[The results of open comparative randomized study the efficacy and safety of the two treatment regimens Teraflex in patients with osteoarthritis]

"Open randomized comparative study of the efficacy and safety of treatment with dvuhskhem" Teraflex "in patients with osteoarthritis of the knee. The study duration was 12 months (9 months - treatment, 3 months - monitoring to assess the aftereffects of the drug). Lead researcher: Ph.D. LI Alexeyev. PURPOSE OF THE STUDY: To compare the efficacy, safety and duration of permanent aftereffects of the drug Teraflex for 9 months of intermittent therapy (3 months. - Reception, 3 months. - Break 3 months. - Reception) in patients with osteoarthritis (OA) of the knee. MATERIALS AND METHODS: The study included 100 outpatients with knee OA (1 group - the permanent Teraflex taking the drug for 9 months - 50 people) - the main group (group 2 - the drug intermittently Teraflex 3 months. - Reception, 3 months. - break 3 months. - Reception - 50) - the comparison group. The duration of follow-up was 12 months (9 months - treatment for group 1 and 6 months - 2 treatment group and 3 months - monitoring to assess the after-effect of drugs in both groups). As concomitant therapy to all patients received ibuprofen (400 mg three times a day with the possibility of reducing the dose) after the washout period. CRITERIA FOR INCLUSION: The study included outpatients (99 women and 1 man), aged 45-73 years, suffering from knee OA, OA meet the diagnostic criteria of the American College of Rheumatology, having radiological stage II-III on the Kellgren-Lawrence, with pain when walking more than 40 mm visual analog scale (VAS), with regular NSAID for 30 days in the last 3 months, and signed informed consent to participate in the study. EXCLUSION CRITERIA: 1. Pain when walking <40 mm on the VAS 2. X-ray of the knee joint failure stage IV (according Kelgrenu) 3. The phenomena of synovitis of osteoarthritis in the background 4. Surgical treatment of osteoarthritis history 5. The need for intra-articular injection at the time of enrollment 6. Chondrocalcinosis 7. Secondary arthrosis 8. Treatment of corticosteroids during the last month 9. Severe liver disease, kidney, blood, cardiovascular system 10. Phenylketonuria 11. Gastric ulcer and 12 duodenal ulcer in the past 12 months 12. Intolerance of NSAIDs (including "Aspirin" asthma) 13. Type 1 diabetes 14. Simultaneous participation in a clinical trial of other drugs 15. The presence of other rheumatic diseases (including RA, SLE, ReA) 16. Pregnancy, lactation 17. The absence of written consent of the patient to participate in the study.