Efficacy of Flavocoxid Compared With Naproxen in Subjects With Moderate-severe Osteoarthritis of the Knee

Study Description

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Brief Summary:

To compare flavocoxid with naproxen for patients with moderate to severe osteoarthritis of the knee.

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

Detailed Description:

Efficay of flavocoxid compared with naproxen in subjects with moderate-severe osteoarthritis of the knee.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	220 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Phase 3. Efficacy of Flavocoxid Compared With Naproxen in Subjects With Moderate-severe Osteoarthritis of the Knee
Study Start Date :	January 2008
Actual Primary Completion Date :	August 2008
Actual Study Completion Date :	August 2008

Arms and Interventions

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Arm	Intervention/treatment
Experimental: flavocoxid 500 mg; flavonoid mixture	Dietary Supplement: flavocoxid; medical food; Other Name: limbrel
Active Comparator: naproxen; nonsteroidal anti-inflammatory drug	Drug: Naproxen; antiinflammatory drug; Other Name: naprosyn

Outcome Measures

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Eligibility Criteria

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Ages Eligible for Study:	35 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Willing and able to read and understand informed consent and questionnaires in English.
• Adults of either gender age 35-75 years, in general good health.
• Established X-ray diagnosis of osteoarthritis of at least one knee.
• Taken NSAID including COX-2 inhibitor in full therapeutic dose for at least one month prior to screening.
• Able and will to discontinue OA medications until flare criteria met.
• BMI</= 45
• Subjects must rate target knee at least 5 out of 10 on discomfort VAS at baseline visit.
• Have an increase of at least 15mm on a 100mm pain VAS from screening to baseline visit.
• Must use acceptable birth control if female.
• Screening fecal occult must be negative.
• Able to attend all required visits
• Physical Therapy is allowed as long as the type and frequency remains unchanged for the duration of the study.

Exclusion Criteria:

• Refusal to sign consent.
• Inability to attend all clinic visits
• Grade 0-1 K-L changes in both knees or grade 4 K-L changes in either knee on standing A/P radiograph
• Pregant or lactating women
• History of serious cardio-vascular disease.
• Recurrent arrythmias, except PAT, cardiomyopathy, MI within one year of screening.
• History of chronic esophageal, gastric or duodenal disease
• History of upper GI bleeding within the past 2 years.
• Any GI disorder associated with malabsorption
• Any musculo-skeletal or neurological condition that results in pain or gait disturbance that might confound evaluation of target knee.
• Uncontrolled Diabetes Mellitus
• History of bleeding disorder or concurrent use of coumadin or any agent used to reduce blood clotting or platelet adhesiveness.
• Concurrent use of any anti-arthritic medication, including corticosteroids regardless of the reason for use. (low dose aspirin for cardioprotection is allowed)
• History of chronic renal disease with creatinine >2.0 or nephrotic syndrome with 24 hour protein excretion >1000mg.
• Intra-articular injection of any hyaluronic acid preparation in the target knee joint within 4 months of baseline visit.
• Intra-articular injection of a corticosteroid in the target knee joint within 2 months of the baseline visit.
• BMA>45
• History of allergic reaction to flavonoid or flavan containg foods or products (example: red wine, colored fruits and vegetable, brazel nuts, tea, natto)
• History of allergy to aspirin, naproxen or other NSAID
• History of substance abuse including alcohol, or any psychiatric condition that may impair the subject's ability to comply with the study requirements.
• Any medical condition that, in the opinion of the investigator, might put the subject at undue risk or might interfere with the subject's ability to participate in the study.
• Participation in another clinical trial within 30 days or 7 half lives of the study agent, whichever is longer, of the screening visit.

Contacts and Locations

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Sponsors and Collaborators

Primus Pharmaceuticals

Investigators

Study Director:	Paul H Caldron, DO, FACP	AmeRuss Clinical Trials LLC, USA

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Primus Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00790985 History of Changes
Other Study ID Numbers:	LOA-04P
First Posted:	November 14, 2008
Last Update Posted:	October 21, 2015
Last Verified:	October 2015

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