Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT03859869
Status:
TERMINATED
Last Update Posted:
2023-06-05
First Post:
2019-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010188', 'term': 'Exocrine Pancreatic Insufficiency'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020799', 'term': 'Pancrelipase'}], 'ancestors': [{'id': 'D008049', 'term': 'Lipase'}, {'id': 'D002265', 'term': 'Carboxylic Ester Hydrolases'}, {'id': 'D004950', 'term': 'Esterases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D010184', 'term': 'Pancreatic Extracts'}, {'id': 'D014020', 'term': 'Tissue Extracts'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This study was terminated due to low enrollment rates. The decision to terminate the study was not based on any safety or efficacy data.'}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality is reported from enrollment to end of study; time on follow up was 161 days. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; time on study drug was 92 days.', 'description': 'Neither the "Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase" group nor the "Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase" group enrolled any participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Resected Participants Receiving Low Dose (12,000/6,000 Units Lipase) Pancrelipase', 'description': 'Resected participants (surgery to remove pancreatic cancer) will first be given low dose pancrelipase. Low dose is defined as 12,000 USP units (lipase) with meals and 6000 U with snacks. At Weeks 1, 5, or 9, participants will be evaluated, and those who meet criteria for dose increase will be given high dose pancrelipase. High dose is defined as 72,000 U with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase', 'description': 'Resected participants (surgery to remove pancreatic cancer) will receive and continue on high dose pancrelipase throughout the study. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Non-Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase', 'description': 'Non-resected participants (those who did not have surgery to remove pancreatic cancer) will receive high dose pancrelipase throughout the study in an open-label cohort. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'WHITE BLOOD CELLS DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'PERIPHERAL SENSORY NEUROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'POSTURAL DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'HYPERGLYCEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Stool Fat From Baseline (Day 1) to Week 1 (Day 8) Among Participants With Resected Pancreatic Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resected Participants Receiving Low Dose (12,000/6,000 Units Lipase) Pancrelipase', 'description': 'Resected participants (surgery to remove pancreatic cancer) will first be given low dose pancrelipase. Low dose is defined as 12,000 USP units (lipase) with meals and 6000 U with snacks. At Weeks 1, 5, or 9, participants will be evaluated, and those who meet criteria for dose increase will be given high dose pancrelipase. High dose is defined as 72,000 U with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.'}, {'id': 'OG001', 'title': 'Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase', 'description': 'Resected participants (surgery to remove pancreatic cancer) will receive and continue on high dose pancrelipase throughout the study. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 1 (Day 8)', 'description': 'Stool samples were collected during the 48 hours prior to the Day 1 and Week 1 visits and analyzed for fat content.', 'unitOfMeasure': 'g/24 hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of study drug and who had evaluable stool fat at both Baseline and Week 1 visits'}, {'type': 'SECONDARY', 'title': 'Change in Average Daily Stool Frequency From Baseline (Day 1) to Week 1 (Day 8) Among Participants With Resected Pancreatic Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resected Participants Receiving Low Dose (12,000/6,000 Units Lipase) Pancrelipase', 'description': 'Resected participants (surgery to remove pancreatic cancer) will first be given low dose pancrelipase. Low dose is defined as 12,000 USP units (lipase) with meals and 6000 U with snacks. At Weeks 1, 5, or 9, participants will be evaluated, and those who meet criteria for dose increase will be given high dose pancrelipase. High dose is defined as 72,000 U with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.'}, {'id': 'OG001', 'title': 'Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase', 'description': 'Resected participants (surgery to remove pancreatic cancer) will receive and continue on high dose pancrelipase throughout the study. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not calculable/estimable because stool frequency data for Week 1 is missing', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 1 (Day 8)', 'description': 'Participants recorded stool frequency using an electronic diary (eDiary). The average daily stool frequency was calculated from the last 3 days prior to the Baseline and Week 1 visits.', 'unitOfMeasure': 'number of stools/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of study drug'}, {'type': 'SECONDARY', 'title': 'Change in Stool Consistency From Baseline to Week 1 Among Participants With Resected Pancreatic Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resected Participants Receiving Low Dose (12,000/6,000 Units Lipase) Pancrelipase', 'description': 'Resected participants (surgery to remove pancreatic cancer) will first be given low dose pancrelipase. Low dose is defined as 12,000 USP units (lipase) with meals and 6000 U with snacks. At Weeks 1, 5, or 9, participants will be evaluated, and those who meet criteria for dose increase will be given high dose pancrelipase. High dose is defined as 72,000 U with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.'}, {'id': 'OG001', 'title': 'Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase', 'description': 'Resected participants (surgery to remove pancreatic cancer) will receive and continue on high dose pancrelipase throughout the study. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 1 (Day 8)', 'description': 'Participants recorded stool consistency using an electronic diary (eDiary). The change from Baseline to Week 1 is the proportion of days having watery stool consistency in the last 7 days prior to each of Baseline and Week 1 visits. Negative changes from Baseline indicate less frequent watery stools.', 'unitOfMeasure': 'proportion of days w/ watery consistency', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of study drug'}, {'type': 'SECONDARY', 'title': 'Change in the Total EPI Symptoms Score From Baseline to Week 1 Among Participants With Resected Pancreatic Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resected Participants Receiving Low Dose (12,000/6,000 Units Lipase) Pancrelipase', 'description': 'Resected participants (surgery to remove pancreatic cancer) will first be given low dose pancrelipase. Low dose is defined as 12,000 USP units (lipase) with meals and 6000 U with snacks. At Weeks 1, 5, or 9, participants will be evaluated, and those who meet criteria for dose increase will be given high dose pancrelipase. High dose is defined as 72,000 U with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.'}, {'id': 'OG001', 'title': 'Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase', 'description': 'Resected participants (surgery to remove pancreatic cancer) will receive and continue on high dose pancrelipase throughout the study. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 1 (Day 8)', 'description': 'The EPI Symptoms Questionnaire consists of 12 questions. The response scores range from 0 to 4 for each question (0 corresponding to None to 4 corresponding to Very Severe), with the total score ranging from 0 to 48. Positive changes indicate worsening from Baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of study drug'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Resected Participants Receiving Low Dose (12,000/6,000 Units Lipase) Pancrelipase', 'description': 'Resected participants (surgery to remove pancreatic cancer) will first be given low dose pancrelipase. Low dose is defined as 12,000 USP units (lipase) with meals and 6000 U with snacks. At Weeks 1, 5, or 9, participants will be evaluated, and those who meet criteria for dose increase will be given high dose pancrelipase. High dose is defined as 72,000 U with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.'}, {'id': 'FG001', 'title': 'Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase', 'description': 'Resected participants (surgery to remove pancreatic cancer) will receive and continue on high dose pancrelipase throughout the study. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.'}, {'id': 'FG002', 'title': 'Non-Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase', 'description': 'Non-resected participants (those who did not have surgery to remove pancreatic cancer) will receive high dose pancrelipase throughout the study in an open-label cohort. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Neither the Resected Participants Receiving Low Dose Pancrelipase group nor the Non-Resected Participants Receiving High Dose Pancrelipase group enrolled any participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Resected Participants Receiving Low Dose (12,000/6,000 Units Lipase) Pancrelipase', 'description': 'Resected participants (surgery to remove pancreatic cancer) will first be given low dose pancrelipase. Low dose is defined as 12,000 USP units (lipase) with meals and 6000 U with snacks. At Weeks 1, 5, or 9, participants will be evaluated, and those who meet criteria for dose increase will be given high dose pancrelipase. High dose is defined as 72,000 U with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.'}, {'id': 'BG001', 'title': 'Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase', 'description': 'Resected participants (surgery to remove pancreatic cancer) will receive and continue on high dose pancrelipase throughout the study. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.'}, {'id': 'BG002', 'title': 'Non-Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase', 'description': 'Non-resected participants (those who did not have surgery to remove pancreatic cancer) will receive high dose pancrelipase throughout the study in an open-label cohort. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age 21 - 90 years old', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-22', 'size': 4437996, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-03-17T18:33', 'hasProtocol': True}, {'date': '2020-12-13', 'size': 842443, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-03-17T18:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Business Considerations (difficulty with enrollment)', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-02', 'studyFirstSubmitDate': '2019-02-28', 'resultsFirstSubmitDate': '2023-03-17', 'studyFirstSubmitQcDate': '2019-02-28', 'lastUpdatePostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-02', 'studyFirstPostDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Stool Fat From Baseline (Day 1) to Week 1 (Day 8) Among Participants With Resected Pancreatic Cancer', 'timeFrame': 'Baseline (Day 1), Week 1 (Day 8)', 'description': 'Stool samples were collected during the 48 hours prior to the Day 1 and Week 1 visits and analyzed for fat content.'}], 'secondaryOutcomes': [{'measure': 'Change in Average Daily Stool Frequency From Baseline (Day 1) to Week 1 (Day 8) Among Participants With Resected Pancreatic Cancer', 'timeFrame': 'Baseline (Day 1), Week 1 (Day 8)', 'description': 'Participants recorded stool frequency using an electronic diary (eDiary). The average daily stool frequency was calculated from the last 3 days prior to the Baseline and Week 1 visits.'}, {'measure': 'Change in Stool Consistency From Baseline to Week 1 Among Participants With Resected Pancreatic Cancer', 'timeFrame': 'Baseline (Day 1), Week 1 (Day 8)', 'description': 'Participants recorded stool consistency using an electronic diary (eDiary). The change from Baseline to Week 1 is the proportion of days having watery stool consistency in the last 7 days prior to each of Baseline and Week 1 visits. Negative changes from Baseline indicate less frequent watery stools.'}, {'measure': 'Change in the Total EPI Symptoms Score From Baseline to Week 1 Among Participants With Resected Pancreatic Cancer', 'timeFrame': 'Baseline (Day 1), Week 1 (Day 8)', 'description': 'The EPI Symptoms Questionnaire consists of 12 questions. The response scores range from 0 to 4 for each question (0 corresponding to None to 4 corresponding to Very Severe), with the total score ranging from 0 to 48. Positive changes indicate worsening from Baseline.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exocrine Pancreatic Insufficiency (EPI)', 'Pancreatic Cancer', 'Creon', 'Pancrelipase'], 'conditions': ['Exocrine Pancreatic Insufficiency (EPI)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.rxabbvie.com/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a study in participants with Exocrine Pancreatic Insufficiency (EPI) due to pancreatic cancer. This study will include resected participants who are post pancreatic cancer surgery, and an additional cohort in non-resected participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant has diagnosed cancer of pancreas with biopsy and/or radiography, with a life expectancy of at least 5 months at screening\n* Participant's pancreatic cancer must involve the head and/or neck of the pancreas\n* Confirmed exocrine pancreatic insufficiency (EPI) as evidenced by fecal elastase-1 (FE-1) ≤ 150 µg/g stool at screening\n* A positive Sudan stain for participants without history of fat malabsorption (fat malabsorption is defined as clinical steatorrhea, or measured stool fat \\> 7 g/day, or positive stool results by Sudan stain) within 1 week of screening -- Positive stool results are defined as increased level of neutral OR total fats\n\nExclusion Criteria:\n\n* Participant has neuroendocrine pancreatic cancer\n* Participant has fibrosing colonopathy\n* Participant has any other malignancy within 1 year of screening\n* Participant has uncontrolled gout, including those with a recent flare within 60 days of screening\n* Participant has other significant organ or bone marrow abnormality within 60 days of screening"}, 'identificationModule': {'nctId': 'NCT03859869', 'briefTitle': 'A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Creon (Pancrelipase) Therapy for Subjects With Exocrine Pancreatic Insufficiency (EPI) Due to Pancreatic Cancer: A Double-blind, Randomized, Parallel Design With 2 Dose Cohorts of Pancrelipase in Resected Pancreatic Cancer Subjects and an Open-label Single Dose Cohort in Non-resected Pancreatic Cancer Subjects', 'orgStudyIdInfo': {'id': 'M16-142'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase', 'description': 'Resected participants (surgery to remove pancreatic cancer) will first be given low dose pancrelipase. Low dose is defined as 12,000 USP units (lipase) with meals and 6000 U with snacks. At Weeks 1, 5, or 9, participants will be evaluated, and those who meet criteria for dose increase will be given high dose pancrelipase. High dose is defined as 72,000 U with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.', 'interventionNames': ['Drug: Pancrelipase', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase', 'description': 'Resected participants (surgery to remove pancreatic cancer) will receive and continue on high dose pancrelipase throughout the study. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks. All participants will receive placebo as needed to keep the number of pills the same in each group and for blinding.', 'interventionNames': ['Drug: Pancrelipase', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase', 'description': 'Non-resected participants (those who did not have surgery to remove pancreatic cancer) will receive high dose pancrelipase throughout the study in an open-label cohort. High dose is defined as 72,000 USP units (lipase) with meals and 36,000 U with snacks.', 'interventionNames': ['Drug: Pancrelipase']}], 'interventions': [{'name': 'Pancrelipase', 'type': 'DRUG', 'otherNames': ['Creon'], 'description': 'Pancrelipase is administered orally as capsules with a meal or snack', 'armGroupLabels': ['Non-Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase', 'Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase', 'Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo is administered orally as capsules with a meal or snack', 'armGroupLabels': ['Resected Participants Receiving High Dose (72,000/36,000 units lipase) Pancrelipase', 'Resected Participants Receiving Low Dose (12,000/6,000 units lipase) Pancrelipase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35223-2437', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Oncology /ID# 207770', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University of Arizona Medical Center Phoenix /ID# 208402', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '93701-2302', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Fresno /ID# 205757', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '94305-2200', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Med /ID# 208821', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80909-4533', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'UCH-MHS Memorial Hospital Central /ID# 207093', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80528-3400', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'UCHealth Cancer Care and Hematology Clinic /ID# 207091', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '20037-3201', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'George Washington University Medical Faculty Associates /ID# 203363', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida - Archer /ID# 202679', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '31904-8915', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'Columbus Regional Research Institute /ID# 211394', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '60005-2355', 'city': 'Arlington Heights', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwest Community Hospital /ID# 202270', 'geoPoint': {'lat': 42.08836, 'lon': -87.98063}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore University HealthSystem /ID# 209026', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '60426', 'city': 'Harvey', 'state': 'Illinois', 'country': 'United States', 'facility': 'Ingalls Memorial Hosp /ID# 203962', 'geoPoint': {'lat': 41.61003, 'lon': -87.64671}}, {'zip': '60453-2600', 'city': 'Oak Lawn', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Christ Medical Center /ID# 203132', 'geoPoint': {'lat': 41.71087, 'lon': -87.75811}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 204407', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48075-4825', 'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Ascension Providence Hospital /ID# 203449', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'zip': '63104', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis University /ID# 205769', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63128', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mercy Hospital South /ID# 221766', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '11030-3815', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health Center for Liver Diseases /ID# 207321', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Winthrop Hospital /ID# 207513', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University Langone Me /ID# 202290', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032-3729', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center /ID# 204165', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27858', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'East Carolina University /ID# 206661', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Gabrail Cancer Center Research /ID# 208030', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State Cancer Center /ID# 203131', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center /ID# 202288', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19611', 'city': 'Reading', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Reading Hospital /ID# 206869', 'geoPoint': {'lat': 40.33565, 'lon': -75.92687}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Musc /Id# 210727', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37909', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Cancer Specialists /ID# 208235', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '37232-0011', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center /ID# 204231', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75246-2003', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 206156', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'UT MD Anderson Cancer Center /ID# 202271', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 205746', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '53226-3522', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin /ID# 205714', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/abbvie/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link: https://www.abbvieclinicaltrials.com/hcp/data-sharing/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}