Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-02 @ 12:47 PM
Study NCT ID:
NCT00841204
Status:
COMPLETED
Last Update Posted:
2017-12-26
First Post:
2009-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sulindac in Preventing Melanoma in Healthy Participants Who Are at Increased Risk of Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011230', 'term': 'Precancerous Conditions'}], 'ancestors': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013467', 'term': 'Sulindac'}], 'ancestors': [{'id': 'D007192', 'term': 'Indenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'schow@azcc.arizona.edu', 'phone': '520-626-3358', 'title': 'H-H. Sherry Chow, Ph.D.', 'organization': 'The University of Arizona'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sulindac', 'description': 'Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.', 'otherNumAtRisk': 25, 'otherNumAffected': 22, 'seriousNumAtRisk': 25, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.', 'otherNumAtRisk': 25, 'otherNumAffected': 23, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Prutitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Other skin disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Stomach pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Immune system disorders'}, {'term': 'Sinus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Other infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 4}], 'organSystem': 'Infections and infestations'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Extremity/Limb pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Muscle pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Nasal/Paranasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Larynx/Pharynx/Throat pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Uterus pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Skin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 14}], 'organSystem': 'Nervous system disorders'}, {'term': 'Flu-like syndromes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 5}], 'organSystem': 'General disorders'}, {'term': 'Other pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'General disorders'}], 'seriousEvents': [{'term': 'Vasovagal episode', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sulindac Concentration in the Nevi (Moles)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sulindac', 'description': 'Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.51', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'unitOfMeasure': 'µg/g tissue', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants were included in the analysis except one participant in the sulindac arm did not provide nevi sample for analysis'}, {'type': 'PRIMARY', 'title': 'Sulindac Sulfone, an Active Metabolite of Sulindac, Concentration in the Nevi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sulindac', 'description': 'Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.38', 'spread': '2.86', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'unitOfMeasure': 'µg/g tissue', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants were included in the analysis except one participant in the sulindac arm did not provide nevi sample for analysis'}, {'type': 'PRIMARY', 'title': 'Sulindac Sulfide, an Active Metabolite of Sulindac, Concentration in the Nevi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sulindac', 'description': 'Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'unitOfMeasure': 'µg/g tissue', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants were included in the analysis except one participant in the sulindac arm did not provide nevi sample for analysis'}, {'type': 'SECONDARY', 'title': 'Sulindac Effects on Apoptosis in Atypical Nevi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sulindac', 'description': 'Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '-8', 'upperLimit': '32'}, {'value': '-25', 'groupId': 'OG001', 'lowerLimit': '-55', 'upperLimit': '-10'}]}]}], 'analyses': [{'pValue': '0.0056', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Change in the expression of a marker of apoptosis, cleaved caspase 3, in melanocytic junctional component', 'unitOfMeasure': '% of stained cells * intensity score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sulindac Effects on Vascular Endothelial Growth Factor (VEGF) Expression in Atypical Nevi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sulindac', 'description': 'Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '-13', 'upperLimit': '50'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-50', 'upperLimit': '35'}]}]}], 'analyses': [{'pValue': '0.386', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Change in VEGF expression in melanocytic junctional component', 'unitOfMeasure': '% of stained cells * intensity score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Association Between Plasma and Target Tissue Sulindac Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I', 'description': 'Participants receive oral sulindac twice daily for 8 weeks\n\nsulindac: Given orally\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Arm II', 'description': 'Participants receive oral placebo twice daily for 8 weeks\n\nplacebo: Inactive agent\n\nlaboratory biomarker analysis: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '0.41', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'unitOfMeasure': 'correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'The correlation between plasma and target tissue sulindac levels was analyzed for Arm I only because participants in Arm 2 did not have any measurable drug levels.'}, {'type': 'SECONDARY', 'title': 'Association Between Plasma and Target Tissue Sulindac Sulfone Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I', 'description': 'Participants receive oral sulindac twice daily for 8 weeks\n\nsulindac: Given orally\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Arm II', 'description': 'Participants receive oral placebo twice daily for 8 weeks\n\nplacebo: Inactive agent\n\nlaboratory biomarker analysis: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '0.13', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.58', 'groupIds': ['OG000'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'unitOfMeasure': 'correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'The correlation between plasma and target tissue sulindac sulfone levels was analyzed for Arm I only because participants in Arm 2 did not have any measurable drug levels.'}, {'type': 'SECONDARY', 'title': 'Association Between Plasma and Target Tissue Sulindac Sulfide Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I', 'description': 'Participants receive oral sulindac twice daily for 8 weeks\n\nsulindac: Given orally\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Arm II', 'description': 'Participants receive oral placebo twice daily for 8 weeks\n\nplacebo: Inactive agent\n\nlaboratory biomarker analysis: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '0.33', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.12', 'groupIds': ['OG000'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'unitOfMeasure': 'correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'The correlation between plasma and target tissue sulindac sulfide levels was analyzed for Arm I only because participants in Arm 2 did not have any measurable drug levels.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sulindac', 'description': 'Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sulindac', 'description': 'Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.2', 'spread': '10.0', 'groupId': 'BG000'}, {'value': '45.9', 'spread': '8.59', 'groupId': 'BG001'}, {'value': '46.0', 'spread': '9.24', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-30', 'studyFirstSubmitDate': '2009-02-10', 'resultsFirstSubmitDate': '2012-02-14', 'studyFirstSubmitQcDate': '2009-02-10', 'lastUpdatePostDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-02-14', 'studyFirstPostDateStruct': {'date': '2009-02-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sulindac Concentration in the Nevi (Moles)', 'timeFrame': '8 weeks'}, {'measure': 'Sulindac Sulfone, an Active Metabolite of Sulindac, Concentration in the Nevi', 'timeFrame': '8 weeks'}, {'measure': 'Sulindac Sulfide, an Active Metabolite of Sulindac, Concentration in the Nevi', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Sulindac Effects on Apoptosis in Atypical Nevi', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Change in the expression of a marker of apoptosis, cleaved caspase 3, in melanocytic junctional component'}, {'measure': 'Sulindac Effects on Vascular Endothelial Growth Factor (VEGF) Expression in Atypical Nevi', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Change in VEGF expression in melanocytic junctional component'}, {'measure': 'Association Between Plasma and Target Tissue Sulindac Levels', 'timeFrame': '8 weeks'}, {'measure': 'Association Between Plasma and Target Tissue Sulindac Sulfone Levels', 'timeFrame': '8 weeks'}, {'measure': 'Association Between Plasma and Target Tissue Sulindac Sulfide Levels', 'timeFrame': '8 weeks'}]}, 'conditionsModule': {'conditions': ['Precancerous Condition']}, 'descriptionModule': {'briefSummary': 'This randomized phase II trial is studying how well sulindac works in preventing melanoma in healthy participants who are at increased risk of melanoma. Sulindac may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether sulindac is more effective than a placebo in preventing melanoma in individuals with many moles and abnormal moles.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To determine sulindac and metabolite levels in healthy participants with atypical nevi and benign nevus at increased risk for melanoma treated with sulindac versus placebo.\n\nSECONDARY OBJECTIVES:\n\nI. To assess the effects of sulindac on apoptosis in atypical nevi of these participants.\n\nII. To assess the effects of sulindac on VEGF expression in atypical nevi of these participants.\n\nIII. To assess sulindac and metabolite levels in plasma and its association with drug levels in the target tissue.\n\nOUTLINE: This is a multicenter study. Participants are randomized to 1 of 2 treatment arms.\n\nARM I: Participants receive oral sulindac twice daily.\n\nARM II: Participants receive oral placebo twice daily.\n\nIn both arms, treatment continues for 8 weeks in the absence of unacceptable toxicity.\n\nBlood and tissue samples are collected at baseline and/or after completion of study therapy and analyzed for sulindac and metabolite levels via high performance liquid chromatography tandem mass spectrometry; the detection of apoptotic cells via TUNEL assay; and VEGF expression via immunohistochemistry assays.\n\nAfter completion of study therapy, participants are followed for 2 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Criteria:\n\n* Healthy participants at risk for developing melanoma and meeting the following criteria: must have \\>= 4 large (\\>= 5 mm and \\< 15 mm) atypical nevi and have 1 benign nevus amenable to biopsies\n* No histologically confirmed melanoma on the baseline biopsy\n* No more than 1 prior cutaneous melanoma\n* One prior stage I, IIA, or IIB melanoma allowed provided patients have been off treatment \\> 3 months\n* Modified dermoscopy score \\< 4.8\n* Karnofsky performance status 80-100%\n* ANC \\>= 1,500/mm\\^3\n* No family history of melanoma involving \\>= 2 first degree relatives\n* Platelets count \\>= 100,000/mm\\^3\n* Total bilirubin =\\< 2.0 mg/dL\n* AST/ALT =\\< 2.0 times upper limit of normal\n* Creatinine =\\< 1.5 mg/dL\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* More than 6 months since prior and no concurrent tanning bed use or other methods to promote sun-tanning\n* Willing to minimize sunlight exposure by applying sunscreen/sunblock or wearing clothing to shield skin during outdoor activity during study participation\n* Willing or able to limit alcohol consumption to less than 3 servings a week during the study period\n* No frequent, chronic or moderate/severe gastrointestinal (GI) complaints\n* Upper GI problems requiring prescription or nonprescription medical remedies for symptoms of heartburn, dyspepsia, nausea, or abdominal pain \\> once a week on average\n* History of peptic ulcer, occult or gross intestinal bleeding\n* No prior allergic reaction to aspirin (unless subsequent dosing with other NSAIDs has been well tolerated)\n* No history of allergic reaction to lidocaine or xylocaine\n* No history of allergic reaction (e.g., urticaria, asthma, or rhinitis) or gastric intolerance attributed to compounds of similar chemical or biological composition to sulindac\n* No invasive cancer or cancer treatment within the past 5 years, except nonmelanoma skin cancer\n* No immunosuppression by medication or disease, including any of the following: AIDS, oral prednisone, immunosuppressant/immunomodulator (i.e., cyclosporine, chemotherapeutic agent, or biologic therapy)\n* No uncontrolled intercurrent illness\n* No ongoing or active infection\n* No symptomatic congestive heart failure\n* No unstable angina pectoris\n* No cardiac arrhythmia\n* No psychiatric illness/social situations that would limit compliance with study requirements\n* At least 30 days since prior participation and no concurrent enrollment or planning to enroll in another clinical trial\n* No NSAIDs for more than 5 days per month within the past 3 months and no concurrent non-study NSAIDs, except low dose aspirin (81 mg/day)\n* Willing or able to refrain from herbal medicines, above-standard vitamins, or minerals during study\n* Standard daily multivitamin/mineral supplement (i.e., therapeutic doses of calcium and vitamin D for osteoporosis) allowed\n* No concurrent lithium, phenytoin, or sulfonamides\n* WBC \\>= 3,000/mm\\^3\n* No history of bleeding or clotting disorder\n* At least 3 months since prior and no concurrent coumadin or other systemic anticoagulant other than aspirin'}, 'identificationModule': {'nctId': 'NCT00841204', 'briefTitle': 'Sulindac in Preventing Melanoma in Healthy Participants Who Are at Increased Risk of Melanoma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase II Trial of Sulindac in Individuals at Increased Risk for Melanoma', 'orgStudyIdInfo': {'id': 'NCI-2009-01115'}, 'secondaryIdInfos': [{'id': 'NCI-2009-01115', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'UARIZ-08-0841-04'}, {'id': 'CDR0000633938'}, {'id': 'N01CN35158', 'link': 'https://reporter.nih.gov/quickSearch/N01CN35158', 'type': 'NIH'}, {'id': '08-0841-04', 'type': 'OTHER', 'domain': 'University of Arizona Health Sciences Center'}, {'id': 'UAZ05-2-10', 'type': 'OTHER', 'domain': 'DCP'}, {'id': 'P30CA023074', 'link': 'https://reporter.nih.gov/quickSearch/P30CA023074', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Participants receive oral sulindac twice daily for 8 weeks', 'interventionNames': ['Drug: sulindac', 'Other: laboratory biomarker analysis']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm II', 'description': 'Participants receive oral placebo twice daily for 8 weeks', 'interventionNames': ['Other: placebo', 'Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'sulindac', 'type': 'DRUG', 'otherNames': ['Aflodac', 'Algocetil', 'Clinoril', 'SULIN'], 'description': 'Given orally', 'armGroupLabels': ['Arm I']}, {'name': 'placebo', 'type': 'OTHER', 'otherNames': ['PLCB'], 'description': 'Inactive agent', 'armGroupLabels': ['Arm II']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I', 'Arm II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona Health Sciences Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Hospitals and Clinics', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Hsiao-Hui (Sherry) Chow', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona Health Sciences Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}