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

NCT ID: NCT00435292

Last Updated: 2015-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2007-12-31

Brief Summary

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

Detailed 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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

flavocoxid 250 mg

flavonoid mixture

Group Type: EXPERIMENTAL

flavocoxid 250 mg

Intervention Type: DIETARY_SUPPLEMENT

flavonoid mixture

flavocoxid 500 mg

flavonoid mixture

Group Type: ACTIVE_COMPARATOR

flavocoxid 500 mg

Intervention Type: DIETARY_SUPPLEMENT

flavonoid mixture

naproxen

nonsteroidal antiinflammatory drug

Group Type: ACTIVE_COMPARATOR

Naproxen

Intervention Type: DRUG

nonsteroidal anti-inflammatory drug

Interventions

Naproxen

nonsteroidal anti-inflammatory drug

Intervention Type: DRUG

flavocoxid 250 mg

flavonoid mixture

Intervention Type: DIETARY_SUPPLEMENT

flavocoxid 500 mg

flavonoid mixture

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

naprosyn; Limbrel 250 mg; limbrel 500 mg

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Primus Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert M Levy, MD

Role: STUDY_DIRECTOR

Primus Pharmaceuticals,Inc

Alan Kivitz, MD

Role: PRINCIPAL_INVESTIGATOR

Private Practice

Locations

Primus Pharmaceuticals, Inc

Scottsdale, Arizona, United States

Countries

United States

Other Identifiers

LOA-03P

Identifier Type: -

Identifier Source: org_study_id