Efficacy of Flavocoxid Compared With Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee
This study has been completed.
Information provided by:
First received: January 16, 2008
Last updated: November 13, 2008
Last verified: November 2008
To compare flavocoxid with naproxen for patients with moderate to severe osteoarthritis of the knee.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
||Phase 3. Efficacy of Flavocoxid Compared With Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2008 (Final data collection date for primary outcome measure)
500 mg bid
Efficay of flavocoxid compared with naproxen in subjects with moderate-severe osteoarthritis of the knee.
|Ages Eligible for Study:
||35 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790985
||Paul H Caldron, DO, FACP
||AmeRuss Clinical Trials LLC USA
No publications provided
||Paul Caldron D.O.,FACP,MBA-IM, AmeRuss Clinical Trials LLC, USA
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 16, 2008
||November 13, 2008
||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:
ClinicalTrials.gov processed this record on March 05, 2014
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents