Clinical Trials Resource Center


November 30, 2009

Eurand reported positive results from a phase II/III trial of capsules for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis. This double-blind, randomized, dose-response control, crossover study enrolled 76 subjects in the United States, Italy and Ukraine. The subjects received either a low dose of Zenpep (35,000 lipase units/day) or a high dose (140,000 lipase units/day) taken with meals. Significant improvements in fat and protein absorption and body weight were observed in both dose arms. The mean coefficient of fat absorption (CFA) was 88.9% and 89.9% with the Zenpep lower and higher dose, respectively (p<0.001 compared to baseline). In a subgroup of patients with more severe exocrine pancreatic insufficiency, the higher dose of 140,000 lipase units/day was more effective (mean CFA 84.1%) than the lower dose (mean CFA 81.1%). Both Zenpep daily doses were safe and well tolerated.

June 4, 2007

Amsterdam Molecular Therapeutics reported positive results from a phase I/II trial of AMT-011 for the treatment of pancreatitis in subjects with Complete Lipoprotein Lipase (LPL) deficiency. This open-label, dose-escalating trial enrolled 8 subjects. Along with safety, the primary endpoints included either median fasting plasma triglyceride (TG) levels after administration of AMT-010 equal to or less than10 mmol/L, or a 40% reduction in median fasting plasma TG after administration on top of a fat-free diet. Treatment was well tolerated, with no drug related serious adverse events and no dose limiting toxicities. While a substantial reduction in median TG levels was observed in all the participants, both primary endpoints were reached by three subjects. A one year follow-up study is currently underway.

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