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

This study has been completed.
Sponsor:
Information provided by:
Primus Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00303017
First received: March 13, 2006
Last updated: November 12, 2008
Last verified: November 2008
History of Changes
  Purpose

safety, efficacy and acceptability of Flavocoxid


Condition Intervention
Osteoarthritis
 Drug: Flavocoxid ( Medical Food)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Safety, Efficacy and Acceptability of Flavocoxid (Limbrel) Compared With Naproxen in Subjects With Osteoarthritis of the Knee. A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Primus Pharmaceuticals:

Primary Outcome Measures:
  • compare efficacy

Secondary Outcome Measures:
  • evaluate safety

Estimated Enrollment: 60
Study Start Date: March 2006
Study Completion Date: September 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00303017

Locations
United States, Florida
Timothy Truitt MD
Melbourne, Florida, United States, 32901
Sponsors and Collaborators
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
  More Information

Additional Information:
Primus Pharmaceuticals, Inc  This link exits the ClinicalTrials.gov site

No publications provided by Primus Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00303017     History of Changes
Other Study ID Numbers: Primus Protocol #OAPS
Study First Received: March 13, 2006
Last Updated: November 12, 2008
Health Authority: United States: Primus Pharmaceuticals, Inc

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013