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

This study has been completed.
Sponsor:
Information provided by:
Primus Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00928837
First received: November 12, 2008
Last updated: June 25, 2009
Last verified: June 2009
  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
Other: Flavocoxid (Medical Food)
Drug: Naproxen
Other: Placebo
Other: Limbrel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • to comapre the efficacy,safety, quality of life and economic impact [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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: Limbrel
Medical Food product
Other: Flavocoxid (Medical Food)
Limbrel 250 mg
Other: Limbrel
Medical food product
Other: Limbrel
medical food product
Active Comparator: Naproxen
antiinflammatory
Drug: Naproxen
500 mg
Drug: Naproxen
antiinflammatory
Placebo Comparator: Placebo
Placebo
Other: Placebo
Placebo

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   35 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Robert M Levy MD, Primus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00928837     History of Changes
Other Study ID Numbers: Primus Pharmaceuticals LOA-03P
Study First Received: November 12, 2008
Last Updated: June 25, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 27, 2014