Trial | NCT00928837  Report issue

Title

Study of Flavocoxid (Limbrel) Versus Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee
A Double-Blind,Randomized, Placebo Controlled, Parallel Group, Multi-Center Study of Flavocoxid (Limbrel) Versuss Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    350
The purpose of the study is to compare the efficacy and safety of flavocoxid (Limbrel) with Naproxen and placebo in OA of the knee.
To compare the efficacy, safety, quality of life and economic impact of flavocoxid vs naproxen.
Study Started
Mar 31
2006
Primary Completion
Jun 30
2007
Study Completion
Sep 30
2007
Last Update
Dec 13
2017

Dietary Supplement Flavocoxid 500 mg

flavonoid mixture

  • Other names: Limbrel 500 mg

Drug Naproxen

non-steroidal anti-inflammatory drug

  • Other names: naprosyn

Other Placebo

Placebo

Other flavocoxid 250 mg

Medical food product

  • Other names: Limbrel 250 mg

flavocoxid 250 mg Active Comparator

Medical Food product

Naproxen Active Comparator

antiinflammatory

Placebo Placebo Comparator

Placebo

flavocoxid 500 mg Experimental

medical food product

Criteria 

Inclusion Criteria:Major inclusión criteria:

Adults of either gender, ages 35-85, in general good health
Diagnosed with OA of the knee, K-L Grade 2-3
History of positive response to NSAID's or COX-2 inhibitors
Able and willing to discontinue other medicinal OA therapies for length of the study (subjects may continue low dose aspirin for cardioprotection)
Females of child bearing potential must use acceptable method of birth control

Major exclusion criteria:

Unwilling or unable to read and sign informed consent document
Pregnant and nursing women
History of severe cardiovascular disease including, but not limited to chronic angina, congestive heart failure, uncontrolled hypertension, acute myocardial infarction within past year
K-L grade 1 or 4 OA of the target knee
chronic bleeding disorder or present use of anticoagulants
History of upper G-I bleed in the past 5 years
Significant renal disease including nephrotic syndrome, proteinuria >1 gm/24 hrs or serum Creatinine >2.0
Any arthritic disease that is or has the potential to affect the knees during the course of the study
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.
No Results Posted