Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-01-02 @ 12:52 AM
Study NCT ID:
NCT01707667
Status:
COMPLETED
Last Update Posted:
2021-07-02
First Post:
2012-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Investigate Prucalopride vs. Polyethylene Glycol 3350 on Colon Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C406662', 'term': 'prucalopride'}, {'id': 'C000595212', 'term': 'polyethylene glycol 3350'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTransparency@shire.com', 'phone': '+1 866 842 5335', 'title': 'Study Director', 'organization': 'Shire'}, 'certainAgreement': {'otherDetails': 'If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Prucalopride', 'description': 'A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.', 'otherNumAtRisk': 13, 'otherNumAffected': 3, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Polyethylene Glycol', 'description': '13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'RECTAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Number of High-Amplitude Propagating Contractions (HAPC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prucalopride', 'description': 'A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.'}, {'id': 'OG001', 'title': 'PEG 3350', 'description': '13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).'}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '2.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.8', 'ciLowerLimit': '1.6', 'ciUpperLimit': '9.9', 'statisticalMethod': 'Linear Mixed-Effect Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'over 12 hours post-dose', 'description': 'Manometry recordings were read by an experienced gastroenterologist who was blinded to the treatment each subject received. The tracings were analyzed using computer-based validated software. HAPC and manometry data were available for every sensor as well as average values for each HAPC and manometry time point. The primary outcome analysis of HAPC data used the following threshold: Mean amplitude ≥100mmHg and extension ≥20cm (9 sensors).', 'unitOfMeasure': 'Number of HAPC with amplitude ≥100mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration Curve (AUC) of All HAPCs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prucalopride', 'description': 'A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.'}, {'id': 'OG001', 'title': 'PEG 3350', 'description': '13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).'}], 'classes': [{'categories': [{'measurements': [{'value': '110204.1', 'spread': '28279.91', 'groupId': 'OG000'}, {'value': '41152.7', 'spread': '34432.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.079', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '69051.4', 'ciLowerLimit': '-12004.5', 'ciUpperLimit': '150107.3', 'statisticalMethod': 'Linear Mixed-Effect Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'over 12 hours post-dose', 'description': 'The AUC of all HAPCs during the first 12 hours after treatment was calculated as the sum of the AUC at all sensors of each HAPC at the ≥100mmHg and ≥20cm threshold.', 'unitOfMeasure': 'mmHg.sec', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.'}, {'type': 'SECONDARY', 'title': 'The Mean Amplitude of HAPC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prucalopride', 'description': 'A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.'}, {'id': 'OG001', 'title': 'PEG 3350', 'description': '13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).'}], 'classes': [{'categories': [{'measurements': [{'value': '199.0', 'spread': '15.15', 'groupId': 'OG000'}, {'value': '189.8', 'spread': '19.56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.717', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.2', 'ciLowerLimit': '-45.3', 'ciUpperLimit': '63.7', 'statisticalMethod': 'Linear Mixed-Effect Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'over 12 hours post-dose', 'description': 'The mean amplitude of all HAPCs was calculated as the sum of the mean amplitude for each HAPC divided by the number of HAPCs.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.'}, {'type': 'SECONDARY', 'title': 'Time to First HAPC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prucalopride', 'description': 'A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.'}, {'id': 'OG001', 'title': 'PEG 3350', 'description': '13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '9.3'}, {'value': 'NA', 'comment': 'The median time to first HAPC after administration of investigational product with amplitude ≥100mmHg and extension ≥20cm in the PEG 3350 group could not be calculated as only 6 subjects had HAPCs that met this threshold.', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.295', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'over 12 hours post-dose', 'description': 'The median (95% CI) time to first HAPC after administration of investigational product with amplitude ≥100mmHg and extension ≥20cm.', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacodynamic Analysis Set included all subjects in the Safety Analysis Set who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.'}, {'type': 'SECONDARY', 'title': 'Propagation Velocity of HAPC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prucalopride', 'description': 'A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.'}, {'id': 'OG001', 'title': 'PEG 3350', 'description': '13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.467', 'spread': '0.0803', 'groupId': 'OG000'}, {'value': '0.646', 'spread': '0.1074', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.180', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.179', 'ciLowerLimit': '-0.465', 'ciUpperLimit': '0.107', 'statisticalMethod': 'Linear Mixed-Effect Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'over 12 hours post-dose', 'description': 'Propagation velocity was calculated as the extension divided by the duration for each HAPC. Mean propagation velocity is the sum of the propagation velocities divided by the number of HAPCs.', 'unitOfMeasure': 'cm/sec', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.'}, {'type': 'SECONDARY', 'title': 'Duration of HAPC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prucalopride', 'description': 'A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.'}, {'id': 'OG001', 'title': 'PEG 3350', 'description': '13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).'}], 'classes': [{'categories': [{'measurements': [{'value': '84.9', 'spread': '8.05', 'groupId': 'OG000'}, {'value': '69.1', 'spread': '10.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.225', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.8', 'ciLowerLimit': '-12.6', 'ciUpperLimit': '44.3', 'statisticalMethod': 'Linear Mixed-Effect Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'over 12 hours post-dose', 'description': 'The mean duration of all HAPCs was calculated as the sum of the duration of each HAPC divided by the number of HAPCs.', 'unitOfMeasure': 'sec', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.'}, {'type': 'SECONDARY', 'title': 'Motility Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prucalopride', 'description': 'A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.'}, {'id': 'OG001', 'title': 'PEG 3350', 'description': '13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).'}], 'classes': [{'title': 'Pre-Dose', 'categories': [{'measurements': [{'value': '9.467', 'spread': '0.4668', 'groupId': 'OG000'}, {'value': '8.312', 'spread': '0.4403', 'groupId': 'OG001'}]}]}, {'title': '0-5 hours post-dose', 'categories': [{'measurements': [{'value': '13.661', 'spread': '0.3221', 'groupId': 'OG000'}, {'value': '13.349', 'spread': '0.3520', 'groupId': 'OG001'}]}]}, {'title': '5-12 hours post-dose', 'categories': [{'measurements': [{'value': '14.208', 'spread': '0.2976', 'groupId': 'OG000'}, {'value': '14.390', 'spread': '0.2489', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'over 12 hours post-dose', 'description': 'Motility index (mmHg) was summarized for the following 3 time points: pre-dose, 0-5 hours post-dose, and 5-12 hours post-dose. The motility index is defined as the natural logarithm of all peak amplitudes of every contraction +1.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PRU-PEG', 'description': 'A single dose of prucalopride 2mg in the first period followed by 2 doses of polyethylene glycol (PEG) 3350 (13.8g) plus electrolytes in the second period.'}, {'id': 'FG001', 'title': 'PEG-PRU', 'description': 'Two doses of PEG 3350 (13.8g) plus electrolytes in the first period followed by a single dose of prucalopride 2mg in the second period.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'expulsion of colonic sensor catheter', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PRU-PEG', 'description': 'A single dose of prucalopride 2mg in the first period followed by 2 doses of polyethylene glycol (PEG) 3350 (13.8g) plus electrolytes in the second period.'}, {'id': 'BG001', 'title': 'PEG-PRU', 'description': 'Two doses of PEG 3350 (13.8g) plus electrolytes in the first period followed by a single dose of prucalopride 2mg in the second period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.3', 'spread': '11.04', 'groupId': 'BG000'}, {'value': '35.2', 'spread': '13.18', 'groupId': 'BG001'}, {'value': '37.9', 'spread': '11.85', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18 - 64', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'UNITED STATES', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Safety Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2013-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-10', 'studyFirstSubmitDate': '2012-10-12', 'resultsFirstSubmitDate': '2014-10-17', 'studyFirstSubmitQcDate': '2012-10-12', 'lastUpdatePostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-10-17', 'studyFirstPostDateStruct': {'date': '2012-10-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number of High-Amplitude Propagating Contractions (HAPC)', 'timeFrame': 'over 12 hours post-dose', 'description': 'Manometry recordings were read by an experienced gastroenterologist who was blinded to the treatment each subject received. The tracings were analyzed using computer-based validated software. HAPC and manometry data were available for every sensor as well as average values for each HAPC and manometry time point. The primary outcome analysis of HAPC data used the following threshold: Mean amplitude ≥100mmHg and extension ≥20cm (9 sensors).'}], 'secondaryOutcomes': [{'measure': 'Area Under the Concentration Curve (AUC) of All HAPCs', 'timeFrame': 'over 12 hours post-dose', 'description': 'The AUC of all HAPCs during the first 12 hours after treatment was calculated as the sum of the AUC at all sensors of each HAPC at the ≥100mmHg and ≥20cm threshold.'}, {'measure': 'The Mean Amplitude of HAPC', 'timeFrame': 'over 12 hours post-dose', 'description': 'The mean amplitude of all HAPCs was calculated as the sum of the mean amplitude for each HAPC divided by the number of HAPCs.'}, {'measure': 'Time to First HAPC', 'timeFrame': 'over 12 hours post-dose', 'description': 'The median (95% CI) time to first HAPC after administration of investigational product with amplitude ≥100mmHg and extension ≥20cm.'}, {'measure': 'Propagation Velocity of HAPC', 'timeFrame': 'over 12 hours post-dose', 'description': 'Propagation velocity was calculated as the extension divided by the duration for each HAPC. Mean propagation velocity is the sum of the propagation velocities divided by the number of HAPCs.'}, {'measure': 'Duration of HAPC', 'timeFrame': 'over 12 hours post-dose', 'description': 'The mean duration of all HAPCs was calculated as the sum of the duration of each HAPC divided by the number of HAPCs.'}, {'measure': 'Motility Index', 'timeFrame': 'over 12 hours post-dose', 'description': 'Motility index (mmHg) was summarized for the following 3 time points: pre-dose, 0-5 hours post-dose, and 5-12 hours post-dose. The motility index is defined as the natural logarithm of all peak amplitudes of every contraction +1.'}]}, 'conditionsModule': {'conditions': ['Chronic Constipation']}, 'referencesModule': {'references': [{'pmid': '27270968', 'type': 'DERIVED', 'citation': 'Miner PB Jr, Camilleri M, Burton D, Achenbach H, Wan H, Dragone J, Mellgard B. Prucalopride induces high-amplitude propagating contractions in the colon of patients with chronic constipation: a randomized study. Neurogastroenterol Motil. 2016 Sep;28(9):1341-8. doi: 10.1111/nmo.12832. Epub 2016 Jun 7.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the different effects of prucalopride and PEG 3350 + electrolytes on colon motor activity in subjects that are chronically constipated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Chronic constipation\n* Male or female ages 18-75 years\n* Non-pregnant, non-lactating female\n\nExclusion Criteria:\n\n* Drug-induced constipation\n* Subjects suffering from secondary causes of chronic constipation, such as:\n* Endocrine disorders, e.g. hypopituitarism, hypothyroidism, hypercalcemia, pseudohypoparathyroidism, pheochromocytoma or glucagon-producing tumors, unless these are controlled by appropriate medical therapy.\n* Metabolic disorders, e.g. porphyria, uremia, hypokalemia or amyloid neuropathy, unless these are controlled by appropriate medical therapy\n* Neurological disorders, e.g. Parkinson's disease, cerebral tumors, cerebrovascular accidents, multiple sclerosis, meningocele, aganglionosis, hypoganglionosis, hyperganglionosis, autonomic neuropathy or neuropathy due to chemotherapy, spinal cord injury, Chaga's disease, or major depression\n* Surgery.\n* Subjects with insulin-dependent diabetes mellitus\n* Rectal evacuation disorder/outlet obstruction\n* Subjects with intestinal perforation or obstruction\n* Severe renal impairment\n* Subjects with a history of alcohol or drug abuse\n* Subjects with lactose intolerance\n* Subjects with clinically significant cardiac, vascular, liver, pulmonary, endocrine, neurological or psychiatric disorders"}, 'identificationModule': {'nctId': 'NCT01707667', 'briefTitle': 'Study to Investigate Prucalopride vs. Polyethylene Glycol 3350 on Colon Activity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'An Open-label, Randomized, Crossover, Reader-blinded Study to Investigate the Effect of Prucalopride and Polyethylene Glycol 3350 on Colon Motility With Intramural Manometry in Subjects With Chronic Constipation', 'orgStudyIdInfo': {'id': 'SPD555-403'}, 'secondaryIdInfos': [{'id': '2012-002495-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prucalopride', 'interventionNames': ['Drug: prucalopride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PEG 3350', 'interventionNames': ['Drug: PEG 3350']}], 'interventions': [{'name': 'prucalopride', 'type': 'DRUG', 'otherNames': ['Resolor (Marketed name in Europe)'], 'description': 'One 2 mg tablet orally administered on Day 1', 'armGroupLabels': ['Prucalopride']}, {'name': 'PEG 3350', 'type': 'DRUG', 'otherNames': ['Movicol'], 'description': '13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1(once in the morning and once prior to lunch).', 'armGroupLabels': ['PEG 3350']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Foundation for Digestive Research', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UNIVERSITY OF LEUVEN, UNVERSITY HOSPITAL, Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'E1 1BB', 'city': 'Whitechapel', 'state': 'London', 'country': 'United Kingdom', 'facility': 'Barts Health NHS Trust', 'geoPoint': {'lat': 51.51382, 'lon': -0.06583}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shire', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}