Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2026-01-03 @ 7:53 PM
Study NCT ID:
NCT03097861
Status:
COMPLETED
Last Update Posted:
2020-01-14
First Post:
2017-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068238', 'term': 'Lubiprostone'}], 'ancestors': [{'id': 'D000527', 'term': 'Alprostadil'}, {'id': 'D005229', 'term': 'Fatty Acids, Monounsaturated'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@mnk.com', 'phone': '800-556-3314', 'title': 'Medical Information Call Center', 'organization': 'Mallinckrodt Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Actual randomization ratio (2:1:1) was different than the planned ratio (1:1:1).'}}, 'adverseEventsModule': {'timeFrame': 'from first dose of study medication through a 1-week follow-up (up to 15 days)', 'description': 'Treatment-related Adverse Events (TRAEs) were any event with possible, probably, or definite relationship with the study medication, and with an onset date on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication. TRAEs were collected in the safety population, defined as all randomized participants who took at least one dose of double-blinded study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo matching to lubiprostone (sprinkle/capsule) twice daily (BID) for 7 days.', 'otherNumAtRisk': 143, 'deathsNumAtRisk': 143, 'otherNumAffected': 15, 'seriousNumAtRisk': 143, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lubiprostone Sprinkle', 'description': 'Lubiprostone 24 mcg sprinkle BID for 7 days.', 'otherNumAtRisk': 275, 'deathsNumAtRisk': 275, 'otherNumAffected': 50, 'seriousNumAtRisk': 275, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Lubiprostone Capsule', 'description': 'Lubiprostone 24 mcg capsule BID for 7 days.', 'otherNumAtRisk': 130, 'deathsNumAtRisk': 130, 'otherNumAffected': 29, 'seriousNumAtRisk': 130, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo'}, {'id': 'OG001', 'title': 'Lubiprostone Sprinkle', 'description': 'Lubiprostone 24 mcg sprinkle twice daily (BID) for 7 days.'}, {'id': 'OG002', 'title': 'Lubiprostone Capsule', 'description': 'Lubiprostone 24 mcg capsule BID for 7 days.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.38', 'spread': '0.692', 'groupId': 'OG000'}, {'value': '1.37', 'spread': '0.693', 'groupId': 'OG001'}, {'value': '1.35', 'spread': '0.720', 'groupId': 'OG002'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '3.68', 'spread': '2.164', 'groupId': 'OG000'}, {'value': '4.82', 'spread': '3.658', 'groupId': 'OG001'}, {'value': '5.74', 'spread': '3.786', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.0020', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Treatment p-value is from ANCOVA using SBM count as dependent variable, treatment as fixed effect and baseline count as random effect'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Treatment p-value is from ANCOVA using SBM count as dependent variable, treatment as fixed effect and baseline count as random effect', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'during the 1-week treatment period', 'description': 'Observed SBM count was based on the observed data reported in the electronic daily diary for the actual number of SBMs during the 1-week treatment period.', 'unitOfMeasure': 'SBMs/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population'}, {'type': 'SECONDARY', 'title': 'Mean SBM Consistency Score Within 1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matching to lubiprostone (sprinkle/capsule) twice daily (BID) for 7 days.'}, {'id': 'OG001', 'title': 'Lubiprostone Sprinkle', 'description': 'Lubiprostone 24 mcg sprinkle BID for 7 days.'}, {'id': 'OG002', 'title': 'Lubiprostone Capsule', 'description': 'Lubiprostone 24 mcg capsule BID for 7 days.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.47', 'spread': '1.122', 'groupId': 'OG000'}, {'value': '2.39', 'spread': '1.211', 'groupId': 'OG001'}, {'value': '2.28', 'spread': '1.045', 'groupId': 'OG002'}]}]}, {'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.43', 'spread': '1.270', 'groupId': 'OG000'}, {'value': '3.94', 'spread': '1.516', 'groupId': 'OG001'}, {'value': '4.22', 'spread': '1.409', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during the 1-week treatment period', 'description': 'Stool consistency associated with SBMs was rated according to the 7-point Bristol Stool Form Scale (1-7) where 1 = Separate hard lumps, like nuts (hard to pass), 2 = Sausage-shaped but lumpy, 3 = Like a sausage but with cracks on the surface, 4 = Like a sausage or snake, smooth and soft, 5 = Soft blobs with clear-cut edges (passed easily), 6 = Fluffy pieces with ragged edges, a mushy stool, 7 = Watery, no solid pieces; entirely liquid. Scores in the mid-range of this scale indicate better stool consistency.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population. Number of participants analysed indicates participants who were evaluated for this outcome measure at each categorical time point.'}, {'type': 'SECONDARY', 'title': 'Mean SBM Straining Score Within 1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matching to lubiprostone (sprinkle/capsule) twice daily (BID) for 7 days.'}, {'id': 'OG001', 'title': 'Lubiprostone Sprinkle', 'description': 'Lubiprostone 24 mcg sprinkle BID for 7 days.'}, {'id': 'OG002', 'title': 'Lubiprostone Capsule', 'description': 'Lubiprostone 24 mcg capsule BID for 7 days.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.39', 'spread': '0.739', 'groupId': 'OG000'}, {'value': '2.31', 'spread': '0.911', 'groupId': 'OG001'}, {'value': '2.40', 'spread': '0.892', 'groupId': 'OG002'}]}]}, {'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.76', 'spread': '0.871', 'groupId': 'OG000'}, {'value': '1.45', 'spread': '0.937', 'groupId': 'OG001'}, {'value': '1.19', 'spread': '0.917', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during the 1-week treatment period', 'description': 'Bowel straining associated with SBMs was rated on a scale of 0-4 where 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Very severe. Higher score indicates more straining, so a worse condition.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population. Number of participants analysed indicates participants who were evaluated for this outcome measure at each time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matching to lubiprostone (sprinkle/capsule) twice daily (BID) for 7 days.'}, {'id': 'OG001', 'title': 'Lubiprostone Sprinkle', 'description': 'Lubiprostone 24 mcg sprinkle BID for 7 days.'}, {'id': 'OG002', 'title': 'Lubiprostone Capsule', 'description': 'Lubiprostone 24 mcg capsule BID for 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study medication to follow-up (up to 15 days)', 'description': 'An adverse event (AE) is any untoward medical occurrence (including clinically significant changes in laboratory values or other clinical tests) experienced by a participant administered a pharmaceutical product regardless of causal relationship with the treatment. A TEAE is an episode which occur after the administration of the first dose of study medication and within 7 days after final dose.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population, defined as all randomized participants who took at least one dose of double-blinded study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo matching to lubiprostone (sprinkle/capsule) twice daily (BID) for 7 days.'}, {'id': 'FG001', 'title': 'Lubiprostone Sprinkle', 'description': 'Lubiprostone 24 mcg sprinkle BID for 7 days.'}, {'id': 'FG002', 'title': 'Lubiprostone Capsule', 'description': 'Lubiprostone 24 mcg capsule BID for 7 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '145'}, {'groupId': 'FG001', 'numSubjects': '276'}, {'groupId': 'FG002', 'numSubjects': '131'}]}, {'type': 'Safety Population', 'comment': 'Randomized and took at least one dose of study drug, by treatment actually received', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}, {'groupId': 'FG001', 'numSubjects': '275'}, {'groupId': 'FG002', 'numSubjects': '130'}]}, {'type': 'Modified Intent to Treat', 'comment': 'As randomized, received at least one dose of study drug and had at least one diary entry', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}, {'groupId': 'FG001', 'numSubjects': '275'}, {'groupId': 'FG002', 'numSubjects': '130'}]}, {'type': 'Completers', 'comment': 'Completed the entire treatment period with a recorded primary endpoint', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '255'}, {'groupId': 'FG002', 'numSubjects': '121'}]}, {'type': 'Per-protocol Population (PP)', 'comment': 'Main population for efficacy analysis', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '234'}, {'groupId': 'FG002', 'numSubjects': '113'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}, {'groupId': 'FG001', 'numSubjects': '254'}, {'groupId': 'FG002', 'numSubjects': '122'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Investigator Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Reason not provided', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This trial was conducted at 66 investigative sites in the United States.', 'preAssignmentDetails': 'Actual randomization ratio of sprinkle:placebo:capsule (2:1:1) was different than the planned randomization ratio (1:1:1)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '234', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}, {'value': '473', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo matching to lubiprostone (sprinkle/capsule) twice daily (BID) for 7 days.'}, {'id': 'BG001', 'title': 'Lubiprostone Sprinkle', 'description': 'Lubiprostone 24 mcg sprinkle BID for 7 days.'}, {'id': 'BG002', 'title': 'Lubiprostone Capsule', 'description': 'Lubiprostone 24 mcg capsule BID for 7 days.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.7', 'spread': '13.32', 'groupId': 'BG000'}, {'value': '47.4', 'spread': '13.17', 'groupId': 'BG001'}, {'value': '48.8', 'spread': '13.38', 'groupId': 'BG002'}, {'value': '47.6', 'spread': '13.25', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}, {'value': '399', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '170', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '345', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], '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': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '197', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '250', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Per Protocol Population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-06', 'size': 2384625, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-12-13T14:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 552}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'dispFirstSubmitDate': '2018-03-22', 'completionDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-10', 'studyFirstSubmitDate': '2017-03-27', 'dispFirstSubmitQcDate': '2018-03-26', 'resultsFirstSubmitDate': '2019-12-13', 'studyFirstSubmitQcDate': '2017-03-30', 'dispFirstPostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-10', 'studyFirstPostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week', 'timeFrame': 'during the 1-week treatment period', 'description': 'Observed SBM count was based on the observed data reported in the electronic daily diary for the actual number of SBMs during the 1-week treatment period.'}], 'secondaryOutcomes': [{'measure': 'Mean SBM Consistency Score Within 1 Week', 'timeFrame': 'during the 1-week treatment period', 'description': 'Stool consistency associated with SBMs was rated according to the 7-point Bristol Stool Form Scale (1-7) where 1 = Separate hard lumps, like nuts (hard to pass), 2 = Sausage-shaped but lumpy, 3 = Like a sausage but with cracks on the surface, 4 = Like a sausage or snake, smooth and soft, 5 = Soft blobs with clear-cut edges (passed easily), 6 = Fluffy pieces with ragged edges, a mushy stool, 7 = Watery, no solid pieces; entirely liquid. Scores in the mid-range of this scale indicate better stool consistency.'}, {'measure': 'Mean SBM Straining Score Within 1 Week', 'timeFrame': 'during the 1-week treatment period', 'description': 'Bowel straining associated with SBMs was rated on a scale of 0-4 where 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Very severe. Higher score indicates more straining, so a worse condition.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'From first dose of study medication to follow-up (up to 15 days)', 'description': 'An adverse event (AE) is any untoward medical occurrence (including clinically significant changes in laboratory values or other clinical tests) experienced by a participant administered a pharmaceutical product regardless of causal relationship with the treatment. A TEAE is an episode which occur after the administration of the first dose of study medication and within 7 days after final dose.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Idiopathic Constipation']}, 'referencesModule': {'references': [{'pmid': '33834354', 'type': 'DERIVED', 'citation': 'Adams A, Barish C, Chen A, Dennis P, Krause R, Lichtlen P, Losch-Beridon T, Mareya S, Schneider J. Capsule and Sprinkle Formulations of Lubiprostone Are Not Biologically Similar in Patients with Functional Constipation. Adv Ther. 2021 Jun;38(6):2936-2952. doi: 10.1007/s12325-021-01707-9. Epub 2021 Apr 8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the bioequivalence of sprinkle and capsule formulations of lubiprostone, as compared to placebo, when administered orally in participants with Chronic Idiopathic Constipation (CIC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Either has medically-confirmed diagnosis of chronic constipation (per Rome III), or meets the diagnosis as confirmed using the Rome III constipation module questionnaire during the Screening period.\n* Is male or female, 18 or older years of age\n* Should be on stable dose of fiber supplement or a concomitant medication for the indication of lowering blood pressure\n\nExclusion Criteria:\n\n* Has any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation\n* Is unable to eat or drink, take oral medications, or to hold down oral medications due to vomiting'}, 'identificationModule': {'nctId': 'NCT03097861', 'briefTitle': 'Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mallinckrodt'}, 'officialTitle': 'A Randomized, Placebo-controlled, Double-blinded, Multicenter Study of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo, in Adult Subjects With Chronic Idiopathic Constipation', 'orgStudyIdInfo': {'id': 'SCMP-0211-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lubiprostone Capsule', 'description': 'Lubiprostone 24 mcg capsule twice daily (BID) for 7 days.', 'interventionNames': ['Drug: Lubiprostone']}, {'type': 'EXPERIMENTAL', 'label': 'Lubiprostone Sprinkle', 'description': 'Lubiprostone 24 mcg sprinkle BID for 7 days.', 'interventionNames': ['Drug: Lubiprostone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo matching to lubiprostone (sprinkle/capsule) BID for 7 days.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lubiprostone', 'type': 'DRUG', 'otherNames': ['Amitiza'], 'description': '24 mcg administered orally BID', 'armGroupLabels': ['Lubiprostone Capsule', 'Lubiprostone Sprinkle']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '24 mcg administered orally BID', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36535', 'city': 'Foley', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 30.40659, 'lon': -87.6836}}, {'zip': '72212', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Investigative Site', 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