Phase III Study of CG100649 in Osteoarthritis Patients (NCT01765296) | Clinical Trial Compass
CompletedPhase 3
Phase III Study of CG100649 in Osteoarthritis Patients
South Korea362 participantsStarted 2013-03
Plain-language 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.
Who can participate
Age range20 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Males or females, age 20 years or above, able and willing to provide written informed consent
✓. Knee or Hip OA diagnosed according to American College of Rheumatology guidelines
✓. Chronic pain for ≥3 months from OA
✓. BP \[systolic 90-140 mmHg, diastolic 50-90 mmHg\] and pulse rate \[resting 40-100 bpm\].
✓. WOMAC-Pain score in the index joint must be between 4-8 on a 0-10 numerical rating scale
✓. Blood chemistry must be within 2x normal range
✓. Urinalysis must be within normal limits; minor deviations are acceptable
✓. 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
Exclusion criteria
✕. Use of any analgesics except the study medication or acetaminophen at any time
✕. 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.
✕. Subject is legally incompetent, or has active psychosis, or significant emotional problems which are sufficient to interfere with the conduct of the study
✕. Use of anticoagulants (aspirin, warfarin, heparin, etc.) within 2 weeks of V1
✕. Previous history of hypersensitivity or allergy to NSAIDs, COX-2 inhibitors, carbonic anhydrase inhibitors, sulfa drugs, aspirin, or acetaminophen/paracetamol
✕. 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
✕. Diagnosed or treated for active GI ulcer, GI bleeding, ulcerative colitis, or severe renal, hepatic, or coagulant disorder within 6 months prior to randomization
✕. History of nasal polyps, bronchospasm, urticaria, or anaphylactic shock