Clinical Trial: OPT-80 in Clostridium Difficile-Associated Diarrhea (CDAD)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Optimer Pharmaceuticals LLC

Current Primary Outcome: Relief of symptoms of CDAD

Original Primary Outcome: Same as current

Current Secondary Outcome: Recurrence Rate.

Original Secondary Outcome: Same as current

Information By: Optimer Pharmaceuticals LLC

Dates:
Date Received: November 23, 2004
Date Started: November 1, 2004
Date Completion:
Last Updated: March 23, 2017
Last Verified: March 2017