Status:

COMPLETED

Study of Flavocoxid (Limbrel) vs Naproxen in Subjects With Mod-Severe Osteoarthritis of the Knee

Lead Sponsor:

Primus Pharmaceuticals

Conditions:

Osteoarthritis

Eligibility:

All Genders

35-85 years

Phase:

NA

Brief Summary

Randomized, double-blind, placebo controlled parallel group, multi center study in subjects with moderate-severe osteoarthritis.

Detailed Description

This will be a randomized, double blind, placebo controlled, parallel group, multi-center study in subjects with moderate-severe OA. Subjects will be randomized to receive flavocoxid 250 mg bid, flavo...

Eligibility Criteria

Inclusion

  • OA of the Knee
  • K-L Grade 2-3
  • Positive response to NSAIDS

Exclusion

  • K-L grade 1 0r 4 OA of the knee
  • History of GI Bleed within past 5 years
  • Chronic bleeding disorder

Key Trial Info

Start Date :

April 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2007

Estimated Enrollment :

350 Patients enrolled

Trial Details

Trial ID

NCT00435292

Start Date

April 1 2006

End Date

December 1 2007

Last Update

October 21 2015

Active Locations (1)

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1

Primus Pharmaceuticals, Inc

Scottsdale, Arizona, United States, 85251