AN OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF EURAND PANCREATIC ENM

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 Eurand Spa设计了一项开放标签、多剂量、单一治疗、多中心的临床研究，用于治疗年龄较小的CF和EPI患者(年龄小于7岁)，以确定Eurand PEP微片的有效性和安全性。这项研究的结果将与现有的安全性数据一起提交，作为505(B)(2)新药申请的一部分。这项研究是根据FDA 2004年关于胰腺外分泌功能不全药物产品的指南草案设计的。按研究期划分的评估时间表和程序载于附录1。

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. Eurand SpA has designed an open-label, multiple-dose, single-treatment, multicenter, clinical study in younger patients with CF and EPI (age younger than 7 years) to determine the efficacy and safety of Eurand PEP Microtabs ¿. The results from this study will be submitted in conjunction with existing safety data as part of a 505(b) (2) new drug application. The study has been designed in accordance with FDA 2004 draft guidelines on exocrine pancreatic insufficiency drug products. The Schedule of Assessments and Procedures by Study Period is provided in Appendix 1.