A 2012 one week, double-blind, randomised, placebo-controlled, parallel-group, multicentre study in India. 61 patients (34 pancreatin, 28 placebo) from a pool of subjects, men and women ≥18 years of age with proven CP and PEI, were randomised 1:1 to pancreatin or placebo (two capsules orally per main meal, one with snacks). The results provide evidence for the efficacy of pancreatin (Creon 40000 MMS) in patients with pancreatic exocrine insufficiency due to chronic pancreatitis, and confirm that this formulation is well tolerated, with a good safety profile.
References:
Thorat, V., Reddy, N., Bhatia, S., Bapaye, A., Rajkumar, J.S., Kini, D.D., Kalla, M.M. and Ramesh, H. (2012), Randomised clinical trial: the efficacy and safety of pancreatin enteric-coated minimicrospheres (Creon 40000 MMS) in patients with pancreatic exocrine insufficiency due to chronic pancreatitis – a double-blind, placebo-controlled study. Aliment Pharmacol Ther, 36: 426-436. https://doi.org/10.1111/j.1365-2036.2012.05202.x