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Oral Ciclosporin for Colonic Release in Ulcerative Colitis (CyCol™) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT01033305•Sigmoid Pharma

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female aged \> 18 years
•Diagnosis of mild to moderate diagnosis of UC involving at least the rectum and sigmoid colon
•Clinical severity assessed at screening using the Disease Activity Index (DAI)
•Clinical severity documented and confirmed by flexible sigmoidoscopy, within 7 days of starting study treatment
•Signed and dated written informed consent.
•Willing to maintain current UC medication dosing regimen from screening until the end of the 4-week treatment period.
•Able and willing to refrain from intake of St. Johns Wort or any other prescription, over-the-counter, or herbal preparation that is known to affect cytochrome P450 metabolism throughout the 4-week treatment period.
•Able and willing to refrain from intake of grapefruit or grapefruit juice or any other food or drink that is known to affect cytochrome P450 metabolism throughout the 4 week treatment period of the study.

Exclusion Criteria

•Severe or fulminant UC.
•UC limited to rectum only.
•Any previous colonic surgery.
•Any histological evidence of dysplasia on colonoscopic biopsy.
•Women of childbearing potential who are unable or unwilling to use adequate contraceptive methods to avoid pregnancy.
•Previous unsuccessful ciclosporin therapy.
•Biologic therapy within the past 2 months prior to study treatment.
•Methotrexate therapy within 4 weeks of study treatment.
•A steroid treatment dose of greater than 10 mg/day prednisolone (or equivalent) within 4 weeks of study treatment.
•Use of topical treatment (e.g. enemas) within 4 weeks of study treatment and unwilling to refrain from use of topical treatments from the screening visit until the end of the 4-week treatment period.
+4 more criteria

Locations (22)

Cork University Hospital

Cork, Co. Cork, Ireland

Mater Misercordiae University Hospital

Dublin, Co. Dublin, Ireland

St. James's Hospital

Dublin, Co. Dublin, Ireland

Clinical Science Institute

Galway, Co. Galway, Ireland

The Adelaide and The Meath Hospital (Tallaght)

Tallaght, Dublin, Ireland

Beaumont Hospital

Dublin, Ireland

St. Vincent's University Hospital

Dublin, Ireland

MidWestern Regional Hospital

Limerick, Ireland

University College Hospital London

London, London, United Kingdom

Queen Elizabeth Hospital

Birmingham, United Kingdom

Key Dates

Start Date

March 1, 2010

Primary Completion Date

August 1, 2011

Completion Date

September 1, 2011

Last Updated

April 19, 2012

Enrollment

118

ACTUAL participants

Conditions

Mild to Moderate Ulcerative Colitis

Interventions

CyCol™

DRUG

Placebo

DRUG