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

Phase 2

Completed

• Conditions: Diarrhea

• Registration Number: NCT00097422
• Lead Sponsor: Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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.

Study Timeline

• Study Start: 2004-11-01
• Study First Submitted: 2004-11-23
• Study First Submitted QC: 2004-11-23
• Study First Posted: 2004-11-24
• Primary Completion: 2005-04-01
• Study Completion: 2005-04-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-23
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients with CDAD

Exclusion Criteria

• Patients with severe CDAD

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Relief of symptoms of CDAD

Secondary Outcome Measures

Name	Time	Method
Recurrence Rate.

Trial Locations

Locations (1)

Advanced Biologics; 🇺🇸 New Hope, Pennsylvania, United States