Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-01-25 @ 6:11 AM
Study NCT ID:
NCT01965158
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2013-09-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation
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': 'C000620491', 'term': 'naldemedine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shionogiclintrials-admin@shionogi.co.jp', 'phone': '800-849-9707', 'title': 'Shionogi Clinical Trials Administrator', 'phoneExt': '1454', 'organization': 'Shionogi Inc.'}, 'certainAgreement': {'otherDetails': "The sponsor can embargo results from a PI's center until the combined results from the completed study have been published in full or the sponsor confirms there will be no multicenter study publication. Results communications must be provided to the sponsor for review at least 60 days before submission for publication. By written request, the sponsor can extend the embargo up to an additional 60 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of study drug to 28 days after the last dose of study drug (16 weeks).', 'description': 'The Safety Population included all randomized participants who received at least 1 dose of study drug. One participant was excluded from each arm due to simultaneous enrollment at 2 different sites.', 'eventGroups': [{'id': 'EG000', 'title': 'Naldemedine', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 12 weeks.', 'otherNumAtRisk': 271, 'otherNumAffected': 29, 'seriousNumAtRisk': 271, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 12 weeks.', 'otherNumAtRisk': 272, 'otherNumAffected': 11, 'seriousNumAtRisk': 272, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 272, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 272, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 272, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 272, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 272, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Patent ductus arteriosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Device failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 272, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 272, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With a Spontaneous Bowel Movement (SBM) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '272', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naldemedine', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.6', 'groupId': 'OG000', 'lowerLimit': '41.6', 'upperLimit': '53.7'}, {'value': '34.6', 'groupId': 'OG001', 'lowerLimit': '28.9', 'upperLimit': '40.5'}]}]}], 'analyses': [{'pValue': '0.0020', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.0', 'ciLowerLimit': '4.8', 'ciUpperLimit': '21.3', 'pValueComment': 'To control the overall type I error rate to be ≤ 0.05 for the primary and secondary efficacy endpoints, a fixed-sequence (hierarchical) testing approach was applied.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.19', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by Cochran-Mantel-Haenszel test adjusted by the opioid dose strata.'}], 'paramType': 'NUMBER', 'timeFrame': '12-week treatment period', 'description': 'A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of rescue laxative therapy during the 24 hours prior to the BM.\n\nA responder was defined as a participant having 9 or more positive response weeks out of the 12-week Treatment Period and 3 positive response weeks out of last 4 weeks of the 12-week Treatment Period. A positive response week was defined as ≥ 3 SBMs per week and an increase from baseline of ≥ 1 SBM per week for that week. If a participant had less than 4 days of diary entries for a week, that week was treated as a "non-response" week.\n\nAny participant with insufficient primary endpoint data (data for less than 9 out of 12 weeks of the Treatment Period or less than 3 out of the last 4 weeks of the 12-week Treatment Period) was treated as a non-responder.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '272', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naldemedine', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.42', 'spread': '0.193', 'groupId': 'OG000'}, {'value': '2.12', 'spread': '0.192', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.30', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.83', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.271', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and the last 2 weeks of the treatment period (Weeks 11 and 12 for participants who completed 12 weeks of treatment)', 'description': 'A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of a rescue laxative therapy during the 24 hours prior to the BM.\n\nBaseline was defined as the 14 days in the screening period prior to study drug administration.', 'unitOfMeasure': 'spontaneous bowel movements / week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 1 in the Number of Spontaneous Bowel Movements Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '272', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naldemedine', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.48', 'spread': '0.185', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '0.184', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.11', 'ciLowerLimit': '1.60', 'ciUpperLimit': '2.63', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.260', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 1', 'description': 'A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of a rescue laxative therapy during the 24 hours prior to the BM.\n\nBaseline was defined as the 14 days in the screening period prior to study drug administration.', 'unitOfMeasure': 'spontaneous bowel movements / week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Complete Spontaneous Bowel Movements Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '272', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naldemedine', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.58', 'spread': '0.170', 'groupId': 'OG000'}, {'value': '1.57', 'spread': '0.170', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1.48', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.240', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and the last 2 weeks of the treatment period (Weeks 11 and 12 for participants who completed 12 weeks of treatment)', 'description': 'A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. A complete spontaneous bowel movement (CSBM) was defined as an SBM which was accompanied by the feeling of complete evacuation.', 'unitOfMeasure': 'complete spontaneous BMs / week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements With No Straining Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '272', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naldemedine', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.46', 'spread': '0.141', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '0.140', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.34', 'ciUpperLimit': '1.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.198', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and the last 2 weeks of the treatment period (Weeks 11 and 12 for participants who completed 12 weeks of treatment)', 'description': 'A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation.\n\nThe severity of straining with each bowel movement was assessed on the following scale: 0=no straining, 1=mild straining, 2=moderate straining, 3=severe straining, 4=very severe straining. SBMs without straining were defined as SBMs with a straining score of 0.', 'unitOfMeasure': 'SBMs with no straining / week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Naldemedine', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 12 weeks.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Includes 1 participant enrolled at 2 different sites simultaneously', 'groupId': 'FG000', 'numSubjects': '274'}, {'comment': 'Includes 1 participant enrolled at 2 different sites simultaneously', 'groupId': 'FG001', 'numSubjects': '273'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '272'}, {'groupId': 'FG001', 'numSubjects': '273'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '233'}, {'groupId': 'FG001', 'numSubjects': '238'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '35'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other - Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted at 68 sites in North America and Europe, including Austria, Czech Republic, Germany, Poland, Spain, United Kingdom, and the United States.', 'preAssignmentDetails': 'Participants were randomized in a 1:1 ratio to 0.2 mg of naldemedine or placebo. Participants were stratified based on their documented opioid use (average total daily dose (TDD) during the 14-consecutive-day qualifying period) as follows:\n\n* 30 to 100 mg equivalents of oral morphine sulfate\n* \\> 100 mg equivalents of oral morphine sulfate'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'BG000'}, {'value': '272', 'groupId': 'BG001'}, {'value': '545', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Naldemedine', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 12 weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.3', 'spread': '10.44', 'groupId': 'BG000'}, {'value': '53.4', 'spread': '11.03', 'groupId': 'BG001'}, {'value': '53.4', 'spread': '10.73', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 40 years', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}, {'title': '≥ 40 to < 65 years', 'categories': [{'measurements': [{'value': '209', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '408', 'groupId': 'BG002'}]}]}, {'title': '≥ 65 years', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '329', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '247', 'groupId': 'BG000'}, {'value': '245', 'groupId': 'BG001'}, {'value': '492', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '216', 'groupId': 'BG000'}, {'value': '220', 'groupId': 'BG001'}, {'value': '436', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Stratification by Opioid Dose', 'classes': [{'title': '30-100 mg', 'categories': [{'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '308', 'groupId': 'BG002'}]}]}, {'title': '> 100 mg', 'categories': [{'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': "Dose of opioid was calculated using maintenance and breakthrough morphine equivalent dose. If any participants were treated with \\< 30 mg, the participants were counted in '30-100 mg'.", 'unitOfMeasure': 'participants'}, {'title': 'Spontaneous Bowel Movements per Week', 'classes': [{'categories': [{'measurements': [{'value': '1.31', 'spread': '0.746', 'groupId': 'BG000'}, {'value': '1.30', 'spread': '0.713', 'groupId': 'BG001'}, {'value': '1.31', 'spread': '0.729', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'spontaneous bowel movements', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The intent-to-treat population included all randomized participants; one participant was excluded from each arm due to enrollment at 2 different sites simultaneously.'}}, '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': 547}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-01-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-19', 'studyFirstSubmitDate': '2013-09-30', 'resultsFirstSubmitDate': '2017-04-19', 'studyFirstSubmitQcDate': '2013-10-15', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-19', 'studyFirstPostDateStruct': {'date': '2013-10-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With a Spontaneous Bowel Movement (SBM) Response', 'timeFrame': '12-week treatment period', 'description': 'A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of rescue laxative therapy during the 24 hours prior to the BM.\n\nA responder was defined as a participant having 9 or more positive response weeks out of the 12-week Treatment Period and 3 positive response weeks out of last 4 weeks of the 12-week Treatment Period. A positive response week was defined as ≥ 3 SBMs per week and an increase from baseline of ≥ 1 SBM per week for that week. If a participant had less than 4 days of diary entries for a week, that week was treated as a "non-response" week.\n\nAny participant with insufficient primary endpoint data (data for less than 9 out of 12 weeks of the Treatment Period or less than 3 out of the last 4 weeks of the 12-week Treatment Period) was treated as a non-responder.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements Per Week', 'timeFrame': 'Baseline and the last 2 weeks of the treatment period (Weeks 11 and 12 for participants who completed 12 weeks of treatment)', 'description': 'A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of a rescue laxative therapy during the 24 hours prior to the BM.\n\nBaseline was defined as the 14 days in the screening period prior to study drug administration.'}, {'measure': 'Change From Baseline to Week 1 in the Number of Spontaneous Bowel Movements Per Week', 'timeFrame': 'Baseline and Week 1', 'description': 'A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of a rescue laxative therapy during the 24 hours prior to the BM.\n\nBaseline was defined as the 14 days in the screening period prior to study drug administration.'}, {'measure': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Complete Spontaneous Bowel Movements Per Week', 'timeFrame': 'Baseline and the last 2 weeks of the treatment period (Weeks 11 and 12 for participants who completed 12 weeks of treatment)', 'description': 'A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. A complete spontaneous bowel movement (CSBM) was defined as an SBM which was accompanied by the feeling of complete evacuation.'}, {'measure': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements With No Straining Per Week', 'timeFrame': 'Baseline and the last 2 weeks of the treatment period (Weeks 11 and 12 for participants who completed 12 weeks of treatment)', 'description': 'A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation.\n\nThe severity of straining with each bowel movement was assessed on the following scale: 0=no straining, 1=mild straining, 2=moderate straining, 3=severe straining, 4=very severe straining. SBMs without straining were defined as SBMs with a straining score of 0.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Opioid-induced Constipation'], 'conditions': ['Opioid-induced Constipation']}, 'referencesModule': {'references': [{'pmid': '34377150', 'type': 'DERIVED', 'citation': 'Hale ME, Wild JE, Yamada T, Yokota T, Tack J, Andresen V, Drewes AM. Naldemedine is effective in the treatment of opioid-induced constipation in patients with chronic non-cancer pain who had a poor response to laxatives. Therap Adv Gastroenterol. 2021 Jul 31;14:17562848211032320. doi: 10.1177/17562848211032320. eCollection 2021.'}, {'pmid': '34295186', 'type': 'DERIVED', 'citation': 'Camilleri M, Hale M, Morlion B, Tack J, Webster L, Wild J. Naldemedine Improves Patient-Reported Outcomes of Opioid-Induced Constipation in Patients with Chronic Non-Cancer Pain in the COMPOSE Phase 3 Studies. J Pain Res. 2021 Jul 16;14:2179-2189. doi: 10.2147/JPR.S282738. eCollection 2021.'}, {'pmid': '33965574', 'type': 'DERIVED', 'citation': 'Tack J, Camilleri M, Hale M, Morlion B, Nalamachu S, Webster L, Wild J. Establishing Minimal Clinically Important Differences in Quality of Life Measures in Opioid-Induced Constipation. Clin Gastroenterol Hepatol. 2022 Apr;20(4):855-863. doi: 10.1016/j.cgh.2021.05.004. Epub 2021 Aug 5.'}, {'pmid': '32280263', 'type': 'DERIVED', 'citation': 'Webster LR, Hale ME, Yamada T, Wild JE. A Renal Impairment Subgroup Analysis of the Safety and Efficacy of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Chronic Non-Cancer Pain Receiving Opioid Therapy. J Pain Res. 2020 Mar 24;13:605-612. doi: 10.2147/JPR.S237833. eCollection 2020.'}, {'pmid': '32086791', 'type': 'DERIVED', 'citation': 'Wild J, Webster L, Yamada T, Hale M. Safety and Efficacy of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Chronic Non-Cancer Pain Receiving Opioid Therapy: A Subgroup Analysis of Patients >/= 65 Years of Age. Drugs Aging. 2020 Apr;37(4):271-279. doi: 10.1007/s40266-020-00753-2.'}, {'pmid': '31145214', 'type': 'DERIVED', 'citation': 'Wild J, Yamada T, Arjona Ferreira JC, Hale M. Onset of action of naldemedine in the treatment of opioid-induced constipation in patients with chronic noncancer pain: results from 2 randomized, placebo-controlled, phase 3 trials. Pain. 2019 Oct;160(10):2358-2364. doi: 10.1097/j.pain.0000000000001629.'}, {'pmid': '28576452', 'type': 'DERIVED', 'citation': 'Hale M, Wild J, Reddy J, Yamada T, Arjona Ferreira JC. Naldemedine versus placebo for opioid-induced constipation (COMPOSE-1 and COMPOSE-2): two multicentre, phase 3, double-blind, randomised, parallel-group trials. Lancet Gastroenterol Hepatol. 2017 Aug;2(8):555-564. doi: 10.1016/S2468-1253(17)30105-X. Epub 2017 May 30.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who are not using laxatives.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects aged 18 to 80 years inclusive at the time of informed consent\n2. Subjects must have non-malignant chronic pain treated with opioids and must have opioid-induced constipation (OIC)\n3. Subjects must be treated with a stable opioid regimen at a total daily dose on average of ≥ 30 mg equivalents of oral morphine sulfate\n4. Subjects must not be currently using laxatives or must be willing to discontinue laxative use at Screening and must be willing to use only the rescue laxatives provided throughout the study duration\n5. Subjects must meet opioid-induced constipation criteria based on the Bowel Movement and Constipation Assessment (BMCA) Diary\n\nExclusion Criteria:\n\n1. Evidence of significant structural abnormalities of the gastrointestinal (GI) tract\n2. Evidence of active medical diseases affecting bowel transit\n3. History or presence of pelvic disorders that may be a cause of constipation\n4. Surgery (except for minor procedures) within 60 days of Screening\n5. History of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (e.g., mechanical GI obstruction)\n6. Subjects who have never taken laxatives for the treatment of OIC\n7. History of active treatment for cancer within the last 2 years (except for basal cell or squamous cell carcinoma of the skin that have been successfully resected) or tamoxifen \\[Nolvadex®\\] and raloxifene \\[Evista®\\] when being used for prevention of breast cancer\n8. Current use of any prohibited medication including opioid antagonists, partial agonists or mixed agonists/antagonists'}, 'identificationModule': {'nctId': 'NCT01965158', 'briefTitle': 'Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shionogi Inc.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Naldemedine in the Treatment of Opioid-induced Constipation in Subjects With Non-malignant Chronic Pain Receiving Opioid Therapy', 'orgStudyIdInfo': {'id': '1314V9231'}, 'secondaryIdInfos': [{'id': '2013-002241-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Naldemedine', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 12 weeks.', 'interventionNames': ['Drug: Naldemedine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received matching placebo orally once daily for 12 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Naldemedine', 'type': 'DRUG', 'otherNames': ['S 297995', 'Symproic®'], 'description': 'Naldemedine 0.2 mg tablet taken orally once a day', 'armGroupLabels': ['Naldemedine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablet taken orally once a day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Shionogi Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Shionogi Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Shionogi Research Site', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United 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'state': 'New Mexico', 'country': 'United States', 'facility': 'Shionogi Research Site', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'Shionogi Research Site', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'city': 'Hollis', 'state': 'New York', 'country': 'United States', 'facility': 'Shionogi Research Site', 'geoPoint': {'lat': 40.71344, 'lon': -73.76708}}, {'city': 'New Windsor', 'state': 'New York', 'country': 'United States', 'facility': 'Shionogi Research Site', 'geoPoint': {'lat': 41.47676, 'lon': -74.02375}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Shionogi Research Site', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Shionogi Research Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 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