Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2026-02-21 @ 4:09 AM
Study NCT ID:
NCT02232893
Status:
COMPLETED
Last Update Posted:
2020-06-19
First Post:
2014-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C121414', 'term': 'dai-kenchu-to'}, {'id': 'C559645', 'term': '12,13-dihydro-N-methyl-6,11,13-trioxo-5H-benzo(4,5)cyclohepta(1,2-b)naphthalen-5,12-imine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Yu Tanaka <tanaka_yuu@mail.tsumura.co.jp>', 'phone': '609-799-2083', 'title': 'Yu Tanaka', 'organization': 'Tsumura USA Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 months', 'eventGroups': [{'id': 'EG000', 'title': 'Daikenchuto (TU-100)', 'description': 'Daikenchuto (TU-100) 5g TID (15g/day)\n\nDaikenchuto (TU-100): Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and 28 days after surgery.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 29, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo TID\n\nPlacebo: Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and 28 days after surgery.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 23, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Incision site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Procedural nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Bladder Spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}], 'seriousEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Post-operative Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Post-operative Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Small bowel obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Mental Status Changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Quality of Life After Surgery Based on Gastrointestinal Quality of Life Index (GIQLI) Global Score From Baseline to Visit 4.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TU-100', 'description': 'TU-100: 5g TID (15g/day)\n\nTU-100: Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and 28 days after surgery.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo TID\n\nPlacebo: Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and 28 days after surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.20', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '-10.10', 'spread': '2.99', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 15 days', 'description': 'The primary endpoint was change in The Gastrointestinal Quality of Life Index (GIQLI) global score from baseline to Visit 4 (Day 15 minus baseline). The global score could range from 0 (lowest quality of life) to 144 (highest quality of life). The effect of TU-100 on the change in GIQLI global score from baseline was assessed by using an analysis of covariance (ANCOVA) model with treatment group as a fixed effect and with baseline GIQLI global score, scheduled surgical location in the colon, and solid food before/after the first flatus as covariates.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Among the ITT population, patients who provided GIQLI scores both at baseline and Visit 4 were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Daikenchuto (TU-100)', 'description': 'Daikenchuto (TU-100) 5g TID (15g/day)\n\nDaikenchuto (TU-100): Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and for 28 days after surgery.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo TID\n\nPlacebo: Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and for 28 days after surgery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Safety Population', 'achievements': [{'comment': "Pts who rec'd at least 1 dose of study drug. All safety analyses performed using this population.", 'groupId': 'FG000', 'numSubjects': '34'}, {'comment': "Pts who rec'd at least 1 dose of study drug. All safety analyses performed using this population.", 'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'Primary Endpoint Population', 'achievements': [{'comment': 'Patients who provided GIQLI scores both at baseline and Visit 4 were analyzed for primary endpoint', 'groupId': 'FG000', 'numSubjects': '24'}, {'comment': 'Patients who provided GIQLI scores both at baseline and Visit 4 were analyzed for primary endpoint', 'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Sponsor request early termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Developed exclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'The study was carried out at 16 sites in the United States (US).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TU-100', 'description': 'TU-100: 5g TID (15g/day)\n\nTU-100: Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose for 3 days before surgery and for 28 days after surgery.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo TID\n\nPlacebo: Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose for 3 days before surgery and for 28 days after surgery.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.8', 'spread': '9.76', 'groupId': 'BG000'}, {'value': '58.4', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '58.6', 'spread': '11.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '62', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Intent-to-Treat (ITT) Population - patients who were randomized, underwent surgery after randomization, and received at least one dose of study medication. This population was used for all efficacy analyses.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-22', 'size': 135411, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-04-24T14:01', 'hasProtocol': True}]}}, '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': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'dispFirstSubmitDate': '2018-04-26', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-17', 'studyFirstSubmitDate': '2014-09-03', 'dispFirstSubmitQcDate': '2018-04-26', 'resultsFirstSubmitDate': '2020-04-24', 'studyFirstSubmitQcDate': '2014-09-03', 'dispFirstPostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-17', 'studyFirstPostDateStruct': {'date': '2014-09-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life After Surgery Based on Gastrointestinal Quality of Life Index (GIQLI) Global Score From Baseline to Visit 4.', 'timeFrame': 'Baseline and 15 days', 'description': 'The primary endpoint was change in The Gastrointestinal Quality of Life Index (GIQLI) global score from baseline to Visit 4 (Day 15 minus baseline). The global score could range from 0 (lowest quality of life) to 144 (highest quality of life). The effect of TU-100 on the change in GIQLI global score from baseline was assessed by using an analysis of covariance (ANCOVA) model with treatment group as a fixed effect and with baseline GIQLI global score, scheduled surgical location in the colon, and solid food before/after the first flatus as covariates.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Gastrointestinal Quality of Life Index (GIQLI)', 'Postoperative Quality of Life', 'Abdominal Bloating', 'Laparoscopic colectomy', 'Postoperative ileus (POI)'], 'conditions': ['Postoperative Ileus']}, 'descriptionModule': {'briefSummary': 'TU-100 is a gastrointestinal drug produced from the three botanical raw materials, Asian ginseng, Zanthoxylum fruit (Japanese pepper), and ginger, based on proprietary aqueous decoction and granulation technology. The aim of this study is to assess the effect of TU-100 on post-operative quality of life during the 4 week postoperative period after straight, hand-assisted, or robot-assisted laparoscopic colectomy. Optimal efficacy parameters for subsequent outcome studies also will be explored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be at least 18 years of age\n* Has a current diagnosis of colon cancer, diverticulitis, or benign colonic neoplasm\n* Requires straight, hand-assisted, or robot-assisted laparoscopic colectomy\n* Requires hospitalization for surgery and recovery\n\nExclusion Criteria:\n\n* Has been diagnosed with rectal cancer, advanced or metastatic colon cancer, Crohn disease, ulcerative colitis, or volvulus\n* Requires resection of rectal lesion\n* Has received or is scheduled to receive chemotherapy during the duration of the study\n* Is a pregnant or lactating female\n* Has diabetic neuropathy\n* Has a history or presence of diabetic gastroparesis\n* Has a compromised immune system, either from treatment with corticosteroids or other immunosuppressive agent within 2 weeks of surgery or from immunosuppressive disease (e.g., human immunodeficiency virus)\n* Has any other serious condition that might adversely affect suitability for participation in this study, such as liver disorder (including alanine aminotransferase or aspartate aminotransferase level greater than 2.5 times the upper limit of normal), kidney disorders, heart failure, blood disorders, or metabolic disorders\n* Has a history or presence of interstitial pneumonia\n* Has a history of allergic reaction to ginseng, ginger or Zanthoxylum fruit (Japanese pepper)\n* Plans to receive any abdominal irradiation\n* Is clinically lactose intolerant'}, 'identificationModule': {'nctId': 'NCT02232893', 'acronym': 'TU100P2T3', 'briefTitle': 'Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tsumura USA'}, 'officialTitle': 'A Randomized, Double-Blinded, Placebo-Controlled Trial of TU-100 in Patients Undergoing Laparoscopic Colectomy', 'orgStudyIdInfo': {'id': 'TU100P2T3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Daikenchuto (TU-100)', 'description': 'Daikenchuto (TU-100) 5g TID (15g/day)', 'interventionNames': ['Drug: Daikenchuto (TU-100)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo TID', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Daikenchuto (TU-100)', 'type': 'DRUG', 'description': 'Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and for 28 days after surgery.', 'armGroupLabels': ['Daikenchuto (TU-100)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and for 28 days after surgery.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Aurora Site', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'facility': 'Weston Site', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Chicago Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Metairie Site', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Burlington, MA Site', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '55433', 'city': 'Coon Rapids', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Coon Rapids Site', 'geoPoint': {'lat': 45.11997, 'lon': -93.28773}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis Site', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '39042', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Jackson Site', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Burlington, VT Site', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Spokane Site', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Christine Jensen, M.D., M.P.H.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Colon & Rectal Surgery Associates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tsumura USA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Cato Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}