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

Osteoarthritis Clinical Trial

Official title:

A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Multi Center Study of Flavocoxid ( Limbrel) vs Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435292
• Other study ID #: LOA-03P
• Status: Completed
• Phase: N/A
• First received: February 12, 2007
• Last updated: October 19, 2015
• Start date: April 2006
• Est. completion date: December 2007

Study information

• Verified date: November 2008
• Source: Primus Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Naproxen
nonsteroidal anti-inflammatory drug

Dietary Supplement:
• flavocoxid 250 mg
flavonoid mixture
• flavocoxid 500 mg
flavonoid mixture

Locations

Country	Name	City	State
United States	Primus Pharmaceuticals, Inc	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Primus Pharmaceuticals

Country where clinical trial is conducted

United States,