Osteoarthritis
Conditions
Brief summary
The purpose of the study is to compare the efficacy and safety of flavocoxid (Limbrel) with Naproxen and placebo in OA of the knee.
Detailed description
To compare the efficacy, safety, quality of life and economic impact of flavocoxid vs naproxen.
Interventions
DIETARY_SUPPLEMENTFlavocoxid 500 mg
flavonoid mixture
DRUGNaproxen
non-steroidal anti-inflammatory drug
OTHERPlacebo
Placebo
OTHERflavocoxid 250 mg
Medical food product
Sponsors
Primus Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Major inclusión criteria: 1. Adults of either gender, ages 35-85, in general good health 2. Diagnosed with OA of the knee, K-L Grade 2-3 3. History of positive response to NSAID's or COX-2 inhibitors 4. Able and willing to discontinue other medicinal OA therapies for length of the study (subjects may continue low dose aspirin for cardioprotection) 5. Females of child bearing potential must use acceptable method of birth control Major
Exclusion criteria
1. Unwilling or unable to read and sign informed consent document 2. Pregnant and nursing women 3. History of severe cardiovascular disease including, but not limited to chronic angina, congestive heart failure, uncontrolled hypertension, acute myocardial infarction within past year 4. K-L grade 1 or 4 OA of the target knee 5. chronic bleeding disorder or present use of anticoagulants 6. History of upper G-I bleed in the past 5 years 7. Significant renal disease including nephrotic syndrome, proteinuria \>1 gm/24 hrs or serum Creatinine \>2.0 8. Any arthritic disease that is or has the potential to affect the knees during the course of the study 9. Any other condition that might confound evaluation of the target joint including, but not limited to, bursitis, tendonitis or internal derangement in or about the knee, gait disturbances (e.g. mechanical, neurological conditions or disorders of the back), fibromyalgia, polyneuropathies, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| to compare the efficacy of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks | 3 months | comparison of short WOMAC and timed walk |
| to compare the safety of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks | 3 months | Comparison of FS-36, subject tolerability VAS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| to compare the efficacy of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks | 6 months | comparison of short WOMAC and timed walk |
| to compare the safety of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks | 6 months | Comparison of FS-36, subject tolerability VAS |
Countries
United States
Outcome results
None listed