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AS 013 IN LIPID EMULSION IN SUBJECTS W/ SEVERE LIMB ISCHEMIA

AS 013 IN LIPID EMULSION IN SUBJECTS W/ SEVERE LIMB ISCHEMIA
AS 013 在脂质乳剂中用于患有严重肢体缺血的受试者
批准号：
6265163
负责人：
JOHN F HANSBROUGH
金额：
$1.15万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN DIEGO
依托单位国家：
美国
项目类别：
财政年份：
1998
资助国家：
美国
项目状态：
已结题
起止时间：
1998-12-01 至 1999-11-30
来源：
https://reporter.nih.gov/project-details/6265163
关键词：
acute disease /disorder amputation analgesics artery occlusion cardiovascular disorder chemotherapy clinical research disease /disorder prevention /control drug administration rate /duration drug screening /evaluation emulsions functional ability human subject human therapy evaluation insulin ischemia limbs neuropathology opiate alkaloid peripheral blood vessel disorder placebos prodrugs prostaglandin E ulcer

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中文摘要
翻译
使用以下评估证明30或60 mg/天AS-013相对于安慰剂在方丹IV期外周动脉闭塞性疾病（PAOD）受试者中的疗效：大截肢需求的减少、截肢时间、完全靶溃疡愈合的发生率、任何截肢或PAOD相关手术的需求以及功能状态的变化。 此外，评价AS-013在目标人群中的剂量反应关系，评估AS-013的安全性，并对AS-013对神经病变、胰岛素需求和阿片类镇痛药消耗的影响进行探索性分析。
英文摘要
Demonstrate the efficacy of 30 or 60 mg per day of AS-013 to placebo in subjects with Fontaine stage IV peripheral arterial occlusive disease (PAOD) utilizing the following assessments: reduction in need for major amputation, time to amputate, incidence of complete target ulcer healing, need for any amputation or PAOD-related surgery, and change in functional status. Also, evaluate the dose response relationship of AS-013 in target population, assess the safety of AS-013, and perform exploratory analyses on the effects of AS-013 on neuropathy, insulin requirement, and opiate analgesic consumption.
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BURN/TRAUMA RESEARCH TRAINING GRANT
BURN/TRAUMA RESEARCH TRAINING GRANT
BURN/TRAUMA RESEARCH TRAINING GRANT
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