Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-01-01 @ 12:35 AM
Study NCT ID:
NCT00770328
Status:
COMPLETED
Last Update Posted:
2017-11-30
First Post:
2008-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effects of Pentoxifylline on PAI-1 in an Obese Population
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010431', 'term': 'Pentoxifylline'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D013805', 'term': 'Theobromine'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'james.muldowney@vanderbilt.edu', 'phone': '615-936-1720', 'title': 'James Muldowney', 'organization': 'Vanderbilt University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'The subjects were followed from baseline to 8 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Pentoxifylline', 'description': 'Patients receive Pentoxifylline 400 mg po TID for 8 weeks.\n\nPentoxifylline: 400mg PO TID x 8 weeks', 'otherNumAtRisk': 22, 'otherNumAffected': 11, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Patients take a placebo TID for 8 weeks.\n\nPlacebo: PO TID x 8 weeks', 'otherNumAtRisk': 15, 'otherNumAffected': 2, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea/Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in PAI-1 Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pentoxifylline', 'description': 'Patients receive Pentoxifylline 400 mg po TID for 8 weeks.\n\nPentoxifylline: 400mg PO TID x 8 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients take a placebo TID for 8 weeks.\n\nPlacebo: PO TID x 8 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '39.5', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '31.6', 'spread': '7.6', 'groupId': 'OG001'}]}]}, {'title': '8 Weeks', 'categories': [{'measurements': [{'value': '28.6', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '37.9', 'spread': '8.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 weeks', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in CRP Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pentoxifylline', 'description': 'Patients receive Pentoxifylline 400 mg po TID for 8 weeks.\n\nPentoxifylline: 400mg PO TID x 8 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients take a placebo TID for 8 weeks.\n\nPlacebo: PO TID x 8 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.2', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': '8 weeks', 'categories': [{'measurements': [{'value': '4.6', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0114', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 weeks', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in TNF-alpha Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pentoxifylline', 'description': 'Patients receive Pentoxifylline 400 mg po TID for 8 weeks.\n\nPentoxifylline: 400mg PO TID x 8 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients take a placebo TID for 8 weeks.\n\nPlacebo: PO TID x 8 weeks'}], 'timeFrame': 'Baseline and 8 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'TNF-a assay did not work properly. Meaningless data resulted including negative values which are impossible.'}, {'type': 'SECONDARY', 'title': 'Changes in the Relationship Between PAI-1, CRP, and TNF-a With Therapy.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pentoxifylline', 'description': 'Patients receive Pentoxifylline 400 mg po TID for 8 weeks.\n\nPentoxifylline: 400mg PO TID x 8 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients take a placebo TID for 8 weeks.\n\nPlacebo: PO TID x 8 weeks'}], 'timeFrame': 'Baseline and 8 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Unable to complete analysis due to TNF-a assay failure (see Outcome measure #3)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pentoxifylline', 'description': 'Patients receive Pentoxifylline 400 mg po TID for 8 weeks.\n\nPentoxifylline: 400mg PO TID x 8 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Patients take a placebo TID for 8 weeks.\n\nPlacebo: PO TID x 8 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pentoxifylline', 'description': 'Patients receive Pentoxifylline 400 mg po TID for 8 weeks.\n\nPentoxifylline: 400mg PO TID x 8 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Patients take a placebo TID for 8 weeks.\n\nPlacebo: PO TID x 8 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '37.7', 'spread': '3.1', 'groupId': 'BG000'}, {'value': '38.6', 'spread': '2.5', 'groupId': 'BG001'}, {'value': '38.2', 'spread': '1.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Study was completed and submitted for publication in 2011. We do not have the complete data set to answer questions about patients who did not complete the study.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Study submitted for publication in 2011. Records no longer exist to answer questions about screen failures and dropouts.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-24', 'studyFirstSubmitDate': '2008-10-09', 'resultsFirstSubmitDate': '2017-03-16', 'studyFirstSubmitQcDate': '2008-10-09', 'lastUpdatePostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-24', 'studyFirstPostDateStruct': {'date': '2008-10-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in PAI-1 Level', 'timeFrame': 'Baseline and 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in CRP Level', 'timeFrame': 'Baseline and 8 weeks'}, {'measure': 'Change in TNF-alpha Level', 'timeFrame': 'Baseline and 8 weeks'}, {'measure': 'Changes in the Relationship Between PAI-1, CRP, and TNF-a With Therapy.', 'timeFrame': 'Baseline and 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Plasma PAI-1 level at 0, 4, 8 weeks', 'Plasma hsCRP level at 0, 4, 8 weeks', 'Plasma TNF-a level at 0, 4, 8 weeks'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'PAI-1 is elevated in obese individuals. TNF-alpha, an inflammatory mediator is believed to play a role in obesity mediated elevations in PAI-1 levels. TNF-alpha blockade with antibodies and the drug pentoxifylline have been shown to lower PAI-1 levels in animal models. This study tests the hypothesis that pentoxifylline will lower PAI-1 levels in human subjects.', 'detailedDescription': 'Obese individuals with elevated PAI-1 levels (greater than 10 ng/ml) are randomized to pentoxifylline 400mg, three times a day (TID) or placebo for 8 weeks. PAI-1, TNF-a and high sensitivity C-Reactive Protein are measured at week 0, 4 and 8.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusions: 1. A Body Mass Index of ≥ 30.0 2. Age 21 or older 3. Few or no medical problems 4. PAI-1 level ≥ 10 ng/dl\n\nExclusions: 1. Cigarette use 2. Present use of angiotensin converting enzyme (ACE) Inhibitors 3. Recent cerebral and/or retinal hemorrhage 4. Intolerance to pentoxifylline or methylxanthines such as caffeine, theophylline, and theobromine 5. Presently on warfarin therapy 6. Pregnancy or breast-feeding 7. Recent surgery 8. Recent diagnosis/treatment for peptic ulcer'}, 'identificationModule': {'nctId': 'NCT00770328', 'briefTitle': 'The Effects of Pentoxifylline on PAI-1 in an Obese Population', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'The Effects of Pentoxifylline on PAI-1 in an Obese Population', 'orgStudyIdInfo': {'id': '030497'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pentoxifylline', 'description': 'Patients receive Pentoxifylline 400 mg po TID for 8 weeks.', 'interventionNames': ['Drug: Pentoxifylline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients take a placebo TID for 8 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Pentoxifylline', 'type': 'DRUG', 'otherNames': ['Trental'], 'description': '400mg PO TID x 8 weeks', 'armGroupLabels': ['Pentoxifylline']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Sugar Pill'], 'description': 'PO TID x 8 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'James A S Muldowney, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'James Muldowney', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}