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

This study has been completed.
Information provided by:
Primus Pharmaceuticals Identifier:
First received: February 12, 2007
Last updated: November 12, 2008
Last verified: November 2008

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

Condition Intervention Phase
Drug: Naproxen
Drug: Limbrel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by Primus Pharmaceuticals:

Estimated Enrollment: 350
Study Start Date: April 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   35 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00435292

United States, Arizona
Primus Pharmaceuticals, Inc
Scottsdale, Arizona, United States, 85251
Sponsors and Collaborators
Primus Pharmaceuticals
Study Director: Robert M Levy, MD Primus Pharmaceuticals,Inc
Principal Investigator: Alan Kivitz, MD Private Practice
  More Information

No publications provided Identifier: NCT00435292     History of Changes
Other Study ID Numbers: LOA-03P
Study First Received: February 12, 2007
Last Updated: November 12, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on October 02, 2015