Paediatric PK Ulcerative Colitis Study, version number: 6.0,04SEP2012

• Research type

  Research Study

• Full title

  A Phase 1, Multicenter,Open-label Study to Determine the Safety and Pharmacokinetics of MMX Mesalamine Following Administration in Children and Adolescents With Ulcerative Colitis

• IRAS ID

  113170

• Contact name

  Nicholas Croft

• Contact email

  n.m.croft@gmul.ac.uk

• Sponsor organisation

  Shire Pharmaceutical Development Limited

• Eudract number

  2011-000164-10

• Clinicaltrials.gov Identifier

  NCT01130844

• Research summary

  Ulcerative colitis (UC) is a serious chronic inflammatory disease of the colon and rectum distinguished by cycles of remission and relapse over the life of the patient. The major clinical feature is diarrhea with or without blood. Life expectancy after recovery from a first attack is unchanged; however, morbidity can be long lasting and may be associated with various extra intestinal and late complications. Shire is proposing to evaluate SPD476 (MMX mesalamine) in children and adolescents diagnosed with ulcerative colitis. The first study of this program will be this Phase 1, open label study in children and adolescents exploring the exposure to 5-ASA and its steady state pharmacokinetics following 7 days of SPD476 (study drug) dosing. The results of this study will be used to guide appropriate dose selection for a larger, Phase 3 efficacy and safety study.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  12/LO/1628

• Date of REC Opinion

  4 Jan 2013

• REC opinion

  Further Information Favourable Opinion