Creon use in patients with low faecal pancreatic elastase

• Research type

  Research Study

• Full title

  Randomized, double blind, placebo-controlled trial of Creon in patients with low faecal pancreatic elastase

• IRAS ID

  114736

• Contact name

  David S Sanders

• Sponsor organisation

  Sheffield Teaching Hospitals NHS Foundation Trust

• Eudract number

  2011-006019-73

• Research summary

  Faecal elastase is an enzyme test used to identify the presence of pancreatic exocrine insufficiency. This condition manifests with symptoms of diarrhoea, weight loss, causing potential impairment on an individual??s quality of life. Creon, a pancreatic enzyme supplement, marketed by Abbott Laboratories, Inc. is currently the standard treatment for this condition. However, there has been limited work evaluating the merits of this medication in this condition. This study aims to evaluate the benefits that Creon may have in patients with low faecal pancreatic elastase by randomising patients with low faecal pancreatic elastase (<200 æg/g) to either treatment with Creon or placebo. Outcome measures that we aim to assess to determine the benefits of Creon include evaluation of stool frequency, abdominal pain, body mass index (BMI) and quality of life.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  12/YH/0445

• Date of REC Opinion

  31 Oct 2012

• REC opinion

  Further Information Favourable Opinion