Viewing Study NCT00380250

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Ignite Creation Date: 2025-12-24 @ 4:46 PM
Ignite Modification Date: 2026-01-05 @ 5:21 PM
Study NCT ID: NCT00380250
Status: COMPLETED
Last Update Posted: 2019-11-15
First Post: 2006-09-21
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

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': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 weeks', 'description': 'Any subject who took at least 1 dose of study medication made up the safety population. The N of this population is different from both the total subjects randomized and the ITT population', 'eventGroups': [{'id': 'EG000', 'title': 'Lubiprostone Study Period I', 'description': '8 mcg capsules twice daily (BID)', 'otherNumAffected': 75, 'seriousNumAtRisk': 396, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Placebo Study Period I', 'description': 'Matching placebo capsules twice daily (BID)', 'otherNumAffected': 25, 'seriousNumAtRisk': 192, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numEvents': 47, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Thyroid gland cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.54', 'spread': '2.462', 'groupId': 'OG000'}, {'value': '1.21', 'spread': '2.286', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.117', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'van Elteren nonparametric test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Adjusted for center'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline for month 1', 'description': 'SBMs are any bowel movement not associated with rescue medication use.', 'unitOfMeasure': 'SBM/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT with LOCF'}, {'type': 'SECONDARY', 'title': 'Month 1 Stool Consistency Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.51', 'spread': '0.690', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '0.626', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'van Elteren nonparametric test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Adjusted for center'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline for month 1', 'description': '0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)', 'unitOfMeasure': 'Scale score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT with LOCF'}, {'type': 'SECONDARY', 'title': 'Month 1 Bowel Straining Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.53', 'spread': '0.739', 'groupId': 'OG000'}, {'value': '-0.36', 'spread': '0.694', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.050', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'van Elteren nonparametric test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Adjusted for center'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline for month 1', 'description': '0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe', 'unitOfMeasure': 'Scale score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT with LOCF'}, {'type': 'SECONDARY', 'title': 'Month 1 Constipation Severity Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.41', 'spread': '0.602', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '0.568', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.159', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'van Elteren nonparametric test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Adjusted for center'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline at 28 days', 'description': '0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe', 'unitOfMeasure': 'Scale score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT with LOCF'}, {'type': 'SECONDARY', 'title': 'Month 1 Symptom Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.66', 'spread': '1.212', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '1.088', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.378', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Stratified by pooled center'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline for month 1', 'description': 'Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3', 'unitOfMeasure': 'Scale score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT with LOCF'}, {'type': 'SECONDARY', 'title': 'Quality of Life Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'spread': '17.36', 'groupId': 'OG000'}, {'value': '16.8', 'spread': '19.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.588', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Adjusted for clinical site'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline at 12 weeks', 'description': 'Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire included 34 questions with 5 possible responses yielding the following sub-categories: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationship Results range from 34 (low) to 100 (high); meaningful clinical improvement=14 point increase', 'unitOfMeasure': 'Scale score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT without LOCF'}, {'type': 'PRIMARY', 'title': 'Overall Responder Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '13.8', 'groupId': 'OG000'}, {'value': '7.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.029', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustment', 'groupDescription': '90% statistical power to detect 70.6% improvement in response with lubiprostone', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality'}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Monthly responder: \\>=Moderately relieved symptoms 4 weeks/month or Significantly relieved \\>= 2 weeks/month IF:\n\nRescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month.\n\nOverall responder: responder for at least 2/3 months', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) without Last Observation Carried Forward (LOCF)'}, {'type': 'SECONDARY', 'title': 'Month 2 Responder Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000'}, {'value': '9.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.028', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Sequential closed testing procedures were employed', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality'}], 'paramType': 'NUMBER', 'timeFrame': 'month 2 (28 days)', 'description': 'Monthly responder: \\>=Moderately relieved symptoms 4 weeks/month or Significantly relieved \\>= 2 weeks/month IF:\n\nRescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month.', 'unitOfMeasure': 'percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT without LOCF'}, {'type': 'SECONDARY', 'title': 'Month 3 Responder Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000'}, {'value': '10.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.069', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Sequential closed testing procedures were employed', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality'}], 'paramType': 'NUMBER', 'timeFrame': 'month 3 (28 days)', 'description': 'Symptoms \\>= Moderately relieved for 4 weeks/month or Significantly relieved for \\>=2 weeks/month AND:\n\n1. Rescue medication use does not increase during the month as compared to baseline;\n2. No discontinuation during the month due to lack of efficacy;AND\n3. No ratings during the month of Moderately worse or Significantly worse.', 'unitOfMeasure': 'percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT without LOCF'}, {'type': 'SECONDARY', 'title': 'Month 1 Responder Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}, {'value': '6.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.098', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Sequential closed testing procedures were employed', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality'}], 'paramType': 'NUMBER', 'timeFrame': 'month 1 (28 days)', 'description': 'Symptoms \\>= Moderately relieved for 4 weeks/month or Significantly relieved for \\>=2 weeks/month AND:\n\n1. Rescue medication use does not increase during the month as compared to baseline;\n2. No discontinuation during the month due to lack of efficacy;AND\n3. No ratings during the month of Moderately worse or Significantly worse.', 'unitOfMeasure': 'percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT without LOCF'}, {'type': 'SECONDARY', 'title': 'Month 2 Abdominal Bloating Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.42', 'spread': '0.693', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '0.621', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.286', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'van Elteren nonparametric test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Adjusted for center'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline for month 2', 'description': '0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe', 'unitOfMeasure': 'Scale score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT with LOCF'}, {'type': 'SECONDARY', 'title': 'Month 3 Abdominal Bloating Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.43', 'spread': '0.734', 'groupId': 'OG000'}, {'value': '-0.37', 'spread': '0.693', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.337', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'van Elteren nonparametric test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Adjusted for center'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline for month 3', 'description': '0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe', 'unitOfMeasure': 'Scale score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT with LOCF'}, {'type': 'SECONDARY', 'title': 'Month 2 Spontaneous Bowel Movement Frequency Rates Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.59', 'spread': '2.795', 'groupId': 'OG000'}, {'value': '1.41', 'spread': '2.587', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.334', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'van Elteren nonparametric test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Adjusted for center'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline for month 2', 'description': 'Any bowel movement not associated with rescue medication use', 'unitOfMeasure': 'SBM/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT with LOCF'}, {'type': 'SECONDARY', 'title': 'Month 3 Spontaneous Bowel Movement Frequency Rates Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.51', 'spread': '2.990', 'groupId': 'OG000'}, {'value': '1.39', 'spread': '2.851', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.242', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'van Elteren nonparametric test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Adjusted for center'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline for month 3', 'description': 'Any bowel movement not associated with rescue medication use', 'unitOfMeasure': 'SBM/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT with LOCF'}, {'type': 'SECONDARY', 'title': 'Month 2 Stool Consistency Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.53', 'spread': '0.756', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '0.658', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.030', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'van Elteren nonparametric test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Adjusted for center'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline for month 2', 'description': '0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)', 'unitOfMeasure': 'Scale score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT with LOCF'}, {'type': 'SECONDARY', 'title': 'Month 3 Stool Consistency Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.52', 'spread': '0.725', 'groupId': 'OG000'}, {'value': '-0.41', 'spread': '0.696', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.130', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'van Elteren nonparametric test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Adjusted for center'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline for month 3', 'description': '0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)', 'unitOfMeasure': 'Scale score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT with LOCF'}, {'type': 'SECONDARY', 'title': 'Month 2 Bowel Straining Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.58', 'spread': '0.846', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '0.762', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.049', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'van Elteren nonparametric test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Adjusted for center'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline for month 2', 'description': '0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe', 'unitOfMeasure': 'Scale score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT with LOCF'}, {'type': 'SECONDARY', 'title': 'Month 3 Bowel Straining Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.56', 'spread': '0.847', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '0.760', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.348', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'van Elteren nonparametric test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Adjusted for center'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline for month 3', 'description': '0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe', 'unitOfMeasure': 'Scale score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Month 2 Constipation Severity Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.50', 'spread': '0.719', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '0.670', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.064', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'van Elteren nonparametric test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Adjusted for center'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline for month 2', 'description': '0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe', 'unitOfMeasure': 'Scale score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT with LOCF'}, {'type': 'SECONDARY', 'title': 'Month 3 Constipation Severity Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.51', 'spread': '0.755', 'groupId': 'OG000'}, {'value': '-0.41', 'spread': '0.712', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.111', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'van Elteren nonparametric test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline for month 3', 'description': '0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe', 'unitOfMeasure': 'Scale score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT with LOCF'}, {'type': 'SECONDARY', 'title': 'Month 2 Symptom Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.76', 'spread': '1.278', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '1.203', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.144', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Stratified by pooled center'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline for month 2', 'description': 'Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3', 'unitOfMeasure': 'Scale score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT with LOCF'}, {'type': 'SECONDARY', 'title': 'Month 3 Symptom Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.74', 'spread': '1.259', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '1.277', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.168', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Adjusted by pooled center'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline for month 3', 'description': 'Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3', 'unitOfMeasure': 'Scale score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT with LOCF'}, {'type': 'SECONDARY', 'title': 'Month 1 Abdominal Bloating Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.30', 'spread': '0.585', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '0.516', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.615', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'van Elteren nonparametic test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Adjusted for center'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline for month 1', 'description': '0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe', 'unitOfMeasure': 'Scale score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT with LOCF'}, {'type': 'SECONDARY', 'title': 'Month 1 Bowel Movement Frequency Rates Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.22', 'spread': '2.234', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '2.093', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.108', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'van Elteren nonparametric test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline for month 1', 'unitOfMeasure': 'BM/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, with LOCF'}, {'type': 'SECONDARY', 'title': 'Month 2 Bowel Movement Frequency Rates Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.23', 'spread': '2.440', 'groupId': 'OG000'}, {'value': '1.10', 'spread': '2.581', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.483', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'van Elteren nonparametric test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline for month 2', 'unitOfMeasure': 'BM/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, with LOCF'}, {'type': 'SECONDARY', 'title': 'Month 3 Bowel Movement Frequency Rates Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.15', 'spread': '2.744', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '2.731', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.491', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'van Elteren nonparametric test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline for month 3', 'unitOfMeasure': 'BM/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, with LOCF'}, {'type': 'SECONDARY', 'title': 'Month 1 Abdominal Pain Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.29', 'spread': '0.588', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '0.508', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'van Elteren nonparametric test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Adjusted for center'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline for month 1', 'description': '0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe', 'unitOfMeasure': 'Scale Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Month 2 Abdominal Pain Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.43', 'spread': '0.695', 'groupId': 'OG000'}, {'value': '-0.37', 'spread': '0.614', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'van Elteren nonparametric test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Adjusted for center'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline for month 2', 'description': '0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe', 'unitOfMeasure': 'Scale Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Month 3 Abdominal Pain Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'OG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.42', 'spread': '0.722', 'groupId': 'OG000'}, {'value': '-0.36', 'spread': '0.684', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'van Elteren nonparametric test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Adjusted for center'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline for month 3', 'description': '0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe', 'unitOfMeasure': 'Scale Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'FG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '396'}, {'groupId': 'FG001', 'numSubjects': '194'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '297'}, {'groupId': 'FG001', 'numSubjects': '139'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '55'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'First subject entered 5/12/05; Last subject observation 7/18/08; Multicenter study performed at 65 study sites/centers across the US', 'preAssignmentDetails': 'Subjects were enrolled after an up to 4 week screening period to meet inclusion/exclusion criteria and randomized on Day 0'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'BG000'}, {'value': '193', 'groupId': 'BG001'}, {'value': '583', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lubiprostone Study Period I', 'description': 'Subjects who received active drug'}, {'id': 'BG001', 'title': 'Placebo Study Period I', 'description': 'Subjects who received placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.7', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '83'}, {'value': '48.1', 'groupId': 'BG001', 'lowerLimit': '20', 'upperLimit': '85'}, {'value': '47.2', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '85'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '355', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '535', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '336', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '496', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '64.9', 'spread': '2.9', 'groupId': 'BG000'}, {'value': '64.8', 'spread': '3.09', 'groupId': 'BG001'}, {'value': '64.9', 'spread': '2.96', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Inches', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The Baseline participants data is taken from the intent to treat(ITT) population Whereas the Participant flow data is for all randomized subjects.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 590}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-04', 'studyFirstSubmitDate': '2006-09-21', 'resultsFirstSubmitDate': '2008-10-07', 'studyFirstSubmitQcDate': '2006-09-21', 'lastUpdatePostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-01-13', 'studyFirstPostDateStruct': {'date': '2006-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Responder Rate', 'timeFrame': '12 weeks', 'description': 'Monthly responder: \\>=Moderately relieved symptoms 4 weeks/month or Significantly relieved \\>= 2 weeks/month IF:\n\nRescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month.\n\nOverall responder: responder for at least 2/3 months'}], 'secondaryOutcomes': [{'measure': 'Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline', 'timeFrame': 'Change from baseline for month 1', 'description': 'SBMs are any bowel movement not associated with rescue medication use.'}, {'measure': 'Month 1 Stool Consistency Change From Baseline', 'timeFrame': 'Change from baseline for month 1', 'description': '0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)'}, {'measure': 'Month 1 Bowel Straining Change From Baseline', 'timeFrame': 'Change from baseline for month 1', 'description': '0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe'}, {'measure': 'Month 1 Constipation Severity Change From Baseline', 'timeFrame': 'Change from baseline at 28 days', 'description': '0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe'}, {'measure': 'Month 1 Symptom Relief', 'timeFrame': 'Change from baseline for month 1', 'description': 'Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3'}, {'measure': 'Quality of Life Change From Baseline', 'timeFrame': 'Change from baseline at 12 weeks', 'description': 'Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire included 34 questions with 5 possible responses yielding the following sub-categories: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationship Results range from 34 (low) to 100 (high); meaningful clinical improvement=14 point increase'}, {'measure': 'Month 2 Responder Rate', 'timeFrame': 'month 2 (28 days)', 'description': 'Monthly responder: \\>=Moderately relieved symptoms 4 weeks/month or Significantly relieved \\>= 2 weeks/month IF:\n\nRescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month.'}, {'measure': 'Month 3 Responder Rate', 'timeFrame': 'month 3 (28 days)', 'description': 'Symptoms \\>= Moderately relieved for 4 weeks/month or Significantly relieved for \\>=2 weeks/month AND:\n\n1. Rescue medication use does not increase during the month as compared to baseline;\n2. No discontinuation during the month due to lack of efficacy;AND\n3. No ratings during the month of Moderately worse or Significantly worse.'}, {'measure': 'Month 1 Responder Rate', 'timeFrame': 'month 1 (28 days)', 'description': 'Symptoms \\>= Moderately relieved for 4 weeks/month or Significantly relieved for \\>=2 weeks/month AND:\n\n1. Rescue medication use does not increase during the month as compared to baseline;\n2. No discontinuation during the month due to lack of efficacy;AND\n3. No ratings during the month of Moderately worse or Significantly worse.'}, {'measure': 'Month 2 Abdominal Bloating Change From Baseline', 'timeFrame': 'Change from baseline for month 2', 'description': '0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe'}, {'measure': 'Month 3 Abdominal Bloating Change From Baseline', 'timeFrame': 'Change from baseline for month 3', 'description': '0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe'}, {'measure': 'Month 2 Spontaneous Bowel Movement Frequency Rates Change From Baseline', 'timeFrame': 'Change from baseline for month 2', 'description': 'Any bowel movement not associated with rescue medication use'}, {'measure': 'Month 3 Spontaneous Bowel Movement Frequency Rates Change From Baseline', 'timeFrame': 'Change from baseline for month 3', 'description': 'Any bowel movement not associated with rescue medication use'}, {'measure': 'Month 2 Stool Consistency Change From Baseline', 'timeFrame': 'Change from baseline for month 2', 'description': '0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)'}, {'measure': 'Month 3 Stool Consistency Change From Baseline', 'timeFrame': 'Change from baseline for month 3', 'description': '0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)'}, {'measure': 'Month 2 Bowel Straining Change From Baseline', 'timeFrame': 'Change from baseline for month 2', 'description': '0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe'}, {'measure': 'Month 3 Bowel Straining Change From Baseline', 'timeFrame': 'Change from baseline for month 3', 'description': '0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe'}, {'measure': 'Month 2 Constipation Severity Change From Baseline', 'timeFrame': 'Change from baseline for month 2', 'description': '0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe'}, {'measure': 'Month 3 Constipation Severity Change From Baseline', 'timeFrame': 'Change from baseline for month 3', 'description': '0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe'}, {'measure': 'Month 2 Symptom Relief', 'timeFrame': 'Change from baseline for month 2', 'description': 'Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3'}, {'measure': 'Month 3 Symptom Relief', 'timeFrame': 'Change from baseline for month 3', 'description': 'Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3'}, {'measure': 'Month 1 Abdominal Bloating Change From Baseline', 'timeFrame': 'Change from baseline for month 1', 'description': '0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe'}, {'measure': 'Month 1 Bowel Movement Frequency Rates Change From Baseline', 'timeFrame': 'Change from baseline for month 1'}, {'measure': 'Month 2 Bowel Movement Frequency Rates Change From Baseline', 'timeFrame': 'Change from baseline for month 2'}, {'measure': 'Month 3 Bowel Movement Frequency Rates Change From Baseline', 'timeFrame': 'Change from baseline for month 3'}, {'measure': 'Month 1 Abdominal Pain Change From Baseline', 'timeFrame': 'Change from baseline for month 1', 'description': '0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe'}, {'measure': 'Month 2 Abdominal Pain Change From Baseline', 'timeFrame': 'Change from baseline for month 2', 'description': '0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe'}, {'measure': 'Month 3 Abdominal Pain Change From Baseline', 'timeFrame': 'Change from baseline for month 3', 'description': '0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe'}]}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome With Constipation']}, 'referencesModule': {'references': [{'pmid': '19006537', 'type': 'RESULT', 'citation': 'Drossman DA, Chey WD, Johanson JF, Fass R, Scott C, Panas R, Ueno R. Clinical trial: lubiprostone in patients with constipation-associated irritable bowel syndrome--results of two randomized, placebo-controlled studies. Aliment Pharmacol Ther. 2009 Feb 1;29(3):329-41. doi: 10.1111/j.1365-2036.2008.03881.x. Epub 2008 Nov 4.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the efficacy and safety of administration of lubiprostone in patients with irritable bowel syndrome with constipation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age and older\n* Stable fiber therapy\n* Normal colonoscopy/sigmoidoscopy\n* Able to refrain from use of medications known to treat or associated with constipation symptoms\n* Experiences abdominal discomfort/pain associated with bowel movements\n* Reports decreased bowel movement frequency and/or other symptoms associated with constipation\n\nExclusion Criteria:\n\n* Diarrhea-predominant or alternating (diarrhea and constipation cycling) irritable bowel syndrome (IBS), or constipation other than that associated with IBS\n* Open gastrointestinal or abdominal surgery prior to IBS onset\n* Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, unexplained weight loss or rectal bleeding\n* Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, other systemic disease, or abnormal laboratory tests per investigator discretion\n* If female, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study'}, 'identificationModule': {'nctId': 'NCT00380250', 'briefTitle': 'Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mallinckrodt'}, 'officialTitle': 'Phase 3, 12-Week, Multicenter, Double-Blind, Randomized, Efficacy and Safety Study of Lubiprostone for the Treatment of Irritable Bowel Syndrome With Constipation', 'orgStudyIdInfo': {'id': '0211SIB-0431'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lubiprostone', 'description': '8 mcg capsule twice daily (BID)', 'interventionNames': ['Drug: Lubiprostone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo capsule twice daily (BID)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lubiprostone', 'type': 'DRUG', 'armGroupLabels': ['Lubiprostone']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sucampo Pharmaceuticals, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sucampo Pharma Americas, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Takeda', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}