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Lupus Clinical Trials

New Medical Therapies™

Pancreatitis

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.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.