Prospective, Clinical Trial to Investigate Safety, Tolerability and Efficacy of Dexibuprofen Gebro 400 mg Powder for Oral Suspension (Test) Compared to Ibuprofen 400 mg Powder for Oral Suspension (Reference) in Patients Suffering From Osteoarthritis of the Hip or Knee
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 482
- 试验地点
- 2
- 主要终点
- Tolerability profile of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients with painful osteoarthritis of the hip or knee
研究概览
简要总结
Medical condition under investigation: Osteoarthritis of the hip or knee
Number of patients planned: 480 adult patients
Main objective: To evaluate and compare the tolerability profile of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients with painful osteoarthritis of the hip or knee
Secondary objectives: To compare the overall efficacy of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients suffering from different complaints due to painful osteoarthritis of the hip or knee
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female patients aged between 18 and 75 years
- •everyday joint pain for the past three months
- •global pain intensity in the involved joint (hip or knee) of "moderate" to "severe" within the last 48 h
排除标准
- •acute inflammation or ischaemic necrosis
- •paget's disease, chondrocalcinosis, ochronosis of the hip/knee joint
- •slowly progressing hip/knee arthropathy in particular of tuberculosis aetiology
- •hip/knee arthropathy due to diabetes mellitus
- •Charcot's joint
- •villous synovitis
- •chondromatosis of the synovium
- •patients with existing gastritis or existing ulcers or bleedings in the gastrointestinal tract or patients with history of gastrointestinal ulcers or gastrointestinal haemorrhage in the past 6 months
研究组 & 干预措施
Dexibuprofen
Dexibuprofen 400 mg powder for oral suspension
干预措施: Dexibuprofen (Drug)
Ibuprofen
Ibuprofen 400 mg powder for oral suspension
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Tolerability profile of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients with painful osteoarthritis of the hip or knee
时间窗: 14 days
次要结局
- Overall efficacy of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients suffering from different complaints due to painful osteoarthritis of the hip or knee(14 days)