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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01033305
• Other study ID #: CYC-201
• Status: Completed
• Phase: Phase 2
• First received: December 15, 2009
• Last updated: April 18, 2012
• Start date: March 2010
• Est. completion date: September 2011

Study information

• Verified date: April 2012
• Source: Sigmoid Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Irish Medicines BoardUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Mild to Moderate Ulcerative Colitis
• Ulcer

Intervention

Drug:
• CyCol™
Orally, once per day for 4 weeks
• Placebo
Orally, once per day for 4 weeks

Locations

Country	Name	City	State
Ireland	Cork University Hospital	Cork	Co. Cork
Ireland	St. James's Hospital	Dublin	Co. Dublin
Ireland	St. Vincent's University Hospital	Dublin 4
Ireland	Mater Misercordiae University Hospital	Dublin 7	Co. Dublin
Ireland	Beaumont Hospital	Dublin 9
Ireland	Clinical Science Institute	Galway	Co. Galway
Ireland	MidWestern Regional Hospital	Limerick
Ireland	The Adelaide and The Meath Hospital (Tallaght)	Tallaght	Dublin
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	University College Hospital London	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

Sponsors (1)

Lead Sponsor	Collaborator
Sigmoid Pharma

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of CyCol™ in inducing clinical remission of mild to moderate Ulcerative Colitis.		4 weeks	No

External Links

•   company website