Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2025-12-26 @ 6:50 AM
Study NCT ID:
NCT01694966
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2012-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rjones@cosmopharma.com', 'phone': '111111111', 'title': 'R&D Manager', 'phoneExt': '11111', 'organization': 'Cosmo Technologies Ltd'}, 'certainAgreement': {'otherDetails': 'Publications to be reviewed by sponsor prior to submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Methylene Blue MMX® 200mg', 'description': 'Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule\n\nMethylene Blue MMX®', 'otherNumAtRisk': 488, 'otherNumAffected': 234, 'seriousNumAtRisk': 485, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Methylene Blue MMX® 100mg', 'description': 'Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule\n\nMethylene Blue MMX®\n\nPlacebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet.', 'otherNumAtRisk': 241, 'otherNumAffected': 102, 'seriousNumAtRisk': 241, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Oral dose, 8 Placebo tablets over a 4hr schedule\n\nPlacebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet.', 'otherNumAtRisk': 479, 'otherNumAffected': 7, 'seriousNumAtRisk': 479, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'faeces discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 488, 'numEvents': 95, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 241, 'numEvents': 43, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 479, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'chromaturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 488, 'numEvents': 234, 'numAffected': 234}, {'groupId': 'EG001', 'numAtRisk': 241, 'numEvents': 102, 'numAffected': 102}, {'groupId': 'EG002', 'numAtRisk': 479, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders'}], 'seriousEvents': [{'term': 'viral bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 485, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 479, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 485, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 479, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'To Assess the Detection Efficacy of Chromoendoscopy Performed With 200mg Methylene Blue MMX® 25 mg Tablets Versus Placebo Tablets (White Light Endoscopy) in Terms of the Proportion of Subjects With at Least One Histologically Proven Adenoma or Carcinoma.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}, {'value': '479', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylene Blue MMX® 200mg', 'description': 'Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule\n\nMethylene Blue MMX®'}, {'id': 'OG001', 'title': 'Methylene Blue MMX® 100mg', 'description': 'Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule\n\nMethylene Blue MMX®\n\nPlacebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Oral dose, 8 Placebo tablets over a 4hr schedule\n\nPlacebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.3', 'groupId': 'OG000'}, {'value': '51.5', 'groupId': 'OG001'}, {'value': '47.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '+7 days', 'description': 'Adenoma Detection Rate', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Methylene Blue MMX® 200mg', 'description': 'Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule\n\nMethylene Blue MMX®'}, {'id': 'FG001', 'title': 'Methylene Blue MMX® 100mg', 'description': 'Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule\n\nMethylene Blue MMX®\n\nPlacebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Oral dose, 8 Placebo tablets over a 4hr schedule\n\nPlacebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '504'}, {'groupId': 'FG001', 'numSubjects': '247'}, {'groupId': 'FG002', 'numSubjects': '498'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '470'}, {'groupId': 'FG001', 'numSubjects': '232'}, {'groupId': 'FG002', 'numSubjects': '464'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '34'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '504', 'groupId': 'BG000'}, {'value': '247', 'groupId': 'BG001'}, {'value': '498', 'groupId': 'BG002'}, {'value': '1249', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Methylene Blue MMX® 200mg', 'description': 'Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule\n\nMethylene Blue MMX®'}, {'id': 'BG001', 'title': 'Methylene Blue MMX® 100mg', 'description': 'Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule\n\nMethylene Blue MMX®\n\nPlacebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Oral dose, 8 Placebo tablets over a 4hr schedule\n\nPlacebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'BG000'}, {'value': '241', 'groupId': 'BG001'}, {'value': '479', 'groupId': 'BG002'}, {'value': '1205', 'groupId': 'BG003'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '313', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '298', 'groupId': 'BG002'}, {'value': '774', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}, {'value': '431', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'ITT=1249, FAS=1205'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'BG000'}, {'value': '241', 'groupId': 'BG001'}, {'value': '479', 'groupId': 'BG002'}, {'value': '1205', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '191', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}, {'value': '478', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '294', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}, {'value': '727', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'ITT=1249 FAS=1205'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1249}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-03', 'studyFirstSubmitDate': '2012-09-25', 'resultsFirstSubmitDate': '2017-08-25', 'studyFirstSubmitQcDate': '2012-09-25', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-03', 'studyFirstPostDateStruct': {'date': '2012-09-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Assess the Detection Efficacy of Chromoendoscopy Performed With 200mg Methylene Blue MMX® 25 mg Tablets Versus Placebo Tablets (White Light Endoscopy) in Terms of the Proportion of Subjects With at Least One Histologically Proven Adenoma or Carcinoma.', 'timeFrame': '+7 days', 'description': 'Adenoma Detection Rate'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '30742834', 'type': 'DERIVED', 'citation': 'Repici A, Wallace MB, East JE, Sharma P, Ramirez FC, Bruining DH, Young M, Gatof D, Irene Mimi Canto M, Marcon N, Cannizzaro R, Kiesslich R, Rutter M, Dekker E, Siersema PD, Spaander M, Kupcinskas L, Jonaitis L, Bisschops R, Radaelli F, Bhandari P, Wilson A, Early D, Gupta N, Vieth M, Lauwers GY, Rossini M, Hassan C. Efficacy of Per-oral Methylene Blue Formulation for Screening Colonoscopy. Gastroenterology. 2019 Jun;156(8):2198-2207.e1. doi: 10.1053/j.gastro.2019.02.001. Epub 2019 Feb 10.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of the histologically proven adenoma and carcinoma detection rate in patients undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with 200 mg of Methylene Blue MMX® tablets.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males or females, aged between 50 and 75.\n* Outpatients scheduled for screening or surveillance colonoscopy for polyps or colorectal cancer )\n* Able to comprehend the full nature and purpose of the study, including possible risks and side effects.\n* Able to co-operate with the investigator and to comply with the requirements of the entire study.\n* Signed written informed consent prior to inclusion in the study.\n\nExclusion Criteria:\n\n* Patients at high risk of colorectal cancer e.g. ulcerative colitis\n* Previous medical history of, or suspected hypersensitivity to, the Methylene Blue and/or formulations' ingredients.\n* Previous medical history of, or suspected hypersensitivity to, the PEG based bowel cleansing preparation and/or bowel cleansing formulations' ingredients.\n* Previous medical history of gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection, severe diverticulitis, heart failure (Class III or IV), serious cardiovascular disease, ulcerative colitis or Crohn's disease."}, 'identificationModule': {'nctId': 'NCT01694966', 'briefTitle': 'The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy', 'organization': {'class': 'UNKNOWN', 'fullName': 'CosmoTech'}, 'officialTitle': 'The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy', 'orgStudyIdInfo': {'id': 'CB-17-01/06'}, 'secondaryIdInfos': [{'id': '2012-003983-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Methylene Blue MMX® 200mg', 'description': 'Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule', 'interventionNames': ['Drug: Methylene Blue MMX®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Methylene Blue MMX® 100mg', 'description': 'Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule', 'interventionNames': ['Drug: Methylene Blue MMX®', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral dose, 8 Placebo tablets over a 4hr schedule', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Methylene Blue MMX®', 'type': 'DRUG', 'otherNames': ['Investigational Product: Methylene Blue MMX® modified release tablets', 'Active Ingredient: Methylene Blue'], 'armGroupLabels': ['Methylene Blue MMX® 100mg', 'Methylene Blue MMX® 200mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Sugar pill manufactured to mimic Methylene Blue MMX® tablet.', 'armGroupLabels': ['Methylene Blue MMX® 100mg', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Dr Michelle Young', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Dr Francesco Ramirez', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '80026', 'city': 'Lafayette', 'state': 'Colorado', 'country': 'United States', 'facility': 'Dr David Gatof', 'geoPoint': {'lat': 39.9936, 'lon': -105.08971}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Dr Michael Wallace', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '66103', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Dr Prateek Sharma', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Dr Marcia Canto', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Dr David Bruining', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': 'Dr Raf Bisschop', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr Norman Marcon', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Wiesbaden', 'country': 'Germany', 'facility': 'Dr Ralf Kiesslich', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}, {'city': 'Aviano', 'country': 'Italy', 'facility': 'Dr Renato Cannizzaro', 'geoPoint': {'lat': 46.07056, 'lon': 12.59472}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'Dr Cesare Hassan', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Rozzano', 'country': 'Italy', 'facility': 'Dr Alessandro Repici', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Dr Limas Kupcinskas', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Dr Evelien Dekker', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Dr Manoon Spander', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Dr Peter Siersema', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Dr James East', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'city': 'Stockton-on-Tees', 'country': 'United Kingdom', 'facility': 'Dr Matthew Rutter', 'geoPoint': {'lat': 54.56848, 'lon': -1.3187}}], 'overallOfficials': [{'name': 'Alessandro Repici, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Co-ordinating Investigator EU'}, {'name': 'Michael Wallace, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Co-ordinating Investigator US'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cosmo Technologies Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}