ULTRASE MT20 FOR CORRECTION OF STEATORRHEA IN PATIENTS WITH CYSTIC FIBROSIS

ULTRASE MT20 用于纠正囊性纤维化患者的脂肪泻

• 批准号: 7604922
• 负责人: RICHARD C AHRENS
• 金额: $ 2.21万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604922
• 关键词: Collection; Computer Retrieval of Information on Scientific Projects Database; Cross-Over Studies; Data; Double-Blind Method; Enzymes; Evaluable Disease; Fatty acid glycerol esters; Feces; Funding; Grant; Hour; Inpatients; Institution; Marketing; Measures; Outpatients; Pancreatic enzyme; Phase; Placebo Control; Placebos; Randomized; Research; Research Personnel; Resources; Safety; Screening procedure; Site; Source; Steatorrhea; United States Food and Drug Administration; United States National Institutes of Health; cystic fibrosis patients; day

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a multicenter phase III, randomized, double-blind, placebo-controlled crossover study evaluating the safety and efficacy of Ultrase MT20 (pancreatic enzyme product). The study consists of an outpatient screening phase of up to 11 days, 2 study enzyme stabilization periods and 2 inpatient stays lasting 6-7 days each for comparing active study enzymes to placebo in amount of fecal fat measured during a 72-hour stool collection. A sufficient numer of CF subjects will be randomized in order to get a total of 24 evaluable subjects from approximately 8 sites. This is to meet the FDA mandate that after 2008, all enzyme products must submit efficacy/safety data or be pulled from the market.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 这是一项多中心 III 期、随机、双盲、安慰剂对照交叉研究，评估 Ultrase MT20（胰酶产品）的安全性和有效性。 该研究包括长达 11 天的门诊筛查阶段、2 个研究酶稳定期和 2 个持续 6-7 天的住院期，用于比较活性研究酶与安慰剂在 72 小时粪便收集期间测量的粪便脂肪量。 将随机分配足够数量的 CF 受试者，以便从大约 8 个地点获得总共 24 名可评估受试者。 这是为了满足 FDA 的要求，即 2008 年之后，所有酶产品必须提交功效/安全数据，否则将被撤出市场。