CTRI/2022/05/042923已完成3 期
A Prospective, Multicenteric, Double blind, Randomized, Active Controlled, Parallel Study to Evaluate the Efficacy and Safety of Polmacoxib 2mg in Adult Patients with Idiopathic (Primary) Osteoarthritis of Hip/Knee.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 294
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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 <20 mm/hour b)Radiographic femoral or acetabular osteophytes c)Radiographic joint space narrowing (superior, axial, and/or medial)
- •- Knee pain and Osteophytes with at least 1 of the following 3 features a) Age >50 years b) Stiffness <30 minutes c)Crepitus
- •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.
排除标准
- •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
研究者
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.A.PER-006-98MERCK SHARP & DOHME PERU S.R.L.,