Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT00602420
Status:
COMPLETED
Last Update Posted:
2015-11-09
First Post:
2008-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009288', 'term': 'Naproxen'}], 'ancestors': [{'id': 'D009280', 'term': 'Naphthaleneacetic Acids'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'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': 'checkler@urmc.rochester.edu', 'phone': '585-273-1141', 'title': 'Charles E. Heckler, PhD, MS. Research Assistant Professor', 'organization': 'University of Rochester Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Naproxen', 'description': 'Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.\n\nnaproxen: Oral naproxen twice daily for 5-8 days.', 'otherNumAtRisk': 257, 'otherNumAffected': 4, 'seriousNumAtRisk': 257, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.\n\nplacebo: Oral placebo twice daily for 5-8 days.', 'otherNumAtRisk': 253, 'otherNumAffected': 3, 'seriousNumAtRisk': 253, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Supraventricular tachycardia (SVT); Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Infection - right breast w/ cellulitis, normal ANC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Acute pain secondary to marrow expansion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hospitalized d/t NV, Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Neutropenic fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 253, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under Curve (AUC) of Average Pain From Diary vs. Day (1-5), Calculated by the Trapezoidal Rule.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen', 'description': 'Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.\n\nnaproxen: Oral naproxen twice daily for 5-8 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.\n\nplacebo: Oral placebo twice daily for 5-8 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.04', 'groupId': 'OG000', 'lowerLimit': '4.94', 'upperLimit': '7.14'}, {'value': '7.71', 'groupId': 'OG001', 'lowerLimit': '6.59', 'upperLimit': '8.84'}]}]}], 'analyses': [{'pValue': '0.037', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.67', 'ciLowerLimit': '0.10', 'ciUpperLimit': '3.24', 'groupDescription': 'Tested at the two-sided 0.05 significance level.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Tested at the two-sided 0.05 significance level.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From baseline through day 5', 'description': 'Severity and duration of bone pain (day 1 being the day pegfilgrastim is administered) as measured by a daily diary. Patients recorded daily pain (Pain Scale Score) severity on a scale of 0 (no pain) to 10 (pain as bad as you can imagine) for the last 24 hours. The AUC range was 0-40, and the units are (Pain Scale Score)\\*Days.', 'unitOfMeasure': '(Pain Scale Score)*Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Naproxen', 'description': 'Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.\n\nnaproxen: Oral naproxen twice daily for 5-8 days.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.\n\nplacebo: Oral placebo twice daily for 5-8 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '257'}, {'groupId': 'FG001', 'numSubjects': '253'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '232'}, {'groupId': 'FG001', 'numSubjects': '229'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Chemotoxicity, Inc. Data,Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '253', 'groupId': 'BG001'}, {'value': '510', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Naproxen', 'description': 'Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.\n\nnaproxen: Oral naproxen twice daily for 5-8 days.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.\n\nplacebo: Oral placebo twice daily for 5-8 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.6', 'spread': '12.8', 'groupId': 'BG000'}, {'value': '56.8', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '56.2', 'spread': '12.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '222', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '86% female, 14% male patients.', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '228', 'groupId': 'BG000'}, {'value': '227', 'groupId': 'BG001'}, {'value': '455', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '257', 'groupId': 'BG000'}, {'value': '253', 'groupId': 'BG001'}, {'value': '510', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Tumor Type', 'classes': [{'title': 'Breast', 'categories': [{'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '341', 'groupId': 'BG002'}]}]}, {'title': 'Gynecologic', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': 'Hematologic', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'Lung', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Patients required to have diagnosis of nonmyeloid cancer and were approached for study participation before first dose of pegfilgrastim on day 2, 3, or 4 of chemotherapy cycle.', 'unitOfMeasure': 'participants'}, {'title': 'Marital Status', 'classes': [{'title': 'Married', 'categories': [{'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '360', 'groupId': 'BG002'}]}]}, {'title': 'Not Married', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education', 'classes': [{'title': 'Some college', 'categories': [{'measurements': [{'value': '180', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '344', 'groupId': 'BG002'}]}]}, {'title': 'High school or less', 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Previous tamoxifen', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '245', 'groupId': 'BG000'}, {'value': '240', 'groupId': 'BG001'}, {'value': '485', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Previous chemotherapy', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '369', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Previous Radiation Therapy', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '235', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '456', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pain at its worst in last 24 hours (scale, 0-10)', 'classes': [{'categories': [{'measurements': [{'value': '1.78', 'spread': '2.24', 'groupId': 'BG000'}, {'value': '1.87', 'spread': '2.23', 'groupId': 'BG001'}, {'value': '1.83', 'spread': '2.24', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Any rating of bone pain from 1 to 10 was considered a day with pain. "No pain" is an instance in which patients scored their pain 0, and "any pain" for all other responses. Severe pain was similarly defined as any bone pain score greater than 5.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Bone pain today or during previous 3 days (scale, 0-10)', 'classes': [{'categories': [{'measurements': [{'value': '0.47', 'spread': '1.44', 'groupId': 'BG000'}, {'value': '0.64', 'spread': '1.60', 'groupId': 'BG001'}, {'value': '0.56', 'spread': '1.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Any rating of bone pain from 1 to 10 was considered a day with pain. "No pain" is an instance in which patients scored their pain 0, and "any pain" for all other responses. Severe pain was similarly defined as any bone pain score greater than 5.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'At least 145 evaluable patients in each treatment group, thus 290 evaluable patients in total, required for an 80% power analysis.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 510}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-13', 'studyFirstSubmitDate': '2008-01-22', 'resultsFirstSubmitDate': '2014-06-24', 'studyFirstSubmitQcDate': '2008-01-22', 'lastUpdatePostDateStruct': {'date': '2015-11-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-05-08', 'studyFirstPostDateStruct': {'date': '2008-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under Curve (AUC) of Average Pain From Diary vs. Day (1-5), Calculated by the Trapezoidal Rule.', 'timeFrame': 'From baseline through day 5', 'description': 'Severity and duration of bone pain (day 1 being the day pegfilgrastim is administered) as measured by a daily diary. Patients recorded daily pain (Pain Scale Score) severity on a scale of 0 (no pain) to 10 (pain as bad as you can imagine) for the last 24 hours. The AUC range was 0-40, and the units are (Pain Scale Score)\\*Days.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pain', 'musculoskeletal complications', 'unspecified adult solid tumor, protocol specific'], 'conditions': ['Musculoskeletal Complications', 'Pain', 'Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Naproxen may help prevent or lessen bone pain caused by pegfilgrastim. It is not yet known whether naproxen is more effective than a placebo in preventing bone pain caused by pegfilgrastim in patients with non-hematologic cancer undergoing chemotherapy.\n\nPURPOSE: This randomized phase III trial is studying naproxen to see how well it works compared with a placebo in preventing bone pain caused by pegfilgrastim in patients with non-hematologic cancer undergoing chemotherapy.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To compare the efficacy of daily administration of naproxen vs placebo in preventing or reducing the severity and duration of pegfilgrastim-induced bone pain (PIBP) in patients with non-hematologic malignancies undergoing chemotherapy.\n\nSecondary\n\n* To identify potential risk factors for the development of PIBP.\n* To identify potential clinical predictors for the response or failure to respond to naproxen in preventing PIBP.\n* To assess the toxicity of naproxen when administered in the preventive setting.\n\nOUTLINE: This is a multicenter study. Patients are stratified by Clinical Community Oncology Program (CCOP) site. Patients are randomized to 1 treatment arm vs placebo.\n\n* Arm I: Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.\n* Arm II: Patients receive matching placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of a non-hematologic (non-myeloid) malignancy\n* Scheduled to receive chemotherapy; chemotherapy may be given for adjuvant, neoadjuvant, curative, or palliative intent\n* Scheduled to receive the first dose of pegfilgrastim (Neulasta®) to ameliorate chemotherapy-induced neutropenia\n* Creatinine ≤ 1.5 times upper limit of normal\n* Able to understand English\n* More than 6 months since prior surgery on the heart\n\nExclusion Criteria:\n\n* Pregnant or nursing\n* Clinical evidence of active gastrointestinal bleeding, prior gastrointestinal bleeding, or gastric or duodenal ulcers\n* Allergy to naproxen\n* Prior development of the triad of asthma, rhinitis, and nasal polyps after taking acetylsalicylic acid (aspirin) or other NSAIDs\n* Concurrent nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, or any product containing naproxen (e.g., Naprosyn, EC-Naprosyn, Anaprox, Anaprox-DS, Naprosyn suspension, or Aleve), on a regular basis\n* Concurrent steroids on a regular basis\n* Concurrent prescription or non-prescription medications for preexisting chronic pain; concurrent cardioprotective doses (≤ 325 mg/day) of aspirin allowed\n* Concurrent therapeutic doses of warfarin'}, 'identificationModule': {'nctId': 'NCT00602420', 'briefTitle': 'Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Prevention of Pegfilgrastim-Induced Bone Pain (PIBP): A Phase III Double-Blind Placebo-Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'CDR0000584341'}, 'secondaryIdInfos': [{'id': 'U10CA037420', 'link': 'https://reporter.nih.gov/quickSearch/U10CA037420', 'type': 'NIH'}, {'id': 'URCC-07079', 'type': 'OTHER', 'domain': 'URCC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Naproxen', 'description': 'Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.', 'interventionNames': ['Drug: naproxen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'naproxen', 'type': 'DRUG', 'description': 'Oral naproxen twice daily for 5-8 days.', 'armGroupLabels': ['Naproxen']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'Oral placebo twice daily for 5-8 days.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'MBCCOP - Hawaii', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '62526', 'city': 'Decatur', 'state': 'Illinois', 'country': 'United States', 'facility': 'CCOP - Central Illinois', 'geoPoint': {'lat': 39.84031, 'lon': -88.9548}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'CCOP - Evanston', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '67214-3882', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'CCOP - Wichita', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'CCOP - Grand Rapids', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '55416', 'city': 'Saint Louis Park', 'state': 'Minnesota', 'country': 'United States', 'facility': 'CCOP - Metro-Minnesota', 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}, {'zip': '64131', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'CCOP - Kansas City', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '13215', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'CCOP - Hematology-Oncology Associates of Central New York', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '27534-9479', 'city': 'Goldsboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'CCOP - Southeast Cancer Control Consortium', 'geoPoint': {'lat': 35.38488, 'lon': -77.99277}}, {'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'CCOP - Columbus', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '45429', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'CCOP - Dayton', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'CCOP - Greenville', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'CCOP - Upstate Carolina', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'CCOP - Virginia Mason Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98405-0986', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'CCOP - Northwest', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '54449', 'city': 'Marshfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'CCOP - Marshfield Clinic Research Foundation', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}], 'overallOfficials': [{'name': 'Jeffrey J. Kirshner, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'CCOP - Hematology-Oncology Associates of Central New York'}, {'name': 'Gary R. Morrow, PhD, MS', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Rochester'}, {'name': 'Jeffrey K. Giguere, MD, FACP', 'role': 'STUDY_CHAIR', 'affiliation': 'CCOP - Greenville'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gary Morrow', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director, URCC / University of Rochester NCORP Research Base', 'investigatorFullName': 'Gary Morrow', 'investigatorAffiliation': 'University of Rochester NCORP Research Base'}}}}