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

April 18, 2012 updated by: Sigmoid Pharma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin 4, Ireland
        • St. Vincent's University Hospital
      • Dublin 9, Ireland
        • Beaumont Hospital
      • Limerick, Ireland
        • Midwestern Regional Hospital
    • Co. Cork
      • Cork, Co. Cork, Ireland
        • Cork University Hospital
    • Co. Dublin
      • Dublin, Co. Dublin, Ireland
        • St. James's Hospital
      • Dublin 7, Co. Dublin, Ireland
        • Mater Misercordiae University Hospital
    • Co. Galway
      • Galway, Co. Galway, Ireland
        • Clinical Science Institute
    • Dublin
      • Tallaght, Dublin, Ireland, Dublin 24
        • The Adelaide and The Meath Hospital (Tallaght)
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital
      • Birmingham, United Kingdom, B71 4HJ
        • Sandwell and West MidlandsHospitals NHS Trust
      • Bristol, United Kingdom, BS2 8HW
        • Bristol Royal Infirmary
      • Coventry, United Kingdom, CV2 2DX
        • Conventry university Hospital
      • Leeds, United Kingdom
        • Leeds General Infirmary
      • Liverpool, United Kingdom, L7 8XP
        • Royal Liverpool and Broadgreen University Hospitals NHS Trust
      • London, United Kingdom, SE5 9RS
        • Kings College London
      • London, United Kingdom
        • St. Mark's Hospital
      • London, United Kingdom, NW1 2BU
        • University College Hospital London
      • Manchester, United Kingdom, M13 9WL
        • Manchester Royal Infirmary
      • Nuneaton, United Kingdom, CV10 7DJ
        • George Elliot hospital
      • Oxford, United Kingdom, OX3 9DU
        • John Radcliff Hospital
      • Shrewsbury, United Kingdom, SY3 8XQ
        • Royal Shrewsbury Hospital
      • Wolverhampton, United Kingdom, WV10 0QP
        • New Cross Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Orally, once per day for 4 weeks
Other Names:
  • Sugar Pill
Experimental: CyCol™
Drug: CyCol™
Orally, once per day for 4 weeks
Other Names:
  • Ciclosporin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of CyCol™ in inducing clinical remission of mild to moderate Ulcerative Colitis.
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sigmoid Pharma

Investigators

  • Principal Investigator: Diarmuid O'Donoghue, Prof, St. Vincent's University Hospital
  • Principal Investigator: Stuart Bloom, M.D., University College Hospital NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

December 15, 2009

First Submitted That Met QC Criteria

December 15, 2009

First Posted (Estimate)

December 16, 2009

Study Record Updates

Last Update Posted (Estimate)

April 19, 2012

Last Update Submitted That Met QC Criteria

April 18, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYC-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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