OPT-80 in Clostridium Difficile-Associated Diarrhea (CDAD)

NCT00097422 — Phase 2, Completed, Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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An Open-Label, Dose Ranging, Randomized Clinical Evaluation of OPT-80 in Patients With Clostridium Difficile-Associated Diarrhea (CDAD)

Registry	NCT00097422
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: none, treatment
Sponsor	Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) (Industry)
Conditions	Diarrhea
Interventions	OPT-80 (Drug)
Dates	start 2004-11-01, primary completion 2005-04-01, completion 2005-04-01, first posted 2004-11-24, last updated 2017-03-27
Locations	1 site in United States

-Summary

The purpose of this study is to investigate the safety and perform preliminary clinical evaluation in patients with mild to moderate CDAD.

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+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.

+Arms and interventions

OPT-80 (Drug)

+Outcome measures

Primary outcomes

Relief of symptoms of CDAD

Secondary outcomes

Recurrence Rate.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patients with CDAD

Exclusion Criteria:

* Patients with severe CDAD

+Locations (1)

Facility	City	Country	Status
Advanced Biologics	New Hope, Pennsylvania	United States

+Publications

Results publication: 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. PMID 18955525