search
Back to results

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

Primary Purpose

Mild to Moderate Ulcerative Colitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CyCol™
Placebo
Sponsored by
Sigmoid Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild to Moderate Ulcerative Colitis focused on measuring UC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.
  • 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.

Sites / Locations

  • Cork University Hospital
  • Mater Misercordiae University Hospital
  • St. James's Hospital
  • Clinical Science Institute
  • The Adelaide and The Meath Hospital (Tallaght)
  • St. Vincent's University Hospital
  • Beaumont Hospital
  • MidWestern Regional Hospital
  • Queen Elizabeth Hospital
  • Sandwell and West MidlandsHospitals NHS Trust
  • Bristol Royal Infirmary
  • Conventry university Hospital
  • Leeds General infirmary
  • Royal Liverpool and Broadgreen University Hospitals NHS Trust
  • University College Hospital London
  • Kings College London
  • St. Mark's Hospital
  • Manchester Royal Infirmary
  • George Elliot hospital
  • John Radcliff Hospital
  • Royal Shrewsbury Hospital
  • New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

CyCol™

Arm Description

Outcomes

Primary Outcome Measures

Efficacy of CyCol™ in inducing clinical remission of mild to moderate Ulcerative Colitis.

Secondary Outcome Measures

Full Information

First Posted
December 15, 2009
Last Updated
April 18, 2012
Sponsor
Sigmoid Pharma
search

1. Study Identification

Unique Protocol Identification Number
NCT01033305
Brief Title
Oral Ciclosporin for Colonic Release in Ulcerative Colitis (CyCol™)
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sigmoid Pharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild to Moderate Ulcerative Colitis
Keywords
UC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
CyCol™
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CyCol™
Other Intervention Name(s)
Ciclosporin
Intervention Description
Orally, once per day for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar Pill
Intervention Description
Orally, once per day for 4 weeks
Primary Outcome Measure Information:
Title
Efficacy of CyCol™ in inducing clinical remission of mild to moderate Ulcerative Colitis.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diarmuid O'Donoghue, Prof
Organizational Affiliation
St. Vincent's University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stuart Bloom, M.D.
Organizational Affiliation
University College Hospital NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cork University Hospital
City
Cork
State/Province
Co. Cork
Country
Ireland
Facility Name
Mater Misercordiae University Hospital
City
Dublin 7
State/Province
Co. Dublin
Country
Ireland
Facility Name
St. James's Hospital
City
Dublin
State/Province
Co. Dublin
Country
Ireland
Facility Name
Clinical Science Institute
City
Galway
State/Province
Co. Galway
Country
Ireland
Facility Name
The Adelaide and The Meath Hospital (Tallaght)
City
Tallaght
State/Province
Dublin
ZIP/Postal Code
Dublin 24
Country
Ireland
Facility Name
St. Vincent's University Hospital
City
Dublin 4
Country
Ireland
Facility Name
Beaumont Hospital
City
Dublin 9
Country
Ireland
Facility Name
MidWestern Regional Hospital
City
Limerick
Country
Ireland
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Sandwell and West MidlandsHospitals NHS Trust
City
Birmingham
ZIP/Postal Code
B71 4HJ
Country
United Kingdom
Facility Name
Bristol Royal Infirmary
City
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
Conventry university Hospital
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Leeds General infirmary
City
Leeds
Country
United Kingdom
Facility Name
Royal Liverpool and Broadgreen University Hospitals NHS Trust
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
University College Hospital London
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
Kings College London
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
St. Mark's Hospital
City
London
Country
United Kingdom
Facility Name
Manchester Royal Infirmary
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
George Elliot hospital
City
Nuneaton
ZIP/Postal Code
CV10 7DJ
Country
United Kingdom
Facility Name
John Radcliff Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Royal Shrewsbury Hospital
City
Shrewsbury
ZIP/Postal Code
SY3 8XQ
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.sigmoidpharma.com
Description
company website

Learn more about this trial

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

We'll reach out to this number within 24 hrs