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

This study has been completed.
Information provided by (Responsible Party):
Primus Pharmaceuticals Identifier:
First received: March 13, 2006
Last updated: October 19, 2015
Last verified: November 2008
safety, efficacy and acceptability of Flavocoxid

Condition Intervention
Dietary Supplement: flavocoxid
Drug: Naproxen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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:

Further study details as provided by Primus Pharmaceuticals:

Primary Outcome Measures:
  • compare efficacy

Secondary Outcome Measures:
  • evaluate safety

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)
Arms Assigned Interventions
Experimental: flavocoxid
medical food
Dietary Supplement: flavocoxid
flavonoid mixture
Other Name: Limbrel
Active Comparator: naproxen
Drug: Naproxen
non-steroidal anti-inflammatory drug
Other Name: naprosyn

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

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

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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Please refer to this study by its identifier: NCT00303017

United States, Florida
Timothy Truitt MD
Melbourne, Florida, United States, 32901
Sponsors and Collaborators
Primus Pharmaceuticals
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:
No publications provided by Primus Pharmaceuticals

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Primus Pharmaceuticals Identifier: NCT00303017     History of Changes
Other Study ID Numbers: Primus Protocol #OAPS
Study First Received: March 13, 2006
Last Updated: October 19, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on November 25, 2015