Clinical trial NCT00530452 (phase 2, status: unknown status)
Conditions: osteoarthritis, knee, osteoarthritis, hip
ICD codes: M17.9, M17.0, M17.10, M17.11, M17.12, M17.2, M17.30, M16.9, M16.0, M16.10, M16.11, M16.12, M16.30, M16.31
Drugs: cg100649, silicified microcrystalline cellulose + talc
SMILES: CC1(C)OC(=C(C1=O)C1=CC=CC(F)=C1)C1=CC=C(C=C1)S(N)(=O)=O
Eligibility criteria:

        Inclusion Criteria:

          1. Males, age 18-75 years old;

          2. BMI 19-35 kg/m2;

          3. Good health;

          4. Systolic BP 90-140 mmHg, diastolic BP 50-90 mmHg, resting HR 45-90 bpm without
             medication;

          5. Clinical chemistry profile within 2x normal range without medication;

          6. Urinalysis including urinary creatinine within 2x normal limits;

          7. OA confirmed by radiographs obtained within the past 20 years and diagnosed according
             to ACR guidelines; subjects must qualify as ACR global functional status I, II, or III
             (excluding IV) and Kellgren-Lawrence grade 1, 2 or 3 (excluding grades 0 and 4);

          8. Subjects must have had chronic pain for ≥3 months from OA;

          9. Subjects must have been receiving stable oral doses of NSAIDs or COX-2 inhibitors at
             least 3 days per week for one month or longer;

         10. Subjects may take paracetamol ≤2g/day) for breakthrough pain;

         11. During the washout period, the average daily pain intensity (DPI) score must be
             between 4 and 8 on a 0-10 numerical rating scale for at least 3 days, and no greater
             than 9 for more than 1 day, in the last 5 days prior to randomization per Baseline
             pain diary;

         12. Subjects must be able to read, understand and follow the study instructions;

         13. Subjects and their sexual partners must agree to use double barrier contraception
             during the study period and for 2 months afterward.

        Exclusion Criteria:

          1. Use of any analgesics except the study medication or paracetamol;

          2. Presence or history of peripheral edema within the past 5 years;

          3. History of congestive heart failure;

          4. Use of chemotherapy agents or history of cancer within five years prior to the
             screening visit;

          5. History of bacterial or viral infection requiring treatment with antibiotics,
             antivirals, or anti-retrovirals within 3 months of study;

          6. Use of drugs which are P450 3A4 inducers or inhibitors within the past 30 days;

          7. Use of prescribed systemic or topical medications or any dietary aids or foods that
             are known to modulate drug metabolizing enzymes within 14 days of dose administration;

          8. Difficulty in swallowing oral medications;

          9. Subjects with gout, pseudogout, inflammatory arthritis, Paget's disease of bone,
             chronic pain syndrome, fibromyalgia, or another major joint disease;

         10. 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;

         11. Subjects who have had surgery on the affected joint within one year prior to the study
             and subjects with a prosthesis at the index joint;

         12. Use of systemic corticosteroids within 2 months of screening, or intra-articular
             viscosupplementation within the past 6 months;

         13. History of seizure disorder;

         14. Use of antidepressants or anticonvulsants for any reason including for chronic pain
             within 2 months of screening;

         15. Serious psychosocial co-morbidities;

         16. Cognitive or psychiatric disorders, or daytime use of medications that could diminish
             compliance with study procedures, including maintenance of a daily pain and symptom
             diary and accurate dosing of study medication;

         17. Use of anticoagulants within 2 weeks of screening;

         18. Use of any medications that will affect pain perception;

         19. History of drug or alcohol abuse within one year prior to screening;

         20. Use of any other investigational drug within 1 month prior to randomization;

         21. Active gastrointestinal, renal, hepatic, or coagulant disorder within 1 month prior to
             randomization;

         22. Esophageal or gastroduodenal ulceration within 1 month prior to randomization;

         23. Hypersensitivity to NSAIDs, sulfonamides, COX-2 inhibitors, or carbonic anhydrase
             inhibitors;

         24. History of nasal polyps, bronchospasm or urticaria;

         25. Known allergy or hypersensitivity to sulfa drugs;

         26. Family history of significant cardiac disease;

         27. Occult blood in stool.