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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sigmoid Pharma
ClinicalTrials.gov Identifier:
NCT01033305
First received: December 15, 2009
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Mild to Moderate Ulcerative Colitis
Drug: CyCol™
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sigmoid Pharma:

Primary Outcome Measures:
  • Efficacy of CyCol™ in inducing clinical remission of mild to moderate Ulcerative Colitis. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 118
Study Start Date: March 2010
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Orally, once per day for 4 weeks
Other Name: Sugar Pill
Experimental: CyCol™ Drug: CyCol™
Orally, once per day for 4 weeks
Other Name: Ciclosporin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01033305

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

Additional Information:
No publications provided

Responsible Party: Sigmoid Pharma
ClinicalTrials.gov Identifier: NCT01033305     History of Changes
Other Study ID Numbers: CYC-201
Study First Received: December 15, 2009
Last Updated: April 18, 2012
Health Authority: Ireland: Irish Medicines Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Sigmoid Pharma:
UC

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes
Cyclosporine
Cyclosporins
Anti-Infective Agents
Antifungal Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014