Mild to Moderate Ulcerative ColitisPhase 2NCT01033305
Oral Ciclosporin for Colonic Release in Ulcerative Colitis (CyCol™)
A Phase 2 study testing CyCol™ in people with Mild to Moderate Ulcerative Colitis, run by Sigmoid Pharma at 22 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild to Moderate Ulcerative Colitis
- What is being tested?
- CyCol™
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 22 sitesin 2 countries
- Study dates
- Mar 2010to Sep 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United Kingdom14 sites
Queen Elizabeth Hospital
Birmingham, B15 2TH
Sandwell and West MidlandsHospitals NHS Trust
Birmingham, B71 4HJ
Bristol Royal Infirmary
Bristol, BS2 8HW
Conventry university Hospital
Coventry, CV2 2DX
Leeds General infirmary
Leeds
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Liverpool, L7 8XP
University College Hospital London
London, London, NW1 2BU
Kings College London
London, SE5 9RS
St. Mark's Hospital
London
Manchester Royal Infirmary
Manchester, M13 9WL
George Elliot hospital
Nuneaton, CV10 7DJ
John Radcliff Hospital
Oxford, OX3 9DU
Royal Shrewsbury Hospital
Shrewsbury, SY3 8XQ
New Cross Hospital
Wolverhampton, WV10 0QP
Ireland8 sites
Cork University Hospital
Cork, Co. Cork
Mater Misercordiae University Hospital
Dublin, Co. Dublin
St. James's Hospital
Dublin, Co. Dublin
Beaumont Hospital
Dublin
St. Vincent's University Hospital
Dublin
Clinical Science Institute
Galway, Co. Galway
MidWestern Regional Hospital
Limerick
The Adelaide and The Meath Hospital (Tallaght)
Tallaght, Dublin, Dublin 24
About this study
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
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.
- Conditions
- Mild to Moderate Ulcerative Colitis
- Being tested
- CyCol™, Placebo
- Keywords
- UC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyCol™Drug
Also called Ciclosporin
Orally, once per day for 4 weeks
PlaceboDrug
Also called Sugar Pill
Orally, once per day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| CyCol™ | Experimental | Not described Receives: Drug: CyCol™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of CyCol™ in inducing clinical remission of mild to moderate Ulcerative Colitis.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startMar 2010
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sigmoid Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diarmuid O'Donoghue, Prof, Principal investigator, St Vincent's University Hospital, IrelandStuart Bloom, M.D., Principal investigator, University College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033305
- Sponsor's protocol ID
- CYC-201
- Status last verified
- Apr 2012
- First submitted
- 15 Dec 2009
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01033305
- Acronym / sponsor ID
- CYC-201
- Conditions
- Mild to Moderate Ulcerative Colitis
- Keywords
- UC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Sigmoid PharmaIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 16 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| CyCol™ | Experimental | Drug: CyCol™ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyCol™Also: CiclosporinOrally, once per day for 4 weeks | Drug | CyCol™ |
| PlaceboAlso: Sugar PillOrally, once per day for 4 weeks | Drug | Placebo |
Primary outcome
Efficacy of CyCol™ in inducing clinical remission of mild to moderate Ulcerative Colitis.
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2012.
- company websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diarmuid O'Donoghue, Prof principal investigator
St Vincent's University Hospital, Ireland
Stuart Bloom, M.D. principal investigator
University College Hospital NHS Trust
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CyCol™ in people with Mild to Moderate Ulcerative Colitis, run by Sigmoid Pharma at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United Kingdom, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of CyCol™ in inducing clinical remission of mild to moderate Ulcerative Colitis. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2012.