Oral Ciclosporin for Colonic Release in Ulcerative Colitis (CyCol™)
NCT ID: NCT01033305
Last Updated: 2012-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
118 participants
INTERVENTIONAL
2010-03-31
2011-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Orally, once per day for 4 weeks
CyCol™
CyCol™
Orally, once per day for 4 weeks
Interventions
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CyCol™
Orally, once per day for 4 weeks
Placebo
Orally, once per day for 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
* Significant renal impairment, hepatic impairment, uncontrolled hypertension, premalignant skin lesions or current malignancies, or any other severe co-morbid condition.
* Known hypersensitivity to ciclosporin or any of its excipients.
* Positive screening stool assay for Clostridium difficile, hemorrhagic E.coli 0157:H7, Salmonella or Shigella
* Diagnosis of Crohn's colitis, ischemic colitis, NSAID-induced colitis, or radiation colitis.
18 Years
ALL
No
Sponsors
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Sigmoid Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Diarmuid O'Donoghue, Prof
Role: PRINCIPAL_INVESTIGATOR
St Vincent's University Hospital
Stuart Bloom, M.D.
Role: PRINCIPAL_INVESTIGATOR
University College Hospital NHS Trust
Locations
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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
Sandwell and West MidlandsHospitals NHS Trust
Birmingham, , United Kingdom
Bristol Royal Infirmary
Bristol, , United Kingdom
Conventry university Hospital
Coventry, , United Kingdom
Leeds General infirmary
Leeds, , United Kingdom
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Liverpool, , United Kingdom
Kings College London
London, , United Kingdom
St. Mark's Hospital
London, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
George Elliot hospital
Nuneaton, , United Kingdom
John Radcliff Hospital
Oxford, , United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Countries
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Related Links
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company website
Other Identifiers
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CYC-201
Identifier Type: -
Identifier Source: org_study_id
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