Mild to Moderate Ulcerative Colitis Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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