Study of Flavocoxid (Limbrel) Versus Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee

Primus Pharmaceuticals

Status: Completed

Conditions: Osteoarthritis

Treatments: Drug: Naproxen; Other: Placebo; Other: flavocoxid 250 mg; Dietary Supplement: Flavocoxid 500 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00928837

Primus Pharmaceuticals LOA-03P

Details and patient eligibility

About

The purpose of the study is to compare the efficacy and safety of flavocoxid (Limbrel) with Naproxen and placebo in OA of the knee.

Full description

To compare the efficacy, safety, quality of life and economic impact of flavocoxid vs naproxen.

Enrollment: 350 patients

Sex: All

Ages: 35 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

350 participants in 4 patient groups, including a placebo group

flavocoxid 250 mg

Active Comparator group

Description:

Medical Food product

Treatment:

Other: flavocoxid 250 mg

Naproxen

Active Comparator group

Description:

antiinflammatory

Treatment:

Drug: Naproxen

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo

flavocoxid 500 mg

Experimental group

Description:

medical food product

Treatment:

Dietary Supplement: Flavocoxid 500 mg