STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ZENTASE (EUR-1008) IN CP PATIENTS

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。 胰腺外分泌功能不全EPI是一种以脂肪、蛋白质和较小程度的碳水化合物吸收不良为特征的综合征，其在慢性胰腺炎CP患者中表现出来。 1 Zentase是一种新的猪源性胰酶替代产品，用于治疗与EPI相关的吸收不良。 本研究旨在评估与安慰剂相比，高剂量和低剂量Zentase治疗EPI CP患者吸收不良体征和症状的疗效。 将比较两种不同剂量的Zentase与安慰剂给药后脂肪吸收系数CFA的平均改善。 每例受试者将开始安慰剂研究，然后随机分配至两个治疗阶段之一。 研究的每个阶段要求受试者填写日记，其中包含研究药物消耗、饮食和临床体征和症状、使用的其他药物和任何不良事件的数据。 受试者将前往综合临床研究中心共3次，进行定量粪便脂肪评估，包括100 g脂肪饮食，72小时定量粪便脂肪收集和分析。

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. Exocrine pancreatic insufficiency EPI is a syndrome characterized by poor absorption of fats, proteins and to a lesser extent, carbohydrates, which manifests in patients with chronic pancreatitis CP. 1 Zentase is a new porcine-derived pancreatic enzyme replacement product developed for the treatment of malabsorption associated with EPI. This study has been designed to assess the efficacy of a high and low dose of Zentase compared to placebo in the treatment of the signs and symptoms of malabsorption in CP patients with EPI. A comparison will be made of the mean improvement in the Coefficient of Fat Absorption CFA after administration of the two different doses of Zentase vs. placebo. Each subject will begin the study on placebo then be randomized to one of the two treatment phases. Each phase of the study requires the subject to fill in a diary containing data on study drug consumption, diet and clinical signs and symptoms, other drugs taken and any adverse events. Subjects will come to the General Clinical Research Center for a total of 3 times to have a quantitative fecal fat assessment which will include a 100g fat diet with a 72 hour quantitative fecal fat collection and analysis.