Efficacy of Flavocoxid Compared With Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee

This study has been completed.
Sponsor:
Information provided by:
Primus Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00790985
First received: January 16, 2008
Last updated: November 13, 2008
Last verified: November 2008
  Purpose

To compare flavocoxid with naproxen for patients with moderate to severe osteoarthritis of the knee.


Condition Intervention
Osteoarthritis
Other: flavocoxid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: Phase 3. Efficacy of Flavocoxid Compared With Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee

Resource links provided by NLM:


Further study details as provided by Primus Pharmaceuticals:

Estimated Enrollment: 250
Study Start Date: January 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: flavocoxid
    500 mg bid
Detailed Description:

Efficay of flavocoxid compared with naproxen in subjects with moderate-severe osteoarthritis of the knee.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Willing and able to read and understand informed consent and questionnaires in English.
  • Adults of either gender age 35-75 years, in general good health.
  • Established X-ray diagnosis of osteoarthritis of at least one knee.
  • Taken NSAID including COX-2 inhibitor in full therapeutic dose for at least one month prior to screening.
  • Able and will to discontinue OA medications until flare criteria met.
  • BMI</= 45
  • Subjects must rate target knee at least 5 out of 10 on discomfort VAS at baseline visit.
  • Have an increase of at least 15mm on a 100mm pain VAS from screening to baseline visit.
  • Must use acceptable birth control if female.
  • Screening fecal occult must be negative.
  • Able to attend all required visits
  • Physical Therapy is allowed as long as the type and frequency remains unchanged for the duration of the study.

Exclusion Criteria:

  • Refusal to sign consent.
  • Inability to attend all clinic visits
  • Grade 0-1 K-L changes in both knees or grade 4 K-L changes in either knee on standing A/P radiograph
  • Pregant or lactating women
  • History of serious cardio-vascular disease.
  • Recurrent arrythmias, except PAT, cardiomyopathy, MI within one year of screening.
  • History of chronic esophageal, gastric or duodenal disease
  • History of upper GI bleeding within the past 2 years.
  • Any GI disorder associated with malabsorption
  • Any musculo-skeletal or neurological condition that results in pain or gait disturbance that might confound evaluation of target knee.
  • Uncontrolled Diabetes Mellitus
  • History of bleeding disorder or concurrent use of coumadin or any agent used to reduce blood clotting or platelet adhesiveness.
  • Concurrent use of any anti-arthritic medication, including corticosteroids regardless of the reason for use. (low dose aspirin for cardioprotection is allowed)
  • History of chronic renal disease with creatinine >2.0 or nephrotic syndrome with 24 hour protein excretion >1000mg.
  • Intra-articular injection of any hyaluronic acid preparation in the target knee joint within 4 months of baseline visit.
  • Intra-articular injection of a corticosteroid in the target knee joint within 2 months of the baseline visit.
  • BMA>45
  • History of allergic reaction to flavonoid or flavan containg foods or products (example: red wine, colored fruits and vegetable, brazel nuts, tea, natto)
  • History of allergy to aspirin, naproxen or other NSAID
  • History of substance abuse including alcohol, or any psychiatric condition that may impair the subject's ability to comply with the study requirements.
  • Any medical condition that, in the opinion of the investigator, might put the subject at undue risk or might interfere with the subject's ability to participate in the study.
  • Participation in another clinical trial within 30 days or 7 half lives of the study agent, whichever is longer, of the screening visit.
  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: NCT00790985

Sponsors and Collaborators
Primus Pharmaceuticals
Investigators
Study Director: Paul H Caldron, DO, FACP AmeRuss Clinical Trials LLC USA
  More Information

No publications provided

Responsible Party: Paul Caldron D.O.,FACP,MBA-IM, AmeRuss Clinical Trials LLC, USA
ClinicalTrials.gov Identifier: NCT00790985     History of Changes
Other Study ID Numbers: LOA-04P, LOA-04P
Study First Received: January 16, 2008
Last Updated: November 13, 2008
Health Authority: United States: Institutional Review Board
Russia: Ministry of Health of the Russian Federation
Russia: Federal Agency on Healthcare and Social Development Control

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
Pharmacologic Actions
Anti-Inflammatory Agents
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 July 26, 2014