Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT04355169
Status:
TERMINATED
Last Update Posted:
2022-01-18
First Post:
2020-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Naldemedine in Participants Undergoing Surgeries That Include a Bowel Resection or Bowel Transection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000620491', 'term': 'naldemedine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shionogiclintrials-admin@shionogi.co.jp', 'phone': '800-849-9707', 'title': 'Shionogi Clinical Trials Administrator Clinical Support Help Line', 'organization': 'Shionogi Inc.'}, 'certainAgreement': {'otherDetails': 'The sponsor can embargo results from a PIs 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 45 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.'}}, 'adverseEventsModule': {'timeFrame': 'This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.', 'description': 'This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Naldemedine 1.25 mg', 'description': 'Participants received 1.25 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Naldemedine 2.5 mg', 'description': 'Participants received 2.5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Naldemedine 5 mg', 'description': 'Participants received 5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Participants received matching placebo BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time From the End of Surgery to Time to First Toleration of Solid Food and First Bowel Movement (GI2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Naldemedine 1.25 mg', 'description': 'Participants received 1.25 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}, {'id': 'OG001', 'title': 'Naldemedine 2.5 mg', 'description': 'Participants received 2.5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}, {'id': 'OG002', 'title': 'Naldemedine 5 mg', 'description': 'Participants received 5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received matching placebo BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}], 'timeFrame': 'Up to 10 days After Surgery', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.'}, {'type': 'SECONDARY', 'title': 'Time From the End of Surgery to Time When the Discharge Order is Written', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Naldemedine 1.25 mg', 'description': 'Participants received 1.25 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}, {'id': 'OG001', 'title': 'Naldemedine 2.5 mg', 'description': 'Participants received 2.5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}, {'id': 'OG002', 'title': 'Naldemedine 5 mg', 'description': 'Participants received 5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received matching placebo BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}], 'timeFrame': 'Up to 10 days After Surgery', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Requiring Postoperative Reinsertion of the Nasogastric Tube', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Naldemedine 1.25 mg', 'description': 'Participants received 1.25 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}, {'id': 'OG001', 'title': 'Naldemedine 2.5 mg', 'description': 'Participants received 2.5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}, {'id': 'OG002', 'title': 'Naldemedine 5 mg', 'description': 'Participants received 5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received matching placebo BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}], 'timeFrame': 'Up to 10 days After Surgery', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Nausea on Days 1 Through 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Naldemedine 1.25 mg', 'description': 'Participants received 1.25 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}, {'id': 'OG001', 'title': 'Naldemedine 2.5 mg', 'description': 'Participants received 2.5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}, {'id': 'OG002', 'title': 'Naldemedine 5 mg', 'description': 'Participants received 5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received matching placebo BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}], 'timeFrame': 'Days 1 to 3 After Surgery', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Vomiting on Days 1 Through 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Naldemedine 1.25 mg', 'description': 'Participants received 1.25 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}, {'id': 'OG001', 'title': 'Naldemedine 2.5 mg', 'description': 'Participants received 2.5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}, {'id': 'OG002', 'title': 'Naldemedine 5 mg', 'description': 'Participants received 5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received matching placebo BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}], 'timeFrame': 'Days 1 to 3 After Surgery', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Discharged by Day 10 Who Are Readmitted for Any Reason Within 30 Days After Discharge From the Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Naldemedine 1.25 mg', 'description': 'Participants received 1.25 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}, {'id': 'OG001', 'title': 'Naldemedine 2.5 mg', 'description': 'Participants received 2.5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}, {'id': 'OG002', 'title': 'Naldemedine 5 mg', 'description': 'Participants received 5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received matching placebo BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}], 'timeFrame': 'From the Discharge Date (Days 1-10) up to 30 Days After Discharge', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Naldemedine 1.25 mg', 'description': 'Participants received 1.25 milligrams (mg) naldemedine twice daily (BID) beginning on the day of surgery (Day 1) and for up to a maximum of 10 days post-surgery.'}, {'id': 'FG001', 'title': 'Naldemedine 2.5 mg', 'description': 'Participants received 2.5 mg naldemedine BID beginning on the day of surgery (Day 1) and for up to a maximum of 10 days post-surgery.'}, {'id': 'FG002', 'title': 'Naldemedine 5 mg', 'description': 'Participants received 5 mg naldemedine BID beginning on the day of surgery (Day 1) and for up to a maximum of 10 days post-surgery.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Participants received matching placebo BID beginning on the day of surgery (Day 1) and for up to a maximum of 10 days post-surgery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'This study was terminated by the Sponsor. The Sponsor terminated the study based on the assessment that an adequate number of study sites were not able to reach the planned enrollment. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Naldemedine 1.25 mg', 'description': 'Participants received 1.25 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}, {'id': 'BG001', 'title': 'Naldemedine 2.5 mg', 'description': 'Participants received 2.5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}, {'id': 'BG002', 'title': 'Naldemedine 5 mg', 'description': 'Participants received 5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Participants received matching placebo BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'unitOfMeasure': 'Years'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}]}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino'}, {'title': 'Not Hispanic or Latino'}, {'title': 'Unknown or Not Reported'}]}]}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native'}, {'title': 'Asian'}, {'title': 'Native Hawaiian or Other Pacific Islander'}, {'title': 'Black or African American'}, {'title': 'White'}, {'title': 'More than one race'}, {'title': 'Unknown or Not Reported'}]}]}], 'populationDescription': 'This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-18', 'size': 3249448, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-12-17T11:59', 'hasProtocol': True}, {'date': '2020-07-02', 'size': 1826007, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-12-17T12:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'This study was terminated before the planned sample size was enrolled due to very slow enrollment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-17', 'studyFirstSubmitDate': '2020-04-17', 'resultsFirstSubmitDate': '2021-12-17', 'studyFirstSubmitQcDate': '2020-04-17', 'lastUpdatePostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-17', 'studyFirstPostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time From the End of Surgery to Time to First Toleration of Solid Food and First Bowel Movement (GI2)', 'timeFrame': 'Up to 10 days After Surgery'}], 'secondaryOutcomes': [{'measure': 'Time From the End of Surgery to Time When the Discharge Order is Written', 'timeFrame': 'Up to 10 days After Surgery'}, {'measure': 'Percentage of Participants Requiring Postoperative Reinsertion of the Nasogastric Tube', 'timeFrame': 'Up to 10 days After Surgery'}, {'measure': 'Percentage of Participants With Nausea on Days 1 Through 3', 'timeFrame': 'Days 1 to 3 After Surgery'}, {'measure': 'Percentage of Participants With Vomiting on Days 1 Through 3', 'timeFrame': 'Days 1 to 3 After Surgery'}, {'measure': 'Percentage of Participants Discharged by Day 10 Who Are Readmitted for Any Reason Within 30 Days After Discharge From the Hospital', 'timeFrame': 'From the Discharge Date (Days 1-10) up to 30 Days After Discharge'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bowel resection', 'Gastrointestinal recovery', 'peripherally acting mu-opioid receptor antagonist', 'Bowel transection'], 'conditions': ['Postoperative Gastrointestinal Dysfunction']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare the efficacy of naldemedine versus placebo and to assess its effect on the time to gastrointestinal (GI) recovery following surgeries that include bowel resection and bowel transection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Scheduled to undergo 1 of the following procedures via open (nonlaparoscopic) surgery under general anesthesia:\n\n * partial small or large bowel resection with primary anastomosis\n * radical cystectomy requiring bowel transection with primary anastomosis\n* Planned to be managed postoperatively with an enhanced recovery protocol, which, at a minimum, includes all of the following elements:\n\n * early removal of the nasogastric tube, which is defined as removal of the nasogastric tube at the end of surgery\n * early ambulation, which is defined as ambulation on Day 1\n * early diet advancement on Day 1\n* Planned to receive primary postoperative pain management with opioid analgesia administered by any route.\n* American Society of Anesthesiologists (ASA) Physical Status Score of I, II, or III (a normal healthy participant, a participant with mild systemic disease, and a participant with systemic disease, respectively).\n\nExclusion Criteria:\n\n* Scheduled to undergo a total colectomy or any procedure that results in a colostomy or ileostomy.\n* Scheduled for endoscopic or laparoscopic surgery.\n* Complete bowel obstruction.\n* Complicated inflammatory bowel disease (such as ulcerative colitis or Crohn's disease).\n* More than 2 major abdominal surgery (for example, gastrectomy, gastric bypass, gastric sleeve, lap banding, pancreatic resection, hepatectomy, intestinal transplant).\n* More than 3 doses of an opioid (regardless of the route of administration) during the 7 days prior to surgery.\n* Pregnancy or lactation.\n* Presence of peritoneal catheter (for example, for dialysis or chemotherapy)."}, 'identificationModule': {'nctId': 'NCT04355169', 'briefTitle': 'A Study of Naldemedine in Participants Undergoing Surgeries That Include a Bowel Resection or Bowel Transection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shionogi Inc.'}, 'officialTitle': 'A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Naldemedine in Patients Undergoing Surgeries That Include a Bowel Resection or Bowel Transection', 'orgStudyIdInfo': {'id': '1902G1721'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Naldemedine 1.25 mg', 'description': 'Participants will receive 1.25 milligrams (mg) naldemedine twice daily (BID) beginning on the day of surgery (Day 1) and for up to a maximum of 10 days post-surgery.', 'interventionNames': ['Drug: Naldemedine']}, {'type': 'EXPERIMENTAL', 'label': 'Naldemedine 2.5 mg', 'description': 'Participants will receive 2.5 mg naldemedine BID beginning on the day of surgery (Day 1) and for up to a maximum of 10 days post-surgery.', 'interventionNames': ['Drug: Naldemedine']}, {'type': 'EXPERIMENTAL', 'label': 'Naldemedine 5 mg', 'description': 'Participants will receive 5 mg naldemedine BID beginning on the day of surgery (Day 1) and for up to a maximum of 10 days post-surgery.', 'interventionNames': ['Drug: Naldemedine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive matching placebo BID beginning on the day of surgery (Day 1) and for up to a maximum of 10 days post-surgery.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Naldemedine', 'type': 'DRUG', 'otherNames': ['S-297995'], 'description': 'Oral tablet', 'armGroupLabels': ['Naldemedine 1.25 mg', 'Naldemedine 2.5 mg', 'Naldemedine 5 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University Medical Center - Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Hospital', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville Hospital', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '40208', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville Division of Surgery', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75701', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'CHRISTUS Mother Frances Hospital - Tyler', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '75702', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'CHRISTUS Trinity Clinic Research', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '75702', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'CHRISTUS Trinity Clinic Surgical Oncology', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}], 'overallOfficials': [{'name': 'Shionogi Clinical Trials Administrator Clinical Support Help Line', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shionogi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shionogi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}