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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00303017
Recruitment Status : Completed
First Posted : March 15, 2006
Last Update Posted : October 21, 2015
Sponsor:
Information provided by (Responsible Party):
Primus Pharmaceuticals

Study Description
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Brief Summary:
safety, efficacy and acceptability of Flavocoxid

Condition or disease Intervention/treatment Phase
Osteoarthritis Dietary Supplement: flavocoxid Drug: Naproxen Not Applicable

Detailed Description:
Safety, Efficacy and acceptability of Flavocoxid (Limbrel) compared with Naproxen in Subjects with Osteoarthritis of the Knee. A Pilot Study
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : March 2006
Actual Primary Completion Date : July 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: flavocoxid
medical food
 Dietary Supplement: flavocoxid
flavonoid mixture
Other Name: Limbrel
Active Comparator: naproxen
NSAID
 Drug: Naproxen
non-steroidal anti-inflammatory drug
Other Name: naprosyn


Outcome Measures
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Primary Outcome Measures :
  1. compare efficacy

Secondary Outcome Measures :
  1. evaluate safety

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00303017


Locations
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United States, Florida
Timothy Truitt MD
Melbourne, Florida, United States, 32901
Sponsors and Collaborators
Primus Pharmaceuticals
Investigators
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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
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Additional Information:

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

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Responsible Party: Primus Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00303017    
Other Study ID Numbers: Primus Protocol #OAPS
First Posted: March 15, 2006    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: November 2008
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action