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

This study has been completed.
Information provided by (Responsible Party):
Primus Pharmaceuticals Identifier:
First received: February 12, 2007
Last updated: October 19, 2015
Last verified: November 2008
Randomized, double-blind, placebo controlled parallel group, multi center study in subjects with moderate-severe osteoarthritis.

Condition Intervention
Drug: Naproxen
Dietary Supplement: flavocoxid 250 mg
Dietary Supplement: flavocoxid 500 mg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:

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)
Arms Assigned Interventions
Experimental: flavocoxid 250 mg
flavonoid mixture
Dietary Supplement: flavocoxid 250 mg
flavonoid mixture
Other Name: Limbrel 250 mg
Active Comparator: flavocoxid 500 mg
flavonoid mixture
Dietary Supplement: flavocoxid 500 mg
flavonoid mixture
Other Name: limbrel 500 mg
Active Comparator: naproxen
nonsteroidal antiinflammatory drug
Drug: Naproxen
nonsteroidal anti-inflammatory drug
Other Name: naprosyn

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, flavocoxid 500 mg bid, naproxen 500 mg bid or placebo in a 2:2:2:1 ratio. Subjects will take study materials twice daily for twelve (12) weeks. After the 12 week visit subjects in the placebo arm will be re-randomized to the two flavocoxid arms. All subjects will then continue on the study for an additional 12 weeks.

Subjects will keep a diary noting date of onset of symptom change (better or worse), adverse events and cost of all aspects of medical care related directly or indirectly to osteoarthritis.

Laboratory studies for inflammatory markers will be drawn and archived at baseline and at the 12 week visit. In addition, a subgroup of subjects will have arthrocenteses performed at baseline and the 12 week visit and the synovial fluid archived for study of intra-articular inflammatory markers.


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

Responsible Party: Primus Pharmaceuticals Identifier: NCT00435292     History of Changes
Other Study ID Numbers: LOA-03P
Study First Received: February 12, 2007
Last Updated: October 19, 2015
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 November 25, 2015