Intervention: Celecoxib
Trial phase: Phase 3
ATC code: C08CA51 | G01AE10 | L01XX33 | M01AH01 | N02AJ16
SMILES: Cc1ccc(-c2cc(C(F)(F)F)nn2-c2ccc(S(N)(=O)=O)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 145
Group description: Celecoxib 200 mg administered orally, once a day for 6 weeks (Treatment Phase); During the extension, all participants received open-label CG100649 2 mg
Eligibility criteria:
Inclusion Criteria (abbreviated)

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
For prior non-steroidal inflammatory drug (NSAID) users only, the subject has a history of positive therapeutic benefit
Subject is willing to limit alcohol intake to 2 or less drinks per day during study and the follow-up period
Subjects must be able to read, understand and follow study related documents.

Exclusion Criteria (abbreviated)

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
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
Pregnant or breast-feeding, or expecting to conceive within the projected duration of the study
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
Subjects who have received even one dose of rofecoxib or etoricoxib at any time in their life
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
Current user of recreational or illicit drugs or has had a recent history (1 year) of drug or alcohol abuse or dependence
History of neoplastic disease or chemotherapy within 5 years of V1, with the exception of non-metastatic skin cancer that has been completely cured
Subjects with gout, pseudogout, inflammatory arthritis, Paget's disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease
Subjects using i.v, i.m., or oral corticosteroids, i.a. steroids or hyaluronic acid injections within 1 month of V1
Subjects receiving a Chinese traditional arthritis treatment within 1 week of V1
Subjects who are not suitable to participate in the study by the investigator's clinical decision