Pentasa (mesalazine) vs placebo in active Crohn's Disease.

• Research type

  Research Study

• Full title

  Pentasa in active Crohn's Disease : A 10-week double-blind, multi-centre trial comparing Pentasa sachet 6g/day (mesalazine) with placebo.

• Sponsor organisation

  Ferring Pharmaceutical A/S

• Eudract number

  2008-002100-26

• ISRCTN Number

  0000000000000

• Clinicaltrials.gov Identifier

  0000000000000

• Research summary

  This is a 10-week, double-blind, multi-centre study which aims to show that 6g of Pentasa is effective in mild to moderate Crohn's disease (CD) patients. There are approx 60,000 patients in the UK who are affected by Crohn's disease. CD can affect any part of the GI tract although the small bowel is most commonly affected and the colon is involved in approx 50% of all CD patients, thus this area is of crucial importance to be studied. Although pentasa is available for use at the moment, it is thought that the current recommended dosage may be too low for some patients and as such the daily dose has been increased for this study to investigate the possibility of a dose response.Current treatment options for CD include anti-inflammatory and immunomodulatory medications, along with surgical intervention in severe cases. Compounds containing 5-acetylsalicylic acid (5-ASA) such as mesalazine, the active ingredient in Pentasa, are anti-inflammatory drugs with few side effects in widest use for the treatment of Irritable Bowel Disease. CD also has a large flunce on quality of life and work productivity. These will be assessed in this study through the use of questionnaires which will be completed by the participants on 4 occassions for each questionnaire.Participants will attend a study clinic 5 times in 10 weeks. They will maintain a daily telephone diary which will be used to assess their response to the study drug using the Crohns disease activity index. This will then be used to ascertain the extent of a response to Pentasa as well as remission status.The study is funded by Ferring Pharmaceuticals based in Denmark and will include 5 UK hospital sites. Worlwide this study will include approx 75 centres in Europe and North America.

• REC name

  Wales REC 3

• REC reference

  08/MRE09/74

• Date of REC Opinion

  7 Jan 2009

• REC opinion

  Further Information Favourable Opinion