Viewing Study NCT03652818

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-25 @ 5:05 AM
Ignite Modification Date: 2026-02-23 @ 9:21 PM
Study NCT ID: NCT03652818
Status: COMPLETED
Last Update Posted: 2021-11-23
First Post: 2018-07-18
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Dental Pain Study of Analgesics in Patients Undergoing Molar Removal
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}}}}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinicaltrials@nevakar.com', 'phone': '(908) 367-7400', 'title': 'Eric Lang, MD', 'organization': 'Nevakar, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Day 15 (± 1 day)', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Group A/ Placebo Group', 'description': 'Pre-surgery placebo and post-surgery placebo 1 and placebo 2', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 2, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group B/ APAP Group', 'description': 'Pre-surgery placebo 1 and post-surgery placebo 1 and acetaminophen (APAP)', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 3, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group C/ PGB Group', 'description': 'Pre-surgery placebo 1 and post-surgery placebo 2 and pregabalin (PGB)', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 14, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Group D/ Combination Co-dosing Group', 'description': 'Pre-surgery placebo 1 and post-surgery APAP and PGB', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 15, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Group E/ Combination Split-dosing Group', 'description': 'Pre-surgery PGB and post-surgery placebo 1 and APAP', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 12, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Retching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Body temperature increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Muscle twitching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sum Pain Intensity Difference Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A/ Placebo Group', 'description': 'Pre-surgery placebo and post-surgery placebo 1 and placebo 2'}, {'id': 'OG001', 'title': 'Group B/ APAP Group', 'description': 'Pre-surgery placebo 1 and post-surgery placebo 1 and acetaminophen (APAP)'}, {'id': 'OG002', 'title': 'Group C/ PGB Group', 'description': 'Pre-surgery placebo 1 and post-surgery placebo 2 and pregabalin (PGB)'}, {'id': 'OG003', 'title': 'Group D/ Combination Co-dosing Group', 'description': 'Pre-surgery placebo 1 and post-surgery APAP and PGB'}, {'id': 'OG004', 'title': 'Group E/ Combination Split-dosing Group', 'description': 'Pre-surgery PGB and post-surgery placebo 1 and APAP'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.4292', 'spread': '12.4980', 'groupId': 'OG000'}, {'value': '-68.0778', 'spread': '11.2879', 'groupId': 'OG001'}, {'value': '-68.3533', 'spread': '11.8092', 'groupId': 'OG002'}, {'value': '-93.3645', 'spread': '11.5794', 'groupId': 'OG003'}, {'value': '-82.4099', 'spread': '17.4418', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG003'], 'paramType': 'Least Square (LS) Mean Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '90', 'paramValue': '-25.2868', 'ciUpperLimit': '-4.4210', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.1594', 'estimateComment': 'Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞', 'groupDescription': 'Group D vs. Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '90', 'paramValue': '-0.2756', 'ciUpperLimit': '20.8083', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.3283', 'estimateComment': 'Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞', 'groupDescription': 'Group C vs. Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '90', 'paramValue': '-65.9241', 'ciUpperLimit': '-43.6959', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '17.2146', 'estimateComment': 'Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞', 'groupDescription': 'Group C vs. Group A', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '90', 'paramValue': '-65.6486', 'ciUpperLimit': '-43.8584', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.8753', 'estimateComment': 'Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞', 'groupDescription': 'Group B vs. Group A', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '90', 'paramValue': '-90.9353', 'ciUpperLimit': '-68.8494', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '17.1044', 'estimateComment': 'Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞', 'groupDescription': 'Group D vs. Group A', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '90', 'paramValue': '-25.0112', 'ciUpperLimit': '-3.6571', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.5376', 'estimateComment': 'Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞', 'groupDescription': 'Group D vs. Group C', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '90', 'paramValue': '10.9546', 'ciUpperLimit': '38.1014', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '21.0237', 'estimateComment': 'Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞', 'groupDescription': 'Group E vs. Group D', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0.5, 0.75, 1, 1.25, 1.75, 2.25 hours (± 5 min) and 3.25, 4.25, 5.25, 6.25, 8.25, 10.25, 12.25, 24 hours (± 10 min)', 'description': 'Beginning post-surgery (at initiation of Dose 2), Pain Intensity was self-reported over 24 hours, using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with score between 0-10 (0= no pain; 10 = pain as bad as can be). Time weighted sum pain intensity difference scores are reported over 0 to 24 hours. Last observation carried forward method was used.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Population included all randomized participants who received study medication post-surgically and did not experience emesis or other major protocol deviations'}, {'type': 'PRIMARY', 'title': 'Total Pain Relief Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A/ Placebo Group', 'description': 'Pre-surgery placebo and post-surgery placebo 1 and placebo 2'}, {'id': 'OG001', 'title': 'Group B/ APAP Group', 'description': 'Pre-surgery placebo 1 and post-surgery placebo 1 and acetaminophen (APAP)'}, {'id': 'OG002', 'title': 'Group C/ PGB Group', 'description': 'Pre-surgery placebo 1 and post-surgery placebo 2 and pregabalin (PGB)'}, {'id': 'OG003', 'title': 'Group D/ Combination Co-dosing Group', 'description': 'Pre-surgery placebo 1 and post-surgery APAP and PGB'}, {'id': 'OG004', 'title': 'Group E/ Combination Split-dosing Group', 'description': 'Pre-surgery PGB and post-surgery placebo 1 and APAP'}], 'classes': [{'categories': [{'measurements': [{'value': '17.1038', 'spread': '15.5619', 'groupId': 'OG000'}, {'value': '88.2775', 'spread': '14.0551', 'groupId': 'OG001'}, {'value': '94.4433', 'spread': '14.7042', 'groupId': 'OG002'}, {'value': '121.9596', 'spread': '14.4180', 'groupId': 'OG003'}, {'value': '91.8373', 'spread': '21.7176', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '90', 'paramValue': '33.6821', 'ciLowerLimit': '7.7011', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '20.1209', 'estimateComment': 'Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞', 'groupDescription': 'Group D vs. Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '90', 'paramValue': '6.1658', 'ciLowerLimit': '-20.0868', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '20.3312', 'estimateComment': 'Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞', 'groupDescription': 'Group C vs. Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '90', 'paramValue': '77.3395', 'ciLowerLimit': '49.6620', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '21.4347', 'estimateComment': 'Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞', 'groupDescription': 'Group C vs. Group A', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '90', 'paramValue': '71.1737', 'ciLowerLimit': '44.0417', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '21.0123', 'estimateComment': 'Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞', 'groupDescription': 'Group B vs. Group A', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '90', 'paramValue': '104.8558', 'ciLowerLimit': '77.3555', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '21.2975', 'estimateComment': 'Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞', 'groupDescription': 'Group D vs. Group A', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '90', 'paramValue': '27.5163', 'ciLowerLimit': '0.9272', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '20.5918', 'estimateComment': 'Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞', 'groupDescription': 'Group D vs. Group C', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '90', 'paramValue': '-30.1223', 'ciLowerLimit': '-63.9240', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '26.1776', 'estimateComment': 'Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞', 'groupDescription': 'Group E vs. Group D', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0.5, 0.75, 1, 1.25, 1.75, 2.25 hours (± 5 min) and 3.25, 4.25, 5.25, 6.25, 8.25, 10.25, 12.25, 24 hours (± 10 min)', 'description': 'Beginning post-surgery (at initiation of Dose 2), Pain Relief was self-reported over 24 hours, using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with score between 0-10 (0= no pain; 10 = pain as bad as can be). Time-weighted sum pain total pain relief scores over 24 hours is reported Last observation carried forward method was used.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Population: Included all randomized participants who received study medication post-surgically and did not experience emesis or other major protocol deviations'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Differing Patient Global Evaluation Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A/ Placebo Group', 'description': 'Pre-surgery placebo and post-surgery placebo 1 and placebo 2'}, {'id': 'OG001', 'title': 'Group B/ APAP Group', 'description': 'Pre-surgery placebo 1 and post-surgery placebo 1 and acetaminophen (APAP)'}, {'id': 'OG002', 'title': 'Group C/ PGB Group', 'description': 'Pre-surgery placebo 1 and post-surgery placebo 2 and pregabalin (PGB)'}, {'id': 'OG003', 'title': 'Group D/ Combination Co-dosing Group', 'description': 'Pre-surgery placebo 1 and post-surgery APAP and PGB'}, {'id': 'OG004', 'title': 'Group E/ Combination Split-dosing Group', 'description': 'Pre-surgery PGB and post-surgery placebo 1 and APAP'}], 'classes': [{'title': '(0) Poor', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '(1) Fair', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '(2) Good', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '(3) Very good', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': '(4) Excellent', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Upto 12.25 hours', 'description': 'Patient global evaluation was self-reported at time of first rescue or at 12.25 hours post-surgery, whichever was first, using a 0-4 categorical rating scale of: (0) poor, (1) fair, (2) good, (3) very good, and (4) excellent. The number of participants with differing patient global evaluation scores were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Population: Included all randomized participants who received study medication post-surgically and did not experience emesis or other major protocol deviations'}, {'type': 'SECONDARY', 'title': 'Cumulative Number of Participants With Onset of First Perceptible Relief (FPR) Confirmed at 24 Hours After Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A/ Placebo Group', 'description': 'Pre-surgery placebo and post-surgery placebo 1 and placebo 2'}, {'id': 'OG001', 'title': 'Group B/ APAP Group', 'description': 'Pre-surgery placebo 1 and post-surgery placebo 1 and acetaminophen (APAP)'}, {'id': 'OG002', 'title': 'Group C/ PGB Group', 'description': 'Pre-surgery placebo 1 and post-surgery placebo 2 and pregabalin (PGB)'}, {'id': 'OG003', 'title': 'Group D/ Combination Co-dosing Group', 'description': 'Pre-surgery placebo 1 and post-surgery APAP and PGB'}, {'id': 'OG004', 'title': 'Group E/ Combination Split-dosing Group', 'description': 'Pre-surgery PGB and post-surgery placebo 1 and APAP'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0 and 24 hours', 'description': 'Beginning post-surgery (at initiation of Dose 2), participants were given a stopwatch and asked to press the stopwatch if and when they feel first perceptible relief; a record of the time was noted in the participants record. Cumulative number of participants with onset of FPR confirmed after dose 2 and was recorded from 0.25 hour till 24 hours after administration of dose 2.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Population: Included all randomized participants who received study medication post-surgically and did not experience emesis or other major protocol deviations'}, {'type': 'SECONDARY', 'title': 'Cumulative Number of Participants With Onset of Meaning Pain Relief (MPR) Confirmed at 24 Hours After Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A/ Placebo Group', 'description': 'Pre-surgery placebo and post-surgery placebo 1 and placebo 2'}, {'id': 'OG001', 'title': 'Group B/ APAP Group', 'description': 'Pre-surgery placebo 1 and post-surgery placebo 1 and acetaminophen (APAP)'}, {'id': 'OG002', 'title': 'Group C/ PGB Group', 'description': 'Pre-surgery placebo 1 and post-surgery placebo 2 and pregabalin (PGB)'}, {'id': 'OG003', 'title': 'Group D/ Combination Co-dosing Group', 'description': 'Pre-surgery placebo 1 and post-surgery APAP and PGB'}, {'id': 'OG004', 'title': 'Group E/ Combination Split-dosing Group', 'description': 'Pre-surgery PGB and post-surgery placebo 1 and APAP'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0 and 24 hours', 'description': 'Beginning post-surgery (at initiation of Dose 2), participants were given a stopwatch and asked to press the stopwatch if and when they feel first perceptible relief; a record of the time was noted in the participants record. Cumulative number of participants with onset of MPR confirmed after dose 2 and was recorded from 0.25 hour till 24 hours after administration of dose 2.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Population: Included all randomized participants who received study medication post-surgically and did not experience emesis or other major protocol deviations'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A/ Placebo Group', 'description': 'Participants received matching placebo capsule orally 60 ± 10 minutes (min) prior to initiating the surgical procedure. Post-surgically the participants received matching placebo capsule orally and matching placebo (saline 100mL) intravenously (IV). The IV infusion was administered over a 15 min period and the capsule was administered immediately prior to the initiation of the IV infusion'}, {'id': 'FG001', 'title': 'Group B/ Acetaminophen (APAP) 1000 mg IV Group', 'description': 'Participants received matching placebo capsule orally 60 ± 10 mins prior to initiating the surgical procedure. Post-surgically the participants received matching placebo capsule orally and APAP 1000 milligram (mg) IV. The IV infusion was administered over a 15 min period and the capsule was administered immediately prior to the initiation of the IV infusion.'}, {'id': 'FG002', 'title': 'Group C/ Pregabalin (PGB) 300 mg Capsule Group', 'description': 'Participants received matching placebo capsule orally 60 ± 10 mins prior to initiating the surgical procedure. Post-surgically the participants received PGB 300 mg capsule orally and matching placebo (saline 100mL) IV. The IV infusion was administered over a 15 min period and the capsule was administered immediately prior to the initiation of the IV infusion.'}, {'id': 'FG003', 'title': 'Group D/ Combination Co-dosing Group (Post-surgery PGB +APAP)', 'description': 'Participants received matching placebo capsule orally 60 ± 10 mins prior to initiating the surgical procedure. Post-surgically the participants received PGB 300 mg capsule orally and APAP 100 mg IV. The IV infusion was administered over a 15 min period and the capsule was administered immediately prior to the initiation of the IV infusion.'}, {'id': 'FG004', 'title': 'Group E/ Combination Split-dosing Group (PGB Pre-surgery + APAP Post-surgery)', 'description': 'Participants received PGB 300 mg capsule orally 60 ± 10 mins prior to initiating the surgical procedure. Post-surgically the participants received matching placebo capsule orally and APAP 1000 mg IV. The IV infusion was administered over a 15 min period and the capsule was administered immediately prior to the initiation of the IV infusion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '23'}, {'groupId': 'FG004', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited from June 2018 till September 2018 from the site', 'preAssignmentDetails': 'Participants were screened from Day-30 to Day 0 before getting randomized'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '115', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A/ Placebo Group', 'description': 'Pre-surgery placebo and post-surgery placebo 1 and placebo 2'}, {'id': 'BG001', 'title': 'Group B/ APAP Group', 'description': 'Pre-surgery placebo 1 and post-surgery placebo 1 and acetaminophen (APAP)'}, {'id': 'BG002', 'title': 'Group C/ PGB Group', 'description': 'Pre-surgery placebo 1 and post-surgery placebo 2 and pregabalin (PGB)'}, {'id': 'BG003', 'title': 'Group D/ Combination Co-dosing Group', 'description': 'Pre-surgery placebo 1 and post-surgery APAP and PGB'}, {'id': 'BG004', 'title': 'Group E/ Combination Split-dosing Group', 'description': 'Pre-surgery PGB and post-surgery placebo 1 and APAP'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '115', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '17.8', 'spread': '1.79', 'groupId': 'BG000'}, {'value': '17.8', 'spread': '1.48', 'groupId': 'BG001'}, {'value': '17.9', 'spread': '1.39', 'groupId': 'BG002'}, {'value': '17.7', 'spread': '0.93', 'groupId': 'BG003'}, {'value': '17.6', 'spread': '1.31', 'groupId': 'BG004'}, {'value': '17.7', 'spread': '1.39', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '115', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '58', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '115', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '106', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', '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': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '115', 'groupId': 'BG005'}]}], 'categories': [{'title': 'American Indian or Alaska Native', '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': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', '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': 'Black or African American', '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': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '110', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '115', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '22.86', 'spread': '3.716', 'groupId': 'BG000'}, {'value': '22.54', 'spread': '3.227', 'groupId': 'BG001'}, {'value': '22.78', 'spread': '3.825', 'groupId': 'BG002'}, {'value': '24.02', 'spread': '3.788', 'groupId': 'BG003'}, {'value': '23.85', 'spread': '3.695', 'groupId': 'BG004'}, {'value': '23.21', 'spread': '3.642', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Participants With Mandibular Molar - 17', 'classes': [{'title': 'Moderate to severe partial bony', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '114', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}]}]}, {'title': 'Full bony impaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '114', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '92', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.'}, {'title': 'Number of Participants With Mandibular Molar - 32', 'classes': [{'title': 'Moderate to severe partial bony', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '114', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}]}]}, {'title': 'Full bony impaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '114', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '90', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.'}, {'title': 'Number of Participants With Maxillary Molar -1', 'classes': [{'title': 'Erupted in tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '114', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}]}, {'title': 'Soft tissue impaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '114', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}, {'title': 'Moderate to severe partial bony', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '114', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}]}]}, {'title': 'Full bony impaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '114', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '97', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.'}, {'title': 'Number of Participants With Maxillary Molar -16', 'classes': [{'title': 'Erupted in tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '114', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}, {'title': 'Soft tissue impaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '114', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}, {'title': 'Mild partial bony impaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '114', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}, {'title': 'Moderate to severe partial bony', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '114', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}]}]}, {'title': 'Full bony impaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '114', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '97', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.'}], 'populationDescription': 'Baseline analysis population was randomized population, that included all randomized participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-10', 'size': 10652446, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-28T00:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'The sponsor, patients, investigators and study staff involved in the protocol procedures or those involved in data collection, data entry, data analysis will be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-25', 'studyFirstSubmitDate': '2018-07-18', 'resultsFirstSubmitDate': '2021-08-28', 'studyFirstSubmitQcDate': '2018-08-27', 'lastUpdatePostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-25', 'studyFirstPostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sum Pain Intensity Difference Scores', 'timeFrame': '0.5, 0.75, 1, 1.25, 1.75, 2.25 hours (± 5 min) and 3.25, 4.25, 5.25, 6.25, 8.25, 10.25, 12.25, 24 hours (± 10 min)', 'description': 'Beginning post-surgery (at initiation of Dose 2), Pain Intensity was self-reported over 24 hours, using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with score between 0-10 (0= no pain; 10 = pain as bad as can be). Time weighted sum pain intensity difference scores are reported over 0 to 24 hours. Last observation carried forward method was used.'}, {'measure': 'Total Pain Relief Measure', 'timeFrame': '0.5, 0.75, 1, 1.25, 1.75, 2.25 hours (± 5 min) and 3.25, 4.25, 5.25, 6.25, 8.25, 10.25, 12.25, 24 hours (± 10 min)', 'description': 'Beginning post-surgery (at initiation of Dose 2), Pain Relief was self-reported over 24 hours, using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with score between 0-10 (0= no pain; 10 = pain as bad as can be). Time-weighted sum pain total pain relief scores over 24 hours is reported Last observation carried forward method was used.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Differing Patient Global Evaluation Scores', 'timeFrame': 'Upto 12.25 hours', 'description': 'Patient global evaluation was self-reported at time of first rescue or at 12.25 hours post-surgery, whichever was first, using a 0-4 categorical rating scale of: (0) poor, (1) fair, (2) good, (3) very good, and (4) excellent. The number of participants with differing patient global evaluation scores were reported.'}, {'measure': 'Cumulative Number of Participants With Onset of First Perceptible Relief (FPR) Confirmed at 24 Hours After Dose 2', 'timeFrame': '0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0 and 24 hours', 'description': 'Beginning post-surgery (at initiation of Dose 2), participants were given a stopwatch and asked to press the stopwatch if and when they feel first perceptible relief; a record of the time was noted in the participants record. Cumulative number of participants with onset of FPR confirmed after dose 2 and was recorded from 0.25 hour till 24 hours after administration of dose 2.'}, {'measure': 'Cumulative Number of Participants With Onset of Meaning Pain Relief (MPR) Confirmed at 24 Hours After Dose 2', 'timeFrame': '0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0 and 24 hours', 'description': 'Beginning post-surgery (at initiation of Dose 2), participants were given a stopwatch and asked to press the stopwatch if and when they feel first perceptible relief; a record of the time was noted in the participants record. Cumulative number of participants with onset of MPR confirmed after dose 2 and was recorded from 0.25 hour till 24 hours after administration of dose 2.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Pain']}, 'descriptionModule': {'briefSummary': '* Accessing the efficacy and safety of pregabalin when used alone and in combo with acetaminophen in a dental pain model.\n* To test whether pre-operative dose of pregabalin increases the time to significant post-operative pain (NRS ≥ 5), and hence time to first analgesia consumed post-operatively.', 'detailedDescription': 'This is a 5 arm randomized, double-blind, parallel group, single-center, placebo-controlled study to evaluate the efficacy and safety of pregabalin-acetaminophen combination in the prevention and treatment of post-surgical dental pain in healthy patients.\n\nSubjects in every treatment arm will receive a dose 60 min prior to surgery. It is not required to receive a post-operative dose if patient does not feel pain at a scale of NRS≥ 5. Dose 2 will be given post-surgically when patients report at least moderate pain on the categorical scale and a score of ≥5 on 0-10 PI-NRS. Subsequent to dose 2, patients can request rescue analgesic at any time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who are scheduled to undergo the surgical removal of up to 4 third molars of which at least 2 have to be mandibular molars with a difficulty rating of 4 or 5.\n* Patient must have a negative urine drug screen for drugs of abuse (including tobacco) at screening and at the day of surgery.\n* No alcohol for a minimum of 1 day prior to the surgery.\n\nExclusion Criteria:\n\n* Patients should not be experiencing oral infections or symptoms of concomitant illness at the time of a scheduled surgery.\n* Patients with a history of any type of malignancy within the past 5 years other than minor skin related cancers.\n* Patients who currently have or have had a history of uncontrolled hypertension.\n* Patients with a known allergy or hypersensitivity to any local anesthetic drug, NSAIDs, gabapentin or pregabalin;.\n* Patients with conditions that affect the absorption, metabolism, or passage of drugs out of the body (e.g., sprue, celiac disease, crohn's disease, etc.)"}, 'identificationModule': {'nctId': 'NCT03652818', 'acronym': 'NVK009-0001', 'briefTitle': 'Dental Pain Study of Analgesics in Patients Undergoing Molar Removal', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nevakar, Inc.'}, 'officialTitle': 'Randomized, Double-blind, Parallel Group, Single-center, Placebo-controlled Study to Evaluate Efficacy and Safety of Analgesic Combo in Prevention and Treatment of Post-surgical Dental Pain in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CP-NVK009-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Pre-op Placebo 1;\n\nPost-op Placebo 1;\n\nPost-op Placebo 2', 'interventionNames': ['Drug: Pre-Op Placebo 1', 'Drug: Post-Op Placebo 1', 'Drug: Post-Op Placebo 2']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Pre-op Placebo 1;\n\nPost-op Placebo 2;\n\nPost-op acetaminophen.', 'interventionNames': ['Drug: Pre-Op Placebo 1', 'Drug: Post-Op Placebo 1', 'Drug: Post-Op acetaminophen']}, {'type': 'EXPERIMENTAL', 'label': 'Group C', 'description': 'Pre-op Placebo 1;\n\nPost-op pregabalin;\n\nPost-op Placebo 2.', 'interventionNames': ['Drug: Pre-Op Placebo 1', 'Drug: Post-Op pregabalin', 'Drug: Post-Op Placebo 2']}, {'type': 'EXPERIMENTAL', 'label': 'Group D', 'description': 'Pre-op Placebo 1;\n\nPost-op pregabalin\n\nPost-op acetaminophen.', 'interventionNames': ['Drug: Pre-Op Placebo 1', 'Drug: Post-Op pregabalin', 'Drug: Post-Op acetaminophen']}, {'type': 'EXPERIMENTAL', 'label': 'Group E', 'description': 'Pre-op pregabalin;\n\nPost-op Placebo 1;\n\nPost-op acetaminophen.', 'interventionNames': ['Drug: Pre-Op pregabalin', 'Drug: Post-Op Placebo 1', 'Drug: Post-Op acetaminophen']}], 'interventions': [{'name': 'Pre-Op pregabalin', 'type': 'DRUG', 'description': 'Pre-op pregabalin will be administered 60 min prior to surgery.', 'armGroupLabels': ['Group E']}, {'name': 'Pre-Op Placebo 1', 'type': 'DRUG', 'otherNames': ['pre-op placebo'], 'description': 'Placebo 1 will be administered 60 min prior to surgery.', 'armGroupLabels': ['Group A', 'Group B', 'Group C', 'Group D']}, {'name': 'Post-Op pregabalin', 'type': 'DRUG', 'description': 'Post-op pregabalin will be administered Post-operatively.', 'armGroupLabels': ['Group C', 'Group D']}, {'name': 'Post-Op Placebo 1', 'type': 'DRUG', 'description': 'Placebo 1 will be administered post-operatively.', 'armGroupLabels': ['Group A', 'Group B', 'Group E']}, {'name': 'Post-Op Placebo 2', 'type': 'DRUG', 'description': 'Placebo 2 will be administered post-operatively.', 'armGroupLabels': ['Group A', 'Group C']}, {'name': 'Post-Op acetaminophen', 'type': 'DRUG', 'description': 'Acetaminophen will be administered Post-operatively.', 'armGroupLabels': ['Group B', 'Group D', 'Group E']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Jean Brown Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Kenneth Somberg, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nevakar, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nevakar, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}