Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2026-02-24 @ 5:02 PM
Study NCT ID:
NCT03017235
Status:
COMPLETED
Last Update Posted:
2018-11-14
First Post:
2017-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® 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'}, {'id': 'D008277', 'term': 'Magnesium Oxide'}, {'id': 'D019343', 'term': 'Citric Acid'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D002951', 'term': 'Citrates'}, {'id': 'D014233', 'term': 'Tricarboxylic Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'DKO-Disclosure@ferring.com', 'phone': '+1 833-548-1402', 'title': 'Global Clinical Compliance', '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': 'From baseline (screening) upto 28 days after colonoscopy.', 'eventGroups': [{'id': 'EG000', 'title': 'NaP/MC Oral Solution', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution\n\nSupplied as two 160 mL ready-to-drink bottles per subject without further reconstitution before administration.', 'otherNumAtRisk': 448, 'deathsNumAtRisk': 448, 'otherNumAffected': 378, 'seriousNumAtRisk': 448, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'PREPOPIK®', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder\n\nSupplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.', 'otherNumAtRisk': 453, 'deathsNumAtRisk': 453, 'otherNumAffected': 384, 'seriousNumAtRisk': 453, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 162, 'numAffected': 150}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 167, 'numAffected': 155}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 157, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 181, 'numAffected': 105}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Diverticulum intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 75, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 73, 'numAffected': 70}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 64, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 59, 'numAffected': 59}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 26, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypermagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 26, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 237, 'numAffected': 133}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 211, 'numAffected': 128}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 29, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 35, 'numAffected': 35}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nervous system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 34, 'numAffected': 30}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Rectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Breast cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Carcinoid tumour of the gastrointestinal tract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 448, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Classified as a Responder Defined by "Excellent" or "Good"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '453', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NaP/MC Oral Solution', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution\n\nSupplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.'}, {'id': 'OG001', 'title': 'PREPOPIK®', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.7', 'groupId': 'OG000', 'lowerLimit': '84.3', 'upperLimit': '90.6'}, {'value': '81.5', 'groupId': 'OG001', 'lowerLimit': '77.6', 'upperLimit': '84.9'}]}]}], 'analyses': [{'pValue': '0.0067', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.3', 'ciLowerLimit': '1.8', 'ciUpperLimit': '10.9', 'pValueComment': 'The above p-value was calculated for superiority and was based on the stratified percentage difference test, where the stratification weight is based on Cochran-Mantel-Haenszel-weight.', 'groupDescription': 'Difference in the percentage of subjects on NaP/MC or PREPOPIK (NaP/MC - PREPOPIK)', 'statisticalMethod': 'Weighted Percentage Difference', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site', 'nonInferiorityComment': 'The NI margin for the difference between treatments (NaP/MC Oral Solution minus PREPOPIK) was pre-specified at -8% (absolute). If NI was demonstrated for both the primary efficacy endpoint and the secondary efficacy endpoint for the right colon, and if the lower bound of the CI was above 0%, then superiority was declared for the primary endpoint. Thus, the pre-specified superiority analysis was conducted at a one-sided significance level of 2.5%.', 'otherAnalysisDescription': 'Lower limit of 95% CI \\> 0% for the primary efficacy endpoint combined with outcome of secondary efficacy endpoint for the right colon allowed for superiority analysis.'}], 'paramType': 'NUMBER', 'timeFrame': 'During colonoscopy procedure (5-9 hours after completed treatment)', 'description': 'The efficacy of overall colon cleansing in terms of responders was measured by a blinded endoscopist using the Modified Aronchick Scale. Modified Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (\\>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (\\>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (\\>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (\\<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed).The participant is considered to be a responder if overall colon cleansing is "excellent" or "good" on this 4-point scale.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Right Segment of the Colon', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '453', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NaP/MC Oral Solution', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution\n\nSupplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.'}, {'id': 'OG001', 'title': 'PREPOPIK®', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.2', 'groupId': 'OG000', 'lowerLimit': '91.6', 'upperLimit': '96.2'}, {'value': '89.6', 'groupId': 'OG001', 'lowerLimit': '86.4', 'upperLimit': '92.3'}]}]}], 'analyses': [{'pValue': '0.0099', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.6', 'ciLowerLimit': '1.1', 'ciUpperLimit': '8.0', 'pValueComment': 'The p-value was calculated for superiority and was based on the stratified percentage difference test, where the stratification weight is based on Cochran-Mantel-Haenszel-weight.', 'groupDescription': 'Difference in the percentage of subjects on NaP/MC or PREPOPIK (NaP/MC - PREPOPIK)', 'statisticalMethod': 'Weighted Percentage Difference', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site', 'nonInferiorityComment': 'If the lower limit of the 95% CI was greater than the margin (-8%), the null hypothesis was rejected and NaP/MC Oral Solution was claimed as non-inferior to PREPOPIK with respect to right colon cleansing in preparation for colonoscopy.'}], 'paramType': 'NUMBER', 'timeFrame': 'During colonoscopy procedure (5-9 hours after completed treatment)', 'description': 'The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the right segment of the colon was determined.\n\nThe BBPS scale:\n\n0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Transverse Segment of the Colon', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '453', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NaP/MC Oral Solution', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution\n\nSupplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.'}, {'id': 'OG001', 'title': 'PREPOPIK®', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.0', 'groupId': 'OG000', 'lowerLimit': '93.7', 'upperLimit': '97.6'}, {'value': '94.0', 'groupId': 'OG001', 'lowerLimit': '91.4', 'upperLimit': '96.0'}]}]}], 'analyses': [{'pValue': '0.1781', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '4.7', 'pValueComment': 'The above p-value was tested for superiority and was based on the stratified percentage difference test, where the stratification weight is based on Cochran Mantel Haenszel weight.', 'groupDescription': 'Difference in percentage of subjects on NaP/MC Oral Solution or PREPOPIK® (NaP/MC - PREPOPIK)', 'statisticalMethod': 'Weighted Percentage Difference', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site', 'nonInferiorityComment': 'If the lower limit of the 95% CI was greater than the margin (-8%), the null hypothesis was rejected and NaP/MC Oral Solution was claimed as non-inferior to PREPOPIK with respect to right colon cleansing in preparation for colonoscopy.'}], 'paramType': 'NUMBER', 'timeFrame': 'During colonoscopy procedure (5-9 hours after completed treatment)', 'description': 'The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the transverse segment of the colon was determined.\n\nThe BBPS scale:\n\n0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Left Segment of the Colon', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '453', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NaP/MC Oral Solution', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution\n\nSupplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.'}, {'id': 'OG001', 'title': 'PREPOPIK®', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.6', 'groupId': 'OG000', 'lowerLimit': '92.1', 'upperLimit': '96.5'}, {'value': '91.2', 'groupId': 'OG001', 'lowerLimit': '88.2', 'upperLimit': '93.6'}]}]}], 'analyses': [{'pValue': '0.0391', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.5', 'ciLowerLimit': '0.2', 'ciUpperLimit': '6.7', 'pValueComment': 'The above p-value was for superiority and was based on the stratified percentage difference, where the stratification weight is based on Cochran-Mantel-Haenszel weight.', 'groupDescription': 'Difference in percentage of subjects on NaP/MC Oral Solution or PREPOPIK® (NaP/MC-PREPOPIK®)', 'statisticalMethod': 'Weighted Percentage Difference', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site', 'nonInferiorityComment': 'If the lower limit of the 95% CI was greater than the margin (-8%), the null hypothesis was rejected and NaP/MC Oral Solution was claimed as non-inferior to PREPOPIK with respect to colon cleansing in preparation for colonoscopy.'}], 'paramType': 'NUMBER', 'timeFrame': 'During colonoscopy procedure (5-9 hours after completed treatment)', 'description': 'The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the left segment of the colon was determined.\n\nThe BBPS scale:\n\n0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.'}, {'type': 'SECONDARY', 'title': 'Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '453', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NaP/MC Oral Solution', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution\n\nSupplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.'}, {'id': 'OG001', 'title': 'PREPOPIK®', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.'}], 'classes': [{'title': '≤3/week', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': '4 to 8/week', 'categories': [{'measurements': [{'value': '264', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}]}]}, {'title': '≥9/week', 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}, {'title': 'Response not provided', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Not applicable', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During colonoscopy procedure (5-9 hours after completed treatment)', 'description': 'Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.'}, {'type': 'SECONDARY', 'title': 'Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '453', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NaP/MC Oral Solution', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution\n\nSupplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.'}, {'id': 'OG001', 'title': 'PREPOPIK®', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.'}], 'classes': [{'title': '<25%', 'categories': [{'measurements': [{'value': '443', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}]}]}, {'title': '25% - 50%', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '50% - 75%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '≥75%', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Response not provided', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Not applicable', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During colonoscopy procedure (5-9 hours after completed treatment)', 'description': 'Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. 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This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.'}, {'type': 'SECONDARY', 'title': 'Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '453', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NaP/MC Oral Solution', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution\n\nSupplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.'}, {'id': 'OG001', 'title': 'PREPOPIK®', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.'}], 'classes': [{'title': 'GoLytely', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Moviprep', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'MiraLax', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Do not remember', 'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During colonoscopy procedure (5-9 hours after completed treatment)', 'description': 'Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.'}, {'type': 'SECONDARY', 'title': 'Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '453', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NaP/MC Oral Solution', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution\n\nSupplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.'}, {'id': 'OG001', 'title': 'PREPOPIK®', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.'}], 'classes': [{'title': 'Worse than before', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'About the same as before', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'Better than before', 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}]}, {'title': 'Response not provided', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During colonoscopy procedure (5-9 hours after completed treatment)', 'description': 'Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Treatment-emergent Adverse Events(AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '453', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NaP/MC Oral Solution', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution\n\nSupplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.'}, {'id': 'OG001', 'title': 'PREPOPIK®', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.4', 'groupId': 'OG000'}, {'value': '84.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (screening) up to day 28 after colonoscopy', 'description': 'Collected as any AE that begins during the treatment period defined as the period during which a subject receives IMP. All endoscopy findings were reported as AEs while cancers/malignancies detected on endoscopy were reported as SAEs.', 'unitOfMeasure': 'Percentage of adverse events', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received'}, {'type': 'SECONDARY', 'title': 'Clinically Significant Changes in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '453', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NaP/MC Oral Solution', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution\n\nSupplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.'}, {'id': 'OG001', 'title': 'PREPOPIK®', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.'}], 'classes': [{'title': 'Hypertension', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Orthostatic hypotension', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Blood pressure increased', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypotension', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline (screening) up to day 28 after colonoscopy', 'description': 'Blood pressure and pulse will be measured after at least 5 minutes of rest in supine position and after 3 minutes in standing position', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received'}, {'type': 'SECONDARY', 'title': 'Clinically Significant Changes in Electrocardiogram (ECG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '453', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NaP/MC Oral Solution', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution\n\nSupplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.'}, {'id': 'OG001', 'title': 'PREPOPIK®', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.'}], 'classes': [{'title': 'Bradycardia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bundle branch block left', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Extrasystoles', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Ventricular extrasystoles', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Atrial fibrillation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bundle branch block right', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Palpitations', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sinus bradycardia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Tachycardia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac murmur', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy', 'description': "Measured by standard 12-lead ECG. At each visit when an ECG was done, the investigator reviewed and initialed the tracing, which was then stored with the subject's source documents. The baseline ECG performed at the Screening Visit was reviewed for major abnormalities before dosing.", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received'}, {'type': 'SECONDARY', 'title': 'Clinically Significant Changes in Laboratory Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '453', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NaP/MC Oral Solution', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution\n\nSupplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.'}, {'id': 'OG001', 'title': 'PREPOPIK®', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.'}], 'classes': [{'title': 'Hematology: Anaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hematology: Leukopenia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hematology: Lymphocytosis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hematology: Neutropenia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hematology: Normocytic anaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hemotology: Platelet count decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Clinical Chemistry: Hypermagnesaemia', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Clinical chemistry:Blood bicarbonate decreased', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Clinical chemistry: Hypokalemia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Clinical chemistry: Hyperglycaemia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Clinical chemistry: Hypoglycaemia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Clinical chemistry: Hyperkalaemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Clinical chemistry: Hypomagnasaemia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Clinical chemistry: Blood creatinine increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Clinical chemistry: Blood potassium decreased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Clinical chemistry: Hypochloraemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Clinical chemistry: Hyperbilirubinaemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Urinalysis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy', 'description': 'Rated by the investigator based on out of range laboratory values', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NaP/MC Oral Solution', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution\n\nSupplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.\n\nSplit dose regimen: Subjects began treatment (first dose) the evening before colonoscopy between 5:00 PM and 9:00 PM, and completed treatment (second dose) the following day, at least 5 hours, but no more than 9 hours, prior to the colonoscopy.'}, {'id': 'FG001', 'title': 'PREPOPIK®', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject.\n\nSplit dose regimen :Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.\n\nSubjects began treatment (first dose) the evening before colonoscopy between 5:00 PM and 9:00 PM, and completed treatment (second dose) the following day, at least 5 hours, but no more than 9 hours, prior to the colonoscopy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '456'}, {'groupId': 'FG001', 'numSubjects': '461'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '444'}, {'groupId': 'FG001', 'numSubjects': '447'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Cancer, emergency, allergy, active UTI', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'BG000'}, {'value': '453', 'groupId': 'BG001'}, {'value': '901', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'NaP/MC Oral Solution', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution\n\nSodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution: Supplied as ready-to-drink without further reconstitution before administration'}, {'id': 'BG001', 'title': 'PREPOPIK®', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.2', 'spread': '11.04', 'groupId': 'BG000'}, {'value': '57.1', 'spread': '10.85', 'groupId': 'BG001'}, {'value': '57.2', 'spread': '10.94', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '252', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '502', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '196', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '380', 'groupId': 'BG000'}, {'value': '381', 'groupId': 'BG001'}, {'value': '761', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', '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': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '376', 'groupId': 'BG000'}, {'value': '394', 'groupId': 'BG001'}, {'value': '770', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Child-bearing potential', 'classes': [{'title': 'Child bearing potential', 'categories': [{'measurements': [{'value': '252', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '502', 'groupId': 'BG002'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '203', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '406', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Modified intention-to-treat (mITT) was considered as the main analysis set. mITT was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-25', 'size': 5722443, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-09-03T04:14', 'hasProtocol': True}, {'date': '2017-12-01', 'size': 1176751, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-09-03T04:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 917}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-18', 'studyFirstSubmitDate': '2017-01-09', 'resultsFirstSubmitDate': '2018-09-03', 'studyFirstSubmitQcDate': '2017-01-09', 'lastUpdatePostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-18', 'studyFirstPostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects Classified as a Responder Defined by "Excellent" or "Good"', 'timeFrame': 'During colonoscopy procedure (5-9 hours after completed treatment)', 'description': 'The efficacy of overall colon cleansing in terms of responders was measured by a blinded endoscopist using the Modified Aronchick Scale. Modified Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (\\>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (\\>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (\\>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (\\<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed).The participant is considered to be a responder if overall colon cleansing is "excellent" or "good" on this 4-point scale.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Right Segment of the Colon', 'timeFrame': 'During colonoscopy procedure (5-9 hours after completed treatment)', 'description': 'The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the right segment of the colon was determined.\n\nThe BBPS scale:\n\n0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.'}, {'measure': 'Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Transverse Segment of the Colon', 'timeFrame': 'During colonoscopy procedure (5-9 hours after completed treatment)', 'description': 'The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the transverse segment of the colon was determined.\n\nThe BBPS scale:\n\n0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.'}, {'measure': 'Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Left Segment of the Colon', 'timeFrame': 'During colonoscopy procedure (5-9 hours after completed treatment)', 'description': 'The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the left segment of the colon was determined.\n\nThe BBPS scale:\n\n0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.'}, {'measure': 'Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?)', 'timeFrame': 'During colonoscopy procedure (5-9 hours after completed treatment)', 'description': 'Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.'}, {'measure': 'Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?)', 'timeFrame': 'During colonoscopy procedure (5-9 hours after completed treatment)', 'description': 'Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.'}, {'measure': 'Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?)', 'timeFrame': 'During colonoscopy procedure (5-9 hours after completed treatment)', 'description': 'Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.'}, {'measure': 'Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?)', 'timeFrame': 'During colonoscopy procedure (5-9 hours after completed treatment)', 'description': 'Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.'}, {'measure': 'Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?)', 'timeFrame': 'During colonoscopy procedure (5-9 hours after completed treatment)', 'description': 'Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. Subjects in response to questions could provide multiple response if applicable.'}, {'measure': 'Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?)', 'timeFrame': 'During colonoscopy procedure (5-9 hours after completed treatment)', 'description': 'Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.'}, {'measure': 'Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?)', 'timeFrame': 'During colonoscopy procedure (5-9 hours after completed treatment)', 'description': 'Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.'}, {'measure': 'Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?)', 'timeFrame': 'During colonoscopy procedure (5-9 hours after completed treatment)', 'description': 'Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.'}, {'measure': 'Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?)', 'timeFrame': 'During colonoscopy procedure (5-9 hours after completed treatment)', 'description': 'Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.'}, {'measure': 'Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?)', 'timeFrame': 'During colonoscopy procedure (5-9 hours after completed treatment)', 'description': 'Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.'}, {'measure': 'Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?)', 'timeFrame': 'During colonoscopy procedure (5-9 hours after completed treatment)', 'description': 'Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.'}, {'measure': 'Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?)', 'timeFrame': 'During colonoscopy procedure (5-9 hours after completed treatment)', 'description': 'Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.'}, {'measure': 'Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?)', 'timeFrame': 'During colonoscopy procedure (5-9 hours after completed treatment)', 'description': 'Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.'}, {'measure': 'Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation)', 'timeFrame': 'During colonoscopy procedure (5-9 hours after completed treatment)', 'description': 'Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.'}, {'measure': 'Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations)', 'timeFrame': 'During colonoscopy procedure (5-9 hours after completed treatment)', 'description': 'Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.'}, {'measure': 'Percentage of Treatment-emergent Adverse Events(AEs)', 'timeFrame': 'From baseline (screening) up to day 28 after colonoscopy', 'description': 'Collected as any AE that begins during the treatment period defined as the period during which a subject receives IMP. All endoscopy findings were reported as AEs while cancers/malignancies detected on endoscopy were reported as SAEs.'}, {'measure': 'Clinically Significant Changes in Vital Signs', 'timeFrame': 'From baseline (screening) up to day 28 after colonoscopy', 'description': 'Blood pressure and pulse will be measured after at least 5 minutes of rest in supine position and after 3 minutes in standing position'}, {'measure': 'Clinically Significant Changes in Electrocardiogram (ECG)', 'timeFrame': 'At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy', 'description': "Measured by standard 12-lead ECG. At each visit when an ECG was done, the investigator reviewed and initialed the tracing, which was then stored with the subject's source documents. The baseline ECG performed at the Screening Visit was reviewed for major abnormalities before dosing."}, {'measure': 'Clinically Significant Changes in Laboratory Values', 'timeFrame': 'At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy', 'description': 'Rated by the investigator based on out of range laboratory values'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bowel Preparation']}, 'referencesModule': {'references': [{'pmid': '34262611', 'type': 'DERIVED', 'citation': 'Mankaney GN, Ando M, Dahdal DN, Burke CA. Safety and efficacy of sodium picosulfate, magnesium oxide, and citric acid bowel preparation in patients with baseline renal impairment or diabetes: subanalysis of a randomized, controlled trial. Therap Adv Gastroenterol. 2021 Jun 28;14:17562848211024458. doi: 10.1177/17562848211024458. eCollection 2021.'}, {'pmid': '32313553', 'type': 'DERIVED', 'citation': 'Hookey L, Bertiger G, Johnson KL 2nd, Boules M, Ando M, Dahdal DN. Efficacy, safety, and tolerability of a ready-to-drink bowel preparation in overweight and obese adults: subanalysis by body mass index from a phase III, assessor-blinded study. Therap Adv Gastroenterol. 2020 Apr 9;13:1756284820910050. doi: 10.1177/1756284820910050. eCollection 2020.'}, {'pmid': '32095161', 'type': 'DERIVED', 'citation': 'Hookey L, Bertiger G, Johnson KL, Boules M, Ando M, Dahdal DN. Efficacy, safety, and tolerability of a ready-to-drink bowel preparation: subanalysis by age from a phase III, assessor-blinded study. Therap Adv Gastroenterol. 2020 Feb 7;13:1756284820902878. doi: 10.1177/1756284820902878. eCollection 2020.'}, {'pmid': '31205487', 'type': 'DERIVED', 'citation': 'Hookey L, Bertiger G, Lee Johnson K 2nd, Ayala J, Seifu Y, Brogadir SP. Efficacy and safety of a ready-to-drink bowel preparation for colonoscopy: a randomized, controlled, non-inferiority trial. Therap Adv Gastroenterol. 2019 May 19;12:1756284819851510. doi: 10.1177/1756284819851510. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution with PREPOPIK® for colon cleansing in adult subjects undergoing colonoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or non-pregnant female subjects aged 18 to 80 years, inclusive, being scheduled to undergo elective colonoscopy\n* Females of childbearing potential must agree to use an adequate contraception during the course of the trial. Accepted forms of contraception are: i.e., implants, injectables, hormonal intrauterine device, combined hormonal contraceptives, sexual abstinence, and vasectomized sexual partner. Premenopausal women who are of childbearing potential must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result at randomization prior to colonoscopy. In the case of oral contraceptive use, women should have been taking the same pill consistently for a minimum of twelve (12) weeks before taking study medication. Sterilized or postmenopausal women may also participate. Women are considered to be postmenopausal and are not considered to be of childbearing potential if they have had twelve (12) months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation.\n* An average of at least 3 spontaneous bowel movements per week for one month prior to the colonoscopy\n\nExclusion Criteria:\n\n* Known or suspected gastrointestinal obstruction, perforation, ileus, or gastric retention\n* Acute intestinal or gastric ulceration\n* Severe acute inflammatory bowel disease (IBD), toxic colitis, or toxic megacolon\n* Undergoing colonoscopy for foreign body removal or decompression\n* Reduced level of consciousness or inability to swallow without aspiration\n* Any prior colorectal surgery, excluding appendectomy, hemorrhoid surgery, or prior endoscopic procedures\n* Upper gastrointestinal surgery (gastrectomy, gastric banding, gastric by-pass)\n* Uncontrolled angina and/or myocardial infarction (MI) within last three months, congestive heart failure (CHF), uncontrolled hypertension, or ascites\n* Severely reduced renal function (\\<30 mL/min/1.73 m2)\n* Pregnant or lactating women\n* Any clinically relevant abnormal findings in medical history, physical examination, vital signs, ECG, clinical chemistry, hematology, coagulation, or urinalysis at Screening Visit 1\n* Rhabdomyolysis\n* Chronic nausea and vomiting\n* Hypermagnesemia\n* Undergoing treatment with Lithium'}, 'identificationModule': {'nctId': 'NCT03017235', 'briefTitle': 'A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® for Colon Cleansing in Preparation for Colonoscopy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'A Randomized, Assessor-Blinded, Multi-Center Study Investigating the Efficacy, Safety, and Tolerability of Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution Versus Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Powder for Oral Solution (PREPOPIK®) for Colon Cleansing in Preparation for Colonoscopy', 'orgStudyIdInfo': {'id': '000253'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NaP/MC Oral Solution', 'description': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution', 'interventionNames': ['Drug: Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PREPOPIK®', 'interventionNames': ['Drug: Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder']}], 'interventions': [{'name': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution', 'type': 'DRUG', 'description': 'Supplied as two 160 mL ready-to-drink bottles, per subject, without further reconstitution, before administration.', 'armGroupLabels': ['NaP/MC Oral Solution']}, {'name': 'Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder', 'type': 'DRUG', 'otherNames': ['PREPOPIK®', 'PicoPrep®'], 'description': 'Supplied as two sachets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.', 'armGroupLabels': ['PREPOPIK®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Clinical Research Associates', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Associated Gastroenterology Medical Group', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '91910', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'GW Research, Inc.', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '92114', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Precision Research Institute', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '06010', 'city': 'Bristol', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Connecticut Clinical Research Foundation', 'geoPoint': {'lat': 41.67176, 'lon': -72.94927}}, {'zip': '33759', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Clinical Research Group', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '34452', 'city': 'Inverness', 'state': 'Florida', 'country': 'United States', 'facility': 'Nature Coast Clinical Research', 'geoPoint': {'lat': 28.83582, 'lon': -82.33037}}, {'zip': '11023', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Gastrointestinal Research Group LLC', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '28501', 'city': 'Kinston', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Kinston Medical Specialists, PA', 'geoPoint': {'lat': 35.26266, 'lon': -77.58164}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Research Associates, LLC', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '19031', 'city': 'Flourtown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hillmont GI', 'geoPoint': {'lat': 40.10344, 'lon': -75.2124}}, {'zip': '84405', 'city': 'Ogden', 'state': 'Utah', 'country': 'United States', 'facility': 'Advanced Research Institute', 'geoPoint': {'lat': 41.223, 'lon': -111.97383}}, {'zip': 'K7L 5G2', 'city': 'Kingston', 'country': 'Canada', 'facility': 'Hotel Dieu Hospital', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'M3J 2C5', 'city': 'Toronto', 'country': 'Canada', 'facility': 'Canadian Phase Onward, Inc.', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Clinical Development Support', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ferring Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}