Study of CG100649 Versus Celecoxib in Osteoarthritis Patients

Inclusion Criteria

• Males and females, age 20 years old and more, able and willing to provide written informed consent to participate in the study
• Confirmed osteoarthritis (OA) of the knee or hip by radiograph obtained within the past 20 years and diagnosed according to American College of Rheumatology (ACR) guidelines.
• Subject must have pain at least 3 month duration from osteoarthritis (OA)
• Normal blood pressure (BP) [systolic BP 90-140 mmHg, diastolic BP 50-90 mmHg] and heart rate (HR) [resting 45-90 beats per minute (bpm)]
• Subjects with hypertension should have stably taken ACE inhibitor, angiotensin II receptor (type AT1) antagonist, beta-blocker and/or diuretics at least 3 months at the time of screening in order to keep normal blood pressure. Subjects should not change or stop hypertension drug during the study.
• Clinical Chemistry must be within 2x normal limits
• Urinalysis must be within normal range.
• Prior to randomization on Day 1, the mean WOMAC pain score in the index joint must be between 4 and 8 on a 0-10 numerical rating scale.
• Subjects and their sexual partners must agree to use double barrier contraception during the study period and for 3 months afterwards or provide proof of surgical sterility or post-menopause more than 1 year.
• Subject must be able to read and understand and follow the study instructions.

Exclusion Criteria

• Use of any analgesics except the study medication or paracetamol (acetaminophen) at any time during this study;
• Use of corticosteroids or intra-articular viscosupplementation within 3 months of screening;
• Use of antidepressants or anticonvulsants within 2 months of screening;
• Cognitive or psychiatric disorders, or daytime use of medications (alcohol, benzodiazepines, barbiturates, muscle relaxants) that could diminish compliance with study procedures;
• Use of anticoagulants (aspirin, warfarin, heparin) within 2 weeks of screening;
• Use of any medications that will affect pain perception (e.g. tranquilizers, hypnotics);
• Hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase (COX)-2 inhibitors, or carbonic anhydrase inhibitors;
• Use of oriental medicine (herbal medicine) or glucosamine within 14 days of dose administration
• History of drug or alcohol abuse within one year prior to screening;
• Known allergy or hypersensitivity to sulfa drugs;
• History of congestive heart failure, ischemic heart disease, peripheral arterial disease, cerebrovascular disease or subjects who have one of these diseases;
• Use of chemotherapy agents or history of cancer, other than non-metastatic skin cancer that has been completely excised, within five (5) years prior to the screening visit;
• Subjects with gout, pseudogout, inflammatory arthritis, Paget's disease, chronic pain syndrome, fibromyalgia, or another major joint disease;
• Subjects requiring knee or hip arthroplasty within 2 months of screening or anticipating any need for a surgical procedure on the index joint during the study;
• Subjects who have had surgery on the affected joint within 6 months of screening and subjects with a prosthesis at the index joint;
• History of seizure disorder;
• Subjects with serious psychosocial co-morbidities;
• Subjects with gastrointestinal, renal, hepatic, or coagulant disorder within 6 months of screening;
• Esophageal or duodenal ulcer within 6 months of screening;
• History of nasal polyps, bronchospasm, and urticaria;
• Pregnant or breast-feeding;
• Subject with genetic problem of galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption (because celecoxib contains lactose)