Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT01033305
Status:
COMPLETED
Last Update Posted:
2012-04-19
First Post:
2009-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oral Ciclosporin for Colonic Release in Ulcerative Colitis (CyCol™)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-18', 'studyFirstSubmitDate': '2009-12-15', 'studyFirstSubmitQcDate': '2009-12-15', 'lastUpdatePostDateStruct': {'date': '2012-04-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of CyCol™ in inducing clinical remission of mild to moderate Ulcerative Colitis.', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['UC'], 'conditions': ['Mild to Moderate Ulcerative Colitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sigmoidpharma.com', 'label': 'company website'}]}, 'descriptionModule': {'briefSummary': '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).\n\nInformed 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).\n\nHalf 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female aged \\> 18 years\n* Diagnosis of mild to moderate diagnosis of UC involving at least the rectum and sigmoid colon\n* Clinical severity assessed at screening using the Disease Activity Index (DAI)\n* Clinical severity documented and confirmed by flexible sigmoidoscopy, within 7 days of starting study treatment\n* Signed and dated written informed consent.\n* Willing to maintain current UC medication dosing regimen from screening until the end of the 4-week treatment period.\n* 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.\n* 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.\n\nExclusion Criteria:\n\n* Severe or fulminant UC.\n* UC limited to rectum only.\n* Any previous colonic surgery.\n* Any histological evidence of dysplasia on colonoscopic biopsy.\n* Women of childbearing potential who are unable or unwilling to use adequate contraceptive methods to avoid pregnancy.\n* Previous unsuccessful ciclosporin therapy.\n* Biologic therapy within the past 2 months prior to study treatment.\n* Methotrexate therapy within 4 weeks of study treatment.\n* A steroid treatment dose of greater than 10 mg/day prednisolone (or equivalent) within 4 weeks of study treatment.\n* 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.\n* Significant renal impairment, hepatic impairment, uncontrolled hypertension, premalignant skin lesions or current malignancies, or any other severe co-morbid condition.\n* Known hypersensitivity to ciclosporin or any of its excipients.\n* Positive screening stool assay for Clostridium difficile, hemorrhagic E.coli 0157:H7, Salmonella or Shigella\n* Diagnosis of Crohn's colitis, ischemic colitis, NSAID-induced colitis, or radiation colitis."}, 'identificationModule': {'nctId': 'NCT01033305', 'briefTitle': 'Oral Ciclosporin for Colonic Release in Ulcerative Colitis (CyCol™)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sigmoid Pharma'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CYC-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'CyCol™', 'interventionNames': ['Drug: CyCol™']}], 'interventions': [{'name': 'CyCol™', 'type': 'DRUG', 'otherNames': ['Ciclosporin'], 'description': 'Orally, once per day for 4 weeks', 'armGroupLabels': ['CyCol™']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Sugar Pill'], 'description': 'Orally, once per day for 4 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cork', 'state': 'Co. Cork', 'country': 'Ireland', 'facility': 'Cork University Hospital', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}, {'city': 'Dublin', 'state': 'Co. Dublin', 'country': 'Ireland', 'facility': 'Mater Misercordiae University Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Dublin', 'state': 'Co. Dublin', 'country': 'Ireland', 'facility': "St. James's Hospital", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Galway', 'state': 'Co. Galway', 'country': 'Ireland', 'facility': 'Clinical Science Institute', 'geoPoint': {'lat': 53.27245, 'lon': -9.05095}}, {'zip': 'Dublin 24', 'city': 'Tallaght', 'state': 'Dublin', 'country': 'Ireland', 'facility': 'The Adelaide and The Meath Hospital (Tallaght)', 'geoPoint': {'lat': 53.2859, 'lon': -6.37344}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Beaumont Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': "St. Vincent's University Hospital", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Limerick', 'country': 'Ireland', 'facility': 'MidWestern Regional Hospital', 'geoPoint': {'lat': 52.66472, 'lon': -8.62306}}, {'zip': 'NW1 2BU', 'city': 'London', 'state': 'London', 'country': 'United Kingdom', 'facility': 'University College Hospital London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'B15 2TH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'B71 4HJ', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Sandwell and West MidlandsHospitals NHS Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BS2 8HW', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Bristol Royal Infirmary', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'CV2 2DX', 'city': 'Coventry', 'country': 'United Kingdom', 'facility': 'Conventry university Hospital', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Leeds General infirmary', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'L7 8XP', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Royal Liverpool and Broadgreen University Hospitals NHS Trust', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Kings College London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "St. Mark's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester Royal Infirmary', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'CV10 7DJ', 'city': 'Nuneaton', 'country': 'United Kingdom', 'facility': 'George Elliot hospital', 'geoPoint': {'lat': 52.52323, 'lon': -1.46523}}, {'zip': 'OX3 9DU', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'John Radcliff Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'SY3 8XQ', 'city': 'Shrewsbury', 'country': 'United Kingdom', 'facility': 'Royal Shrewsbury Hospital', 'geoPoint': {'lat': 52.71009, 'lon': -2.75208}}, {'zip': 'WV10 0QP', 'city': 'Wolverhampton', 'country': 'United Kingdom', 'facility': 'New Cross Hospital', 'geoPoint': {'lat': 52.58547, 'lon': -2.12296}}], 'overallOfficials': [{'name': "Diarmuid O'Donoghue, Prof", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St Vincent's University Hospital, Ireland"}, {'name': 'Stuart Bloom, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University College Hospital NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sigmoid Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}