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

October 19, 2015 updated by: Primus Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Primus Pharmaceuticals, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: flavocoxid 250 mg
flavonoid mixture
Dietary supplement: flavocoxid 250 mg
flavonoid mixture
Other Names:
  • Limbrel 250 mg
Active Comparator: flavocoxid 500 mg
flavonoid mixture
Dietary supplement: flavocoxid 500 mg
flavonoid mixture
Other Names:
  • limbrel 500 mg
Active Comparator: naproxen
nonsteroidal antiinflammatory drug
Drug: Naproxen
nonsteroidal anti-inflammatory drug
Other Names:
  • naprosyn

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Primus Pharmaceuticals

Investigators

  • Study Director: Robert M Levy, MD, Primus Pharmaceuticals,Inc
  • Principal Investigator: Alan Kivitz, MD, Private Practice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

February 12, 2007

First Submitted That Met QC Criteria

February 13, 2007

First Posted (Estimate)

February 14, 2007

Study Record Updates

Last Update Posted (Estimate)

October 21, 2015

Last Update Submitted That Met QC Criteria

October 19, 2015

Last Verified

November 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOA-03P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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