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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Optimer Pharmaceuticals LLC
ClinicalTrials.gov Identifier:
NCT00097422
First received: November 23, 2004
Last updated: March 23, 2017
Last verified: March 2017
  Purpose
The purpose of this study is to investigate the safety and perform preliminary clinical evaluation in patients with mild to moderate CDAD.

Condition Intervention Phase
Diarrhea Drug: OPT-80 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: An Open-Label, Dose Ranging, Randomized Clinical Evaluation of OPT-80 in Patients With Clostridium Difficile-Associated Diarrhea (CDAD)

Resource links provided by NLM:


Further study details as provided by Optimer Pharmaceuticals LLC:

Primary Outcome Measures:
  • Relief of symptoms of CDAD

Secondary Outcome Measures:
  • Recurrence Rate.

Actual Study Start Date: November 1, 2004
Study Completion Date: April 1, 2005
Primary Completion Date: April 1, 2005 (Final data collection date for primary outcome measure)
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.
  Eligibility

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

Inclusion Criteria:

  • Patients with CDAD

Exclusion Criteria:

  • Patients with severe CDAD
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097422

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

Publications:
Responsible Party: Optimer Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT00097422     History of Changes
Other Study ID Numbers: 5119-022
OPT-80 Phase 2A ( Other Identifier: Optimerpharma Study Number )
Study First Received: November 23, 2004
Last Updated: March 23, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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


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

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

ClinicalTrials.gov processed this record on August 16, 2017