 33542 | United States |
| Atlanta | Georgia | 30309 | United States |
| Fort Eisenhower | Georgia | 30905 | United States |
| Savannah | Georgia | 31405 | United States |
| Honolulu | Hawaii | 96813 | United States |
| Chicago | Illinois | 60634 | United States |
| Decatur | Illinois | 62526 | United States |
| Hines | Illinois | 60141 | United States |
| Maywood | Illinois | 60153 | United States |
| North Chicago | Illinois | 60064 | United States |
| Anderson | Indiana | 46011 | United States |
| Indianapolis | Indiana | 46202 | United States |
| Lafayette | Indiana | 47904 | United States |
| Muncie | Indiana | 47303 | United States |
| Clive | Iowa | 50325 | United States |
| Des Moines | Iowa | 50302 | United States |
| Des Moines | Iowa | 50309 | United States |
| Dubuque | Iowa | 52002 | United States |
| Iowa City | Iowa | 52242 | United States |
| Bowling Green | Kentucky | 42101 | United States |
| Louisville | Kentucky | 40202 | United States |
| Louisville | Kentucky | 40206-1499 | United States |
| New Orleans | Louisiana | 70115 | United States |
| New Orleans | Louisiana | 70121 | United States |
| Baltimore | Maryland | 21201 | United States |
| Hagerstown | Maryland | 21740 | United States |
| Boston | Massachusetts | 02114 | United States |
| Boston | Massachusetts | 02115 | United States |
| Worcester | Massachusetts | 01608-1320 | United States |
| Worcester | Massachusetts | 01655 | United States |
| Detroit | Michigan | 48201 | United States |
| Detroit | Michigan | 48202 | United States |
| Muskegon | Michigan | 49444 | United States |
| Rochester | Minnesota | 55905 | United States |
| Ocean Springs | Mississippi | 39564 | United States |
| Everton | Missouri | 65646 | United States |
| Kansas City | Missouri | 64111 | United States |
| St Louis | Missouri | 63110 | United States |
| Butte | Montana | 59701 | United States |
| Missoula | Montana | 59802 | United States |
| Lebanon | New Hampshire | 03756 | United States |
| Cedar Knolls | New Jersey | 07927 | United States |
| Neptune City | New Jersey | 07753 | United States |
| Newark | New Jersey | 07103 | United States |
| Trenton | New Jersey | 08629 | United States |
| Albany | New York | 12208 | United States |
| New Hyde Park | New York | 11040 | United States |
| New York | New York | 10016 | United States |
| Syracuse | New York | 13210 | United States |
| Asheville | North Carolina | 28801 | United States |
| Greenville | North Carolina | 27834 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Fargo | North Dakota | 58122 | United States |
| Akron | Ohio | 44304 | United States |
| Centerville | Ohio | 45459 | United States |
| Toledo | Ohio | 43608 | United States |
| Allentown | Pennsylvania | 18102 | United States |
| Doylestown | Pennsylvania | 18901 | United States |
| Lancaster | Pennsylvania | 17602 | United States |
| Philadelphia | Pennsylvania | 19140 | United States |
| Philadelphia | Pennsylvania | 19141 | United States |
| Pittsburgh | Pennsylvania | 15212 | United States |
| Pittsburgh | Pennsylvania | 15261 | United States |
| Charleston | South Carolina | 29401 | United States |
| Greenville | South Carolina | 29605 | United States |
| Rapid City | South Dakota | 57701 | United States |
| Hermitage | Tennessee | 37076 | United States |
| Houston | Texas | 77030 | United States |
| Tyler | Texas | 75702 | United States |
| Burlington | Vermont | 05403 | United States |
| Danville | Virginia | 24541 | United States |
| Richmond | Virginia | 23249 | United States |
| Richmond | Virginia | 23298 | United States |
| Winchester | Virginia | 22601 | United States |
| Tacoma | Washington | 98431 | United States |
| Eau Claire | Wisconsin | 54710 | United States |
| Marshfield | Wisconsin | 54449 | United States |
| Milwaukee | Wisconsin | 53226 | United States |
| Calgary | Alberta | T2N 2T9 | Canada |
| Edmonton | Alberta | T5H 3V9 | Canada |
| Kelowna | British Columbia | V1V 1Y5 | Canada |
| Kelowna | British Columbia | V1Y 1T2 & V1Y3G8 | Canada |
| Vancouver | British Columbia | V5Z 3J5 | Canada |
| Victoria | British Columbia | V8R 1J8 | Canada |
| Winnipeg | Manitoba | R3A 1R9 | Canada |
| Winnipeg | Manitoba | R3C 0N2 | Canada |
| Moncton | New Brunswick | E1C 6Z8 | Canada |
| Saint John | New Brunswick | E2K 4L2 | Canada |
| Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Ajax | Ontario | L1S 2J5 | Canada |
| Guelph | Ontario | N1E 4J4 | Canada |
| Hamilton | Ontario | L8N 4A6 | Canada |
| Kingston | Ontario | K7L 3N6 | Canada |
| London | Ontario | N6A 4G5 | Canada |
| Ottawa | Ontario | K1H 8L6 | Canada |
| Peterborough | Ontario | K9J 7B3 | Canada |
| Scarborough Village | Ontario | M1E 4B9 | Canada |
| Thunder Bay | Ontario | P7B 6V1 | Canada |
| Toronto | Ontario | M2K 1E1 | Canada |
| Toronto | Ontario | M3N 2V6 | Canada |
| Toronto | Ontario | M4N 3M5 | Canada |
| Toronto | Ontario | M5G 1X5 | Canada |
| Toronto | Ontario | M5G 2M9 & M5G 1X5 | Canada |
| Windsor | Ontario | N8X 3V6 | Canada |
| Windsor | Ontario | N9A 1E1 | Canada |
| Chicoutimi | Quebec | G7H 5H6 | Canada |
| Green Field Park | Quebec | J4V 2H1 | Canada |
| Lévis | Quebec | G6V 3Z1 | Canada |
| Montreal | Quebec | H1T 2M4 | Canada |
| Montreal | Quebec | H3A 1A1 | Canada |
| Montreal | Quebec | H3G 1A4 | Canada |
| Québec | Quebec | G1L 3L5 | Canada |
| Québec | Quebec | G1R 2J6 | Canada |
| Saint-Charles-Borromée | Quebec | J6E 2C3 | Canada |
| Saint-Hyacinthe | Quebec | J2S 4Y8 | Canada |
| Sainte-Foy | Quebec | G1V 4G2 | Canada |
| Trois-Rivières | Quebec | G9A 1Y1 | Canada |
| Saskatoon | Saskatchewan | S7K 1J5 | Canada |
| San Juan | 00935 | Puerto Rico |
| ID | Term |
|---|---|
| D004761 | Enterocolitis, Pseudomembranous |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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