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| ID | Type | Description | Link |
|---|---|---|---|
| OPT-80 Phase 2A | Other Identifier | Optimerpharma Study Number |
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The purpose of this study is to investigate the safety and perform preliminary clinical evaluation in patients with mild to moderate CDAD.
This is a dose-finding study to select a safe and efficacious dose of OPT-80. Patients will be evaluated for safety and efficacy and pharmacokinetic parameters will be investigated.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPT-80 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Relief of symptoms of CDAD |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence Rate. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Biologics | New Hope | Pennsylvania | 18938 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18955525 | Result | Louie T, Miller M, Donskey C, Mullane K, Goldstein EJ. Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection. Antimicrob Agents Chemother. 2009 Jan;53(1):223-8. doi: 10.1128/AAC.01442-07. Epub 2008 Oct 27. |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C487655 | OPT 80 |
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