NCT01271348已完成1 期
Multiple-dose, Randomized, Double Blinded, Placebo-controlled, Cross Over Study of Etoricoxib for the Treatment of Muscle Pain and Inflammation Induced by Eccentric Exercise
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain during muscle contraction
研究概览
简要总结
Comparison of the effect of etoricoxib to placebo on muscle pain caused by eccentric contractions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed and dated informed consent prior to participation
- •Subjects in good health as determined by the Investigator
- •Age 18-40 or 50-70
- •BMI > 20 and < 30
- •Pain in the target muscle (thigh) during muscle contraction of at least 5 on an 11 point categorical pain rating scale
- •Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study treatment periods (Screening to Final Visit)
- •For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are not allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are allowed for participation
排除标准
- •Participation in another clinical study within the last 30 days and during the study
- •Subjects who are inmates of psychiatric wards, prisons, or other state institutions
- •Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
- •Pregnancy or lactation
- •Alcohol or drug abuse
- •Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma
- •Known hypersensitivity to etoricoxib or other NSAID´s including Cox-2, or any of their excipients
- •Bronchospasm, acute rhinitis, nasal congestion, angioneurotic edema, urticaria or allergic reactions after taking aspirin or other NSAIDs including Cox-2 inhibitors
- •Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-sceletal system of the lower limbs
- •Pain conditions which might interfere with pain rating during the study, e.g. neuropathic pain
- •Significant neurological or psychiatric symptoms resulting in disorientation, memory impairment, or inability to report accurately (e.g. depressive disorders, Alzheimer's disease, schizophrenia or other psychosis), that in the investigator's opinion may affect efficacy or safety assessments or may compromise subject safety during the study
- •Heart failure (NYHA II-IV)
- •Long term blood pressure > 140/90 mm Hg without adequate treatment
- •Peripheral arterial disease, coronary heart disease and/or cerebrovascular disease
- •History of stroke or myocardial infarction
- •Clinically relevant ECG changes
- •Estimated creatinine clearance < 60 ml/min
- •Liver dysfunction (e.g. defined by ALT and/or AST levels above upper limit of normal range)
- •Coagulopathy or bleeding diathesis, or concomitant use of anticoagulants including low dose aspirin
- •History of pancreatitis, peptic ulcers or gastrointestinal bleedings
- •Inflammatory GI disease (e.g. M. Crohn, colitis ulcerosa)
- •Any other analgesic therapy including cough and cold drugs containing analgesic properties as well as any other substance used for the treatment of pain during the study observation period (Screening to final Visit)
- •Any other drug that might alter pain perception like CNS active drugs
- •Statins within 3 months of screening and throughout the study
- •Oral anticonceptives
研究组 & 干预措施
Etoricoxib
Active Comparator
干预措施: Etoricoxib (Drug)
Placebo tablet
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Pain during muscle contraction
时间窗: 7 days
次要结局
未报告次要终点
研究者
研究点 (1)
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