NCT00170898已完成4 期
A 7-Day Multicenter Randomized Double-Blind, Double-Dummy Parallel Group Trial to Assess the Safety and Efficacy of 400 mg Lumiracoxib Once Daily Versus 500 mg Naproxen Twice Daily in Patients With Acute Musculoskeletal Pain Due to Uncomplicated Soft Tissue Injury
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 419
- 试验地点
- 1
- 主要终点
- Decrease in sum of pain intensity difference scores over first 5 days of treatment
研究概览
简要总结
This study is designed to develop our understanding of the risk-benefit of using lumiracoxib in patients with acute musculoskeletal pain due to uncomplicated soft tissue injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute musculoskeletal pain following an uncomplicated soft tissue injury (within the last 72 hours) which is expected to be self-limiting, requiring short-term treatment with a NSAID.
- •Patients' acute musculoskeletal pain at baseline must be ≥ 50 mm on a 0 - 100 mm on a Visual Analogue Scale.
- •Patients may have taken analgesic therapy following injury. However, the baseline pain intensity assessment should be taken: (i) 4 hours after the last dose of ≤ 400 mg ibuprofen, ≤ 1000 mg paracetamol, ≤ 600 mg aspirin or ≤ 2 tablets of other over-the-counter analgesic aspirin-based or paracetamol-based combination medications (ii) or 8 hours after the last dose of > 400 mg ibuprofen or ≤ 50 mg diclofenac
排除标准
- •Patients whose pain is due to an acute exacerbation of a chronic condition e.g. osteoarthritis, rheumatoid arthritis, systemic lupus erythematosus.
- •Patients who have taken non-steroidal anti-inflammatory drugs in the previous 24 hours (other than aspirin, ibuprofen, diclofenac, as described above).
- •Other protocol-defined inclusion/ exclusion criteria may apply.
结局指标
主要结局
Decrease in sum of pain intensity difference scores over first 5 days of treatment
次要结局
- Decrease in sum of pain intensity difference scores over 7 days of treatment; Improvement in how pts feel about their pain; Comparable perceived pain relief; Comparable treatment satisfaction
- Safety and efficacy as compared to naproxen.
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Efficacy and Safety of Lumiracoxib 400 mg Once Daily in Acute Flares of GoutAcute Gouty ArthritisNCT00170781Novartis234
已完成
3 期
Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis (OA)Knee OsteoarthritisNCT00367315Novartis1,684
已完成
4 期
Efficacy of Lumiracoxib in Relieving Moderate to Severe Post-dental Surgery Pain, Compared to Both Placebo and CelecoxibPainNCT00348491Novartis Pharmaceuticals364
已完成
3 期
Efficacy and Safety of Lumiracoxib in Patients With Knee Osteoarthritis (OA).Osteoarthritis, KneeNCT00366938Novartis1,464
已完成
3 期
6 Week Open-label Trial With Lumiracoxib 200mg o.d. in Primary Knee Osteoarthritis or Rheumatoid ArthritisRheumatoid ArthritisOsteoarthritisNCT00170872Novartis135