Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:24 AM
Study NCT ID:
NCT00603733
Status:
COMPLETED
Last Update Posted:
2016-04-22
First Post:
2008-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Canadian Active & Maintenance Modified Pentasa Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'DK0-Disclosure@ferring.com', 'title': 'Clinical Development Support', 'organization': 'Ferring Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Study was amended to modify sample size as subject enrolment was lower than anticipated. A data lock was imposed, pending completion of the Maintenance Phase by 12 subjects to report all Active Phase efficacy data \\& all available safety data.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Event data is collected from the time Informed Consent is taken up to 28 days post study.', 'description': 'Safety dataset represents all patients in all study phases exposed to study drug at anytime during study. Safety dataset was a combination of the active, run-in and maintenance phases and therefore it is not possible to report the adverse events per phase.', 'eventGroups': [{'id': 'EG000', 'title': 'Pentasa® Modified Extended Release', 'description': '5-ASA (5-Aminosalicylate)\n\n5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)', 'otherNumAtRisk': 143, 'otherNumAffected': 27, 'seriousNumAtRisk': 143, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Pentasa®', 'description': '5-ASA (5-Aminosalicylate)\n\n5-ASA (5-Aminosalicylate): 500 mg tablet', 'otherNumAtRisk': 144, 'otherNumAffected': 28, 'seriousNumAtRisk': 144, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Colitis Ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Active Phase: Proportion of Active Subjects Achieving Overall Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pentasa® Modified Extended Release', 'description': '5-ASA (5-Aminosalicylate)\n\n5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)'}, {'id': 'OG001', 'title': 'Pentasa®', 'description': '5-ASA (5-Aminosalicylate)\n\n5-ASA (5-Aminosalicylate): 500 mg tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '64.1', 'groupId': 'OG000', 'lowerLimit': '55.17', 'upperLimit': '73.04'}, {'value': '69.2', 'groupId': 'OG001', 'lowerLimit': '60.63', 'upperLimit': '77.83'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to week 8', 'description': "Overall improvement is defined as either a complete remission or a clinical response to therapy as measured by the Ulcerative Colitis Disease Activity Index (UCDAI).\n\nComplete remission is defined as: i) a score of 0 or 1 for stool frequency; ii) a score of 0 for rectal bleeding; iii) a score of 0 for endoscopy findings and iv) a Physician's Global Assessment (PGA) score of 0 or 1.\n\nA clinical response to therapy in the active disease phase is defined as i) improvement in the baseline PGA score; ii) improvement in endoscopy findings and in at least one other clinical assessment (stool frequency, rectal bleeding); iii) no worsening in any other clinical assessment; iv) a decrease of 2 or more points on the UCDAI score.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Analysis Set'}, {'type': 'PRIMARY', 'title': 'Maintenance Phase: Proportion of Subjects Experiencing Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pentasa® Modified Extended Release', 'description': '5-ASA (5-Aminosalicylate)\n\n5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)'}, {'id': 'OG001', 'title': 'Pentasa®', 'description': '5-ASA (5-Aminosalicylate)\n\n5-ASA (5-Aminosalicylate): 500 mg tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000', 'lowerLimit': '15.52', 'upperLimit': '33.66'}, {'value': '11.8', 'groupId': 'OG001', 'lowerLimit': '5.34', 'upperLimit': '18.19'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to week 24', 'description': 'Relapse is defined as a UCDAI score of at least 3 and a score of at least 1 for endoscopy', 'unitOfMeasure': '% of subjects with relapse (90% CI)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Analysis Set'}, {'type': 'SECONDARY', 'title': 'Frequency of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pentasa® Modified Extended Release', 'description': '5-ASA (5-Aminosalicylate)\n\n5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)'}, {'id': 'OG001', 'title': 'Pentasa®', 'description': '5-ASA (5-Aminosalicylate)\n\n5-ASA (5-Aminosalicylate): 500 mg tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '52.4', 'groupId': 'OG000'}, {'value': '45.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to week 24', 'description': 'Safety dataset represents all patients in all study phases exposed to study drug at anytime during study. Safety dataset was a combination of the active, run-in and maintenance phases and therefore it is not possible to report the adverse events per phase.', 'unitOfMeasure': 'percentage of patients with TEAEs', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety dataset for Active and Maintenance Phases'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pentasa® Modified Extended Release', 'description': '5-ASA (5-Aminosalicylate)\n\n5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)'}, {'id': 'FG001', 'title': 'Pentasa®', 'description': '5-ASA (5-Aminosalicylate)\n\n5-ASA (5-Aminosalicylate): 500 mg tablet'}], 'periods': [{'title': 'Active Phase ITT', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Note: a total of 190 new participants were enrolled and randomized in the Active Phase', 'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '95'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Did not meet inclusion/exclusion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Subject moved, site closed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Run-In Phase - 4 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Note: Of the 98 subjects randomized at Run-In, 71 progressed into the maintenance phase.', 'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Did not meet incl/excl criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Maintenance Phase ITT', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Note:82 subjects randomized at Active phase \\& 71 at Run-In phase progressed to the maintenance phase', 'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Site withdrew, subject away, lost IMP', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Total number of unique patients enrolled in the study is 288 whereby 190 patients were enrolled in the Active Phase and 98 patients were enrolled in the Run-In Phase.\n\nThe patients enrolled in the Maintenance Phase are a combination of patients who completed the Active (82) and Run In (71) Phases and were eligible to move forward into Maintenance.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '285', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pentasa® Modified Extended Release', 'description': '5-ASA (5-Aminosalicylate)\n\n5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)'}, {'id': 'BG001', 'title': 'Pentasa®', 'description': '5-ASA (5-Aminosalicylate)\n\n5-ASA (5-Aminosalicylate): 500 mg tablet'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Active Phase', 'categories': [{'measurements': [{'value': '44.2', 'spread': '12.88', 'groupId': 'BG000'}, {'value': '44.5', 'spread': '12.53', 'groupId': 'BG001'}, {'value': '44.35', 'spread': '12.71', 'groupId': 'BG002'}]}]}, {'title': 'Maintenance Phase', 'categories': [{'measurements': [{'value': '46.4', 'spread': '12.20', 'groupId': 'BG000'}, {'value': '45.8', 'spread': '13.45', 'groupId': 'BG001'}, {'value': '46.1', 'spread': '12.83', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Active Phase', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '68'}, {'value': '43.5', 'groupId': 'BG001', 'lowerLimit': '22', 'upperLimit': '76'}, {'value': '44.3', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '76'}]}]}, {'title': 'Maintenance Phase', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '65'}, {'value': '44.5', 'groupId': 'BG001', 'lowerLimit': '23', 'upperLimit': '76'}, {'value': '46.3', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '76'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Active Phase, Female', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}, {'title': 'Active Phase, Male', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}, {'title': 'Maintenance Phase, Female', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}, {'title': 'Maintenance Phase, Male', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '285', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline characteristics were reported for the Per Protocol population who participated in the Active phase and in the maintenance phase of this study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 288}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-21', 'studyFirstSubmitDate': '2008-01-16', 'resultsFirstSubmitDate': '2015-03-04', 'studyFirstSubmitQcDate': '2008-01-28', 'lastUpdatePostDateStruct': {'date': '2016-04-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-21', 'studyFirstPostDateStruct': {'date': '2008-01-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Active Phase: Proportion of Active Subjects Achieving Overall Improvement', 'timeFrame': 'From baseline to week 8', 'description': "Overall improvement is defined as either a complete remission or a clinical response to therapy as measured by the Ulcerative Colitis Disease Activity Index (UCDAI).\n\nComplete remission is defined as: i) a score of 0 or 1 for stool frequency; ii) a score of 0 for rectal bleeding; iii) a score of 0 for endoscopy findings and iv) a Physician's Global Assessment (PGA) score of 0 or 1.\n\nA clinical response to therapy in the active disease phase is defined as i) improvement in the baseline PGA score; ii) improvement in endoscopy findings and in at least one other clinical assessment (stool frequency, rectal bleeding); iii) no worsening in any other clinical assessment; iv) a decrease of 2 or more points on the UCDAI score."}, {'measure': 'Maintenance Phase: Proportion of Subjects Experiencing Relapse', 'timeFrame': 'Up to week 24', 'description': 'Relapse is defined as a UCDAI score of at least 3 and a score of at least 1 for endoscopy'}], 'secondaryOutcomes': [{'measure': 'Frequency of Adverse Events', 'timeFrame': 'From baseline to week 24', 'description': 'Safety dataset represents all patients in all study phases exposed to study drug at anytime during study. Safety dataset was a combination of the active, run-in and maintenance phases and therefore it is not possible to report the adverse events per phase.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ulcerative Colitis', '5-Aminosalicylate'], 'conditions': ['Active Ulcerative Colitis', 'Remission of Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate that the new modified oral extended-release Pentasa® 500mg tablet is at least as efficacious as the currently marketed Pentasa® 500mg tablet in active mild to moderate Ulcerative Colitis (UC) and also in maintenance of quiescent disease.', 'detailedDescription': 'A multi-centre, randomized, double-blind, non-inferiority trial comparing the efficacy and safety of a new modified oral extended release Pentasa® (mesalamine) 500 mg tablet to the currently marketed Pentasa® (mesalamine) 500 mg tablet in subjects with active mild to moderate ulcerative colitis treated with 4 g/day for 8 weeks and in maintenance of remission of ulcerative colitis in subjects treated with 2 g/day for 24 weeks. The study involves male or non-pregnant female subjects aged 18 to 75 years.\n\nSubjects were randomised on entry into the trial, and if they were in remission at the end of the 8-week Active Phase or the 4-week Run-in Phase, they were eligible for enrolment into the 24-week Maintenance Phase, remaining on the original randomised treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria for Active phase:\n\n* Newly diagnosed or recurrent, mild to moderate Ulcerative Colitis patients.\n* Extent of colonic involvement confirmed within the past 36 months\n* UCDAI score of at least 3 but not greater than 8 and a score of at least 1 for endoscopy\n* Screening tests to rule out any abnormalities in stool, heart or kidney.\n* Male or non-pregnant females between 18 to 75 years.\n* Women of childbearing potential to use efficacious contraception as judged by the investigator.\n* Written informed consent given.\n\nInclusion Criteria for Maintenance phase:\n\n* Newly recruited subjects with documented mild to moderate UC entering the Run-in Phase: in clinical remission for at least 1 month and for a maximum of 3 years, and receiving 5-ASA 1.4 to 2.5 g/day for maintenance of quiescent disease\n* Subjects from Active Phase: meeting remission criteria after the 8-week active period\n* Extent of colonic involvement confirmed within the past 36 months by colonoscopy\n* In complete remission at entry into the Maintenance Phase, defined as i) a score of 0 or 1 for stool frequency; ii) a score of 0 for rectal bleeding; iii) a score of 0 for endoscopy findings; and iv) a Physician's Global Assessment (PGA) score of 0 or 1\n* Screening tests to rule out any abnormalities in stool, heart or kidney.\n\nExclusion Criteria:\n\n* Use of 5-ASA products at a dose \\>2.5g/day within 7 days prior to entry.\n* Proctitis, short bowel syndrome, prior bowel surgery, severe UC, other forms of Inflammatory Bowel Disease\n* Infectious diseases, parasites, bacterial pathogens\n* Allergy to aspirin or salicylate\n* Liver or kidney abnormalities\n* Alcohol or drug abuse\n* Pregnancy\n* Cancer\n* Bleeding disorders, ulcers, autoimmune diseases\n* Mental disorders\n* Participation in clinical trial in last 30 days\n* Inability to fill in diary cards / comply with protocol requirements"}, 'identificationModule': {'nctId': 'NCT00603733', 'acronym': 'CAMMP', 'briefTitle': 'Canadian Active & Maintenance Modified Pentasa Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'A Multicentre, Randomised, Double-blind, Non-inferiority Trial Comparing the Efficacy and Safety of a New Modified Oral Extended Release Pentasa® (Mesalamine) 500 mg Tablet to the Currently Marketed Pentasa® (Mesalamine) 500 mg Tablet in Subjects With Active Mild to Moderate Ulcerative Colitis Treated With 4 g/Day for 8 Weeks and in Maintenance of Remission of Ulcerative Colitis in Subjects Treated With 2 g/Day for 24 Weeks', 'orgStudyIdInfo': {'id': 'CLN 35.3.11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pentasa® modified extended release', 'description': '5-ASA (5-Aminosalicylate)', 'interventionNames': ['Drug: 5-ASA (5-Aminosalicylate)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pentasa®', 'description': '5-ASA (5-Aminosalicylate)', 'interventionNames': ['Drug: 5-ASA (5-Aminosalicylate)']}], 'interventions': [{'name': '5-ASA (5-Aminosalicylate)', 'type': 'DRUG', 'otherNames': ['Pentasa®', 'mesalamine'], 'description': '500 mg tablet (modified extended release)', 'armGroupLabels': ['Pentasa® modified extended release']}, {'name': '5-ASA (5-Aminosalicylate)', 'type': 'DRUG', 'otherNames': ['Pentasa®', 'mesalamine'], 'description': '500 mg tablet', 'armGroupLabels': ['Pentasa®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary, Faculty of Medicine', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Castledowns Medicentre', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Brandon', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Investigational site', 'geoPoint': {'lat': 49.84692, 'lon': -99.95306}}, {'city': 'Saint John', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Hilyard Place Building A', 'geoPoint': {'lat': 45.27076, 'lon': -66.05616}}, {'city': 'Barrie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Barrie GI Associates', 'geoPoint': {'lat': 44.40011, 'lon': -79.66634}}, {'city': 'Greater Sudbury', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Investigational site', 'geoPoint': {'lat': 46.49, 'lon': -80.99001}}, {'city': 'Guelph', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Investigational site', 'geoPoint': {'lat': 43.54594, 'lon': -80.25599}}, {'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Healthcare", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Oshawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Investigational site', 'geoPoint': {'lat': 43.90012, 'lon': -78.84957}}, {'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Investigational site - Phenix Building', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa General Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Richmond Hill', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Digestive Health Clinic', 'geoPoint': {'lat': 43.87111, 'lon': -79.43725}}, {'city': 'Sarnia', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Investigational site', 'geoPoint': {'lat': 42.97866, 'lon': -82.40407}}, {'city': 'Thunder Bay', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Investigational site', 'geoPoint': {'lat': 48.38202, 'lon': -89.25018}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'JJ Dig Research Ltd', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Keele Medical Place', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Digestive Disease Association (TDDA)', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hotel Dieu Grace Hospital', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Investigational site', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'city': 'Woodstock', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Investigational site', 'geoPoint': {'lat': 43.13339, 'lon': -80.7497}}, {'city': 'Lévis', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hotel Dieu de Levis', 'geoPoint': {'lat': 46.80326, 'lon': -71.17793}}, {'city': 'Loretteville', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Alpha Recherche Clinique Inc.', 'geoPoint': {'lat': 46.85057, 'lon': -71.36084}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital Maissonneuve Rosemont', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'MUHC-Royal Victoria Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': "Gastro Centre Hospitalier Universitaire de Québec/St-François-d'Assise Hospital", 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': "L'Hotel Dieu de Quebec", 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Clinical Development Support', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ferring Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}