Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-26 @ 12:27 PM
Study NCT ID:
NCT01732692
Status:
COMPLETED
Last Update Posted:
2014-05-15
First Post:
2012-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Efficacy, Safety and Tolerance of Experimental Morning-only MOVIPREP® Bowel Preparation in Comparison With Split-dose With Nocturnal Pause MOVIPREP® Bowel Preparation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C520497', 'term': 'MoviPrep'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialregistry@tpna.com', 'phone': '800-778-2860', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours.', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'MOVIPREP (Morning-only Dose)', 'description': 'MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.', 'otherNumAtRisk': 70, 'otherNumAffected': 41, 'seriousNumAtRisk': 70, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MOVIPREP (Split-dose)', 'description': 'MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.', 'otherNumAtRisk': 70, 'otherNumAffected': 43, 'seriousNumAtRisk': 70, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Product taste abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood calcium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood calcium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood chloride increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood iron decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood iron increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Body temperature increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Successful Colon Cleansing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MOVIPREP (Morning-only Dose)', 'description': 'MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.'}, {'id': 'OG001', 'title': 'MOVIPREP (Split-dose)', 'description': 'MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.29', 'groupId': 'OG000'}, {'value': '91.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.0286', 'ciLowerLimit': '-0.097', 'estimateComment': 'Treatment Difference is the difference in proportion of participants with successful colon cleansing between treatments -experimental vs. control', 'statisticalMethod': 'Exact Farrington - Manning', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The primary endpoint was analyzed by a non-inferiority test using the exact Farrington-Manning method. Non-inferiority of the two treatments was to be concluded if the lower end of the confidence interval of the difference the experimental treatment group (morning-only dose) - control treatment group (split dose) was above a non-inferiority margin of -0.15%.'}], 'paramType': 'NUMBER', 'timeFrame': '1 day (the day of colonoscopy)', 'description': 'Bowel cleansing was assessed by a blinded endoscopist through visual evaluation of 5 colon segments and scored using the Harefield Cleansing Scale (HCS): A = success, all segments clean/scored 4 or 3; B = success, ≥1 segment with liquid/semi-solid amounts of stool, fully removable, ≥1 segment scored 2; C = failure, ≥1 segment with semi-solid or solid amounts of stool, at least 1 segment scored 1; and D = failure, ≥ 1 segment with irremovable, heavy, hard stools, ≥ 1 segment scored 0. Segmental evaluation of colon cleansing scores is as follows: 4: Colon empty and clean, no remaining stool or liquid. 3: Presence of clear liquid in the gut which can be removed by suction. 2: Brown liquid or semisolid remaining amounts of stool, fully removable. 1: Semisolid amounts of stool, only partially removable, difficult to make colonoscopy; 0: Irremovable, heavy, hard stools, colonoscopy impossible. Success of cleansing was defined as Grades of bowel cleansing А and В.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction of Colonoscopy Preparation (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MOVIPREP (Morning-only Dose)', 'description': 'MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.'}, {'id': 'OG001', 'title': 'MOVIPREP (Split-dose)', 'description': 'MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.2', 'spread': '20.97', 'groupId': 'OG000'}, {'value': '79.6', 'spread': '23.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day (the day of colonoscopy)', 'description': 'Patient satisfaction was measured on a 100 mm visual analog scale (VAS) where 0 (left end of the line) is marked as "totally unacceptable" (lowest patient satisfaction of colonoscopy preparation) and 100 is "fully acceptable" (highest patient satisfaction with the procedure). Satisfaction was scored based on a mark placed on the line by the participant.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population with available VAS data.'}, {'type': 'SECONDARY', 'title': 'Total Compliance Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MOVIPREP (Morning-only Dose)', 'description': 'MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.'}, {'id': 'OG001', 'title': 'MOVIPREP (Split-dose)', 'description': 'MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.1', 'spread': '6.10', 'groupId': 'OG000'}, {'value': '99.5', 'spread': '2.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day (the day of colonoscopy)', 'description': 'Compliance score = 100 \\* (total amount MOVIPREP® intake) / (planned MOVIPREP intake).\n\nTotal compliance score of MOVIPREP is the average score of the compliance for the first and second litre.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat with available data'}, {'type': 'SECONDARY', 'title': 'Patient Compliance - Amount of Additional Clear Liquid Consumed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MOVIPREP (Morning-only Dose)', 'description': 'MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.'}, {'id': 'OG001', 'title': 'MOVIPREP (Split-dose)', 'description': 'MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.'}], 'classes': [{'title': 'After first liter of study drug', 'categories': [{'measurements': [{'value': '545.43', 'spread': '128.6', 'groupId': 'OG000'}, {'value': '640.29', 'spread': '243.4', 'groupId': 'OG001'}]}]}, {'title': 'After second liter of study drug', 'categories': [{'measurements': [{'value': '539.71', 'spread': '116.5', 'groupId': 'OG000'}, {'value': '585.65', 'spread': '145.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day (the day of colonoscopy)', 'description': 'To prevent any potential dehydration risk participants were recommended the intake of at least 500 ml of additional clear liquid (juices without pulp, tea, water) per liter of the Moviprep solution. The amount of additional clear liquid taken is reported for each liter of Moviprep taken.', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population with available data'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Experienced Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MOVIPREP (Morning-only Dose)', 'description': 'MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.'}, {'id': 'OG001', 'title': 'MOVIPREP (Split-dose)', 'description': 'MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.'}], 'classes': [{'title': 'Any adverse event (AE)', 'categories': [{'measurements': [{'value': '58.6', 'groupId': 'OG000'}, {'value': '61.4', 'groupId': 'OG001'}]}]}, {'title': 'Mild adverse event', 'categories': [{'measurements': [{'value': '52.9', 'groupId': 'OG000'}, {'value': '54.3', 'groupId': 'OG001'}]}]}, {'title': 'Moderate adverse event', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}]}]}, {'title': 'Severe adverse event', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Serious adverse event', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'AE leading to study discontinuation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-related adverse event', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}, {'value': '58.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug until the end of colonoscopy procedure, maximum of 24 hours.', 'description': 'An AE was a worsening in severity or frequency of a concomitant illness or any new illness diagnosed during the clinical trial period. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability / incapacity; is a congenital anomaly / birth defect; is medically important. Severity is a clinical observation and describes the intensity of the event: Mild: Transient symptoms, no interference with daily activities; Moderate: Marked symptoms, moderate interference with daily activities; Severe: Considerable interference with daily activities. Relatedness to study drug was assessed by the Investigator.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MOVIPREP (Morning-only Dose)', 'description': 'MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.'}, {'id': 'FG001', 'title': 'MOVIPREP (Split-dose)', 'description': 'MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 6 investigative sites in the Russian Federation and the Republic of Kazakhstan from 22 November 2012 to 5 April 2013.', 'preAssignmentDetails': 'Participants indicated for a colonoscopy were enrolled equally in 1 of 2 treatment groups, morning-only on the day of the clinical procedure or split-dosing in 2 stages with a nocturnal pause.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MOVIPREP (Morning-only Dose)', 'description': 'MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.'}, {'id': 'BG001', 'title': 'MOVIPREP (Split-dose)', 'description': 'MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.3', 'spread': '17.41', 'groupId': 'BG000'}, {'value': '49.1', 'spread': '16.26', 'groupId': 'BG001'}, {'value': '49.8', 'spread': '16.79', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '171.1', 'spread': '9.36', 'groupId': 'BG000'}, {'value': '165.1', 'spread': '7.83', 'groupId': 'BG001'}, {'value': '168.1', 'spread': '9.07', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '73.5', 'spread': '16.92', 'groupId': 'BG000'}, {'value': '68.3', 'spread': '13.86', 'groupId': 'BG001'}, {'value': '71.1', 'spread': '15.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '25.1', 'spread': '5.30', 'groupId': 'BG000'}, {'value': '25.1', 'spread': '5.10', 'groupId': 'BG001'}, {'value': '25.1', 'spread': '5.25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russia', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}, {'title': 'Kazakhstan', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-16', 'studyFirstSubmitDate': '2012-10-19', 'resultsFirstSubmitDate': '2014-04-05', 'studyFirstSubmitQcDate': '2012-11-19', 'lastUpdatePostDateStruct': {'date': '2014-05-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-16', 'studyFirstPostDateStruct': {'date': '2012-11-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Successful Colon Cleansing', 'timeFrame': '1 day (the day of colonoscopy)', 'description': 'Bowel cleansing was assessed by a blinded endoscopist through visual evaluation of 5 colon segments and scored using the Harefield Cleansing Scale (HCS): A = success, all segments clean/scored 4 or 3; B = success, ≥1 segment with liquid/semi-solid amounts of stool, fully removable, ≥1 segment scored 2; C = failure, ≥1 segment with semi-solid or solid amounts of stool, at least 1 segment scored 1; and D = failure, ≥ 1 segment with irremovable, heavy, hard stools, ≥ 1 segment scored 0. Segmental evaluation of colon cleansing scores is as follows: 4: Colon empty and clean, no remaining stool or liquid. 3: Presence of clear liquid in the gut which can be removed by suction. 2: Brown liquid or semisolid remaining amounts of stool, fully removable. 1: Semisolid amounts of stool, only partially removable, difficult to make colonoscopy; 0: Irremovable, heavy, hard stools, colonoscopy impossible. Success of cleansing was defined as Grades of bowel cleansing А and В.'}], 'secondaryOutcomes': [{'measure': 'Patient Satisfaction of Colonoscopy Preparation (VAS)', 'timeFrame': '1 day (the day of colonoscopy)', 'description': 'Patient satisfaction was measured on a 100 mm visual analog scale (VAS) where 0 (left end of the line) is marked as "totally unacceptable" (lowest patient satisfaction of colonoscopy preparation) and 100 is "fully acceptable" (highest patient satisfaction with the procedure). Satisfaction was scored based on a mark placed on the line by the participant.'}, {'measure': 'Total Compliance Score', 'timeFrame': '1 day (the day of colonoscopy)', 'description': 'Compliance score = 100 \\* (total amount MOVIPREP® intake) / (planned MOVIPREP intake).\n\nTotal compliance score of MOVIPREP is the average score of the compliance for the first and second litre.'}, {'measure': 'Patient Compliance - Amount of Additional Clear Liquid Consumed', 'timeFrame': '1 day (the day of colonoscopy)', 'description': 'To prevent any potential dehydration risk participants were recommended the intake of at least 500 ml of additional clear liquid (juices without pulp, tea, water) per liter of the Moviprep solution. The amount of additional clear liquid taken is reported for each liter of Moviprep taken.'}, {'measure': 'Percentage of Patients Who Experienced Adverse Events (AEs)', 'timeFrame': 'From first dose of study drug until the end of colonoscopy procedure, maximum of 24 hours.', 'description': 'An AE was a worsening in severity or frequency of a concomitant illness or any new illness diagnosed during the clinical trial period. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability / incapacity; is a congenital anomaly / birth defect; is medically important. Severity is a clinical observation and describes the intensity of the event: Mild: Transient symptoms, no interference with daily activities; Moderate: Marked symptoms, moderate interference with daily activities; Severe: Considerable interference with daily activities. Relatedness to study drug was assessed by the Investigator.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bowel preparation, MOVIPREP®'], 'conditions': ['Bowel Preparation Prior to Endoscopic, Radiological and Other Examinations as Well as to Surgical Procedures Which Require Empty Bowel.']}, 'descriptionModule': {'briefSummary': 'To compare colon cleansing quality induced by the 2 different modes of MOVIPREP® intake in 5 colon segments prior to colonoscopy.', 'detailedDescription': 'All participants enrolled to the study will be allocated to one of two arms. Patients of the experimental morning-only regimen arm will prepare and take MOVIPREP® solution in the full dose - 2 litres of MOVIPREP® preparation in the early morning on the day of the colonoscopy clinical procedure. Participants in the standard split-dose regimen arm will prepare and take MOVIPREP® solution in split doses - ½ of dose (1 litre) the evening before + ½ of dose (1 litre) of MOVIPREP® preparation in the morning of the day of the colonoscopy.\n\nThe study consists of three visits. Participation in the study lasts no more than 11 days; 3 days as minimum.\n\nThere is no follow-up period planned except in case of any adverse events (AEs) when the follow-up period will last until the participant has recovered or until all AE-related queries for the participant have been resolved.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* male or female ≥18 years and ≤ 85 years\n* colonoscopy procedure indicated\n* willing to stay in the outpatient clinical site for colonoscopy and questionnaire completion\n* willing and able to undergo study-related procedures\n* informed consent signed by a patient for participation in the study\n* negative pregnancy test in women with childbearing potential and consent for double barrier method birth control for subjects, men and women, during the study\n\nExclusion Criteria:\n\n* ileus\n* suspected colonic tumor with manifestations of intestinal obstruction\n* delayed gastric emptying (gastroparesis), weak vomiting reflex, tendency to aspiration and regurgitation\n* toxic megacolon which is a result of severe inflammatory conditions of the colon including Crohn's disease and ulcerative colitis\n* suspected intestinal perforation or risk of gastrointestinal perforation\n* signs of severe intestinal bleeding\n* acute inflammatory anal or perianal pathology\n* severe concomitant diseases of internal organs\n* psychiatric diseases in aggravation stage\n* hypersensitivity to polyethylene glycol and/or any component of MOVIPREP® preparation\n* phenylketonuria or diagnosed glucose-6-phosphate dehydrogenate deficiency\n* unconsciousness\n* dehydration\n* severe inflammatory diseases\n* acute abdominal pain of unknown etiology\n* pregnancy and lactation period\n* participation in any other clinical study (including studies of experimental devices) in 30 days prior participation in the present trial\n* patients who test positive for human immunodeficiency virus (HIV)/autoimmune disease (AID), Wasserman reaction (RW) or hepatitis B virus (HBC)\n* any condition or circumstance that, in the opinion of the Investigator, would compromise the safety of the participant or the quality of study data"}, 'identificationModule': {'nctId': 'NCT01732692', 'briefTitle': 'Evaluation of the Efficacy, Safety and Tolerance of Experimental Morning-only MOVIPREP® Bowel Preparation in Comparison With Split-dose With Nocturnal Pause MOVIPREP® Bowel Preparation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Multicenter Endoscopist-blinded Randomized Parallel-group Comparative Study to Assess Efficacy, Safety and Tolerance of Morning-only Dosing Compared to Control Split-dosing With Nocturnal Pause in MOVIPREP® Bowel Preparation Prior to Colonoscopy', 'orgStudyIdInfo': {'id': 'MV-9999-301-RU'}, 'secondaryIdInfos': [{'id': 'U1111-1135-2011', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MOVIPREP (Morning-only dose)', 'description': 'MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.', 'interventionNames': ['Drug: MOVIPREP']}, {'type': 'OTHER', 'label': 'MOVIPREP (Split-dose)', 'description': 'MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.', 'interventionNames': ['Drug: MOVIPREP']}], 'interventions': [{'name': 'MOVIPREP', 'type': 'DRUG', 'description': 'MOVIPREP solution', 'armGroupLabels': ['MOVIPREP (Morning-only dose)', 'MOVIPREP (Split-dose)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alma-Ata', 'country': 'Kazakhstan', 'geoPoint': {'lat': 43.25249, 'lon': 76.9115}}, {'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'overallOfficials': [{'name': 'Medical Director Clinical Science', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Norgine BV', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}