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

Primary Purpose

Diarrhea

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

OPT-80

About this trial

This is an interventional treatment trial for Diarrhea focused on measuring CDAD, diarrhea, Clostridium difficile-Associated Diarrhea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with CDAD Exclusion Criteria: Patients with severe CDAD

Sites / Locations

Advanced Biologics

Outcomes

Primary Outcome Measures

Relief of symptoms of CDAD

Secondary Outcome Measures

Recurrence Rate.

Full Information

NCT ID

NCT00097422

First Posted

November 23, 2004

Last Updated

March 23, 2017

Sponsor

Optimer Pharmaceuticals LLC

1. Study Identification

Unique Protocol Identification Number

NCT00097422

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

November 1, 2004 (Actual)

Primary Completion Date

April 1, 2005 (Actual)

Study Completion Date

April 1, 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Optimer Pharmaceuticals LLC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diarrhea

Keywords

CDAD, diarrhea, Clostridium difficile-Associated Diarrhea

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

OPT-80

Primary Outcome Measure Information:

Title

Relief of symptoms of CDAD

Secondary Outcome Measure Information:

Title

Recurrence Rate.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with CDAD Exclusion Criteria: Patients with severe CDAD

Facility Information:

Facility Name

Advanced Biologics

City

New Hope

State/Province

Pennsylvania

ZIP/Postal Code

18938

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Citations:

PubMed Identifier

18955525

Citation

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.

Results Reference

result

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

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