Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT00708656
Status:
COMPLETED
Last Update Posted:
2020-01-30
First Post:
2008-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Colitis Once Daily Asacol Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D003092', 'term': 'Colitis'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019804', 'term': 'Mesalamine'}], 'ancestors': [{'id': 'D062368', 'term': 'meta-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000636', 'term': 'Aminosalicylic Acids'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 213}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-28', 'studyFirstSubmitDate': '2008-04-08', 'studyFirstSubmitQcDate': '2008-07-01', 'lastUpdatePostDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess whether a once daily dose of three 800mg tablets of mesalazine (Asacol®) in the morning is equivalent to mesalazine (Asacol®) given as 800mg three times daily in preventing relapse over a 12 month period.', 'timeFrame': 'At relapse or 12 month follow up'}], 'secondaryOutcomes': [{'measure': 'To assess equivalence in terms of safety', 'timeFrame': '12 months'}, {'measure': 'To assess equivalence in terms of time to relapse', 'timeFrame': '12 months'}, {'measure': 'To assess equivalence in terms of progression of disease (measured by Mayo score)', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IBD', 'Colitis', 'UC'], 'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '28274254', 'type': 'DERIVED', 'citation': 'Gillespie D, Farewell D, Barrett-Lee P, Casbard A, Hawthorne AB, Hurt C, Murray N, Probert C, Stenson R, Hood K. The use of randomisation-based efficacy estimators in non-inferiority trials. Trials. 2017 Mar 9;18(1):117. doi: 10.1186/s13063-017-1837-3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the safety and effectiveness of dosing mesalazine 800 mg tablets (Asacol®) at 2.4 g once daily versus divided doses three times daily in the maintenance of remission of ulcerative colitis.', 'detailedDescription': "Study design\n\n* Multicentre, randomized, single-blind, comparator-controlled, parallel-armed study\n* One year follow-up, or until relapse (whichever shorter)\n* 40-60 UK centres\n\nSubject population\n\n* Ulcerative colitis in remission (sigmoidoscopy score of 0 or 1 with no symptoms of active disease, with no treatment for active colitis) for at least 4 weeks, and for no more than 2 years\n* Taking mesalazine or sulfasalazine prior to study entry\n* Patients excluded if they have Crohn's disease, symptoms of active colitis, have used corticosteroids, ciclosporin or oral/enema mesalazine in the past 4 weeks, are intolerant to mesalazine or Asacol, are pregnant or lactating, or have known HIV, hepatic disease, renal impairment or other serious medical or psychiatric illness\n* Sample size 250\n* Gender: male or female\n* Ethnicity: no restriction\n* Age: over 18\n\nTest Product\n\nOnce daily group: Asacol® 2.4g daily given as three 800mg tablets orally qAM\n\nThree times daily group: Asacol® 2.4g daily given as one 800mg tablet orally three times daily\n\nCriteria for Evaluation:\n\nPrimary Outcome Variable: Relapse rate over 1 year in the intention to treat population, with the study powered to detect non-inferiority of the once-daily regimen.\n\nSecondary Outcome Variables: assessment of superiority of the once-daily regimen, if non-inferiority is demonstrated; safety analysis; per protocol analysis of relapse rate; time course of relapse; medication compliance; changes in modified Baron sigmoidoscopy scores between trial entry and relapse/12 month; impact of various factors on relapse rate (time from last relapse at study entry, concomitant azathioprine or 6-mercaptopurine therapy; disease extent; disease duration; smoking status; age at diagnosis; previous dose of mesalazine; baseline calprotectin; baseline CRP level)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients who meet the following criteria will be eligible for study entry:\n\n* Male and female patients aged over 18 with ulcerative colitis confirmed by histology who are in remission (no symptoms of active disease, and modified Baron sigmoidoscopic score of 0 or 1)\n* If female, must be (as documented in patient notes):\n\n * postmenopausal (at least 1 year without spontaneous menses), or\n * surgically sterile (tubal ligation or hysterectomy at least 6 months prior to enrollment), or\n * using acceptable contraception (e.g., oral, intramuscular, or implanted hormonal contraception) at least 3 months prior to enrollment, or\n * have a sexual partner with non-reversed vasectomy (with confirmed azoospermia), or\n * be using 1 barrier method (e.g., condom, diaphragm, spermicide, or intra-uterine device)\n* Patients whose ulcerative colitis has been in clinical remission for 4 weeks or longer, and who have had a symptomatic relapse within the past two years\n* Patients taking mesalazine, sulfasalazine or other drug containing 5-ASA for 4 weeks or longer\n* Patients capable of giving written informed consent\n\nExclusion Criteria:\n\nThe following patients will be excluded from the study:\n\n* Patients with Crohn's disease\n* Patients with symptoms of active colitis\n* Modified Baron sigmoidoscopy score of 2 or 3\n* Patients who have used oral, enema, intravenous or suppository preparations of corticosteroids, oral or intravenous ciclosporin, mesalazine enemas or suppositories within the past four weeks\n* Patients taking azathioprine or 6-mercaptopurine who have altered the dose or started treatment within the past three months, (these drugs permitted in stable dose during the study)\n* Patients with intolerance to Asacol 400 mg or mesalazine\n* Women who are pregnant or lactating\n* Patients with known HIV infection\n* Patients with hepatic disease\n* Patients with renal impairment (creatinine above local reference range), or with positive urine dipstick test to blood or protein\n* Other serious medical or psychiatric illness that in the opinion of the investigator would possibly comprise the study\n* Patients with problem alcohol excess or drug abuse"}, 'identificationModule': {'nctId': 'NCT00708656', 'acronym': 'CODA', 'briefTitle': 'The Colitis Once Daily Asacol Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Cardiff and Vale University Health Board'}, 'officialTitle': 'A Randomized, Single-Blind Study to Assess Efficacy and Safety of Dosing Mesalazine 800 mg Tablets (Asacol®) at 2.4 g Once Daily Versus Divided Doses 3 Times Daily for 12 Months in Maintenance of Remission of Ulcerative Colitis.', 'orgStudyIdInfo': {'id': 'HAW0105'}, 'secondaryIdInfos': [{'id': 'ISRCTN:35600632'}, {'id': 'EudraCT Number:2005-002784-91'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1: once daily', 'description': 'Three 800mg tablets of mesalazine (Asacol®) in the morning', 'interventionNames': ['Drug: mesalazine (Asacol®)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2: tds', 'description': 'Mesalazine (Asacol®) 800mg given three times daily', 'interventionNames': ['Drug: mesalazine (Asacol®)']}], 'interventions': [{'name': 'mesalazine (Asacol®)', 'type': 'DRUG', 'otherNames': ['Mesalazine', 'Asacol'], 'description': '800 mg tablets', 'armGroupLabels': ['1: once daily', '2: tds']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barnsley', 'country': 'United Kingdom', 'facility': 'Barnsley District General Hospital', 'geoPoint': {'lat': 53.55, 'lon': -1.48333}}, {'city': 'Basingstoke', 'country': 'United Kingdom', 'facility': 'North Hampshire Hospital', 'geoPoint': {'lat': 51.26249, 'lon': -1.08708}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Birmingham Heartlands Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Selly Oak Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Bishop Auckland', 'country': 'United Kingdom', 'facility': 'Bishop Auckland General Hospital', 'geoPoint': {'lat': 54.65554, 'lon': -1.67706}}, {'city': 'Blackpool', 'country': 'United Kingdom', 'facility': 'Blackpool Victoria Hospital', 'geoPoint': {'lat': 53.81667, 'lon': -3.05}}, {'city': 'Bodelwyddan', 'country': 'United Kingdom', 'facility': 'Glan Clwyd Hospital', 'geoPoint': {'lat': 53.26827, 'lon': -3.50078}}, {'city': 'Boston', 'country': 'United Kingdom', 'facility': 'Pilgrim Hospital', 'geoPoint': {'lat': 52.97633, 'lon': -0.02664}}, {'city': 'Brighton', 'country': 'United Kingdom', 'facility': 'Princess Royal Hospital', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}, {'city': 'Brighton', 'country': 'United Kingdom', 'facility': 'Royal Sussex County Hospital', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}, {'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Bristol Royal Infirmary', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'Llandough Hospital', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'University Hospital of Wales', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'city': 'Carlisle', 'country': 'United Kingdom', 'facility': 'Cumberland Infirmary', 'geoPoint': {'lat': 54.8951, 'lon': -2.9382}}, {'city': 'Coventry', 'country': 'United Kingdom', 'facility': 'Walsgrave Hospital', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'city': 'Derby', 'country': 'United Kingdom', 'facility': 'Derby City General Hospital', 'geoPoint': 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{'city': 'Llantrisant', 'country': 'United Kingdom', 'facility': 'Royal Glamorgan Hospital', 'geoPoint': {'lat': 51.54028, 'lon': -3.37389}}, {'city': 'Louth', 'country': 'United Kingdom', 'facility': 'County Hospital', 'geoPoint': {'lat': 53.36664, 'lon': -0.00438}}, {'city': 'Luton', 'country': 'United Kingdom', 'facility': 'Luton & Dunstable Hospital', 'geoPoint': {'lat': 51.87967, 'lon': -0.41748}}, {'city': 'Macclesfield', 'country': 'United Kingdom', 'facility': 'Macclesfield District General Hospital', 'geoPoint': {'lat': 53.26023, 'lon': -2.12564}}, {'city': 'Melrose', 'country': 'United Kingdom', 'facility': 'Borders General Hospital', 'geoPoint': {'lat': 55.59969, 'lon': -2.7277}}, {'city': 'Merthyr Tydfil', 'country': 'United Kingdom', 'facility': 'Prince Charles Hospital', 'geoPoint': {'lat': 51.74794, 'lon': -3.37779}}, {'city': 'Norwich', 'country': 'United Kingdom', 'facility': 'Norfolk and Norwich University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 52.62783, 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'geoPoint': {'lat': 54.56848, 'lon': -1.3187}}, {'city': 'Truro', 'country': 'United Kingdom', 'facility': 'Royal Cornwall Hospital', 'geoPoint': {'lat': 50.26526, 'lon': -5.05436}}, {'city': 'Welwyn Garden City', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth II Hospital', 'geoPoint': {'lat': 51.80174, 'lon': -0.20691}}, {'city': 'Wolverhampton', 'country': 'United Kingdom', 'facility': 'New Cross Hospital', 'geoPoint': {'lat': 52.58547, 'lon': -2.12296}}, {'city': 'Worcester', 'country': 'United Kingdom', 'facility': 'Alexandra Hospital', 'geoPoint': {'lat': 52.18935, 'lon': -2.22001}}, {'city': 'Worcester', 'country': 'United Kingdom', 'facility': 'Worcester Royal Infirmary', 'geoPoint': {'lat': 52.18935, 'lon': -2.22001}}, {'city': 'Worthing', 'country': 'United Kingdom', 'facility': 'Worthing Hospital', 'geoPoint': {'lat': 50.81795, 'lon': -0.37538}}, {'city': 'Yeovil', 'country': 'United Kingdom', 'facility': 'Yeovil District Hospital', 'geoPoint': {'lat': 50.94159, 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