Study of MMX® Mesalamine/Mesalazine in Paediatric Ulcerative Colitis

• Research type

  Research Study

• Full title

  A Phase 3, Multicentre, Randomised, Double-Blind study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases

• IRAS ID

  161800

• Contact name

  Nicholas Croft

• Contact email

  n.m.croft@gmul.ac.uk

• Sponsor organisation

  Shire Development LLC

• Eudract number

  2013-001744-65

• Research summary

  The primary objective of the Double-blind Acute Phase of the study is to assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate UC (Ulcerative Colitis).
  The primary objective of the Double-blind Maintenance Phase of the study is to assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years who are in remission.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  14/LO/1459

• Date of REC Opinion

  22 Oct 2014

• REC opinion

  Further Information Favourable Opinion