EUR-1008 vs Creon in pancreatic insufficiency in CF Patients Version 1

• Research type

  Research Study

• Full title

  A Randomized, Double Blind, Active-Controlled, Two-treatment, Crossover Multinational, Multicenter Trial to Compare Two Pancreatic Enzyme Products in the Treatment of Exocrine Pancreatic Insufficiency in Subjects with Cystic Fibrosis

• IRAS ID

  33674

• Contact name

  Christopher Taylor

• Sponsor organisation

  Eurand S.p.A.

• Eudract number

  2009-012842-21

• ISRCTN Number

  n/a

• Research summary

  This study will compare the effectiveness of two different treatments for pancreatic insufficiency in people with cystic fibrosis aged twelve years or older. During the study participants will use both treatments at different times but neither them nor the study doctors will know which treatment is which. The main measurement of effectiveness will be how well the body can absorb fat from food eaten during the study. In addition, the research will compare how well nitrogen is absorbed from food and changes in body weight during treatment with the two products.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  10/H1306/59

• Date of REC Opinion

  20 Sep 2010

• REC opinion

  Further Information Favourable Opinion