Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2026-01-20 @ 5:28 AM
Study NCT ID:
NCT00620061
Status:
COMPLETED
Last Update Posted:
2020-01-21
First Post:
2008-02-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Opioid-induced Bowel Dysfunction: Long-Term 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}}, 'adverseEventsModule': {'timeFrame': '9 months plus 7 days for follow-up', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': 'Lubiprostone: 24 mcg capsules twice daily (BID) for 9 months', 'otherNumAtRisk': 439, 'deathsNumAtRisk': 439, 'otherNumAffected': 100, 'seriousNumAtRisk': 439, 'deathsNumAffected': 1, 'seriousNumAffected': 34}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 39}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 42}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 23}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'seriousEvents': [{'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Papilloma Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Nocardiosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Meningitis Aseptic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Abscess Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Abdominal Abcess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Lumbar Spinal Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Intervertebral Disc Protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Costochondritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Coranary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Oesophageal Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Abdominal Adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Mental Status Changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cognitive Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Spinal Compression Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Road Traffic Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Multiple Fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cholecystitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Jugular Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Renal Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Lung Neoplasm Malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pulmonary Cavitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Lubiprostone: 24 mcg capsules twice daily (BID)'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.98', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.9', 'spread': '2.72', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.9', 'spread': '2.62', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': '2.76', 'groupId': 'OG000'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': '2.71', 'groupId': 'OG000'}]}]}, {'title': 'Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': '2.82', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': '2.86', 'groupId': 'OG000'}]}]}, {'title': 'Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '2.93', 'groupId': 'OG000'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.3', 'spread': '2.91', 'groupId': 'OG000'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '3.19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9', 'description': 'A Spontaneous Bowel Movement (SBM) is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication.', 'unitOfMeasure': 'Weekly SBMs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population with evaluable SBM data during the given month'}, {'type': 'PRIMARY', 'title': 'Mean Weekly Bowel Movements (BMs) Per Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Lubiprostone: 24 mcg capsules twice daily (BID)'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.38', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': '2.73', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': '2.63', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '2.70', 'groupId': 'OG000'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '2.67', 'groupId': 'OG000'}]}]}, {'title': 'Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '2.79', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '2.85', 'groupId': 'OG000'}]}]}, {'title': 'Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '2.90', 'groupId': 'OG000'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '2.88', 'groupId': 'OG000'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.3', 'spread': '3.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9', 'description': 'A Bowel Movement (BM) is defined as any BM (whether spontaneous or not)', 'unitOfMeasure': 'Weekly BMs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population with evaluable BM data during the given month'}, {'type': 'SECONDARY', 'title': 'Number of Participants Classified as Monthly Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Lubiprostone: 24 mcg capsules twice daily (BID) for 9 months'}], 'classes': [{'title': 'Month 1', 'categories': [{'measurements': [{'value': '322', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '323', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '291', 'groupId': 'OG000'}]}]}, {'title': 'Month 4', 'categories': [{'measurements': [{'value': '270', 'groupId': 'OG000'}]}]}, {'title': 'Month 5', 'categories': [{'measurements': [{'value': '259', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '250', 'groupId': 'OG000'}]}]}, {'title': 'Month 7', 'categories': [{'measurements': [{'value': '239', 'groupId': 'OG000'}]}]}, {'title': 'Month 8', 'categories': [{'measurements': [{'value': '233', 'groupId': 'OG000'}]}]}, {'title': 'Month 9', 'categories': [{'measurements': [{'value': '202', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Months 1, 2, 3, 4, 5, 6, 7, 8, and 9', 'description': 'A weekly SBM frequency rate is calculated as (168 x Number of SBMs / Number of hours observed).\n\nA participant with an SBM frequency rate between 3 and 4 was considered a moderate responder. A subject with an SBM frequency rate higher than 4 was considered a full responder. If a subject was a moderate responder or full responder for at least half the weeks in a month, then he or she was considered a monthly responder.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}, {'type': 'SECONDARY', 'title': 'Straining Associated With Spontaneous Bowel Movements by Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Lubiprostone: 24 mcg capsules twice daily (BID) for 9 months'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '383', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '0.87', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '426', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.85', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.85', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.84', 'groupId': 'OG000'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.83', 'groupId': 'OG000'}]}]}, {'title': 'Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.85', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.84', 'groupId': 'OG000'}]}]}, {'title': 'Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.86', 'groupId': 'OG000'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.87', 'groupId': 'OG000'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.92', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9', 'description': 'Participants rate the straining associated with the SBM on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe The highest score is 4, and lower scores are better.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat with evaluable data at the given time point'}, {'type': 'SECONDARY', 'title': 'Stool Consistency of Spontaneous Bowel Movements by Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Lubiprostone: 24 mcg capsules twice daily (BID) for 9 months'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '383', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.84', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '426', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.75', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.73', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.74', 'groupId': 'OG000'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.72', 'groupId': 'OG000'}]}]}, {'title': 'Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.70', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.68', 'groupId': 'OG000'}]}]}, {'title': 'Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.70', 'groupId': 'OG000'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.66', 'groupId': 'OG000'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.70', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9', 'description': 'Participants rate each spontaneous bowel movement on a scale where 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) The highest score is 4, but the best score is 2.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat with evaluable data at the given time point'}, {'type': 'SECONDARY', 'title': 'Constipation Severity by Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Lubiprostone: 24 mcg capsules twice daily (BID) for 9 months'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '0.72', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '426', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.93', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '417', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.94', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '386', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.93', 'groupId': 'OG000'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.96', 'groupId': 'OG000'}]}]}, {'title': 'Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.95', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.94', 'groupId': 'OG000'}]}]}, {'title': 'Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.94', 'groupId': 'OG000'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.97', 'groupId': 'OG000'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.99', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9', 'description': 'Participants rate the severity of their constipation on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.\n\nThe highest score is 4, but the best score is 0.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat with evaluable scores at the given time point'}, {'type': 'SECONDARY', 'title': 'Abdominal Bloating by Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Lubiprostone: 24 mcg capsules twice daily (BID) for 9 months'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.74', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '426', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.88', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '417', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.90', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '386', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.91', 'groupId': 'OG000'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.90', 'groupId': 'OG000'}]}]}, {'title': 'Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.92', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.91', 'groupId': 'OG000'}]}]}, {'title': 'Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.93', 'groupId': 'OG000'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.95', 'groupId': 'OG000'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.95', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9', 'description': 'Participants rate their bloating on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.\n\nThe highest score is 4, but the best score is 0.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat with evaluable data at the given time point'}, {'type': 'SECONDARY', 'title': 'Abdominal Discomfort by Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Lubiprostone: 24 mcg capsules twice daily (BID) for 9 months'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.67', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '426', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.82', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '417', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.82', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '386', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.84', 'groupId': 'OG000'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.83', 'groupId': 'OG000'}]}]}, {'title': 'Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.86', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.85', 'groupId': 'OG000'}]}]}, {'title': 'Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.85', 'groupId': 'OG000'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.89', 'groupId': 'OG000'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.91', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9', 'description': 'Participants rate their abdominal discomfort on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.\n\nThe highest score is 4, but the best score is 0.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat with evaluable data at the given time point'}, {'type': 'SECONDARY', 'title': 'Bowel Habit Regularity by Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Lubiprostone: 24 mcg capsules twice daily (BID) for 9 months'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '1.59', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '426', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '1.39', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '1.38', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '386', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '1.42', 'groupId': 'OG000'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '1.45', 'groupId': 'OG000'}]}]}, {'title': 'Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '1.47', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '1.50', 'groupId': 'OG000'}]}]}, {'title': 'Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '1.47', 'groupId': 'OG000'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '1.49', 'groupId': 'OG000'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '1.51', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9', 'description': 'Participants rate their bowel habit regularity on a balanced scale of 1 to 7 where 1=Very Regular and 7=Very Irregular.\n\nThe highest score is 7, but the best score is 1.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat with evaluable data at the given time point'}, {'type': 'SECONDARY', 'title': 'Treatment Effectiveness by Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Lubiprostone: 24 mcg capsules twice daily (BID) for 9 months'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '426', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '0.98', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.02', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '386', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.04', 'groupId': 'OG000'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.05', 'groupId': 'OG000'}]}]}, {'title': 'Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.05', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.04', 'groupId': 'OG000'}]}]}, {'title': 'Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.05', 'groupId': 'OG000'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.08', 'groupId': 'OG000'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.09', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 1, 2, 3, 4, 5, 6, 7, 8, and 9', 'description': 'Participants rate treatment effectiveness on a scale where 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective.\n\nThe highest and best score is 4.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat with evaluable data at the given time point'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Complete SBMs by Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Lubiprostone: 24 mcg capsules twice daily (BID) for 9 months'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '2.26', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '2.27', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '2.47', 'groupId': 'OG000'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '2.40', 'groupId': 'OG000'}]}]}, {'title': 'Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '2.64', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '2.62', 'groupId': 'OG000'}]}]}, {'title': 'Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '2.79', 'groupId': 'OG000'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '2.69', 'groupId': 'OG000'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '2.95', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 1, 2, 3, 4, 5, 6, 7, 8, and 9', 'description': 'Participants rate each SBM as complete if their bowels feel completely empty after the SBM', 'unitOfMeasure': 'Weekly Complete SBMs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat with evaluable data at the time point'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Complete BMs by Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Lubiprostone: 24 mcg capsules twice daily (BID) for 9 months'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '350', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '2.26', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '2.28', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '2.46', 'groupId': 'OG000'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '2.38', 'groupId': 'OG000'}]}]}, {'title': 'Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '2.65', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '2.62', 'groupId': 'OG000'}]}]}, {'title': 'Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '2.78', 'groupId': 'OG000'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '2.69', 'groupId': 'OG000'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '2.96', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 1, 2, 3, 4, 5, 6, 7, 8, and 9', 'description': 'Participants rate each BM as complete if their bowels feel completely empty after the BM', 'unitOfMeasure': 'Weekly Complete BMs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat with evaluable data at the time point'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lubiprostone', 'description': 'Lubiprostone: 24 mcg capsules twice daily (BID) for 36 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '439'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '286'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}]}]}], 'recruitmentDetails': 'Participants were enrolled from 4 December 2007 to 29 September 2009 at 137 recruitment sites in the United States (n=134) and Canada (n=3)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lubiprostone', 'description': 'Lubiprostone: 24 mcg capsules twice daily (BID) for 36 weeks'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.8', 'spread': '9.99', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '263', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '176', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '436', 'groupId': 'BG000'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 439}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'dispFirstSubmitDate': '2011-03-04', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-10', 'studyFirstSubmitDate': '2008-02-11', 'dispFirstSubmitQcDate': '2013-02-01', 'resultsFirstSubmitDate': '2016-07-12', 'studyFirstSubmitQcDate': '2008-02-20', 'dispFirstPostDateStruct': {'date': '2013-02-05', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-12', 'studyFirstPostDateStruct': {'date': '2008-02-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9', 'description': 'A Spontaneous Bowel Movement (SBM) is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication.'}, {'measure': 'Mean Weekly Bowel Movements (BMs) Per Month', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9', 'description': 'A Bowel Movement (BM) is defined as any BM (whether spontaneous or not)'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Classified as Monthly Responders', 'timeFrame': 'Months 1, 2, 3, 4, 5, 6, 7, 8, and 9', 'description': 'A weekly SBM frequency rate is calculated as (168 x Number of SBMs / Number of hours observed).\n\nA participant with an SBM frequency rate between 3 and 4 was considered a moderate responder. A subject with an SBM frequency rate higher than 4 was considered a full responder. If a subject was a moderate responder or full responder for at least half the weeks in a month, then he or she was considered a monthly responder.'}, {'measure': 'Straining Associated With Spontaneous Bowel Movements by Month', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9', 'description': 'Participants rate the straining associated with the SBM on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe The highest score is 4, and lower scores are better.'}, {'measure': 'Stool Consistency of Spontaneous Bowel Movements by Month', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9', 'description': 'Participants rate each spontaneous bowel movement on a scale where 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) The highest score is 4, but the best score is 2.'}, {'measure': 'Constipation Severity by Month', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9', 'description': 'Participants rate the severity of their constipation on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.\n\nThe highest score is 4, but the best score is 0.'}, {'measure': 'Abdominal Bloating by Month', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9', 'description': 'Participants rate their bloating on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.\n\nThe highest score is 4, but the best score is 0.'}, {'measure': 'Abdominal Discomfort by Month', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9', 'description': 'Participants rate their abdominal discomfort on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.\n\nThe highest score is 4, but the best score is 0.'}, {'measure': 'Bowel Habit Regularity by Month', 'timeFrame': 'Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9', 'description': 'Participants rate their bowel habit regularity on a balanced scale of 1 to 7 where 1=Very Regular and 7=Very Irregular.\n\nThe highest score is 7, but the best score is 1.'}, {'measure': 'Treatment Effectiveness by Month', 'timeFrame': 'Months 1, 2, 3, 4, 5, 6, 7, 8, and 9', 'description': 'Participants rate treatment effectiveness on a scale where 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective.\n\nThe highest and best score is 4.'}, {'measure': 'Mean Weekly Complete SBMs by Month', 'timeFrame': 'Months 1, 2, 3, 4, 5, 6, 7, 8, and 9', 'description': 'Participants rate each SBM as complete if their bowels feel completely empty after the SBM'}, {'measure': 'Mean Weekly Complete BMs by Month', 'timeFrame': 'Months 1, 2, 3, 4, 5, 6, 7, 8, and 9', 'description': 'Participants rate each BM as complete if their bowels feel completely empty after the BM'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Opioid-Induced Bowel Dysfunction']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants with opioid-induced bowel dysfunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has completed 12 weeks of blinded treatment in NCT00595946 or NCT00597428\n* Will continue to be treated consistently for chronic, non-cancer-related pain with any full agonist opiate and will continue opiate therapy for the duration of the study\n* Willing to continue to abstain from use of disallowed medications as defined per protocol\n\nExclusion Criteria:\n\n* Has newly diagnosed impaired renal function identified at the Screening Visit \\[i.e., serum creatinine concentration \\> 1.8 milligrams per deciliter (mg/dL)\\]\n* Has experienced an unexplained and/or clinically significant weight loss defined as \\> 5% within 90 days prior to Screening 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