PANCRELIPASE AND CYSTIC FIBROSIS

胰脂肪酶和囊性纤维化

• 批准号: 7951313
• 负责人: Gavin R Graff
• 金额: $ 0.51万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-01 至 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951313
• 关键词: Clinical Research; Collection; Computer Retrieval of Information on Scientific Projects Database; Cross-Over Studies; Double-Blind Method; Drug Formulations; Exocrine pancreatic insufficiency; Fatty acid glycerol esters; Feces; Funding; Genetic Crossing Over; Grant; Institution; Medical center; Nitrogen; Pancreatic enzyme; Pancrelipase; Patients; Pharmaceutical Preparations; Placebo Control; Placebos; Preparation; Randomized; Research; Research Personnel; Resources; Safety; Source; Supplementation; United States National Institutes of Health; absorption; comparative efficacy; cystic fibrosis patients; novel

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 double-blind, randomized, multicenter but placebo controlled crossover study of a novel formulation of pancreatic enzyme for treatment of patients with cystic fibrosis and pancreatic insufficiency. The study proposes to treat a total of 26 patients at various centers including 5 patients here at the Penn State Hershey Medical Center. The primary study objective is to compare efficacy of this novel formulation to placebo in promoting fat absorption in these patients. There are various other secondary objectives including nitrogen absorption and safety and tolerability. After registration patients will be randomized to either begin with the study drug or begin with placebo, but in each case after initiating treatment with one or the other, patients will be crossed over to the opposite preparation. The GCRC is thus necessary for compliance with the study including six days of stool collection. At the end of the six days of study treatment, the patients will be switched to a "wash out period" of 3 to 14 days of their usual pancreatic enzyme supplementation, and then begin a second period with the opposite preparation (i.e., placebo or study drug). This second preparation will again be performed in the GCRC over a five to six day period.

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。子项目和 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。 这是一项双盲、随机、多中心但安慰剂对照的交叉研究，研究一种新型胰酶制剂，用于治疗囊性纤维化和胰腺功能不全患者。 该研究计划在各个中心治疗总共 26 名患者，其中包括宾夕法尼亚州立大学好时医疗中心的 5 名患者。 主要研究目的是比较这种新型制剂与安慰剂在促进这些患者脂肪吸收方面的功效。 还有各种其他次要目标，包括氮吸收以及安全性和耐受性。 注册后，患者将被随机分配从研究药物开始或从安慰剂开始，但在每种情况下，在开始使用一种或另一种药物治疗后，患者将被交叉到相反的制剂。 因此，GCRC 对于遵守研究（包括六天的粪便收集）是必要的。 在六天的研究治疗结束时，患者将进入为期 3 至 14 天的“清洗期”，继续补充通常的胰酶，然后开始第二个阶段的相反制剂（即安慰剂或研究药物）。第二次准备工作将在 GCRC 中再次进行，为期五到六天。