EUCTR2009-010719-33-AT进行中（未招募）不适用
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 - Dexibuprofen powder for oral suspension
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •male or female patients; age between 18 and 85 years; informed consent of the patient; 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 [on the Likertscale: mild, moderate, severe, extreme]: mild: no impairment of the quality of life, no disorder of night pain, pain at different functions less than 1 hourmoderate: recognizable impairment of the quality of life, pain at single functional sequences, pain dimension is limited to any time of the daysevere: pain impairment of the quality of life at numerous activities of daily lifeextreme: marked impairment of the quality of life over 24h attached with clear pain description; previous treatment with NSAIDs with half-life of > 12 hours after a wash-out period of 5 times of half-life
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •Acute inflammation; ischaemic necrosis; paget’s disease of the hip/knee joint; chondrocalcinosis of the hip/knee joint; ochronosis of the hip/knee joint; haematochromatosis of the hip/knee joint; hip/knee arthropathy in haemophiliacs; unilateral or bilateral inflammatory hip/knee arhtropathy as single manifestation (CP, Bechterew’s disease, psoriasis etc.) with and without involvement of other joints; infectious; slowly progressing hip/knee arthropathy in particular of tuberculosis aetiology; hip/knee arthropathy due to diabetes mellitus; Charcot’s joint; villous sinovitis; chondromatosis of the synovium; contraindication of the trial substance (see SmPC); patients tending to allergies or hypersensitivity to non-steroidal anti-inflammatory agents (triggering asthma attacks or history of urticaria or acute rhinitis); 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; patients with chronic respiratory tract infections, asthma; patients with impaired haematopoesis, porphyria, haemorrhagic diathesis; several renal or hepatic disease; uncontrolled hypertension (constant random diastolic blood pressure in spite of regular medication of at least two measurements > 180 and/or 110); severe heart failure (NYHA III-IV); decompensated diabetes mellitus (at requirement: bland-blood sugar over 400 mg/dl); patients with autoimmune disease (e.g. lupus erythematodes); positive urine pregnancy test at the onset of trial (if required); pregnant woman; breast-feeding woman; adolescents and children; participation in another clinical trial less than 30 days ago; simultaneous participation in another clinical trial
研究者
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