Health Condition 1: M160- Bilateral primary osteoarthritis of hip Health Condition 2: M170- Bilateral primary osteoarthritis of knee
Conditions
Interventions
Intervention1: Polmacoxib 2mg Capsule: Once daily after breakfast for 6 weeks
Control Intervention1: Celecoxib 200 mg Capsule: Once daily after breakfast for 6 weeks
Sponsors
Hetero Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Males or females patients 18 years or above, who are able and willing to provide written informed consent. 2.Idiopathic (Primary) Knee or Hip OA diagnosed according to clinical and radiographic criteria specified by the American College of Rheumatology guidelines. - Hip pain and at least 2 of the following 3 features a) ESR AND/OR - Knee pain and Osteophytes with at least 1 of the following 3 features a) Age >50 years b) Stiffness 3.Patients with chronic pain for = 3 months from OA. 4.Patients with radiographic osteoarthritic changes of grade =2 of Kellgren and Lawrence system of osteoarthritis classification. 5.Patients with index joint pain of at least moderate to severe intensity as measured by visual analog scale (VAS) recording of =40 mm (0–100 mm) 6.Patients with mean WOMAC-Pain score in the index joint between =2 at screening and baseline. 7.Patients (Women of childbearing potential and their partners) must agree to use barrier contraception during the study period and for 3 months afterward and neither become pregnant or lactate. 8.Clinical laboratory evaluations (hematology, clinical chemistry, coagulation, and urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator.
Exclusion criteria
Exclusion criteria: 1.Patients with history of hypersensitivity or allergy to NSAIDs, COX-2 inhibitors, carbonic anhydrase inhibitors, sulfa drugs, aspirin, or acetaminophen/paracetamol. 2.Use of any analgesics except rescue medication (acetaminophen 650 mg/ day) during the washout and follow-up. 3.Patients with ACR global functional status of IV 4.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. 5.Patients using the following medications: a)Use of traditional arthritis treatment within 1 week of screening. b) Use of anticoagulants within 2 weeks of screening c) Use of corticosteroids, intra-articular steroids or hyaluronic acid injections within 1 month of screening; d) Use of chemotherapy within 5 years prior to screening e) Concurrent use of corticosteroids, herbal medicines, traditional medicines, nutraceuticals, glucosamine, and/or chondroitin sulfate 6.Patients 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.Patients with medical conditions of active GI ulcer, GI bleeding, ulcerative colitis, or severe renal, hepatic, or coagulant disorder within 6 months prior to screening 8.Patients with History of nasal polyps, bronchospasm, urticaria, or anaphylactic shock 9.Patients who have had surgery on the affected joint within 6 months prior to screening and subjects with a prosthesis at the index joint 10.Patients 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 11.Patients with history of congestive heart failure with a status of New York Heart Association II-IV, ischemic heart disease, uncontrolled hypertension (controlled hypertension for more than 3 months prior to screening are eligible), peripheral arterial disease, cerebrovascular disease 12.Current user of recreational or illicit drugs or has had a recent history (1 year) of drug or alcohol abuse (2 or less drinks per day allowed) or dependence 13.History of neoplastic disease or chemotherapy within 5 years of screening, with the exception of non-metastatic skin cancer that has been completely cured 14.Patients with secondary osteoarthritis, gout, pseudogout, inflammatory arthritis, Pagets disease of bone, chronic pain syndrome, fibro myalgia or another major joint disease. 15. Patients who are not suitable to participate in the study by the investigators clinical decision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the WOMAC-Pain Subscale.Timepoint: From baseline to Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Mini Osteoarthritis Knee and Hip Quality of Life (OAKHQOL) scoreTimepoint: From baseline to Week 3 and Week 6;Change in Pain Score measured by VAS scaleTimepoint: From baseline to Week 3 and Week 6;Change in Physicians Global Assessment (PGA)Timepoint: From baseline to Week 3 and Week 6;Change in Subjects Global Assessment (SGA)Timepoint: From baseline to Week 3 and Week 6;Change in the WOMAC OA indexTimepoint: From baseline to Week 3 and Week 6;Change in the WOMAC- Pain sub scaleTimepoint: From baseline to week 3;Change in WOMAC OA subscales (stiffness, physical function)Timepoint: From baseline to Week 3 and Week 6;Treatment emergent clinical & laboratory adverse events (TEAEs).Timepoint: Throughout the study period | — |
Countries
India
Contacts
Public ContactDr Shubhadeep Sinha
Hetero Drugs Limited
Outcome results
None listed