Study of Flavocoxid (Limbrel) vs Naproxen in Subjects With Mod-Severe Osteoarthritis of the Knee
Information source: Primus Pharmaceuticals
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis
Intervention: Naproxen (Drug); Limbrel (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Primus Pharmaceuticals Official(s) and/or principal investigator(s):
Robert M Levy, MD, Study Director, Affiliation: Primus Pharmaceuticals,Inc
Alan Kivitz, MD, Principal Investigator, Affiliation: Private Practice
Overall contact:
Robert M Levy, MD, Phone: 480-483-1410, Ext: 122, Email: rlevy@primusrx.com
Summary
Randomized, double-blind, placebo controlled parallel group, multi center study in subjects
with moderate-severe osteoarthritis.
Clinical Details
Official title: A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Multi Center Study of Flavocoxid ( Limbrel) vs Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee
Study design: Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 35 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- OA of the Knee
- K-L Grade 2-3
- Positive response to NSAIDS
Exclusion Criteria:
- K-L grade 1 0r 4 OA of the knee
- History of GI Bleed within past 5 years
- Chronic bleeding disorder
Locations and Contacts
Robert M Levy, MD, Phone: 480-483-1410, Ext: 122, Email: rlevy@primusrx.com
Primus Pharmaceuticals, Inc, Scottsdale, Arizona 85251, United States; Recruiting
Robert M Levy, MD, Phone: 480-483-1410, Ext: 122, Email: rlevy@primusrx.com
Teresa K Barrett, CMA, Phone: 480-483-1410, Ext: 123, Email: tbarrett@primusrx.com
David A McLain, MD, Principal Investigator
Joy Schechtman, DO, Principal Investigator
David Silver, MD, Principal Investigator
Nathan Wei, MD, Principal Investigator
Paul Caldron, DO, Principal Investigator
Warren Rizzo, MD, Principal Investigator
Jay Udani, MD, Principal Investigator
Stuart Weisman, MD, Principal Investigator
Michael Grisanti, MD, Principal Investigator
Matthew Heller, MD, Principal Investigator
Orrim Troum, MD, Principal Investigator
Raymond Adelizzi, MD, Principal Investigator
Kevin Horton, MD, Principal Investigator
Katherine Nguyen, MD, Principal Investigator
Thomas Olenginski, MD, Principal Investigator
James Trice, MD, Principal Investigator
Additional Information
Starting date: April 2006
Last updated: February 15, 2007
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