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

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ClinicalTrials.gov Identifier: NCT00435292

Recruitment Status : Completed

First Posted : February 14, 2007

Last Update Posted : October 21, 2015

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Primus Pharmaceuticals

Study Description

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.

Study Design

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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 Genetics related topics: Osteoarthritis

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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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

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

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United States, Arizona
Primus Pharmaceuticals, Inc
Scottsdale, Arizona, United States, 85251

Sponsors and Collaborators

Primus Pharmaceuticals

Investigators

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Study Director:	Robert M Levy, MD	Primus Pharmaceuticals,Inc
Principal Investigator:	Alan Kivitz, MD	Private Practice

More Information

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Responsible Party:	Primus Pharmaceuticals
ClinicalTrials.gov 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 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

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