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NCT00097422 Clinical Trial

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

Diarrhea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00097422
Other study ID # 5119-022
Secondary ID OPT-80 Phase 2A
Status Completed
Phase Phase 2
First received November 23, 2004
Last updated March 23, 2017
Start date November 1, 2004
Est. completion date April 1, 2005

Study information
Verified date March 2017
Source Optimer Pharmaceuticals LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date April 1, 2005
Est. primary completion date April 1, 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with CDAD

Exclusion Criteria:

- Patients with severe CDAD

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• OPT-80

Locations
Country Name City State
United States Advanced Biologics New Hope Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Optimer Pharmaceuticals LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.014 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Relief of symptoms of CDAD
Secondary Recurrence Rate.
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