Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-29 @ 11:06 AM
Study NCT ID:
NCT00597428
Status:
COMPLETED
Last Update Posted:
2019-12-10
First Post:
2008-01-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079689', 'term': 'Opioid-Induced Constipation'}], 'ancestors': [{'id': 'D003248', 'term': 'Constipation'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, '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': 'info@sucampo.com', 'phone': '301-961-3400', 'title': 'VP, Clinical Development', 'organization': 'Sucampo Pharma Americas, LLC'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Post-study, it was determined that lubiprostone efficacy was dose-dependently decreased with concomitant methadone use (30% higher morphine equivalent daily dose (MEDD) than parallel pivotal study NCT00595946).'}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events (AEs): 13 weeks (from time of first dose to 7 days post-treatment)', 'description': 'Number of participants at risk represents the Safety Evaluable population. Safety Evaluable population includes all subjects who randomzied and dosed. ITT population (in Participant Flow) includes only subjects who dosed and provided at least one post-treatment efficacy assessment.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo : 0 mcg capsules twice daily (BID)', 'otherNumAtRisk': 214, 'otherNumAffected': 36, 'seriousNumAtRisk': 214, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Lubiprostone', 'description': 'Lubiprostone : 24 mcg capsules twice daily (BID)', 'otherNumAtRisk': 223, 'otherNumAffected': 49, 'seriousNumAtRisk': 223, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Faecaloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Tricuspid valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Weekly Spontaneous Bowel Movement (SBM) Frequency in Subjects Without Dose Reduction Prior to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo : 0 mcg capsules twice daily (BID)'}, {'id': 'OG001', 'title': 'Lubiprostone', 'description': 'Lubiprostone : 24 mcg capsules twice daily (BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '3.20', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '3.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8', 'unitOfMeasure': 'Spontaneous Bowel Movements/Week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Weekly SBM Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo : 0 mcg capsules twice daily (BID)'}, {'id': 'OG001', 'title': 'Lubiprostone', 'description': 'Lubiprostone : 24 mcg capsules twice daily (BID)'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '2.6', 'spread': '3.57', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '3.64', 'groupId': 'OG001'}]}]}, {'title': 'Overall', 'categories': [{'measurements': [{'value': '2.3', 'spread': '2.57', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '2.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, and Weeks 1-12', 'description': 'For overall assessment of change, average weekly rating was calculated from data collected from Week 1 through Week 12.', 'unitOfMeasure': 'Spontaneous Bowel Movements/Week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'First Post-dose SBM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo : 0 mcg capsules twice daily (BID)'}, {'id': 'OG001', 'title': 'Lubiprostone', 'description': 'Lubiprostone : 24 mcg capsules twice daily (BID)'}], 'classes': [{'title': '24 hours', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': '48 hours', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 and 48 hours post-dose', 'description': 'The number of participants that experienced first post-dose SBM 24 and 48 hour of dose initiation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Responder Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo : 0 mcg capsules twice daily (BID)'}, {'id': 'OG001', 'title': 'Lubiprostone', 'description': 'Lubiprostone : 24 mcg capsules twice daily (BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 weeks', 'description': 'Number of participants, who remained on treatment for at least 8 weeks, and reported response (\\>=3 SBMs) for at least 50% of weeks on study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Changes From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo : 0 mcg capsules twice daily (BID)'}, {'id': 'OG001', 'title': 'Lubiprostone', 'description': 'Lubiprostone : 24 mcg capsules twice daily (BID)'}], 'classes': [{'title': 'Straining', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': 'Stool consistency', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Constipation severity', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal bloating', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.70', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal discomfort', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'Bowel habit regularity', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '1.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1-12', 'description': 'Ratings over 12-week treatment period were averaged and difference from baseline score calculated Straining scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Stool consistency scale: 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) Constipation severity scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal bloating scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal discomfort scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Bowel habit regularity scale: 7-point scale, where 1 = very regular and 7 = very irregular', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Treatment Effectiveness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo : 0 mcg capsules twice daily (BID)'}, {'id': 'OG001', 'title': 'Lubiprostone', 'description': 'Lubiprostone : 24 mcg capsules twice daily (BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1-12', 'description': 'Treatment effectiveness scale: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment effectiveness scores were collected at the end of each treatment week during the study; the number of participants analyzed reflects those subjects who provided at least one end-of-week assessment of treatment effectiveness. For the analysis, treatment effectiveness scores were averaged across the treatment period (Weeks 1-12).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo : 0 mcg capsules twice daily (BID) for 12 weeks'}, {'id': 'FG001', 'title': 'Lubiprostone', 'description': 'Lubiprostone : 24 mcg capsules twice daily (BID) for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '214'}, {'groupId': 'FG001', 'numSubjects': '223'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '152'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '71'}]}]}], 'recruitmentDetails': 'Recruitment period: 06 August 2007 through 06 March 2009 Recruitment sites: 84 U.S. investigative sites and 4 Canadian investigative sites', 'preAssignmentDetails': "Safety evaluable population (listed below under 'Started') includes all subjects who randomized and dosed. NOTE: these numbers are based on 1 miss randomized subjects - randomized to Lubiprostone and received Placebo. ITT population includes only those subjects who dosed and provided at least one post-treatment efficacy assessment."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'BG000'}, {'value': '223', 'groupId': 'BG001'}, {'value': '435', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo : 0 mcg capsules twice daily (BID)'}, {'id': 'BG001', 'title': 'Lubiprostone', 'description': 'Lubiprostone : 24 mcg capsules twice daily (BID)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.8', 'spread': '10.44', 'groupId': 'BG000'}, {'value': '48.9', 'spread': '9.85', 'groupId': 'BG001'}, {'value': '49.4', 'spread': '10.14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline analysis based on ITT population, which included 212 placebo-treated subjects and 223 lubiprostone-treated subjects.'}}, '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': 437}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'dispFirstSubmitDate': '2010-06-02', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-06', 'studyFirstSubmitDate': '2008-01-09', 'dispFirstSubmitQcDate': '2013-02-01', 'resultsFirstSubmitDate': '2013-11-22', 'studyFirstSubmitQcDate': '2008-01-17', 'dispFirstPostDateStruct': {'date': '2013-02-05', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-11-02', 'studyFirstPostDateStruct': {'date': '2008-01-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Mean Weekly Spontaneous Bowel Movement (SBM) Frequency in Subjects Without Dose Reduction Prior to Week 8', 'timeFrame': 'Baseline and Week 8'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean Weekly SBM Frequency', 'timeFrame': 'Baseline, Week 12, and Weeks 1-12', 'description': 'For overall assessment of change, average weekly rating was calculated from data collected from Week 1 through Week 12.'}, {'measure': 'First Post-dose SBM', 'timeFrame': '24 and 48 hours post-dose', 'description': 'The number of participants that experienced first post-dose SBM 24 and 48 hour of dose initiation.'}, {'measure': 'Responder Rate', 'timeFrame': 'Up to 12 weeks', 'description': 'Number of participants, who remained on treatment for at least 8 weeks, and reported response (\\>=3 SBMs) for at least 50% of weeks on study.'}, {'measure': 'Mean Changes From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity', 'timeFrame': 'Weeks 1-12', 'description': 'Ratings over 12-week treatment period were averaged and difference from baseline score calculated Straining scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Stool consistency scale: 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) Constipation severity scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal bloating scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal discomfort scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Bowel habit regularity scale: 7-point scale, where 1 = very regular and 7 = very irregular'}, {'measure': 'Treatment Effectiveness', 'timeFrame': 'Weeks 1-12', 'description': 'Treatment effectiveness scale: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Opioid-Induced Bowel Dysfunction']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients with opioid-induced bowel dysfunction (OBD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consistent treatment for chronic, non-cancer-related pain with any full agonist opioid for at least 30 days prior to screening.\n* Diagnosis of opioid-induced bowel dysfunction as confirmed during the screening period.\n* If patient has a history of chronic constipation, condition must have been exacerbated by initiation of opioid treatment.\n* Use of prescribed or over-the-counter (OTC) medication that affects gastrointestinal motility (other than opioid therapy) must be discontinued during the study.\n* If treated for clinical depression with selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), or monoamine oxidase (MAO) inhibitors, treatment must have been at a stable dose for at least 30 days prior to screening.\n* Use of laxative and stool softeners (with the exception of approved rescue medications) must be discontinued while on study.\n\nExclusion Criteria:\n\n* Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of administration within 30 days of screening.\n* Non-ambulatory patients, or those who are unable to eat/drink, take oral medications, or to hold down oral medications due to vomiting.\n* Treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction.\n* Patient has been treated for cancer in the past 5 years (with the exception of localized basal cell, squamous cell skin cancer, or in situ cancer that has been resected).\n* Gastrointestinal or abdominal surgical procedures within 90 days prior to screening.\n* Female patients of childbearing potential who are unable/unwilling to use protocol-specified method(s) of birth control and/or are pregnant, nursing, or plan to become pregnant or nurse during the study.'}, 'identificationModule': {'nctId': 'NCT00597428', 'acronym': 'OPAL', 'briefTitle': 'Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mallinckrodt'}, 'officialTitle': 'A Multi-center, Randomized, Double-Blinded Study of the Efficacy and Safety of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction 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