MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PHASE III FOR VIOKASE 16 FOR STEATORRHEA

VIOKASE 16 治疗脂肪泻的多中心、随机、双盲 III 期

• 批准号: 7950751
• 负责人: Phillip TOSKES
• 金额: $ 7.76万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7950751
• 关键词: Blood; Characteristics; Clinical Research; Collection; Computer Retrieval of Information on Scientific Projects Database; Diet; Double-Blind Method; Elastases; Exocrine pancreatic insufficiency; Fatty acid glycerol esters; Feces; Food; Frequencies; Funding; Grant; Hour; Institution; Intake; Laboratories; Monitor; Pancreatic enzyme; Pharmaceutical Preparations; Phase; Placebos; Proton Pump Inhibitors; Randomized; Research; Research Personnel; Resources; Source; Steatorrhea; United States National Institutes of Health; Urinalysis; Work; absorption; base; chronic pancreatitis; design; diaries; enzyme therapy

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. In order to answer the primary question does Viokase 16 decrease steatorrhea in subjects with chronic pancreatitis and steatorrhea exocrine pancreatic insufficiency EPI; a study has been designed that proposes to evaluate the efficacy of Viokase 16 against a placebo. The efficacy will be based on a comparison of the coefficient of fecal fat absorption CFA between Viokase 16 and placebo. The subjects will have baseline studies done off any pancreatic enzyme therapy. These studies will include laboratory blood work, urinalysis, fecal elastase and 100g fat diet studies with 72 hour stool collections for quantitative fecal fats and monitoring of concomitant medications will be done during the study period. To answer the secondary question; subjects will be given a diary at the beginning of the study to record necessary information about food, drug intake, stool frequency and characteristics of stools. Subjects will be on a proton pump inhibitor for the entire study.

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。 为了回答主要问题，Viokase 16是否能降低慢性胰腺炎和脂肪肝外分泌胰腺功能不全EPI受试者的脂肪肝;设计了一项研究，旨在评价Viokase 16相对于安慰剂的疗效。 疗效将基于Viokase 16和安慰剂之间粪便脂肪吸收系数CFA的比较。 受试者将在任何胰酶治疗后进行基线研究。 这些研究将包括实验室血液检查、尿分析、粪便弹性蛋白酶和100 g脂肪饮食研究，其中将在研究期间进行72小时粪便收集以定量粪便脂肪和伴随药物监测。 为了回答次要问题;在研究开始时，将为受试者提供日记，以记录有关食物、药物摄入、排便频率和粪便特征的必要信息。 受试者将在整个研究期间接受质子泵抑制剂治疗。