PANCRELIPASE AND CYSTIC FIBROSIS

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH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 中心，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治疗囊性纤维化和胰腺功能不全患者。 该研究计划在不同的中心治疗26名患者，其中包括宾夕法尼亚州立好时医疗中心的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疗效。 还有各种其他次要目标，包括氮吸收以及安全性和耐受性。 登记后，患者将随机分配至开始研究药物或开始安慰剂，但在每种情况下，在开始一种或另一种治疗后，患者将交叉至相反的制剂。 因此，GCRC对于研究依从性是必要的，包括6天的粪便收集。 在6天的研究治疗结束时，患者将转换到3至14天的“洗脱期”，其通常补充胰酶，然后开始第二个时期，用相反的制剂（即，安慰剂或研究药物）。第二次制备将再次在GCRC中进行，持续5至6天。

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.