Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-29 @ 8:38 AM
Study NCT ID:
NCT01229228
Status:
COMPLETED
Last Update Posted:
2012-05-22
First Post:
2010-10-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Naproxen Capsules to Treat Dental Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014098', 'term': 'Toothache'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005157', 'term': 'Facial Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'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': 'sjensen@iroko.com', 'phone': '267-546-3003', 'title': 'Steven Jensen', 'organization': 'Iroko Pharmaceuticals, LLC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Naproxen Test (Lower Dose)', 'otherNumAtRisk': 51, 'otherNumAffected': 28, 'seriousNumAtRisk': 50, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Naproxen Test (Upper Dose)', 'otherNumAtRisk': 51, 'otherNumAffected': 27, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Naprosyn 250 mg', 'otherNumAtRisk': 50, 'otherNumAffected': 25, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Naprosyn 500 mg', 'otherNumAtRisk': 51, 'otherNumAffected': 26, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Placebo', 'otherNumAtRisk': 51, 'otherNumAffected': 31, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1 or higher'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1 or higher'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1 or higher'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1 or higher'}, {'term': 'Post procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1 or higher'}, {'term': 'Post procedural swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1 or higher'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1 or higher'}], 'seriousEvents': [{'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1 or higher'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Test (Lower Dose)', 'description': '200-mg single dose'}, {'id': 'OG001', 'title': 'Naproxen Test (Upper Dose)', 'description': '400-mg (2 x 200-mg)'}, {'id': 'OG002', 'title': 'Naprosyn 250 mg'}, {'id': 'OG003', 'title': 'Naprosyn 500 mg'}, {'id': 'OG004', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '25.868', 'groupId': 'OG000', 'lowerLimit': '21.943', 'upperLimit': '29.792'}, {'value': '31.948', 'groupId': 'OG001', 'lowerLimit': '28.065', 'upperLimit': '35.831'}, {'value': '24.373', 'groupId': 'OG002', 'lowerLimit': '20.442', 'upperLimit': '28.304'}, {'value': '28.549', 'groupId': 'OG003', 'lowerLimit': '24.660', 'upperLimit': '32.439'}, {'value': '9.531', 'groupId': 'OG004', 'lowerLimit': '5.646', 'upperLimit': '13.416'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.417', 'ciLowerLimit': '16.923', 'ciUpperLimit': '27.910', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.7891', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Over 0 to 12 Hours', 'description': 'Total pain relief as computed as a time-weighted sum of individual patient pain relief scores at each timepoint from 0-12 hours.\n\nValues for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max\n\nThe TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 60.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Naproxen Test (Lower Dose)'}, {'id': 'FG001', 'title': 'Naproxen Test (Upper Dose)'}, {'id': 'FG002', 'title': 'Naprosyn 250 mg'}, {'id': 'FG003', 'title': 'Naprosyn 500 mg'}, {'id': 'FG004', 'title': 'Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '50'}, {'groupId': 'FG003', 'numSubjects': '51'}, {'groupId': 'FG004', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '49'}, {'groupId': 'FG003', 'numSubjects': '51'}, {'groupId': 'FG004', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '254', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Naproxen Test (Lower Dose)'}, {'id': 'BG001', 'title': 'Naproxen Test (Upper Dose)'}, {'id': 'BG002', 'title': 'Naprosyn 250 mg'}, {'id': 'BG003', 'title': 'Naprosyn 500 mg'}, {'id': 'BG004', 'title': 'Placebo'}, {'id': 'BG005', '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '254', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '21.1', 'spread': '2.93', 'groupId': 'BG000'}, {'value': '21.1', 'spread': '3.29', 'groupId': 'BG001'}, {'value': '20.7', 'spread': '2.20', 'groupId': 'BG002'}, {'value': '20.9', 'spread': '2.88', 'groupId': 'BG003'}, {'value': '21.1', 'spread': '3.02', 'groupId': 'BG004'}, {'value': '21.0', 'spread': '2.87', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '148', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '106', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '254', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 254}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-15', 'studyFirstSubmitDate': '2010-10-25', 'resultsFirstSubmitDate': '2011-11-22', 'studyFirstSubmitQcDate': '2010-10-26', 'lastUpdatePostDateStruct': {'date': '2012-05-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-03-01', 'studyFirstPostDateStruct': {'date': '2010-10-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0', 'timeFrame': 'Over 0 to 12 Hours', 'description': 'Total pain relief as computed as a time-weighted sum of individual patient pain relief scores at each timepoint from 0-12 hours.\n\nValues for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max\n\nThe TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 60.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dental Pain']}, 'referencesModule': {'references': [{'pmid': '24127200', 'type': 'DERIVED', 'citation': 'Young CL, Strand V, Altman R, Daniels S. A phase 2 study of naproxen submicron particle capsules in patients with post-surgical dental pain. Adv Ther. 2013 Oct;30(10):885-96. doi: 10.1007/s12325-013-0057-9. Epub 2013 Oct 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether Naproxen Test Formulation Capsules are safe and effective for the treatment of dental pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient is male or female between 18 and 50 years of age\n* For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control\n* Patient requires extraction of 2 or more third molars\n* Patient must be willing to stay at the study site overnight\n\nExclusion Criteria:\n\n* Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs\n* Patient has a current disease or history of a disease that will impact the study or the patient's well-being\n* Patient has used or intends to use any of the medications that are prohibited by the protocol\n* Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test\n* Patient has taken another investigational drug within 30 days prior to screening"}, 'identificationModule': {'nctId': 'NCT01229228', 'briefTitle': 'Study of Naproxen Capsules to Treat Dental Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Iroko Pharmaceuticals, LLC'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blind, Single-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Naproxen [Test] Capsules for the Treatment of Pain After Surgical Removal of Impacted Third Molars', 'orgStudyIdInfo': {'id': 'NAP2-08-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Naproxen Test (lower dose)', 'description': '200-mg', 'interventionNames': ['Drug: Naproxen Test']}, {'type': 'EXPERIMENTAL', 'label': 'Naproxen Test (upper dose)', 'description': '400-mg (2 x 200-mg)', 'interventionNames': ['Drug: Naproxen Test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Naprosyn 250 mg', 'interventionNames': ['Drug: Naprosyn']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Naprosyn 500 mg', 'interventionNames': ['Drug: Naprosyn']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Naproxen Test', 'type': 'DRUG', 'description': '200-mg single dose', 'armGroupLabels': ['Naproxen Test (lower dose)']}, {'name': 'Naproxen Test', 'type': 'DRUG', 'description': '400-mg (2 x 200-mg)', 'armGroupLabels': ['Naproxen Test (upper dose)']}, {'name': 'Naprosyn', 'type': 'DRUG', 'description': 'single dose', 'armGroupLabels': ['Naprosyn 250 mg']}, {'name': 'Naprosyn', 'type': 'DRUG', 'description': 'single dose', 'armGroupLabels': ['Naprosyn 500 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'single dose', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Premier Research Group Limited', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iroko Pharmaceuticals, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}