Phase III Study of CG100649 in Osteoarthritis Patients
Condition: Localized Primary Osteoarthritis of Hip; Localized Primary Osteoarthritis of Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
Intervention: CG100649; Celecoxib; Placebo
Intervention description: 2 mg capsule; 200 mg capsule; Mimic for CG100649 2 mg capsule and for celecoxib 200 mg capsule
Intervention MeSH terms: Celecoxib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 362.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: COX-1; COX-2; carbonic anhydrase; anti-inflammatory; Cyclooxygenase Inhibitors; Polmacoxib

Summary:

      -  6-week Efficacy Study The objective of this study is to prove the safety and
           non-inferiority of analgesic efficacy of CG100649 2 mg vs. celecoxib 200 mg, and
           analgesic superiority of CG100649 2 mg vs. placebo, when administered once a day in
           patients with osteoarthritis of the hip or knee over the 6 week Treatment period. The
           primary efficacy parameter is the difference from Baseline to Week 6 in the Western
           Ontario and McMaster Universities Index of Osteoarthritis (WOMAC)-Pain subscale.

        -  Extended Safety Study The objective of the Extended Safety Study is to collect a total
           of 24 weeks of safety data for CG100649 including the initial 6 weeks of safety data,
           and an additional 18 weeks of safety data for those subjects who agree on the consent
           form to continue into the Extended Safety Study. Subjects will be administered CG100649
           2 mg only during 18 weeks of Extended Safety Study.
    

Eligibility criteria:

        Inclusion Criteria (abbreviated)

          1. Males or females, age 20 years or above, able and willing to provide written informed
             consent

          2. Knee or Hip OA diagnosed according to American College of Rheumatology guidelines

          3. Chronic pain for ≥3 months from OA

          4. BP [systolic 90-140 mmHg, diastolic 50-90 mmHg] and pulse rate [resting 40-100 bpm].

          5. WOMAC-Pain score in the index joint must be between 4-8 on a 0-10 numerical rating
             scale

          6. Blood chemistry must be within 2x normal range

          7. Urinalysis must be within normal limits; minor deviations are acceptable

          8. Subjects and their sexual partners must agree to use double barrier contraception
             during the study period and for 3 months afterward, or be at least one year post-
             menopause, or provide proof of surgical sterility

          9. For prior non-steroidal inflammatory drug (NSAID) users only, the subject has a
             history of positive therapeutic benefit

         10. Subject is willing to limit alcohol intake to 2 or less drinks per day during study
             and the follow-up period

         11. Subjects must be able to read, understand and follow study related documents.

        Exclusion Criteria (abbreviated)

          1. Use of any analgesics except the study medication or acetaminophen at any time

          2. Use of any medications for ongoing chronic symptoms, or psychiatric disorders that
             could significantly diminish the cognitive ability or cause behavioral changes that
             would prevent the subject from complying with study procedures.

          3. Subject is legally incompetent, or has active psychosis, or significant emotional
             problems which are sufficient to interfere with the conduct of the study

          4. Use of anticoagulants (aspirin, warfarin, heparin, etc.) within 2 weeks of V1

          5. Previous history of hypersensitivity or allergy to NSAIDs, COX-2 inhibitors, carbonic
             anhydrase inhibitors, sulfa drugs, aspirin, or acetaminophen/paracetamol

          6. 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

          7. Diagnosed or treated for active GI ulcer, GI bleeding, ulcerative colitis, or severe
             renal, hepatic, or coagulant disorder within 6 months prior to randomization

          8. History of nasal polyps, bronchospasm, urticaria, or anaphylactic shock

          9. Subjects who have had surgery on the affected joint within 6 months prior to the study
             and subjects with a prosthesis at the index joint

         10. Pregnant or breast-feeding, or expecting to conceive within the projected duration of
             the study

         11. Subjects who are currently participating or have participated in other clinical
             studies within 4 weeks of screening or in any other clinical trial evaluating NSAIDs
             or COX-2 inhibitors within 6 months of screening

         12. Subjects who have received even one dose of rofecoxib or etoricoxib at any time in
             their life

         13. History of congestive heart failure with a status of New York Heart Association II-IV,
             ischemic heart disease, uncontrolled hypertension, peripheral arterial disease,
             cerebrovascular disease or subjects who have one of these diseases

         14. Current user of recreational or illicit drugs or has had a recent history (1 year) of
             drug or alcohol abuse or dependence

         15. History of neoplastic disease or chemotherapy within 5 years of V1, with the exception
             of non-metastatic skin cancer that has been completely cured

         16. Subjects with gout, pseudogout, inflammatory arthritis, Paget's disease of bone,
             chronic pain syndrome, fibromyalgia, or another major joint disease

         17. Subjects using i.v, i.m., or oral corticosteroids, i.a. steroids or hyaluronic acid
             injections within 1 month of V1

         18. Subjects receiving a Chinese traditional arthritis treatment within 1 week of V1

         19. Subjects who are not suitable to participate in the study by the investigator's
             clinical decision