Efficacy of Flavocoxid Compared With Naproxen in Subjects With Moderate-severe Osteoarthritis of the Knee
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ClinicalTrials.gov Identifier: NCT00790985 |
Recruitment Status
:
Completed
First Posted
: November 14, 2008
Last Update Posted
: October 21, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoarthritis | Dietary Supplement: flavocoxid Drug: Naproxen | Not Applicable |
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 |

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
|

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

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): NCT00790985
Study Director: | Paul H Caldron, DO, FACP | AmeRuss Clinical Trials LLC, USA |
Responsible Party: | Primus Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00790985 History of Changes |
Other Study ID Numbers: |
LOA-04P |
First Posted: | November 14, 2008 Key Record Dates |
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 |