Not Signed In -
Diarrhea |
Dysentery |
Clinical Trial: OPT-80 in Clostridium defficile-Associated Diarrhea (CDAD)
This study is currently recruiting patients.
|
Purpose
The purpose of this study is to investigate the safety and perform preliminary clinical evaluation in patients with mild to moderate CDAD.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Diarrhea | Drug: OPT-80 | Phase II |
MedlinePlus related topics: Diarrhea
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: An Open-Label, Dose Ranging, Randomized Clinical Evaluation of OPT-80 in Patients with Clostridium difficile-Associated Diarrhea (CDAD)
Secondary Outcomes: Recurrence Rate.
Study start: November 2004; Expected completion: April 2005
Last follow-up: March 2005; Data entry closure: April 2005
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 phamacokinetic parameters will be investigated.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Patients with CDAD
Exclusion Criteria:
- Patients with severe CDAD
Location and Contact Information
Youe Kong Shue, PhD 858-909-0736 ykshue@optimerpharma.com
Pennsylvania
Advanced Biologics, New Hope, Pennsylvania, 18938, United States; Recruiting
Annie Frimm, Sub-Investigator
More Information
Record last reviewed: November 2004
Last Updated: November 23, 2004
Record first received: November 23, 2004
ClinicalTrials.gov Identifier: NCT00097422
Health Authority: United States: Food and Drug Administration; Canada: Health Canada (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
email this page
print this page
bookmark this page
feedback on this page
