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

评估 EURAND 胰腺 ENM 安全性和有效性的开放标签研究

• 批准号: 7605508
• 负责人: L T SPENCER
• 金额: $ 0.05万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-23 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605508
• 关键词: Age; Appendix; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Data; Dose; Exocrine pancreatic insufficiency; Funding; Grant; Guidelines; Institution; Label; Pancreas; Pharmaceutical Preparations; Procedures; Research; Research Personnel; Resources; Safety; Schedule; Source; United States Food and Drug Administration; United States National Institutes of Health; cystic fibrosis patients; design

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.

这个子项目是许多研究子项目中的一个 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来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 Eurand SpA设计了一项开放标签，多剂量，单次治疗，多中心，临床研究，在年轻的CF和EPI患者（年龄小于7岁），以确定Eurand PEP Microtabs的疗效和安全性。本研究的结果将与现有安全性数据一起提交，作为505（B）（2）新药申请的一部分。本研究的设计符合FDA 2004年胰腺外分泌功能不全制剂指南草案。 按研究期列出的评估和程序时间表见附录1。