Study of Flavocoxid (Limbrel) Versus Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee
NCT ID: NCT00928837
Last Updated: 2017-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
350 participants
INTERVENTIONAL
2006-03-31
2007-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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flavocoxid 250 mg
Medical Food product
flavocoxid 250 mg
Medical food product
Naproxen
antiinflammatory
Naproxen
non-steroidal anti-inflammatory drug
Placebo
Placebo
Placebo
Placebo
flavocoxid 500 mg
medical food product
Flavocoxid 500 mg
flavonoid mixture
Interventions
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Flavocoxid 500 mg
flavonoid mixture
Naproxen
non-steroidal anti-inflammatory drug
Placebo
Placebo
flavocoxid 250 mg
Medical food product
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with OA of the knee, K-L Grade 2-3
3. History of positive response to NSAID's or COX-2 inhibitors
4. Able and willing to discontinue other medicinal OA therapies for length of the study (subjects may continue low dose aspirin for cardioprotection)
5. Females of child bearing potential must use acceptable method of birth control
Exclusion Criteria
2. Pregnant and nursing women
3. History of severe cardiovascular disease including, but not limited to chronic angina, congestive heart failure, uncontrolled hypertension, acute myocardial infarction within past year
4. K-L grade 1 or 4 OA of the target knee
5. chronic bleeding disorder or present use of anticoagulants
6. History of upper G-I bleed in the past 5 years
7. Significant renal disease including nephrotic syndrome, proteinuria \>1 gm/24 hrs or serum Creatinine \>2.0
8. Any arthritic disease that is or has the potential to affect the knees during the course of the study
9. Any other condition that might confound evaluation of the target joint including, but not limited to, bursitis, tendonitis or internal derangement in or about the knee, gait disturbances (e.g. mechanical, neurological conditions or disorders of the back), fibromyalgia, polyneuropathies, etc.
35 Years
85 Years
ALL
No
Sponsors
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Primus Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Alan J Kivitz, MD
Role: PRINCIPAL_INVESTIGATOR
Recruiting Altoona Center for Clinical Research 1125 Old Rt 220 North Duncansville PA 16635 Phone 814-693-0300 Fax 814-693-0400
Timothy S Truitt, MD
Role: PRINCIPAL_INVESTIGATOR
Recruiting MIMA Century Research Associates 65 E. Nasa Blvd Suite 106 Melbourne FL 32901 Phone 321-723-1203 Fax 321-725-3602
Joy Schechtman, DO
Role: PRINCIPAL_INVESTIGATOR
Sun Valley Arthritis Ltd. 6525 W. Sack Drive Suite 108 Glendale AZ 85308 Phone 623-825-5591 Fax 623-362-9264
David S Silver, MD
Role: PRINCIPAL_INVESTIGATOR
8691 Wilshire Blvd Suite 301 Beverly Hills CA 90211 phone 310-657-9650 Fax 310-659-2841
Nathan Wei, MD
Role: PRINCIPAL_INVESTIGATOR
Arthritis and Osteoporosis Center of Maryland71 Thomas Johnson Drive Frederick MD 21702 Phone 301-694-5800 Fax 301 694-0187
Norman B Gayliss, MD
Role: PRINCIPAL_INVESTIGATOR
2845 Aventura Blvd. Suite 100 Aventura FL 33180 Phone 305-932-4295 Fax 305-932-6335
David A. McLain, MD
Role: PRINCIPAL_INVESTIGATOR
2022 Brookwood Medical Center Drive Suite 211 Birmingham AL 35209 Phone 205-877-2555 Fax 205-877-2790
Locations
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Alan Kivitz MD
Duncansville, Pennsylvania, United States
Countries
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Related Links
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Primus Pharmaceuticals,Inc.
Other Identifiers
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Primus Pharmaceuticals LOA-03P
Identifier Type: -
Identifier Source: org_study_id