A Phase IV, Post-marketing, Prospective, Multicenteric, Single Arm, Non-comparative Study to Evaluate the Safety and Efficacy of Polmacoxib 2mg in Adult Patients with Osteoarthritis of Hip/Knee
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- Treatment emergent clinical & laboratory adverse events (TEAEs) during the
研究概览
简要总结
This is a Phase IV, post-marketing, prospective, multicenteric, single-arm, non-comparative study to evaluate the safety and efficacy of Polmacoxib 2 mg in adult patients with osteoarthritis of
Hip/Knee. Evaluation of the safety of polmacoxib in patients with osteoarthritis (OA) of hip/knee and evaluation of the efficacy of polmacoxib in patients with osteoarthritis of hip/knee are the primary and secondary objectives, respectively. Assessment of treatment emergent clinical and laboratory adverse events (TEAEs) during the treatment period is the primary end point, which lasts for 6 weeks.
Secondary endpoints include change from baseline to week 6 in the WOMAC Total OA Index and subscale scores and change from baseline to week 6 in pain score measured by VAS scale,
Change from baseline to Week 6 in Subject’s Global Assessment (SGA), and Change from baseline to Week 6 in Physician’s Global Assessment (PGA). Total study duration per patient is 10 weeks, out of which 2 weeks are for screening, followed by 6 weeks of treatment, and another two more weeks for safety follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Males or females patients 18 years or above, who are able and willing to provide written informed consent.
- •Knee or Hip OA diagnosed according to clinical and imaging criteria specified by the American College of Rheumatology guidelines.
- •Patients with chronic pain for ≥ 3 months from OA.
- •Patients with radiographic osteoarthritic changes of grade ≥2 of Kellgren and Lawrence system of osteoarthritis classification1
- •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)
- •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.
排除标准
- •Patients with history of hypersensitivity or allergy to NSAIDs, COX-2 inhibitors, carbonic anhydrase inhibitors, sulfa drugs, aspirin, or acetaminophen/paracetamol.
- •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.
- •Patients with History of nasal polyps, bronchospasm, urticaria, or anaphylactic shock.
- •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.
- •Patients with a recent history (1 year) of drug or alcohol abuse (2 or less drinks per day allowed) or dependence 6.Patients who are not suitable to participate in the study.
结局指标
主要结局
Treatment emergent clinical & laboratory adverse events (TEAEs) during the
时间窗: week 6
treatment period.
时间窗: week 6
次要结局
- 1. Change from baseline to Week 6 in the WOMAC Total OA Index and Subscales Scores.
- 2. Change from baseline to Week 6 in Pain Score measured by VAS scale.(Week 6)
- Change from baseline to Week 6 in Subjects Global(Assessment)
- Change from baseline to Week 6 in Physicians Global(Assessment)
研究者
Dr Shubhadeep Sinha
Hetero Labs Limited