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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00435292
Recruitment Status : Completed
First Posted : February 14, 2007
Last Update Posted : October 21, 2015
Information provided by (Responsible Party):
Primus Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Naproxen Dietary Supplement: flavocoxid 250 mg Dietary Supplement: flavocoxid 500 mg Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : April 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00435292

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United States, Arizona
Primus Pharmaceuticals, Inc
Scottsdale, Arizona, United States, 85251
Sponsors and Collaborators
Primus Pharmaceuticals
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Study Director: Robert M Levy, MD Primus Pharmaceuticals,Inc
Principal Investigator: Alan Kivitz, MD Private Practice
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Responsible Party: Primus Pharmaceuticals Identifier: NCT00435292    
Other Study ID Numbers: LOA-03P
First Posted: February 14, 2007    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: November 2008
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action