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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 为了回答主要问题，VIOKASE 16会减少慢性胰腺炎和脂肪性外分泌胰腺胰腺胰腺胰腺炎不足的受试者的脂肪敏。已经设计了一项研究，建议评估VIOKASE 16对安慰剂的功效。 功效将基于对Viokase 16和安慰剂之间粪便吸收CFA系数的比较。 受试者将进行基线研究，从任何胰腺疗法进行。 这些研究将包括实验室血液检查，尿液分析，粪便弹性酶和100G脂肪饮食研究，并在研究期间将进行72小时的粪便收集，用于定量粪便脂肪以及对随之而来的药物进行监测。 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，粪便频率和粪便特征的必要信息。 整个研究的受试者将在质子泵抑制剂上。