drugset / Trial / NCT02127021

The Effects of High Dose Pancreatic Enzyme Replacement Therapy After Pancreatoduodenectomy

NCT02127021

RandomizedParallel-groupDouble-blindSupportive care

Summary

Up to now, the studies concerning nutritional assessment after pancreatic resection were rare. The low-dose pancreatic enzyme treatment after pancreatectomy showed no significant benefit in terms of nutritional status. This study is a multicenter randomized phase IV study by using high-dose Norzyme® (40,000 IU) to evaluate quality of life and nutritional status after pancreaticoduodenectomy.

Timeline

Start
2014-04
Primary completion
2017-09-07
Completion
2017-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Pancrelipase Protein / enzyme biologic 40000 iu Oral

Indications