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

NCT ID: NCT00097422

Last Updated: 2017-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-01

Study Completion Date

2005-04-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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OPT-80

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with CDAD

Exclusion Criteria

* Patients with severe CDAD
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Advanced Biologics

New Hope, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 18955525 (View on PubMed)

Other Identifiers

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OPT-80 Phase 2A

Identifier Type: OTHER

Identifier Source: secondary_id

5119-022

Identifier Type: -

Identifier Source: org_study_id

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