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

Primus Pharmaceuticals

Status: Completed

Conditions: Osteoarthritis

Treatments: Dietary Supplement: flavocoxid 250 mg; Dietary Supplement: flavocoxid 500 mg; Drug: Naproxen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00435292

LOA-03P

Details and patient eligibility

About

Randomized, double-blind, placebo controlled parallel group, multi center study in subjects with moderate-severe osteoarthritis.

Full 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.

Enrollment: 350 patients

Sex: All

Ages: 35 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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350 participants in 3 patient groups

flavocoxid 250 mg

Experimental group

Description:

flavonoid mixture

Treatment:

Dietary Supplement: flavocoxid 250 mg

flavocoxid 500 mg

Active Comparator group

Description:

flavonoid mixture

Treatment:

Dietary Supplement: flavocoxid 500 mg

naproxen

Active Comparator group

Description:

nonsteroidal antiinflammatory drug

Treatment:

Drug: Naproxen