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Approximately 65 patients will be entered into this study taking place in North America. The aim of this study is to evaluate the safety, efficacy and absorption of an investigational drug in patients with C. difficile-associated diarrhea (CDAD). All study related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is 6 weeks.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GT267-004 (tolevamer potassium sodium) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success | ||
| Safety |
| Measure | Description | Time Frame |
|---|---|---|
| The extent of tolevamer absorption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Modesto | California | United States | ||||
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| Honolulu |
| Hawaii |
| United States |
| Maywood | Illinois | United States |
| Baltimore | Maryland | United States |
| Worcester | Massachusetts | United States |
| West Bloomfield | Michigan | United States |
| Butte | Montana | United States |
| Cedar Knolls | New Jersey | United States |
| Neptune City | New Jersey | United States |
| Syracuse | New York | United States |
| Greenville | North Carolina | United States |
| Toledo | Ohio | United States |
| Lancaster | Pennsylvania | United States |
| ID | Term |
|---|---|
| D004761 | Enterocolitis, Pseudomembranous |
| D003967 | Diarrhea |
| D004403 | Dysentery |
| 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 |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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