Clinical trial NCT00928837: Study of Flavocoxid (Limbrel) Versus Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Primus Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-06-26
Enrollment: 350
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the efficacy and safety of flavocoxid (Limbrel) with Naproxen and placebo in OA of the knee.

Detailed description: To compare the efficacy, safety, quality of life and economic impact of flavocoxid vs naproxen.

Eligibility criteria: Inclusion Criteria:Major inclusión criteria:

1. Adults of either gender, ages 35-85, in general good health
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

Major exclusion criteria:

1. Unwilling or unable to read and sign informed consent document
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.

Primary outcomes:
measure: to compare the efficacy of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks
timeFrame: 3 months
measure: to compare the safety of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks
timeFrame: 3 months
Secondary outcomes:
measure: to compare the efficacy of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks
timeFrame: 6 months
measure: to compare the safety of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks
timeFrame: 6 months
Other outcomes:
Locations:
city: Duncansville
country: United States
facility: Alan Kivitz MD
state: Pennsylvania
Study officials:
affiliation: Recruiting Altoona Center for Clinical Research 1125 Old Rt 220 North Duncansville PA 16635 Phone 814-693-0300 Fax 814-693-0400
name: Alan J Kivitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Recruiting MIMA Century Research Associates 65 E. Nasa Blvd Suite 106 Melbourne FL 32901 Phone 321-723-1203 Fax 321-725-3602
name: Timothy S Truitt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sun Valley Arthritis Ltd. 6525 W. Sack Drive Suite 108 Glendale AZ 85308 Phone 623-825-5591 Fax 623-362-9264
name: Joy Schechtman, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: 8691 Wilshire Blvd Suite 301 Beverly Hills CA 90211 phone 310-657-9650 Fax 310-659-2841
name: David S Silver, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arthritis and Osteoporosis Center of Maryland71 Thomas Johnson Drive Frederick MD 21702 Phone 301-694-5800 Fax 301 694-0187
name: Nathan Wei, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 2845 Aventura Blvd. Suite 100 Aventura FL 33180 Phone 305-932-4295 Fax 305-932-6335
name: Norman B Gayliss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 2022 Brookwood Medical Center Drive Suite 211 Birmingham AL 35209 Phone 205-877-2555 Fax 205-877-2790
name: David A. McLain, MD
role: PRINCIPAL_INVESTIGATOR
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