Safety, Efficacy and Acceptability of Flavocoxid (Limbrel)A Pilot Study

October 19, 2015 updated by: Primus Pharmaceuticals

Safety, Efficacy and Acceptability of Flavocoxid (Limbrel) Compared With Naproxen in Subjects With Osteoarthritis of the Knee. A Pilot Study

safety, efficacy and acceptability of Flavocoxid

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Safety, Efficacy and acceptability of Flavocoxid (Limbrel) compared with Naproxen in Subjects with Osteoarthritis of the Knee. A Pilot Study

Study Type

Interventional

Enrollment (Actual)

60

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
    • Florida
      • Melbourne, Florida, United States, 32901
        • Timothy Truitt MD

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

30 years to 85 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 in general good health is currently taking an NSAID or COX-2 inhibitor -

Exclusion Criteria:

pregant or nursing women grade 1 or 4 OA any significant medical condition that in the opinion of the physician might put the subject at risk in this study any form of arthropathy other than OA any condition that might confound the evaluation of the pain, stiffness or function of the target joint intra-articular cotticosteroid inkection in the target joint within 3 month of the screening visit concomitant use of other anti-inflammatory or anti arthritic medication or products(including OTC and herbal preparations) Low dose aspirin for cardio-protection is allowed concomitant use of coumadin or other anticoagulant or anti-platelet medication concomitant use of gastro-protectiv medications including, but not limited to, H2 blockers and proton pump inhibitors, including OTC and herbal products History of allergy to Flavonoids

-

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
medical food
Dietary supplement: flavocoxid
flavonoid mixture
Other Names:
  • Limbrel
Active Comparator: naproxen
NSAID
Drug: Naproxen
non-steroidal anti-inflammatory drug
Other Names:
  • naprosyn

What is the study measuring?

Primary Outcome Measures

Outcome Measure
compare efficacy

Secondary Outcome Measures

Outcome Measure
evaluate safety

Collaborators and Investigators

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

Sponsor

Primus Pharmaceuticals

Investigators

  • Principal Investigator: Joy Schechtman, DO, Sun Valley Arthritis Ltd, 6525 W. Sack Drive Suite 108 Glendale AZ 85308 Phone 623-825-5591 Fax 623
  • Principal Investigator: Timothy Truitt, MD, MIMA Century Research Associates 65 E. Nasa Blvd. Suite 106 Melbourne FL 32901 Phone 321 723-1203 Fax 321-725-3602

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

March 1, 2006

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

March 13, 2006

First Submitted That Met QC Criteria

March 13, 2006

First Posted (Estimate)

March 15, 2006

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

  • Primus Protocol #OAPS

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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