COMPARISON OF SANDOSTATIN TO SANDOSTATIN LAR DEPOT IN THE TRMT OF PANC PAIN

善他汀与善他汀 LAR Depot 在治疗 PANC 疼痛中的比较

• 批准号: 7374651
• 负责人: Phillip TOSKES
• 金额: $ 2.05万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7374651
• 关键词: COMPARISON; SANDOSTATIN; LAR; DEPOT; TRMT

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. The treatment of abdominal pain in chronic pancreatitis is unsatisfactory. Medical therapy includes abstinence from alcohol, analgesics, and pancreatic enzymes. Nonenteric-coated enzymes are primarily used for pain since they deliver serine proteases to the duodenum and can reduce excess stimulation by CCK in these patients. Randomized trials of these enzymes demonstrate they reduce pain in some patients. Failure of medical therapy is not uncommon. Some patients are candidates for endoscopic or surgical therapy; these can only be applied in a subgroup of patients with substantial abnormalities of the pancreatic duct. Many patients continue to experience pain despite medical and other therapies. Better therapies are needed. The primary objective of this pilot trial is to evaluate the effect of Sandostatin LAR¿ on pain in subjects with painful chronic pancreatitis and to compare it to a bioequivalent dose of Sandostatin¿. The primary endpoint is to determine the reduction in pain as determined by VAS (visual analog scale). Secondary endpoints will be changes in quality of life, nutritional status, percent reduction in pain medication, and effect on subject reported health outcomes. Approximately 25 subjects already taking Sandostatin¿ will be enrolled and serve as their own control. Eligible subjects will be treated with Sandostatin LAR¿ for a total of 6 months. Subjects will keep a daily diary of pain medication usage and will record their worst pain for the day on a VAS. Quality of life, nutritional status and subject reported health outcomes will be assessed on a routine basis.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。慢性胰腺炎腹痛的治疗不令人满意。药物治疗包括戒酒、止痛药和胰酶。非肠溶酶主要用于疼痛，因为它们将丝氨酸蛋白酶递送到十二指肠，并且可以减少这些患者中CCK的过度刺激。这些酶的随机试验表明，它们可以减轻一些患者的疼痛。药物治疗失败并不罕见。有些病人是内镜或手术治疗的候选人;这些只能应用于一个亚组的患者有实质性异常的胰管。尽管有药物和其他治疗，许多患者仍然会感到疼痛。需要更好的治疗。 这项初步试验的主要目的是评价善得定LAR <$对疼痛性慢性胰腺炎受试者疼痛的影响，并将其与生物等效剂量的善得定<$进行比较。主要终点是通过VAS（视觉模拟量表）确定疼痛减轻。次要终点将是生活质量、营养状况、止痛药减少百分比以及对受试者报告的健康结局的影响。 将入组约25例已服用善得定的受试者，并作为其自身对照。合格受试者将接受善得定LAR？治疗，共6个月。受试者将记录止痛药使用的每日日志，并在VAS上记录当天最严重的疼痛。将定期评估生活质量、营养状况和受试者报告的健康结局。