EUR-1008-M

点击翻译按钮获取中文摘要

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 study will be a randomized, double-blind, placebo-controlled, 2-treatment, crossover, multicenter trial in patients with cystic fibrosis and exocrine pancreatic insufficiency. The study sample will consist of a minimum of 30 evaluable male of female patients who are > or equal to 7 years of age, with a body weight of <70kg, a BMI >20kg/m2 for adults or a BMI above the 25th percentile for patients aged 7 through 20 years, and a confirmed diagnosis of CF and EPI. The study design involves a screening period (1-4 days), a dose titration/stabilization period (6 -9 days), a randomized treatment period (approximately 6 days), an open label normalization , a crossover treatment period , followed by a second open-label normalization. The order of treatments will be determined by randomization at the beginning of treatment period 1 only and will carry through the crossover treatment period. The starting dose for treatment will be 1,000 lipase units/kg/meal, with a total dose less than or equal to 2,500 lipase units/kg/meal and less than or equal to 4,000 lipase units/kg/meal, not to exceed 10,000 lipase units/kg/day. All patients will receive a combination of the 4 dosage formulations, which are to be taken with meals. It is recommended that the total dose of pancrelipase (porcine enzyme preparation) being ingested for a meal or snack be dispersed equally (with fluids) before, during, and after the meal of snack. During the study, all patients will consume a diet that will derive 45% if calories from fat, 20% of calories form protein, and 35% of calories from carbohydrate. The sponsor will provide menus from the recommended diet and a nutritionist will discuss all aspects of meal preparation with the patient or guardian. During home treatment periods, patients will record daily food intake and a diary for review by the investigator. During the in-patient portions of the randomized treatment periods, all food will be prepared under the supervision of a nutritionist experienced in the treatment of CF patients. The type and amount of food consumed will be closely monitored during this time.