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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00097422
Recruitment Status : Completed
First Posted : November 24, 2004
Last Update Posted : March 27, 2017
Information provided by (Responsible Party):
Optimer Pharmaceuticals LLC

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

Condition or disease Intervention/treatment Phase
Diarrhea Drug: OPT-80 Phase 2

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 Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Dose Ranging, Randomized Clinical Evaluation of OPT-80 in Patients With Clostridium Difficile-Associated Diarrhea (CDAD)
Actual Study Start Date : November 1, 2004
Actual Primary Completion Date : April 1, 2005
Actual Study Completion Date : April 1, 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Primary Outcome Measures :
  1. Relief of symptoms of CDAD

Secondary Outcome Measures :
  1. Recurrence Rate.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with CDAD

Exclusion Criteria:

  • Patients with severe CDAD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00097422

United States, Pennsylvania
Advanced Biologics
New Hope, Pennsylvania, United States, 18938
Sponsors and Collaborators
Optimer Pharmaceuticals LLC

Publications of Results:
Responsible Party: Optimer Pharmaceuticals LLC Identifier: NCT00097422     History of Changes
Other Study ID Numbers: 5119-022
OPT-80 Phase 2A ( Other Identifier: Optimerpharma Study Number )
First Posted: November 24, 2004    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Keywords provided by Optimer Pharmaceuticals LLC:
CDAD, diarrhea
Clostridium difficile-Associated Diarrhea

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms