Oral Ciclosporin for Colonic Release in Ulcerative Colitis (CyCol)

• Research type

  Research Study

• Full title

  A Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapsule Formulation of Ciclosporin (CyCol™)in the treatment of mild to moderate Ulcerative Colitis

• IRAS ID

  25588

• Contact name

  Stuart Bloom

• Sponsor organisation

  Sigmoid Pharma Ltd

• Eudract number

  2008-003169-19

• ISRCTN Number

  NA

• Clinicaltrials.gov Identifier

  NCT01033305

• Research summary

  This is a randomised, double-blind, placebo-controlled study of a controlled release minicapsule formulation of ciclosporin (CyCol™) in the treatment of patients with mild to moderately active ulcerative colitis. One hundred participants will be enrolled into the study. Following informed consent, confirmation of eligibility and disease assessment the study participants will be randomised (allocated by chance) to take either CyCol™, a new formulation of ciclosporin, or placebo orally once every day for four weeks. Participants will continue to receive their current therapies assessment will include blood tests and flexible sigmoidoscopy (inspection of the bowel wall using a flexible camera). Half the participants will receive CyCol™ and half will receive placebo. At the end of treatment (4 weeks) study participants will be reassessed again and the findings in those who received CyCol™ will be compared with those who received placebo. The effectiveness of treatment will be measured using a “Disease Activity Index” - a system to score the extent of a patients disease that takes into consideration the general health of the patient as assessed by the doctor, the frequency and consistency of stool formation as self-assessed by the patient, the appearance of the colon wall as determined by sigmoidoscopy and the extent of inflammation based on microscopic examination of sample biopsies removed from the patient during sigmoidoscopy. Any side effects experienced and the safety of treatment with CyCol™ will also be evaluated.

• REC name

  London - Central Research Ethics Committee

• REC reference

  10/H0718/14

• Date of REC Opinion

  4 Mar 2010

• REC opinion

  Favourable Opinion