Multi-Center Study Evaluating the Efficacy of Wobenzym(R)N in Treating Knee Osteoarthritis

Inclusion Criteria: * Ambulatory outpatients of either sex, between 45 and 80 years of age, inclusively, with primary OA of the knee meeting the classification criteria set by the American College of Rheumatology (ACR; Appendix C.1), and who are not expected to require surgical treatment for at least three (3) months after inclusion (Visit 1). * Women of childbearing potential must agree to use an adequate contraception (abstinence; device mechanical barrier contraception; male partner sterilized) beginning at least seven days prior to treatment (oral birth control pill should begin at least 4 weeks prior to treatment) and continuing at least 14 days after Visit 4 or the discontinuation visit. A serum or urine pregnancy test will be performed at Visit 1. * Functional Capacity Classification (Appendix C.2) of I-III at Visit 1. * Except for OA, the subject is judged to be in otherwise general good health based on medical history, physical examination, and routine laboratory tests (Appendix B). * Subjects with a WOMAC pain subscale index of at least 40 mm and less than or equal to 90 mm (VAS) at the Baseline Visit after a 24-hour washout of any analgesics and a minimum of 7 days washout of any NSAIDs (Appendix C.3 \& 4). * Subjects with OA of the contra-lateral knee will be included provided contra-lateral knee OA pain intensity is inferior to the index knee. * Able to understand and complete study questionnaires including questions requiring a visual analog scale (VAS) respons…