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

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Other: Placebo; Drug: Naproxen; Other: flavocoxid 250 mg; Dietary supplement: Flavocoxid 500 mg

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Alan Kivitz MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Placebo
Active Comparator: flavocoxid 250 mg; Medical Food product	Other: flavocoxid 250 mg; Medical food product; Other Names: Limbrel 250 mg
Active Comparator: Naproxen; antiinflammatory	Drug: Naproxen; non-steroidal anti-inflammatory drug; Other Names: naprosyn
Experimental: flavocoxid 500 mg; medical food product	Dietary supplement: Flavocoxid 500 mg; flavonoid mixture; Other Names: Limbrel 500 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
to compare the efficacy of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks	comparison of short WOMAC and timed walk	3 months
to compare the safety of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks	Comparison of FS-36, subject tolerability VAS	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
to compare the efficacy of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks	comparison of short WOMAC and timed walk	6 months
to compare the safety of 2 doses of flavocoxid with that of naproxen and placebo at 12 weeks	Comparison of FS-36, subject tolerability VAS	6 months

Collaborators and Investigators

• Sponsor: Primus Pharmaceuticals
• Investigators: Principal Investigator: Alan J Kivitz, MD, Recruiting Altoona Center for Clinical Research 1125 Old Rt 220 North Duncansville PA 16635 Phone 814-693-0300 Fax 814-693-0400; Principal Investigator: Timothy S Truitt, MD, Recruiting MIMA Century Research Associates 65 E. Nasa Blvd Suite 106 Melbourne FL 32901 Phone 321-723-1203 Fax 321-725-3602; Principal Investigator: Joy Schechtman, DO, Sun Valley Arthritis Ltd. 6525 W. Sack Drive Suite 108 Glendale AZ 85308 Phone 623-825-5591 Fax 623-362-9264; Principal Investigator: David S Silver, MD, 8691 Wilshire Blvd Suite 301 Beverly Hills CA 90211 phone 310-657-9650 Fax 310-659-2841; Principal Investigator: Nathan Wei, MD, Arthritis and Osteoporosis Center of Maryland71 Thomas Johnson Drive Frederick MD 21702 Phone 301-694-5800 Fax 301 694-0187; Principal Investigator: Norman B Gayliss, MD, 2845 Aventura Blvd. Suite 100 Aventura FL 33180 Phone 305-932-4295 Fax 305-932-6335; Principal Investigator: David A. McLain, MD, 2022 Brookwood Medical Center Drive Suite 211 Birmingham AL 35209 Phone 205-877-2555 Fax 205-877-2790

Publications and helpful links

Helpful Links

• Primus Pharmaceuticals,Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: November 12, 2008
• First Submitted That Met QC Criteria: June 25, 2009
• First Posted (Estimate): June 26, 2009

Study Record Updates

• Last Update Posted (Actual): December 13, 2017
• Last Update Submitted That Met QC Criteria: December 11, 2017
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gout Suppressants; Naproxen
• Other Study ID Numbers: Primus Pharmaceuticals LOA-03P