Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-29 @ 7:27 PM
Study NCT ID:
NCT04949828
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2021-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of CREON on Exocrine Pancreatic Insufficiency (EPI) Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050500', 'term': 'Pancreatitis, Chronic'}, {'id': 'D010188', 'term': 'Exocrine Pancreatic Insufficiency'}], 'ancestors': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-27', 'studyFirstSubmitDate': '2021-06-21', 'studyFirstSubmitQcDate': '2021-07-01', 'lastUpdatePostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Score of EPI Symptoms Domain Using an EPI Patient-Reported Outcomes Questionnaire', 'timeFrame': 'Up to 1 month'}], 'secondaryOutcomes': [{'measure': 'Change in T-scores for Patient-Reported Outcomes Measurement and Information System(PROMIS) Questionnaires for Anxiety, Depression, and Fatigue', 'timeFrame': 'Up to 1 month'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic pancreatitis', 'Exocrine Pancreatic Insufficiency', 'CREON', 'pancrelipase', 'ABT-SLV245'], 'conditions': ['Chronic Pancreatitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.rxabbvie.com/', 'label': 'Related info'}]}, 'descriptionModule': {'briefSummary': 'Exocrine Pancreatic Insufficiency (EPI) is a condition where pancreatic enzyme quantity or activity is reduced below threshold needed for normal digestion. Symptoms include bloating, flatulence, diarrhea and steatorrhea. This is an observational study assessing for effect of CREON on symptoms of EPI in participants with EPI due to chronic pancreatitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult participants with medical diagnosis of chronic pancreatitis (CP) and exocrine pancreatic insufficiency (EPI)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medical history of chronic pancreatitis (CP).\n* Diagnosis of Exocrine Pancreatic Insufficiency (EPI).\n\nExclusion Criteria:\n\n--History of cystic fibrosis, pancreatic cancer, pancreatic surgery, gastric bypass surgery, extensive bowel surgery, inflammatory bowel disease, celiac disease, irritable bowel syndrome'}, 'identificationModule': {'nctId': 'NCT04949828', 'acronym': 'CisCP', 'briefTitle': 'Effect of CREON on Exocrine Pancreatic Insufficiency (EPI) Symptoms', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Observational Study Assessing for Effect of CREON on Symptoms of Exocrine Pancreatic Insufficiency (EPI) in Patients With EPI Due to Chronic Pancreatitis (CP)', 'orgStudyIdInfo': {'id': 'P20-238'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants on CREON', 'interventionNames': ['Drug: CREON']}], 'interventions': [{'name': 'CREON', 'type': 'DRUG', 'otherNames': ['pancrelipase', 'ABT-SLV245'], 'description': 'Oral Capsules', 'armGroupLabels': ['Participants on CREON']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305-2200', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Med /ID# 229530', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida - Archer /ID# 227057', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '21287-0020', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'John Hopkins University /ID# 227061', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '10016-2708', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health /ID# 230818', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43210-1267', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Wexner Medical Center /ID# 227844', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '77030-3411', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine - Baylor Medical Center /ID# 227067', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}