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

Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Status and phase: Completed; Phase 2

Conditions: Diarrhea

Treatments: Drug: OPT-80

Study type: Interventional

Funder types: Industry

Identifiers

NCT00097422

5119-022

OPT-80 Phase 2A (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with CDAD

Exclusion criteria

• Patients with severe CDAD

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)