Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-02-28 @ 5:28 AM
Study NCT ID:
NCT02239692
Status:
COMPLETED
Last Update Posted:
2016-06-23
First Post:
2014-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial Comparing the PICOPREP Tailored Dosing Schedule to the PICOPREP Day-before Dosing Schedule for Colon Cleansing in Preparation for Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C005701', 'term': 'picosulfate sodium'}]}}, '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}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).', 'eventGroups': [{'id': 'EG000', 'title': 'PICOPREP Day-before Dosing Schedule', 'description': 'Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.\n\nPICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution', 'otherNumAtRisk': 70, 'otherNumAffected': 4, 'seriousNumAtRisk': 70, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PICOPREP Tailored Dosing Schedule', 'description': 'Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.\n\nPICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution', 'otherNumAtRisk': 125, 'otherNumAffected': 14, 'seriousNumAtRisk': 125, 'seriousNumAffected': 1}], 'otherEvents': [{'term': "Gilbert's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Anorectal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Gastrointestinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hypermagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'seriousEvents': [{'term': 'Large intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PICOPREP Day-before Dosing Schedule', 'description': 'Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.\n\nPICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution'}, {'id': 'OG001', 'title': 'PICOPREP Tailored Dosing Schedule', 'description': 'Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.\n\nPICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution'}], 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'spread': '3.54', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '3.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted estimated mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.93', 'ciLowerLimit': '-4.99', 'ciUpperLimit': '-2.87', 'pValueComment': 'p-value corresponds to a two-sided test of superiority.', 'estimateComment': 'Treatment difference in mean total Ottawa Scale score was calculated as PICOPREP tailored dosing schedule minus PICOPREP day-before dosing schedule.', 'groupDescription': 'Null hypothesis was no treatment difference between the two dosing schedules.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANCOVA with treatment, country and time of colonoscopy (AM/PM) as factors.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority is assessed by examining whether the upper limit of the 95% confidence interval is less than the specified non-inferiority margin of 1.5 points.'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (day of colonoscopy)', 'description': 'Measured by the total Ottawa Scale score during the colonoscopy performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set consisted of all randomized subjects.'}, {'type': 'PRIMARY', 'title': 'Overall Colon Cleansing Procedure (PP) Measured by the Total Ottawa Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PICOPREP Day-before Dosing Schedule', 'description': 'Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.\n\nPICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution'}, {'id': 'OG001', 'title': 'PICOPREP Tailored Dosing Schedule', 'description': 'Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.\n\nPICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution'}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '3.38', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '3.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted estimated mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.38', 'ciLowerLimit': '-5.34', 'ciUpperLimit': '-3.41', 'pValueComment': 'p-value corresponds to a two-sided test of superiority.', 'estimateComment': 'Treatment difference in mean total Ottawa Scale score was calculated as PICOPREP tailored dosing schedule minus PICOPREP day-before dosing schedule.', 'groupDescription': 'Null hypothesis was no treatment difference between the two dosing schedules.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANCOVA with treatment, country and time of colonoscopy (AM/PM) as factors.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority is assessed by examining whether the upper limit of the 95% confidence interval is less than the specified non-inferiority margin of 1.5 points.'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (day of colonoscopy)', 'description': 'Measured by the total Ottawa Scale score during the colonoscopy which is performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol (PP) analysis set consisted of all the subjects included in ITT analysis set, but excluding subjects with major protocol deviations (18 subjects) that would impact efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Ascending Colon Cleansing Responder Status (ITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PICOPREP Day-before Dosing Schedule', 'description': 'Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.\n\nPICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution'}, {'id': 'OG001', 'title': 'PICOPREP Tailored Dosing Schedule', 'description': 'Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.\n\nPICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution'}], 'classes': [{'categories': [{'measurements': [{'value': '15.1', 'groupId': 'OG000'}, {'value': '61.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted estimated odds ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.18', 'ciLowerLimit': '4.36', 'ciUpperLimit': '19.32', 'pValueComment': 'p-value corresponds to a two-sided test of superiority.', 'estimateComment': 'The estimated odds ratio compares the odds of being a responder in the PICOPREP tailored dosing schedule vs. the PICOPREP day-before dosing schedule.', 'groupDescription': 'Null hypothesis was no treatment difference between the two dosing schedules.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression with the failure/success status as dependent variable, and treatment, country and timing of colonoscopy as factors.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (day of colonoscopy)', 'description': 'Percentage of subjects classified as responders, i.e. Ottawa Scale score of either 0 (excellent) or 1 (good), during colonoscopy performed by a colonoscopist blinded to the dosing schedules.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set consisted of all randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Frequency and Intensity of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PICOPREP Day-before Dosing Schedule', 'description': 'Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.\n\nPICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution'}, {'id': 'OG001', 'title': 'PICOPREP Tailored Dosing Schedule', 'description': 'Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.\n\nPICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution'}], 'classes': [{'title': 'Frequency of all adverse events', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Frequency of mild adverse events', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Frequency of moderate adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Frequency of severe adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (screening) up to day 10 after colonoscopy', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety analysis set consisted of all treated subjects and was analyzed according to the actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Clinically Significant Changes in Vital Signs (Pulse and Blood Pressure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PICOPREP Day-before Dosing Schedule', 'description': 'Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.\n\nPICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution'}, {'id': 'OG001', 'title': 'PICOPREP Tailored Dosing Schedule', 'description': 'Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.\n\nPICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution'}], 'classes': [{'title': 'Clinically significant change in pulse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Clinically significant change in blood pressure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)', 'description': 'Mean change from baseline to the end-of-trial was observed for pulse and blood pressure (systolic and diastolic).', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety analysis set consisted of all treated subjects and was analyzed according to the actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Clinically Significant Changes in Laboratory Values (Haematology, Clinical Chemistry, Coagulation and Urinalysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PICOPREP Day-before Dosing Schedule', 'description': 'Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.\n\nPICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution'}, {'id': 'OG001', 'title': 'PICOPREP Tailored Dosing Schedule', 'description': 'Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.\n\nPICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution'}], 'classes': [{'title': 'Clinically significant change in haematology', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Clinically significant change in clinical chem', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Clinically significant change in coagulation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Clinically significant change in urinalysis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)', 'description': 'Laboratory parameters included routine haematology, clinical chemistry, coagulation and urinalysis. With the exception of urinalysis and urine pregnancy test, which was performed as dip-stick analyses at the trial site, all laboratory tests were analysed by a central laboratory.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety analysis set consisted of all treated subjects and was analyzed according to the actual treatment received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PICOPREP Day-before Dosing Schedule', 'description': 'Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.\n\nPICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution'}, {'id': 'FG001', 'title': 'PICOPREP Tailored Dosing Schedule', 'description': 'Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.\n\nPICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '131'}]}, {'type': 'Intention-to-treat Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '131'}]}, {'type': 'Per-protocol Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '120'}]}, {'type': 'Safety Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '125'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '118'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Incomplete colonoscopy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from 11 sites in Germany, France and the Netherlands from Nov 2014 to Jun 2015.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PICOPREP Day-before Dosing Schedule', 'description': 'Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.\n\nPICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution'}, {'id': 'BG001', 'title': 'PICOPREP Tailored Dosing Schedule', 'description': 'Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.\n\nPICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.6', 'spread': '15.1', 'groupId': 'BG000'}, {'value': '58.4', 'spread': '13.3', 'groupId': 'BG001'}, {'value': '57.8', 'spread': '13.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The intention-to-treat (ITT) analysis set consisted of all randomized subjects.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-17', 'studyFirstSubmitDate': '2014-09-09', 'resultsFirstSubmitDate': '2016-05-17', 'studyFirstSubmitQcDate': '2014-09-11', 'lastUpdatePostDateStruct': {'date': '2016-06-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-05-17', 'studyFirstPostDateStruct': {'date': '2014-09-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale', 'timeFrame': 'Day 1 (day of colonoscopy)', 'description': 'Measured by the total Ottawa Scale score during the colonoscopy performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).'}, {'measure': 'Overall Colon Cleansing Procedure (PP) Measured by the Total Ottawa Scale', 'timeFrame': 'Day 1 (day of colonoscopy)', 'description': 'Measured by the total Ottawa Scale score during the colonoscopy which is performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).'}], 'secondaryOutcomes': [{'measure': 'Ascending Colon Cleansing Responder Status (ITT)', 'timeFrame': 'Day 1 (day of colonoscopy)', 'description': 'Percentage of subjects classified as responders, i.e. Ottawa Scale score of either 0 (excellent) or 1 (good), during colonoscopy performed by a colonoscopist blinded to the dosing schedules.'}, {'measure': 'Frequency and Intensity of Adverse Events', 'timeFrame': 'From baseline (screening) up to day 10 after colonoscopy'}, {'measure': 'Clinically Significant Changes in Vital Signs (Pulse and Blood Pressure)', 'timeFrame': 'From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)', 'description': 'Mean change from baseline to the end-of-trial was observed for pulse and blood pressure (systolic and diastolic).'}, {'measure': 'Clinically Significant Changes in Laboratory Values (Haematology, Clinical Chemistry, Coagulation and Urinalysis)', 'timeFrame': 'From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)', 'description': 'Laboratory parameters included routine haematology, clinical chemistry, coagulation and urinalysis. With the exception of urinalysis and urine pregnancy test, which was performed as dip-stick analyses at the trial site, all laboratory tests were analysed by a central laboratory.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bowel Cleansing']}, 'referencesModule': {'references': [{'pmid': '28393103', 'type': 'DERIVED', 'citation': 'Kiesslich R, Schubert S, Mross M, Klugmann T, Klemt-Kropp M, Behnken I, Bonnaud G, Keulen E, Groenen M, Blaker M, Ponchon T, Landry W, Stoltenberg M. Efficacy and safety of PICOPREP tailored dosing compared with PICOPREP day-before dosing for colon cleansing: a multi-centric randomised study. Endosc Int Open. 2017 Apr;5(4):E282-E290. doi: 10.1055/s-0043-102433.'}]}, 'descriptionModule': {'briefSummary': 'This was a phase 3, randomised, assessor-blinded, multi-centre trial comparing the efficacy, safety and tolerability of a PICOPREP tailored dosing schedule to the PICOPREP day-before dosing schedule for colon cleansing in preparation for colonoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, 18 years of age or above, being scheduled to undergo elective colonoscopy\n* Subjects must have had more than or equal to 3 spontaneous bowel movements (i.e. without use of any laxative within 24 hours before the bowel movement, with the exception for bulk-forming laxatives (ATC code A06AC)) per week for one month prior to the colonoscopy\n\nExclusion Criteria:\n\n* Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.)\n* Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD)\n* Any prior colorectal surgery, excluding appendectomy, haemorrhoid surgery or prior endoscopic procedures\n* Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudoobstruction, hypomotility syndrome)\n* Ascites\n* Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis, ileus)\n* Upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)\n* Severely reduced renal function (Glomerular filtration rate (GFR) \\<30 (mL/min/1.73 m2))\n* The subject is a pregnant (positive urine pregnancy test at Visit 1 or Visit 2) woman. Women of childbearing potential (defined, for the purpose of this trial, as all females post-puberty, not postmenopausal ≥2 years, or not surgically sterile) who do not agree to use one of the following methods of birth control from the day of signing the Informed Consent Form until End of Trial Visit are excluded:\n\n 1. Transdermal patch\n 2. Hormonal contraception (i.e., oral, implant, or injectable contraceptive)\n 3. Double-barrier birth control (i.e., condom plus intrauterine device, diaphragm plus spermicide, etc.)\n 4. Maintenance of a monogamous relationship with a male who has been surgically sterilised by vasectomy\n 5. Sexual abstinence\n* The subject is a breast-feeding or lactating woman'}, 'identificationModule': {'nctId': 'NCT02239692', 'acronym': 'OPTIMA', 'briefTitle': 'A Trial Comparing the PICOPREP Tailored Dosing Schedule to the PICOPREP Day-before Dosing Schedule for Colon Cleansing in Preparation for Colonoscopy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'A Randomised, Assessor-blinded, Multi-centre Trial Comparing the Efficacy, Safety and Tolerability of the PICOPREP Tailored Dosing Schedule to the PICOPREP Day-before Dosing Schedule for Colon Cleansing in Preparation for Colonoscopy', 'orgStudyIdInfo': {'id': '000121'}, 'secondaryIdInfos': [{'id': '2014-001062-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PICOPREP day-before dosing schedule', 'description': 'Both doses administered the day before colonoscopy.', 'interventionNames': ['Drug: PICOPREP']}, {'type': 'EXPERIMENTAL', 'label': 'PICOPREP tailored dosing schedule', 'description': 'First dose one day before colonoscopy or on the day of colonoscopy, dependent on the planned time for colonoscopy, and second dose on the day of colonoscopy.', 'interventionNames': ['Drug: PICOPREP']}], 'interventions': [{'name': 'PICOPREP', 'type': 'DRUG', 'description': 'Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution', 'armGroupLabels': ['PICOPREP day-before dosing schedule', 'PICOPREP tailored dosing schedule']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lyon', 'country': 'France', 'facility': 'Ed Herriot Hopital (there may be other sites in this country)', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Gastroenterologie am Bayerischen Platz (there may be other sites in this country)', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Alkmaar', 'country': 'Netherlands', 'facility': 'Medisch Centrum Alkmaar (there may be other sites in this country)', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}], 'overallOfficials': [{'name': 'Clinical Development Support', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ferring Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}