MOTUS Version 3.0

• Research type

  Research Study

• Full title

  Multicentre, controlled, randomised, investigator-blinded, comparative study of oral mesalazine 4g per day once daily versus 4g per day in two divided doses in patients with active ulcerative colitis.

• Contact name

  Christopher S J Probert

• Sponsor organisation

  Ferring Pharmaceuticals Ltd.

• Eudract number

  2008-000045-59

• Research summary

  Ulcerative colitis, an inflammatory bowel disease, is a relapsing and remitting disease. It is characterised by inflammation of the lining of the large intestine and rectum. The aim of treatment is to induce remission (absence of symptoms) and then maintain it. A key element in the therapeutic response of ulcerative colitis is treatment compliance. In daily practice, compliance with ulcerative colitis therapy appears mediocre. Reducing the dosing rate from twice daily to once daily constitutes a simple method of improving treatment compliance, but it is necessary to demonstrate at least equivalent efficacy compared to the twice daily dosing. In this study patients with active mild or moderate ulcerative colitis will randomly receive: ?½ either 4 grams per day once daily (morning only) ?½ or 4 grams per day in two divided doses (morning and evening). Patients will receive treatment for 8 weeks, with an additional mesalazine rectal enema every day for the first 4 weeks. If patients are in remission at 8 weeks, they will be given 2g per day once daily for a further 4 weeks. The maximum duration of participation in the study is 12 weeks. Process for the research participant: At a Screening visit the researcher will check the health of the research participant. This Screening visit may be split into two parts dependent upon the availability of the relevant blood test results. If the researcher believes that the research participant meets all the requirements for the study, they will be randomised and dispensed the study medication. The patients will be treated for up to 12 weeks, with clinical evaluations at baseline, week 4, 8 and 12 and endoscopic evaluations (sigmoidoscopy or colonoscopy) at baseline and week 8. This research study is sponsored and funded by Ferring Pharmaceuticals Ltd. Participants will be recruited from hospitals within Europe.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  08/H0106/121

• Date of REC Opinion

  19 Nov 2008

• REC opinion

  Further Information Favourable Opinion