CTRI/2024/06/069581招募中4 期
A Multi-Centric, Prospective, Single Arm, Open label Post Marketing Observational Study To Evaluate The Effectiveness And Safety Of Polmacoxib 2mg Capsule In Patients With Hip/Knee Osteoarthritis. - NI
试验速览
- 阶段
- 4 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Male and female patients in the age group of 20 to 70 years, with a clinical diagnosis of knee or hip osteoarthritis as per the discretion of investigators.
- •2.Patients having chronic pain for 3 months or more due to osteoarthritis.
- •3. The baseline (predose) mean WOMAC pain score in the index joint is between 4 and 8.
- •4. Patients willing to provide written informed consent and comply with study procedures
排除标准
- •1. Use of any analgesics except the study medication or acetaminophen 24 hours before study drug administration and during the study.
- •2. Use of anticoagulants within 2 weeks before study enrollment.
- •3. Use of corticosteroids, herbal medicines, traditional ayurvedic medicines, nutraceuticals, glucosamine, and/or chondroitin sulfate within 3 months before study enrollment.
- •4. Requirement for knee or hip arthroplasty within 2 months of screening or anticipating any need for a surgical procedure on the index joint during the study.
- •5. Hypersensitivity or allergy to NSAID.
- •6. Pregnant and lactating women.
- •7. History of nasal polyps, bronchospasm, urticaria, or anaphylactic shock; history of New York Heart Association stage II-IV congestive heart failure, ischemic heart disease, uncontrolled hypertension, peripheral arterial disease, and/or cerebrovascular disease; pregnancy, breast-feeding, or expecting conception within the duration of the study; active ulcer, GI bleeding, ulcerative colitis, or severe renal, hepatic, or coagulant disorder within 6 months before randomization; ongoing chronic symptoms or psychiatric disorders preventing compliance with study procedures, except for subjects who were physically healthy and had been receiving the specified allowed drugs for =3 months; use of corticosteroids, intra-articular steroids or hyaluronic acid injections within 1 month of screening; chemotherapy within 5 years.
- •8. Patients with any other conditions or diseases that the investigator considers inappropriate to enter the study as per prescribing information
研究者
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