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Study of Flavocoxid (Limbrel) Versus Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00928837
First Posted: June 26, 2009
Last Update Posted: August 3, 2017
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.
Information provided by (Responsible Party):
Primus Pharmaceuticals
  Purpose
The purpose of the study is to compare the efficacy and safety of flavocoxid (Limbrel) with Naproxen and placebo in OA of the knee.

Condition Intervention
Osteoarthritis Dietary Supplement: Flavocoxid 500 mg Drug: Naproxen Other: Placebo Other: flavocoxid 250 mg

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Primus Pharmaceuticals:

Primary Outcome Measures:
  • to compare the efficacy,safety, quality of life and economic impact [ Time Frame: 6 months ]
    Comparison of FS-36, VAS, short WOMAC


Secondary Outcome Measures:
  • to comapre the efficacy,safety, quality of life and economic impact [ Time Frame: 6 months ]
    Comparison of FS-36, VAS, short WOMAC


Enrollment: 350
Study Start Date: March 2006
Study Completion Date: September 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: flavocoxid 250 mg
Medical Food product
Other: flavocoxid 250 mg
Medical food product
Other Name: Limbrel 250 mg
Active Comparator: Naproxen
antiinflammatory
Drug: Naproxen
non-steroidal anti-inflammatory drug
Other Name: naprosyn
Placebo Comparator: Placebo
Placebo
Other: Placebo
Placebo
Experimental: flavocoxid 500 mg
medical food product
Dietary Supplement: Flavocoxid 500 mg
flavonoid mixture
Other Name: Limbrel 500 mg

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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): NCT00928837


Locations
United States, Pennsylvania
Alan Kivitz MD
Duncansville, Pennsylvania, United States, 16635
Sponsors and Collaborators
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
  More Information

Additional Information:
Responsible Party: Primus Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00928837     History of Changes
Other Study ID Numbers: Primus Pharmaceuticals LOA-03P
First Submitted: November 12, 2008
First Posted: June 26, 2009
Last Update Posted: August 3, 2017
Last Verified: June 2009

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
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