Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-02-25 @ 8:25 PM
Study NCT ID:
NCT02273167
Status:
COMPLETED
Last Update Posted:
2018-05-15
First Post:
2014-10-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus MOVIPREP® Using 2-Day Split-Dosing and 1-Day Morning Split-Dosing Regimen in Adults.
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C520497', 'term': 'MoviPrep'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'LClayton@norgine.com', 'phone': '+44-1895-826669', 'title': 'Lucy Clayton', 'organization': 'Norgine Ltd'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Imputation of failure occurred in 4% of patients. This strict analytical approach reduced the cleansing success rates for both treatments.'}}, 'adverseEventsModule': {'timeFrame': 'Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)', 'description': 'Treatment Emergent AEs. Safety analyses were based on the safety population, which included all randomized patients whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=794).', 'eventGroups': [{'id': 'EG000', 'title': 'MOVIPREP, 2-Day Split-Dosing', 'description': 'MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).', 'otherNumAtRisk': 263, 'otherNumAffected': 31, 'seriousNumAtRisk': 263, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'NER1006, 2-Day Split-Dosing', 'description': 'NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).', 'otherNumAtRisk': 262, 'otherNumAffected': 41, 'seriousNumAtRisk': 262, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'NER1006,1-Day Morning Split-Dosing', 'description': 'NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).', 'otherNumAtRisk': 269, 'otherNumAffected': 49, 'seriousNumAtRisk': 269, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'seriousEvents': [{'term': 'Procedural intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Successful Bowel Cleansing (Overall Colon)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MOVIPREP, 2-Day Split-Dosing', 'description': 'MOVIPREP: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).'}, {'id': 'OG001', 'title': 'NER1006, 2-Day Split-Dosing', 'description': 'NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).'}, {'id': 'OG002', 'title': 'NER1006,1-Day Morning Split-Dosing', 'description': 'NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).'}], 'classes': [{'title': 'Successful', 'categories': [{'measurements': [{'value': '238', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}, {'value': '245', 'groupId': 'OG002'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.055', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in success rate', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '4.50', 'ciLowerLimit': '-4.00', 'pValueComment': 'The p-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \\<0.025, the threshold for statistical significance.', 'groupDescription': 'Hypothesis was to demonstrate non-inferiority (NI) of NER1006 2-Day to MOVIPREP (10% margin). Success rate was no. of patients with successful overall bowel cleansing as proportion of no. of patients in each group. Treatment effect was NER1006 2-Day success rate - MOVIPREP success rate. Hochberg procedure used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The confidence limits (CL) were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior, the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CL. Calculated using exact Clopper-Pearson CLs. To accommodate the comparison of 2 NER1006 regimens a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.'}, {'pValue': '0.328', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in success rate', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.59', 'ciLowerLimit': '-6.91', 'pValueComment': 'The p-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \\<0.025, the threshold for statistical significance.', 'groupDescription': 'The hypothesis was to demonstrate NI of NER1006 1-Day to MOVIPREP (10% margin). Success rate was number of patients with successful overall bowel cleansing as proportion of number of patients in each group. Treatment effect was NER1006 1-Day success rate - MOVIPREP success rate. A Hochberg procedure was used to control Type I error since there were two alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The CLs were adjusted for multiple comparisons (2 alternative primary endpoints): To be declared non-inferior, the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CLs. Calculated using exact Clopper-Pearson confidences limits. To accommodate the comparison of two NER1006 regimens a hierarchical testing approach will be used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 2 days (from day of first dosing to day of colonoscopy)', 'description': 'The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). A final HCS grading of A, B, C or D was derived. Grades A and B are classified as successful (i.e. all mucosa could be visualized) and C and D are classified as unsuccessful. Comparison of overall success of cleansing with NER1006 2-Day and 1-Day versus MOVIPREP was evaluated using a non-inferiority study design.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.'}, {'type': 'PRIMARY', 'title': "Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MOVIPREP, 2-Day Split-Dosing', 'description': 'MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).'}, {'id': 'OG001', 'title': 'NER1006, 2-Day Split-Dosing', 'description': 'NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).'}, {'id': 'OG002', 'title': 'NER1006,1-Day Morning Split-Dosing', 'description': 'NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).'}], 'classes': [{'title': 'Excellent plus good', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}]}, {'title': 'Adequate plus failure', 'categories': [{'measurements': [{'value': '231', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '182', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in excellent plus good rate', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '16.56', 'ciLowerLimit': '8.11', 'pValueComment': 'The p-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \\<0.025, the threshold for statistical significance.', 'groupDescription': 'Hypothesis was to demonstrate NI of NER1006 2-Day to MOVIPREP (10% margin). Success rate was no. of patients with highly effective cleansing of the colon ascendens as proportion of no. of patients in each group. Treatment effect was NER1006 2-Day success rate - MOVIPREP success rate. Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Confidence limits (CL) were adjusted for multiple comparisons (2 alternative primary endpoints): To be declared non-inferior the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CLs. Calculated using exact Clopper-Pearson CLs. To accommodate the comparison of two NER1006 regimens a hierarchical testing approach will be used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in excellent plus good rate', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '18.74', 'ciLowerLimit': '10.32', 'pValueComment': 'The p-value was adjusted for multiple comparisons (2 alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \\<0.025, the threshold for statistical significance.', 'groupDescription': 'Hypothesis was to demonstrate NI of NER1006 1-Day to MOVIPREP (10% margin). Success rate was no. of patients with highly effective cleansing of the colon ascendens as proportion of no. of patients in each group. Treatment effect was NER1006 1-Day success rate - MOVIPREP success rate. Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The confidence limits (CLs) were adjusted for multiple comparisons (2 alternative primary endpoints): To be declared non-inferior the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CLs. Calculated using exact Clopper-Pearson CLs. To accommodate the comparison of 2 NER1006 regimens a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 2 days (from day of first dosing to day of colonoscopy)', 'description': "The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). Highly effective cleansing in the colon ascendens corresponded to scores 3 (Good) or 4 (Excellent) of the HCS. Adequate plus failure of cleansing corresponded to score 0-2. Comparison of 'Excellent plus good' cleansing of the colon ascendens using NER1006 2-Day and 1-Day versus MOVIPREP was evaluated using a non-inferiority study design.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.'}, {'type': 'SECONDARY', 'title': 'Adenoma Detection Rate (Colon Ascendens)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MOVIPREP, 2-Day Split-Dosing', 'description': 'MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).'}, {'id': 'OG001', 'title': 'NER1006, 2-Day Split-Dosing', 'description': 'NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).'}, {'id': 'OG002', 'title': 'NER1006,1-Day Morning Split-Dosing', 'description': 'NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).'}], 'classes': [{'title': 'Patients with no adenomas detected', 'categories': [{'measurements': [{'value': '250', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}, {'value': '243', 'groupId': 'OG002'}]}]}, {'title': 'Patients with at least one adenoma detected', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.106', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in ADR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.55', 'ciLowerLimit': '-4.80', 'ciUpperLimit': '12.00', 'pValueComment': 'To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 2-Day relative to MOVIPREP with 1-sided p-value \\<0.025, the threshold for statistical significance.', 'groupDescription': 'If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 2-Day rate - MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.'}, {'pValue': '0.106', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in ADR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.55', 'ciLowerLimit': '-4.80', 'ciUpperLimit': '12.00', 'pValueComment': 'To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 1-Day relative to MOVIPREP with 1-sided p-value \\<0.025, the threshold for statistical significance.', 'groupDescription': 'If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 1-Day rate - MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 2 days (from day of first dosing to day of colonoscopy)', 'description': 'Comparison of the number of patients with at least one adenoma detected in the colon ascendens when NER1006 2-Day and 1-Day is used for bowel cleansing versus MOVIPREP. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the colon ascendens.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.'}, {'type': 'SECONDARY', 'title': 'Adenoma Detection Rate (Overall Colon)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MOVIPREP, 2-Day Split-Dosing', 'description': 'MOVIPREP: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).'}, {'id': 'OG001', 'title': 'NER1006, 2-Day Split-Dosing', 'description': 'NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).'}, {'id': 'OG002', 'title': 'NER1006,1-Day Morning Split-Dosing', 'description': 'NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).'}], 'classes': [{'title': 'Patients with no adenomas detected', 'categories': [{'measurements': [{'value': '199', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}]}, {'title': 'Patients with at least one adenoma detected', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.569', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in ADR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-8.74', 'ciUpperLimit': '8.02', 'pValueComment': 'To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 2-Day relative to MOVIPREP with 1-sided p-value \\<0.025, the threshold for statistical significance.', 'groupDescription': 'If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 2-Day rate - MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.'}, {'pValue': '0.455', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in ADR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '-7.65', 'ciUpperLimit': '9.11', 'pValueComment': 'To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 1-Day relative to MOVIPREP with 1-sided p-value \\<0.025, the threshold for statistical significance.', 'groupDescription': 'If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 1-Day rate - MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 2 days (from day of first dosing to day of colonoscopy)', 'description': 'Comparison of the number of patients with at least one adenoma detected in the overall colon when NER1006 2-Day and 1-Day is used for bowel cleansing versus MOVIPREP. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the overall colon.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.'}, {'type': 'SECONDARY', 'title': 'Polyp Detection Rate (Colon Ascendens)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MOVIPREP, 2-Day Split-Dosing', 'description': 'MOVIPREP: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).'}, {'id': 'OG001', 'title': 'NER1006, 2-Day Split-Dosing', 'description': 'NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).'}, {'id': 'OG002', 'title': 'NER1006,1-Day Morning Split-Dosing', 'description': 'NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).'}], 'classes': [{'title': 'Patients with no polyps detected', 'categories': [{'measurements': [{'value': '228', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '224', 'groupId': 'OG002'}]}]}, {'title': 'Patients with at least one polyp detected', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.024', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in PDR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.10', 'ciLowerLimit': '-1.41', 'ciUpperLimit': '15.47', 'groupDescription': 'If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the colon ascendens was calculated as NER1006 2-Day rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence limits.'}, {'pValue': '0.268', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in PDR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.37', 'ciLowerLimit': '-6.12', 'ciUpperLimit': '10.82', 'pValueComment': 'Superiority of NER1006 1-Day to MOVIPREP not demonstrated statistically.', 'groupDescription': 'If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the colon ascendens was calculated as NER1006 rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence limits. Non-inferiority of NER1006 1-Day to MOVIPREP was proven.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 2 days (from day of first dosing to day of colonoscopy)', 'description': 'Comparison of the number of patients with at least one polyp detected in the colon ascendens when NER1006 2-Day and 1-Day is used for bowel cleansing versus MOVIPREP. Polyp detection rate (PDR) defined as the number of patients with at least one polyp in the colon ascendens.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug'}, {'type': 'SECONDARY', 'title': 'Polyp Detection Rate (Overall Colon)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MOVIPREP, 2-Day Split-Dosing', 'description': 'MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).'}, {'id': 'OG001', 'title': 'NER1006, 2-Day Split-Dosing', 'description': 'NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).'}, {'id': 'OG002', 'title': 'NER1006,1-Day Morning Split-Dosing', 'description': 'NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).'}], 'classes': [{'title': 'Patients with no polyps detected', 'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}]}]}, {'title': 'Patients with at least one polyp detected', 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.579', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in PDR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-8.85', 'ciUpperLimit': '8.00', 'groupDescription': 'If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the overall colon was calculated as NER1006 rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence intervals.'}, {'pValue': '0.478', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in PDR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.61', 'ciLowerLimit': '-7.78', 'ciUpperLimit': '9.09', 'groupDescription': 'If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the overall colon was calculated as NER1006 1-Day rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence limits.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 days (from day of first dosing to day of colonoscopy)', 'description': 'Comparison of the number of patients with at least one polyp detected in the overall colon when NER1006 is used for bowel cleansing versus number detected when MOVIPREP is used. PDR defined as the number of patients with at least one polyp in the overall colon.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analysed is based on the mFAS. This included all randomized patients except those patients who (i) were randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug (n=822).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MOVIPREP, 2-Day Split-Dosing', 'description': 'MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).'}, {'id': 'FG001', 'title': 'NER1006, 2-Day Split-Dosing', 'description': 'NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).'}, {'id': 'FG002', 'title': 'NER1006,1-Day Morning Split-Dosing', 'description': 'NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '283'}, {'groupId': 'FG001', 'numSubjects': '283'}, {'groupId': 'FG002', 'numSubjects': '283'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '259'}, {'groupId': 'FG001', 'numSubjects': '260'}, {'groupId': 'FG002', 'numSubjects': '262'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Various', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'The trial recruited out/in-patients at 29 medical centres in Europe, from October 2014 to June 2015.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'BG000'}, {'value': '283', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}, {'value': '849', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'MOVIPREP, 2-Day Split-Dosing', 'description': 'MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).'}, {'id': 'BG001', 'title': 'NER1006, 2-Day Split-Dosing', 'description': 'NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).'}, {'id': 'BG002', 'title': 'NER1006,1-Day Morning Split-Dosing', 'description': 'NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '228', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '639', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '209', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.3', 'spread': '12.48', 'groupId': 'BG000'}, {'value': '56.3', 'spread': '12.03', 'groupId': 'BG001'}, {'value': '54.9', 'spread': '13.21', 'groupId': 'BG002'}, {'value': '55.2', 'spread': '12.57', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '454', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '395', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The number of participants for analysis, 245 per arm, was based on assumed overall cleansing success rates of 90% for both MOVIPREP and NER1006, a non-inferiority margin of 10%, and at least 90% power to demonstrate non-inferiority. The overall number of participants analyzed was based on the modified full analysis set (mFAS).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 849}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-12', 'studyFirstSubmitDate': '2014-10-16', 'resultsFirstSubmitDate': '2016-08-19', 'studyFirstSubmitQcDate': '2014-10-22', 'lastUpdatePostDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-07', 'studyFirstPostDateStruct': {'date': '2014-10-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Successful Bowel Cleansing (Overall Colon)', 'timeFrame': 'Up to 2 days (from day of first dosing to day of colonoscopy)', 'description': 'The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). A final HCS grading of A, B, C or D was derived. Grades A and B are classified as successful (i.e. all mucosa could be visualized) and C and D are classified as unsuccessful. Comparison of overall success of cleansing with NER1006 2-Day and 1-Day versus MOVIPREP was evaluated using a non-inferiority study design.'}, {'measure': "Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)", 'timeFrame': 'Up to 2 days (from day of first dosing to day of colonoscopy)', 'description': "The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). Highly effective cleansing in the colon ascendens corresponded to scores 3 (Good) or 4 (Excellent) of the HCS. Adequate plus failure of cleansing corresponded to score 0-2. Comparison of 'Excellent plus good' cleansing of the colon ascendens using NER1006 2-Day and 1-Day versus MOVIPREP was evaluated using a non-inferiority study design."}], 'secondaryOutcomes': [{'measure': 'Adenoma Detection Rate (Colon Ascendens)', 'timeFrame': 'Up to 2 days (from day of first dosing to day of colonoscopy)', 'description': 'Comparison of the number of patients with at least one adenoma detected in the colon ascendens when NER1006 2-Day and 1-Day is used for bowel cleansing versus MOVIPREP. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the colon ascendens.'}, {'measure': 'Adenoma Detection Rate (Overall Colon)', 'timeFrame': 'Up to 2 days (from day of first dosing to day of colonoscopy)', 'description': 'Comparison of the number of patients with at least one adenoma detected in the overall colon when NER1006 2-Day and 1-Day is used for bowel cleansing versus MOVIPREP. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the overall colon.'}, {'measure': 'Polyp Detection Rate (Colon Ascendens)', 'timeFrame': 'Up to 2 days (from day of first dosing to day of colonoscopy)', 'description': 'Comparison of the number of patients with at least one polyp detected in the colon ascendens when NER1006 2-Day and 1-Day is used for bowel cleansing versus MOVIPREP. Polyp detection rate (PDR) defined as the number of patients with at least one polyp in the colon ascendens.'}, {'measure': 'Polyp Detection Rate (Overall Colon)', 'timeFrame': 'Up to 2 days (from day of first dosing to day of colonoscopy)', 'description': 'Comparison of the number of patients with at least one polyp detected in the overall colon when NER1006 is used for bowel cleansing versus number detected when MOVIPREP is used. PDR defined as the number of patients with at least one polyp in the overall colon.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer', 'Colorectal Carcinoma', 'Colon Cleansing']}, 'referencesModule': {'references': [{'pmid': '36064325', 'type': 'DERIVED', 'citation': 'Cash BD, Allen C, Poppers DM. Transient alterations in plasma sodium concentrations with NER1006 bowel preparation: an analysis of three phase III, randomized clinical trials. BMC Gastroenterol. 2022 Sep 5;22(1):412. doi: 10.1186/s12876-022-02484-7.'}, {'pmid': '30025414', 'type': 'DERIVED', 'citation': 'Bisschops R, Manning J, Clayton LB, Ng Kwet Shing R, Alvarez-Gonzalez M; MORA Study Group. Colon cleansing efficacy and safety with 1 L NER1006 versus 2 L polyethylene glycol + ascorbate: a randomized phase 3 trial. Endoscopy. 2019 Jan;51(1):60-72. doi: 10.1055/a-0638-8125. Epub 2018 Jul 19.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the efficacy, safety and tolerability of NER1006 versus MOVIPREP in adult patients requiring bowel cleansing prior to any procedure that requires a clean bowel, using a 2-Day evening/morning Split-Dosing and 1-Day morning only Split-Dosing regimens. Approximately 810 patients will be randomised with the aim of achieving a minimum of 245 patients in each of the 3 groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients must provide written informed consent.\n* Male and female outpatients and inpatients aged: ≥18 to ≤85 years undergoing a screening, surveillance or diagnostic colonoscopy.\n* Females of child-bearing potential must have a negative pregnancy test at Screening and at Visit 2 and must be practising one of the following methods of birth control and agree to continue with the regimen throughout the study period (unless postmenopausal or surgically sterile, or whose sole sexual partner has had a successful vasectomy): Oral, implantable, or injectable contraceptives (for a minimum of three months before study entry) in combination with a condom; Intrauterine device in combination with a condom; Double barrier method (condom\\* and occlusive cap \\[diaphragm or cervical/vault caps\\] with spermicidal foam/gel/film/cream/suppository).\n* Willing and able to complete the entire study and to comply with instructions.\n\nExclusion Criteria:\n\n* Patients with past history within last 12 months or current episode of severe constipation (requiring repeated use of laxatives/enema or physical intervention before resolution), known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.\n* Patients with ongoing severe acute Inflammatory Bowel Disease.\n* Patients who have had previous significant gastrointestinal surgeries, including colonic resection, sub-total colectomy, abdomino-perineal resection, de-functioning colostomy, Hartmann's procedure and de-functioning ileostomy or other similar surgeries involving structure and function of the small or large colon.\n* Regular use of laxatives or colon motility altering drugs in the last month (i.e. more than 2-3 times per week) and/or laxative use within 72 hours prior to administration of the preparation.\n* Patients with active intestinal bleeding episodes or with a clinically significant low hemoglobin level \\<9 g/dL for women and \\<11 g/dL for men at screening.\n* Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.\n* Known phenylketonuria.\n* Known hypersensitivity to polyethylene glycols, ascorbic acid and sulfates (not including sulfa-based products) or any other component of the study drug or comparator\n* Past history within the last 12 months or evidence of any on-going clinically relevant electrocardiogram (ECG) abnormalities (e.g. arrhythmias).\n* History of uncontrolled hypertension with systolic blood pressure \\>170 mmHg and diastolic blood pressure \\>100 mmHg.\n* Patients with cardiac insufficiency NYHA grades III or IV.\n* Patients with severe renal insufficiency (i.e. with GFR, \\<30 mL/min/1.73m2).\n* Patient with serum albumin \\<3.4 g/dL.\n* Patients with liver disease of grades B and C according to the Child Pugh classification.\n* Patients suffering from dehydration at screening as evaluated by the Investigator from physical examination and laboratory investigations.\n* Patients with clinically significant electrolyte abnormalities, whether pre-existing or noted at screening, such as hypernatremia, hyponatremia, hyperphosphatemia, hypermagnesemia, hypokalemia, hypocalcaemia dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.\n* Patients with any other clinically significant hematological parameters including coagulation profile at screening.\n* Patients with impaired consciousness that might predispose them to pulmonary aspiration.\n* Patients undergoing colonoscopy for foreign body removal and/or decompression.\n* Patients who are pregnant or lactating, or intending to become pregnant during the study.\n* Clinically relevant findings on physical examination based on the Investigator's judgment.\n* History of drug or alcohol abuse within the 12 months prior to dosing.\n* Concurrent participation in an investigational drug or device study or participation within three months of study entry.\n* Patients who are ordered to live in an institution on court or authority order"}, 'identificationModule': {'nctId': 'NCT02273167', 'acronym': 'MORA', 'briefTitle': 'Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus MOVIPREP® Using 2-Day Split-Dosing and 1-Day Morning Split-Dosing Regimen in Adults.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Norgine'}, 'officialTitle': 'A Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 (a Low Volume Bowel Cleansing Solution) Versus MOVIPREP Using 2-Day Split-Dosing and 1-Day Morning Split-Dosing Regimen in Adults.', 'orgStudyIdInfo': {'id': 'NER1006-02/2014 (MORA)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NER1006, 2-Day Split-Dosing', 'description': 'NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).', 'interventionNames': ['Drug: NER1006, 2-Day Split-Dosing']}, {'type': 'EXPERIMENTAL', 'label': 'NER1006,1-Day Morning Split-Dosing', 'description': 'NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).', 'interventionNames': ['Drug: NER1006,1-Day Morning Split-Dosing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MOVIPREP, 2-Day Split-Dosing', 'description': 'MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).', 'interventionNames': ['Drug: MOVIPREP, 2-Day Split-Dosing']}], 'interventions': [{'name': 'NER1006, 2-Day Split-Dosing', 'type': 'DRUG', 'description': 'The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take mandatory additional clear fluid. Subject will take the second dose together with mandatory additional clear fluids on the morning of the colonoscopy.', 'armGroupLabels': ['NER1006, 2-Day Split-Dosing']}, {'name': 'NER1006,1-Day Morning Split-Dosing', 'type': 'DRUG', 'description': 'The subject will self-administer the first dose of the investigational product on the morning of the colonoscopy and take mandatory additional clear fluid.\n\nAfter a 1-2 hour break the subject will self-administer the second dose plus additional clear mandatory fluid.', 'armGroupLabels': ['NER1006,1-Day Morning Split-Dosing']}, {'name': 'MOVIPREP, 2-Day Split-Dosing', 'type': 'DRUG', 'description': 'The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take recommended additional clear fluid. 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