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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00435292
First Posted: February 14, 2007
Last Update Posted: October 21, 2015
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.
Information provided by (Responsible Party):
Primus Pharmaceuticals
  Purpose
Randomized, double-blind, placebo controlled parallel group, multi center study in subjects with moderate-severe osteoarthritis.

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

Study Type: Interventional
Study Design: 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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00435292


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

Responsible Party: Primus Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00435292     History of Changes
Other Study ID Numbers: LOA-03P
First Submitted: February 12, 2007
First Posted: February 14, 2007
Last Update Posted: October 21, 2015
Last Verified: November 2008

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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