Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-02-27 @ 10:34 AM
Study NCT ID:
NCT01988402
Status:
COMPLETED
Last Update Posted:
2018-02-14
First Post:
2013-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Does Allopurinol Prolong a Treated, Acute Gout Flare?
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006073', 'term': 'Gout'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011686', 'term': 'Purine-Pyrimidine Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000493', 'term': 'Allopurinol'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'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': 'jay.b.higgs.civ@mail.mil', 'phone': '2109160797', 'title': 'Jay B Higgs,', 'organization': 'San Antonio Military Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '28 days', 'eventGroups': [{'id': 'EG000', 'title': 'Allopurinol', 'description': 'Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days\n\nallopurinol', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Sugar Pill (Placebo)', 'description': 'Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.\n\nPlacebo (sugar pill)', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'elevated liver enzymes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea and vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Resolution of the Acute Gout Attack', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allopurinol', 'description': 'Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days\n\nallopurinol'}, {'id': 'OG001', 'title': 'Sugar Pill (Placebo)', 'description': 'Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.\n\nPlacebo (sugar pill)'}], 'classes': [{'categories': [{'measurements': [{'value': '15.4', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '13.4', 'spread': '7.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '1-28 Days', 'description': 'The primary outcome unit of measurement is time (in days) to resolution of the acute gout attack', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allopurinol', 'description': 'Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days\n\nallopurinol'}, {'id': 'OG001', 'title': 'Sugar Pill (Placebo)', 'description': 'Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.\n\nPlacebo (sugar pill)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.79', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported', 'description': 'Patient rated pain on a Likert pain score of 0-10', 'unitOfMeasure': 'units on a Likert scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Physician Global Assessment of Gout Activity at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allopurinol', 'description': 'Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days\n\nallopurinol'}, {'id': 'OG001', 'title': 'Sugar Pill (Placebo)', 'description': 'Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.\n\nPlacebo (sugar pill)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported', 'description': 'Physician rated gout activity is measured on a Likert scale 0-10.', 'unitOfMeasure': 'units on a Likert scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Uric Acid Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allopurinol', 'description': 'Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days\n\nallopurinol'}, {'id': 'OG001', 'title': 'Sugar Pill (Placebo)', 'description': 'Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.\n\nPlacebo (sugar pill)'}], 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 28', 'description': 'Blood test (serum) for uric acid level', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Allopurinol', 'description': 'Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days\n\nallopurinol'}, {'id': 'FG001', 'title': 'Sugar Pill (Placebo)', 'description': 'Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.\n\nPlacebo (sugar pill)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '35 patients were enrolled which achieved a completer number of 31. This was one short of the original completer target of 32. Power analysis suggested that a much larger number would have been required to achieve statistical power, and that enrolling 1-2 more subjects would not have contributed to the data.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Allopurinol', 'description': 'Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days\n\nallopurinol'}, {'id': 'BG001', 'title': 'Sugar Pill (Placebo)', 'description': 'Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.\n\nPlacebo (sugar pill)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000', 'lowerLimit': '40', 'upperLimit': '84'}, {'value': '53', 'groupId': 'BG001', 'lowerLimit': '31', 'upperLimit': '68'}, {'value': '57', 'groupId': 'BG002', 'lowerLimit': '31', 'upperLimit': '84'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Disease duration', 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '20'}, {'value': '4.9', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '17'}, {'value': '5.2', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '20'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'number of prior attacks', 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '12'}, {'value': '6.58', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '35'}, {'value': '5.2', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '35'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'number', 'dispersionType': 'FULL_RANGE'}, {'title': 'participants with history of nephrolithiasis', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'participants with tophi', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Participants with erosions', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-18', 'studyFirstSubmitDate': '2013-11-06', 'resultsFirstSubmitDate': '2014-12-09', 'studyFirstSubmitQcDate': '2013-11-13', 'lastUpdatePostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-12-20', 'studyFirstPostDateStruct': {'date': '2013-11-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resolution of the Acute Gout Attack', 'timeFrame': '1-28 Days', 'description': 'The primary outcome unit of measurement is time (in days) to resolution of the acute gout attack'}], 'secondaryOutcomes': [{'measure': 'Pain Day 28', 'timeFrame': 'Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported', 'description': 'Patient rated pain on a Likert pain score of 0-10'}, {'measure': 'Physician Global Assessment of Gout Activity at Day 28', 'timeFrame': 'Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported', 'description': 'Physician rated gout activity is measured on a Likert scale 0-10.'}, {'measure': 'Serum Uric Acid Level', 'timeFrame': 'day 28', 'description': 'Blood test (serum) for uric acid level'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gout', 'allopurinol'], 'conditions': ['Gout']}, 'descriptionModule': {'briefSummary': 'This is a double blind placebo controlled study to determine whether starting allopurinol during a treated acute gout attack will have any effect on the duration of the attack.', 'detailedDescription': 'Traditional teaching holds that starting allopurinol during an acute gout attack will prolong the attack. Recent expert opinion from the American College of Rheumatology Guidelines is that allopurinol may be started during an acute, treated gout attack. This study is designed to test the hypothesis that allopurinol does not prolong an acute, treated gout attack. Patients will either take allopurinol capsules or and identical capsule containing no allopurinol (placebo) over 28 days, starting within 72 hours of a gout attack that is being treated with other standard measures. During the study, neither the patient nor the examiner will know what pills are being taken. The time to resolution of the attack is the primary outcome measure. Pain level, serum uric acid level, and complications of therapy will also be monitored. A minimum of 32 patients completing the study are needed for a meaningful conclusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria requires both of:\n\n* Crystal proven gout, and\n* An acute gout attack within 72 hours of first treatment\n\nPlus one of the following:\n\n* At least 2 gout attacks in past 12 months\n* Tophus\n* Nephrolithiasis\n* 24hr urine uric acid greater than 1000mg\n\nExclusion Criteria:\n\n* Inability to return for examinations\n* Glomerular filtration rate (calculated) less than 50 milliliters per minute\n* Allopurinol use in past 6 months\n* Ongoing cancer therapy\n* Concomitant azathioprine or cyclophosphamide\n* Any one of the following liver enzymes greater than 1.25 times the upper limit of normal:\n\n * AST \\[Aspartate aminotransferase\\]\n * ALT \\[Alanine aminotransferase\\]\n * alkaline phosphatase\n* Pre-gout pain in involved joint of more than 3 on a scale of 1-10\n* Neurologic deficit around the involved joint'}, 'identificationModule': {'nctId': 'NCT01988402', 'briefTitle': 'Does Allopurinol Prolong a Treated, Acute Gout Flare?', 'organization': {'class': 'FED', 'fullName': '59th Medical Wing'}, 'officialTitle': 'Does Allopurinol Prolong a Treated, Acute Gout Flare?', 'orgStudyIdInfo': {'id': 'FWH20070235H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Allopurinol', 'description': 'Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days', 'interventionNames': ['Drug: allopurinol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar pill (Placebo)', 'description': 'Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.', 'interventionNames': ['Drug: Placebo (sugar pill)']}], 'interventions': [{'name': 'allopurinol', 'type': 'DRUG', 'armGroupLabels': ['Allopurinol']}, {'name': 'Placebo (sugar pill)', 'type': 'DRUG', 'armGroupLabels': ['Sugar pill (Placebo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78236', 'city': 'Lackland Air Force Base', 'state': 'Texas', 'country': 'United States', 'facility': 'Wilford Hall Ambulatory Surgical Center', 'geoPoint': {'lat': 29.38663, 'lon': -98.61797}}], 'overallOfficials': [{'name': 'Jay B Higgs, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '59th Medical Wing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '59th Medical Wing', 'class': 'FED'}, 'collaborators': [{'name': 'United States Air Force', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Program Director, Rheumatology Fellowship', 'investigatorFullName': 'Jay B. Higgs, MD', 'investigatorAffiliation': '59th Medical Wing'}}}}