NCT01033305

Oral Ciclosporin for Colonic Release in Ulcerative Colitis (CyCol™)

A Phase II, Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapsule Formulation of Ciclosporin (CyCol™) in the Treatment of Mild to Moderate Ulcerative Colitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Sigmoid Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center study in Ireland and United Kingdom to determine the effects, safety and tolerability of a drug called CyCol™ in improving mild to moderate ulcerative colitis (UC). Informed consent will be obtained and following confirmation of eligibility and disease assessment, study participants will be randomised (allocated by chance) to take either CyCol™, or placebo, orally once every day for four weeks. Study visit assessments will include blood and stool tests, physical examinations and flexible sigmoidoscopies (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. Any side effects experienced during the study and the safety of treatment with CyCol™ will also be evaluated.

Conditions

• Mild to Moderate Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	CyCol™	Orally, once per day for 4 weeks
DRUG	Placebo	Orally, once per day for 4 weeks

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-08-01
• Completion: 2011-09-01
• First posted: 2009-12-16
• Last updated: 2012-04-19

Locations

22 sites across 2 countries: Ireland, United Kingdom