Long term effect of Mesalamine/mesalazine on ulcerative colitis

• Research type

  Research Study

• Full title

  A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long-term Maintenance Phase With 2.4g/day MMX® Mesalamine/mesalazine Once Daily in Adult Subjects With Ulcerative Colitis

• IRAS ID

  46172

• Contact name

  Ailsa Hart

• Sponsor organisation

  Shire Development Inc

• Eudract number

  2009-017044-13

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a study in approximately 700 patients with active, mild to moderate ulcerative colitis. Successfully screened patients will enter the acute open label treatment phase (receiving 4.8g/day MMX mesalamine/mesalazine). After 8 weeks, patients will be assessed and those who are considered to have partially or completely responded to treatment will be entered into the open label maintenance phase of the study (receiving 2.4g/day MMX mesalamine / mesalazine). The maintenance phase of the trial will last for 12 months, at the end of which the patients’ ulcerative colitis will be assessed. The aim of the study is to determine whether the proportion of patients who were in complete remission at 12 months is equal between the group of patients who were in complete remission at Month 0 and the group who were in partial remission at Month 0. The sites taking part in this study will all be hospital centres.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  10/H0408/48

• Date of REC Opinion

  30 Jun 2010

• REC opinion

  Further Information Favourable Opinion