Ignite Creation Date:
2025-12-24 @ 5:13 PM
Ignite Modification Date:
2025-12-25 @ 2:51 PM
Study NCT ID:
NCT00267150
Status:
COMPLETED
Last Update Posted:
2011-05-20
First Post:
2005-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Simultaneous Pancreas-Kidney Transplants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Switzerland']}, 'interventionBrowseModule': {'meshes': [{'id': 'D009173', 'term': 'Mycophenolic Acid'}], 'ancestors': [{'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'All Patients', 'description': 'All patients', 'otherNumAtRisk': 31, 'otherNumAffected': 2, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in Gastrointestinal Symptom Severity and/or Health-related Quality of Life After Conversion From MMF to Enteric Coated Mycophenolate Sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteric Coated Mycophenolate-sodium', 'description': 'Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.46', 'spread': '0.71', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'weeks 6-8', 'description': 'The Gastrointestinal symptom rating scale (GSRS) is a 15-item instrument designed to assess the symptoms associated with common gastrointestinal disorders. The GSRS has 5 subscales (reflux, diarrhea, constipation,abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). The GSRS total score was computed by the mean of the subscale scores. The primary analysis examined changes from Visit 1 (baseline) to Visit 2 (6-8 weeks) by computing the difference of GSRS total score.', 'unitOfMeasure': 'Change in Score of GSRS', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gastrointestinal Symptoms Under MMF-based Immunosuppressive Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteric Coated Mycophenolate-sodium', 'description': 'Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.'}], 'classes': [{'title': 'Any complication', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Dyspepsia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Abdominal pain/bloating/fullness', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week 0', 'description': 'Assessed by GI complications at baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enteric Coated Mycophenolate-sodium', 'description': 'Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Enteric Coated Mycophenolate-sodium', 'description': 'Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.9', 'spread': '9.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-17', 'studyFirstSubmitDate': '2005-12-16', 'resultsFirstSubmitDate': '2010-12-09', 'studyFirstSubmitQcDate': '2005-12-16', 'lastUpdatePostDateStruct': {'date': '2011-05-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-12-09', 'studyFirstPostDateStruct': {'date': '2005-12-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Gastrointestinal Symptom Severity and/or Health-related Quality of Life After Conversion From MMF to Enteric Coated Mycophenolate Sodium', 'timeFrame': 'weeks 6-8', 'description': 'The Gastrointestinal symptom rating scale (GSRS) is a 15-item instrument designed to assess the symptoms associated with common gastrointestinal disorders. The GSRS has 5 subscales (reflux, diarrhea, constipation,abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). The GSRS total score was computed by the mean of the subscale scores. The primary analysis examined changes from Visit 1 (baseline) to Visit 2 (6-8 weeks) by computing the difference of GSRS total score.'}], 'secondaryOutcomes': [{'measure': 'Gastrointestinal Symptoms Under MMF-based Immunosuppressive Therapy', 'timeFrame': 'week 0', 'description': 'Assessed by GI complications at baseline.'}]}, 'conditionsModule': {'keywords': ['Simultaneous Pancreas-Kidney Transplantation', 'mycophenolate', 'GI problems'], 'conditions': ['Pancreas Transplantation', 'Kidney Transplantation']}, 'descriptionModule': {'briefSummary': 'Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will assess if a switch from MMF to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI and/or health-related quality of life outcomes and determine the proportion of pancreas-kidney transplant recipients who experience any GI complaints under MMF-based immunosuppressive treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Received simultaneous pancreas-kidney (SPK) transplant at least 3 months prior to study enrollment\n* Receiving immunosuppressive regimen that includes MMF in combination with other immunosuppressive drugs (i.e., a calcineurin inhibitor, a mTOR inhibitor, steroids at least for three months at time of study enrollment)\n* Receiving MMF for at least 1 month prior to enrollment; maximal MMF dose 2000 mg/d.\n\nExclusion Criteria:\n\n* Patients with any known hypersensitivity to mycophenolic acid, mycophenolate sodium, mycophenolate mofetil or other components of the formulations (e.g. lactose; see also SCP of EC-MPS)\n* If applicable, GI symptoms assumed or known to be induced by other drugs or infections (e.g. oral biphosphonates induced, infectious diarrhea)\n* Acute rejection \\< 1 month prior to study enrollment\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00267150', 'briefTitle': 'Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Simultaneous Pancreas-Kidney Transplants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Measurement of Patient Reported Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Simultaneous Pancreas-Kidney Transplant Recipients', 'orgStudyIdInfo': {'id': 'CERL080ADE10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Enteric-coated mycophenolate sodium (EC-MPS)']}], 'interventions': [{'name': 'Enteric-coated mycophenolate sodium (EC-MPS)', 'type': 'DRUG', 'otherNames': ['myfortic'], 'description': 'Experimental', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Universitätsklinikum Charité Campus Virchow Klinikum Berlin Nephrologie und Internistische Intensivmedizin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis Pharmaceuticals'}}}}