CTRI/2024/06/069581已完成Unknown
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.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 5
- 主要终点
- 1. The mean change in the pain subscale of Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index from baseline (Day 1) to Week 6 (±1 day), post-treatment with polmacoxib 2mg capsule in patients with knee/hip osteoarthritis
研究概览
简要总结
This is aprospective, multicenter, single-arm, open-label, post-marketing observational study designed to evaluate the effectiveness and safety of polmacoxib 2 mg capsule in the managementof hip or knee osteoarthritis in patients in the age group of ≥20 to ≤70 years. This multicenter study will enroll approximately 150 adult patients with hip or knee osteoarthritis.The patients will be followed up for 8 weeks (6 weeks of treatment + 2-week follow-up) after enrollment into the study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
- •The baseline (predose) mean WOMAC pain score in the index joint is between 4 and
- •Patients willing to provide written informed consent and comply with study procedures.
排除标准
- •Use of any analgesics except the study medication or acetaminophen 24 hours before study drug administration and during the study.
- •Use of anticoagulants within 2 weeks before study enrollment.
- •Use of corticosteroids, herbal medicines, traditional ayurvedic medicines, nutraceuticals, glucosamine, and/or chondroitin sulfate within 3 months before study enrollment.
- •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.
- •Hypersensitivity or allergy to NSAID.
- •Pregnant and lactating women.
- •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.
- •Patients with any other conditions or diseases that the investigator considers inappropriate to enter the study as per prescribing information.
结局指标
主要结局
1. The mean change in the pain subscale of Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index from baseline (Day 1) to Week 6 (±1 day), post-treatment with polmacoxib 2mg capsule in patients with knee/hip osteoarthritis
时间窗: Week 6
次要结局
- 1. The mean change in the stiffness subscale of Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index from baseline (Day 1) to Week 3 (±1 day) and Week 6 (±1 day), post-treatment with polmacoxib 2mg capsule in patients with knee/hip osteoarthritis.(2.The mean change in the physical function subscale of Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index from baseline (Day 1) to Week 3 (±1 day) and Week 6 (±1 day), post-treatment with polmacoxib 2mg capsule in patients with knee/hip osteoarthritis.)
研究者
Dr Rakesh Verma
Jawaharlal Nehru Medical College
研究点 (5)
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