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Approximately 24 patients will be entered into this study taking place in Canada. The aim of this study is to determine if an investigational drug is absorbed (taken up) in patients with C. difficile-associated diarrhea (CDAD). The investigational drug will be given in addition to current standard antibiotic treatment so that all patients will receive active medication. All study related care is provided including doctor visits, physical exams, laboratory tests, and study medication. The total length of participation is approximately 7 days.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tolevamer potassium-sodium (GT267-004) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The extent of GT267-004 absorption as measured in the blood and urine by pharmacokinetic analysis |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as measured by physical examinations (including vital signs), adverse events and changes in safety laboratory values |
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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 |
|---|---|---|---|---|---|---|
| Edmonton | Alberta | T6G 2B7 | Canada | |||
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| Nanaimo |
| British Columbia |
| V9S 2B7 |
| Canada |
| Vancouver | British Columbia | V3Z 1M9 | Canada |
| Ottowa | Ontario | K1H 8L6 | Canada |
| Richmond Hill | Ontario | L4C 4Z3 | Canada |
| Montreal | Quebec | H3T 1E2 | Canada |
| Rimouski | Quebec | G5L 5T1 | Canada |
| Sherbrooke | Quebec | J1H 5N4 | Canada |
| ID | Term |
|---|---|
| D004761 | Enterocolitis, Pseudomembranous |
| 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 |
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