EUCTR2005-003258-87-CZ进行中（未招募）不适用
Efficacy and safety of intra-articular multiple doses of 500 mg icatibant including 40 mg triamcinolone as calibrator in a randomized, double-blind, parallel-group, placebo-controlled 13-week multi-centre study in patients with symptomatic knee osteoarthritis*After the clinical start of the study, an extension of the follow-up period has been established by Amendment n° 2, extending the observation period by further 26 weeks; thus, the overall study duration will become totally 39 weeks. - Not applicable
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 550
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 and female subjects with painful osteoarthritis of the knee
- •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
- •·Subjects with knee OA of Kellgren & Lawrence grade < II
- •·Age < 18 years
- •·Diagnosis of OA < 3 months (based on the 1986 American College of Rheumatology (ACR) diagnostic criteria
- •·History of inflammatory or infectious joint disease of an origin other than OA
- •·Acute major trauma
- •·Existence of another pain problem at localizations other than the target knee joint (e.g., migraine, low back pain etc., but also bilateral symptomatic knee OA)
- •·Any intra-articular injections within the previous 6 months of hyaluronic acid (HA) or within 3 months of corticosteroids, respectively
- •·Surgery of the lower extremities within the last 6 months, or clinically relevant trauma with impact on study objectives within the last 2 months
- •·Cardiovascular diseases or any abnormal findings in the electrocardiogram (ECG) that may require acute treatment or could otherwise interfere with the conduct of the trial
- •·Childbearing potential without an accepted contraceptive regimen, i.e., a measure with a proven low failure rate
- •·Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
- •·Symptoms of a clinically relevant illness in the 3 months before the study with possible impact on the study objectives (e.g. episodes of headache or migraine, intermittent paresis, peripheral obstructive arterial disease etc.)
- •·Pregnancy or breast-feeding
- •·History of hypersensitivity to the study drug or to drugs with a similar chemical structure
- •·Hypersensitivity to paracetamol (acetaminophen)
- •·Hypersensitivity to corticosteroids
- •·Diabetes mellitus type 1 or 2 (due to known interactions of triamcinolone with anti-diabetics resulting in glucose dysbalances)
- •·Treatment with anti-coagulation therapy
- •·Treatment with any investigational product in the last 3 months before study entry
- •Exclusion criteria at baseline (Visit 2)
- •Subjects presenting at baseline additionally with any of the following will not be included in the study:
- •·General knee pain score < 40 units and > 80 units on a 100-unit VAS
- •·Compliance of < 75% of the EPD entries during the entire screening phase
- •·Intake of paracetamol or any other OA-directed medication during the screening phase
研究者
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