Efficacy and Safety of Creon IR in subjects with PEI

• Research type

  Research Study

• Full title

  A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis.

• IRAS ID

  169307

• Contact name

  James GREENWOOD

• Contact email

  james.greenwood@lhch.nhs.uk

• Sponsor organisation

  ABBOTT LABORATORIES GmbH

• Eudract number

  2014-004519-35

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  This Phase II double-blind and dose-ranging study will compare the efficacy and safety of 4 doses of Creon IR compared and currently marketed Creon® in patients with Pancreatic Exocrine Insufficiency due to Cystic Fribrosis.
  The study results will be used to select Creon IR dose(s) for the subsequent Phase III program.

• REC name

  North East - York Research Ethics Committee

• REC reference

  14/NE/1250

• Date of REC Opinion

  23 Feb 2015

• REC opinion

  Further Information Favourable Opinion