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

这个子项目是众多研究子项目之一

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.