NCT00097422
Completed
Phase 2
An Open-Label, Dose Ranging, Randomized Clinical Evaluation of OPT-80 in Patients With Clostridium Difficile-Associated Diarrhea (CDAD)
Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)1 site in 1 countryNovember 1, 2004
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Diarrhea
- Sponsor
- Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Locations
- 1
- Primary Endpoint
- Relief of symptoms of CDAD
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to investigate the safety and perform preliminary clinical evaluation in patients with mild to moderate CDAD.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with CDAD
Exclusion Criteria
- •Patients with severe CDAD
Outcomes
Primary Outcomes
Relief of symptoms of CDAD
Secondary Outcomes
- Recurrence Rate.
Study Sites (1)
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