Study of CG100649 Versus Celecoxib in Osteoarthritis Patients
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: CG100649; Celecoxib
Intervention description: once daily for 28 days; capsule, celecoxib 200 mg, once daily for 28 days
Intervention MeSH terms: Celecoxib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 125.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: COX-1; COX-2; carbonic anhydrase; anti-inflammatory; Cyclooxygenase Inhibitors; Polmacoxib

Summary:

      This is a double-blind, randomized, multicenter, phase 2b, noninferiority comparison of two
      active dose levels of CG100649 vs. a standard anti-arthritic dose of celecoxib (Celebrex).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females, age 20 years old and more, able and willing to provide written
             informed consent to participate in the study

          2. 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.

          3. Subject must have pain at least 3 month duration from osteoarthritis (OA)

          4. 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)]

          5. 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.

          6. Clinical Chemistry must be within 2x normal limits

          7. Urinalysis must be within normal range.

          8. 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.

          9. 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.

         10. Subject must be able to read and understand and follow the study instructions.

        Exclusion Criteria:

          1. Use of any analgesics except the study medication or paracetamol (acetaminophen) at
             any time during this study;

          2. Use of corticosteroids or intra-articular viscosupplementation within 3 months of
             screening;

          3. Use of antidepressants or anticonvulsants within 2 months of screening;

          4. Cognitive or psychiatric disorders, or daytime use of medications (alcohol,
             benzodiazepines, barbiturates, muscle relaxants) that could diminish compliance with
             study procedures;

          5. Use of anticoagulants (aspirin, warfarin, heparin) within 2 weeks of screening;

          6. Use of any medications that will affect pain perception (e.g. tranquilizers,
             hypnotics);

          7. Hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase
             (COX)-2 inhibitors, or carbonic anhydrase inhibitors;

          8. Use of oriental medicine (herbal medicine) or glucosamine within 14 days of dose
             administration

          9. History of drug or alcohol abuse within one year prior to screening;

         10. Known allergy or hypersensitivity to sulfa drugs;

         11. History of congestive heart failure, ischemic heart disease, peripheral arterial
             disease, cerebrovascular disease or subjects who have one of these diseases;

         12. 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;

         13. Subjects with gout, pseudogout, inflammatory arthritis, Paget's disease, chronic pain
             syndrome, fibromyalgia, or another major joint disease;

         14. 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;

         15. Subjects who have had surgery on the affected joint within 6 months of screening and
             subjects with a prosthesis at the index joint;

         16. History of seizure disorder;

         17. Subjects with serious psychosocial co-morbidities;

         18. Subjects with gastrointestinal, renal, hepatic, or coagulant disorder within 6 months
             of screening;

         19. Esophageal or duodenal ulcer within 6 months of screening;

         20. History of nasal polyps, bronchospasm, and urticaria;

         21. Pregnant or breast-feeding;

         22. Subject with genetic problem of galactose intolerance, Lapp lactose deficiency or
             glucose-galactose malabsorption (because celecoxib contains lactose)