EUCTR2005-000508-15-CZ进行中（未招募）1 期
Efficacy and safety assessment of 6 months (24 weeks) treatment with Structum® 500 mg capsule bid in hip osteoarthritis: multicenter randomised double blind parallel group and placebo controlled study. - Not applicable
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
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
- •- Aged from 40 to 75 years,
- •- Suffering from osteoarthritis of the hip:
- •- answering to the ACR (American College of Rheumatology) criteria,
- •- evoluting for more than 6 months,
- •- with a pain score to the VAS (Visual Analogical Scale) higher than 40,
- •- with grade II or III of Kellgren and Lawrence classification established from a radiography dated lesser than 6-months,
- •- Unilateral coxalgia at the inclusion.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Haemochromatosis, ochronosis or haemophilia,
- •- Paget’s disease, chondromatosis or benign synovioma,
- •- Known symptomatic gonarthrosis homolateral to the hip osteoarthritis,
- •- Non osteoartritic pathology, inflammatory, infectious or metabolic arthritis (rheumatoid polyarthritis, ankylosing spondylitis, abarticular rheumatism),
- •- Symptomatic trochanteric bursitis or acute joint trauma of the target hip,
- •- Target hip, arthroscopy within the previous year,
- •- Hip osteoarthritis or other osteoarthritic pathology invalidating and/or that may need surgery during the study period,
- •- Using or having used NSAID within the past 2 days (including topical treatment near the hip osteoarthritis) or an antalgic drug within the past 12 hours,
- •- Having used treatment with SYSADOA (Symptomatic Slow-Acting Drugs for Osteoarthritis) within the 3 months prior to study start,
- •- Having used corticoids (by systemic or local route near the hip osteoarthritis) within the past month,
- •- Having received an intra-articular injection of corticoids, in the hip within the past 3 months,
- •- Being asthmatic needing regular or intermittent corticoid treatment,
- •- Immunodeficient patients or suffering from disease serious or chronic (cardiac, pulmonary, hepatic, renal, haematological, neoplasic or infectious),
- •- Acute or severe chronic pathology judged by the investigator as serious and incompatible with the study,
- •- History of pathology which, in the judgement of the investigator, puts them at risk” or is likely to modify their handling of the study results.
研究者
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