Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-03-02 @ 4:01 PM
Study NCT ID:
NCT01292005
Status:
COMPLETED
Last Update Posted:
2016-10-25
First Post:
2010-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pentoxifylline Treatment of Acute Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D019283', 'term': 'Pancreatitis, Acute Necrotizing'}, {'id': 'D019512', 'term': 'Pancreatitis, Alcoholic'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D020751', 'term': 'Alcohol-Induced Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010431', 'term': 'Pentoxifylline'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vege.santhi@mayo.edu', 'phone': '507-284-2175', 'title': 'Dr. Santhi Swaroop Vege', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pentoxifylline', 'description': 'Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in C-Reactive Protein (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pentoxifylline', 'description': 'Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.'}], 'classes': [{'title': 'Change from baseline to Day 1', 'categories': [{'measurements': [{'value': '48.4', 'groupId': 'OG000', 'lowerLimit': '-37.1', 'upperLimit': '207.3'}, {'value': '60.6', 'groupId': 'OG001', 'lowerLimit': '-71', 'upperLimit': '283.2'}]}]}, {'title': 'Change from baseline to Day 3', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000', 'lowerLimit': '-157.4', 'upperLimit': '255.3'}, {'value': '154', 'groupId': 'OG001', 'lowerLimit': '-170', 'upperLimit': '193.5'}]}]}], 'analyses': [{'pValue': '0.62', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Change from Day 0 to Day 1. p\\<0.05 was considered statistically significant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Change from Day 0 to Day 3. p\\<0.05 was considered statistically significant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, Day 1, Day 3', 'description': 'C-reactive protein is produced by the liver. The level of CRP rises when there is inflammation throughout the body. The normal value range for CRP = 1-10 mg/L.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Tumor Necrosis Factor (TNF)-Alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pentoxifylline', 'description': 'Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.'}], 'classes': [{'title': 'Change from baseline to Day 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '0.52'}, {'value': '-0.05', 'groupId': 'OG001', 'lowerLimit': '-0.9', 'upperLimit': '49.2'}]}]}, {'title': 'Change from baseline to Day 3', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '0.5'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-3.5', 'upperLimit': '17.2'}]}]}], 'analyses': [{'pValue': '0.72', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Change from Day 0 to Day 1. p\\<0.05 was considered statistically significant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.50', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Change from Day 0 to Day 3. p\\<0.05 was considered statistically significant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, Day 1, Day 3', 'description': 'Normal value range for TNF alpha = 0 - 22 pg/ml.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Interleukin (IL) IL-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pentoxifylline', 'description': 'Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.'}], 'classes': [{'title': 'Change from baseline to Day 1', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '-37', 'upperLimit': '25'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '-62', 'upperLimit': '152'}]}]}, {'title': 'Change from baseline to Day 2', 'categories': [{'measurements': [{'value': '-8.6', 'groupId': 'OG000', 'lowerLimit': '-61', 'upperLimit': '15.6'}, {'value': '-2.9', 'groupId': 'OG001', 'lowerLimit': '-213', 'upperLimit': '65.8'}]}]}], 'analyses': [{'pValue': '0.58', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Change from Day 0 to Day 1. p\\<0.05 was considered statistically significant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.80', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Change from Day 0 to Day 3. p\\<0.05 was considered statistically significant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, Day 1, Day 3', 'description': 'Normal value range for IL-6 = 0 - 5 pg/ml.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Changes in Interleukin (IL) IL-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pentoxifylline', 'description': 'Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.'}], 'classes': [{'title': 'Change from baseline to Day 1', 'categories': [{'measurements': [{'value': '-3.0', 'groupId': 'OG000', 'lowerLimit': '-7.2', 'upperLimit': '30.8'}, {'value': '-1.7', 'groupId': 'OG001', 'lowerLimit': '-38.2', 'upperLimit': '49.2'}]}]}, {'title': 'Change from baseline to Day 3', 'categories': [{'measurements': [{'value': '0.35', 'groupId': 'OG000', 'lowerLimit': '-10.3', 'upperLimit': '5.4'}, {'value': '-1.9', 'groupId': 'OG001', 'lowerLimit': '-43.6', 'upperLimit': '18.2'}]}]}], 'analyses': [{'pValue': '0.90', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Change from Day 0 to Day 1. p\\<0.05 was considered statistically significant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.56', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Change from Day 0 to Day 3. p\\<0.05 was considered statistically significant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, Day 1, Day 3', 'description': 'Normal value range for IL-8 = 0 - 5 pg/ml.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number Of Subjects With New Onset Organ Failure During Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pentoxifylline', 'description': 'Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'p\\<0.05 was considered statistically significant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 week or until dismissal date whichever occurs earlier.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pentoxifylline', 'description': 'Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.22', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'p\\<0.05 was considered statistically significant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 week or until dismissal date whichever occurs earlier', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Lengthy Hospital Stays', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pentoxifylline', 'description': 'Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.'}], 'classes': [{'title': 'Length of hospitalization >4 days', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Length of hospitalization >10 days', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Comparison between arms for length of hospitalization \\> 4 days. P \\< 0.05 was considered statistically significant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Comparison was for length of hospitalization \\>10 days. P \\< 0.05 was considered statistically significant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '30 days or until dismissal date, whichever occurs earlier', 'description': '"Lengthy" was defined as either greater than 4 days or greater than 10 days.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pentoxifylline', 'description': 'Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '30'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'P \\< 0.05 was considered statistically significant.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '30 days or until dismissal date, whichever occurs earlier', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Intensive Care Unit (ICU) Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pentoxifylline', 'description': 'Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '13'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'P \\< 0.05 was considered statistically significant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '30 days or until dismissal date, whichever occurs earlier', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Needed an Intensive Care Unit Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pentoxifylline', 'description': 'Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'P \\< 0.05 was considered statistically significant.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '30 days, or until dismissal, whichever came first', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pentoxifylline', 'description': 'Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were enrolled from the Mayo Clinic in Rochester, Minnesota between 2009 and 2012.', 'preAssignmentDetails': '30 subjects signed informed consent; two subjects were excluded after consent because they were found to be not eligible.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pentoxifylline', 'description': 'Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000', 'lowerLimit': '34', 'upperLimit': '87'}, {'value': '58', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '82'}, {'value': '64', 'groupId': 'BG002', 'lowerLimit': '24', 'upperLimit': '87'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '30.2', 'groupId': 'BG000', 'lowerLimit': '20.6', 'upperLimit': '42.9'}, {'value': '32.5', 'groupId': 'BG001', 'lowerLimit': '16.7', 'upperLimit': '50.1'}, {'value': '30.3', 'groupId': 'BG002', 'lowerLimit': '16.7', 'upperLimit': '50.1'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-14', 'studyFirstSubmitDate': '2010-10-19', 'resultsFirstSubmitDate': '2013-09-23', 'studyFirstSubmitQcDate': '2011-02-08', 'lastUpdatePostDateStruct': {'date': '2016-10-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-10-23', 'studyFirstPostDateStruct': {'date': '2011-02-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in C-Reactive Protein (CRP)', 'timeFrame': 'baseline, Day 1, Day 3', 'description': 'C-reactive protein is produced by the liver. The level of CRP rises when there is inflammation throughout the body. The normal value range for CRP = 1-10 mg/L.'}, {'measure': 'Change in Tumor Necrosis Factor (TNF)-Alpha', 'timeFrame': 'baseline, Day 1, Day 3', 'description': 'Normal value range for TNF alpha = 0 - 22 pg/ml.'}, {'measure': 'Change in Interleukin (IL) IL-6', 'timeFrame': 'baseline, Day 1, Day 3', 'description': 'Normal value range for IL-6 = 0 - 5 pg/ml.'}, {'measure': 'Changes in Interleukin (IL) IL-8', 'timeFrame': 'baseline, Day 1, Day 3', 'description': 'Normal value range for IL-8 = 0 - 5 pg/ml.'}], 'secondaryOutcomes': [{'measure': 'Number Of Subjects With New Onset Organ Failure During Hospitalization', 'timeFrame': '1 week or until dismissal date whichever occurs earlier.'}, {'measure': 'Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization', 'timeFrame': '1 week or until dismissal date whichever occurs earlier'}, {'measure': 'Number of Patients With Lengthy Hospital Stays', 'timeFrame': '30 days or until dismissal date, whichever occurs earlier', 'description': '"Lengthy" was defined as either greater than 4 days or greater than 10 days.'}, {'measure': 'Length of Hospital Stay', 'timeFrame': '30 days or until dismissal date, whichever occurs earlier'}, {'measure': 'Length of Intensive Care Unit (ICU) Stay', 'timeFrame': '30 days or until dismissal date, whichever occurs earlier'}, {'measure': 'Number of Subjects Who Needed an Intensive Care Unit Stay', 'timeFrame': '30 days, or until dismissal, whichever came first'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pancreatitis', 'pancreatic necrosis', 'severe acute pancreatitis (SAP)', 'Alcoholic pancreatitis', 'gallstone pancreatitis'], 'conditions': ['Acute Pancreatitis']}, 'referencesModule': {'references': [{'pmid': '26112745', 'type': 'DERIVED', 'citation': 'Vege SS, Atwal T, Bi Y, Chari ST, Clemens MA, Enders FT. Pentoxifylline Treatment in Severe Acute Pancreatitis: A Pilot, Double-Blind, Placebo-Controlled, Randomized Trial. Gastroenterology. 2015 Aug;149(2):318-20.e3. doi: 10.1053/j.gastro.2015.04.019. Epub 2015 Jun 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effects (good and bad) of giving a drug called pentoxifylline to patients with acute pancreatitis, to see if it can improve blood tests associated with inflammation (tissue damage). Pentoxifylline is approved by the US Food and Drug Administration (FDA) for treatment of circulation problems, but its use in this study is investigational, which means that the FDA has not approved it for the treatment of pancreatitis. However, the FDA has allowed the use of pentoxifylline in this research study.', 'detailedDescription': 'Subjects will be put in one of two groups by chance (as in the flip of a coin). This is done so that neither you nor the investigator will know which group you are in.\n\nYou will be put into either the treatment group or the control group.\n\n* The treatment group will receive a drug called pentoxifylline\n* The control group will receive a placebo (matching pill that has no medication in it) You will take the pills by mouth starting from the time of admission. You will receive a total of 9 doses over the first three days of your hospitalization (72 hours).\n\nWhen subject have standard patient care blood draws, additional blood will be taken to do the research tests. The additional blood tests will be done every day for up to 5 days, after the administration of study drug or till the time of discharge whichever occurs earlier. The additional tests will require about 2 teaspoons (10 ml) of blood per day; the maximum amount of extra blood taken would be less than 3 tablespoons (40.0 ml). Information from your medical record will be gathered while you are hospitalized and after your discharge. The study will continue to gather clinical follow up information up to four months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Predicted Severe Acute Pancreatitis\n2. Enrollment within 72 hours of diagnosis\n3. Ability to give informed consent\n4. Age \\>17 years\n\nExclusion Criteria:\n\n1. Moderate or severe congestive heart failure\n2. History of seizure disorder or demyelinating disease\n3. Nursing mothers\n4. Pregnancy\n5. History of prior tuberculosis or risk factors for tuberculosis\n6. Evidence of immunosuppression (malignancy, chronic renal failure, chemotherapy within 60 days, ongoing steroid treatment\\*, and HIV)- (\\*the exception of prednisone use will be allowed to participate).\n7. Evidence of chronic pancreatitis from history and examination (however, "acute on chronic pancreatitis" diagnosis is allowed)\n8. Evidence of active or pending hemorrhage.\n9. Paralytic ileus with vomiting'}, 'identificationModule': {'nctId': 'NCT01292005', 'briefTitle': 'Pentoxifylline Treatment of Acute Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Pentoxifylline Treatment in Acute Pancreatitis; A Double-Blind Placebo-Controlled Randomized Trial', 'orgStudyIdInfo': {'id': '08-006648'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pentoxifylline', 'description': 'Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.', 'interventionNames': ['Drug: Pentoxifylline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Pentoxifylline', 'type': 'DRUG', 'otherNames': ['Trental'], 'description': '400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.', 'armGroupLabels': ['Pentoxifylline']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Santhi S Vege, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Santhi Swaroop Vege, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}