Ignite Creation Date:
2025-12-24 @ 12:13 PM
Ignite Modification Date:
2025-12-29 @ 7:41 PM
Study NCT ID:
NCT01266161
Status:
COMPLETED
Last Update Posted:
2018-08-15
First Post:
2010-12-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multiple Dose Dental Pain Study Of Ibuprofen Extended Release
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D014098', 'term': 'Toothache'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005157', 'term': 'Facial Pain'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007052', 'term': 'Ibuprofen'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours', 'otherNumAtRisk': 52, 'otherNumAffected': 23, 'seriousNumAtRisk': 52, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ibuprofen', 'description': 'Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours', 'otherNumAtRisk': 54, 'otherNumAffected': 8, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Skin burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pain of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores From 0 to 12 Hours After the First Dose (SPRID 0-12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}, {'id': 'OG001', 'title': 'Ibuprofen', 'description': 'Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '18.2', 'spread': '20.0', 'groupId': 'OG000'}, {'value': '41.5', 'spread': '21.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.76', 'ciLowerLimit': '16.45', 'ciUpperLimit': '31.07', 'pValueComment': 'p-Value from analysis of variance (ANOVA) model, with treatment, baseline PSR, gender terms. To protect type I error at 5% significance, 2 primary parameters tested sequentially: SPRID 8-12 not declared significant unless SPRID 0-12 was significant.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 hours', 'description': 'SPRID is time-weighted sum of pain relief (PR) plus pain intensity (PI) difference (PID) (PRID) scores. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0 equals \\[=\\] none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for PI: "How much pain do you have at this time?" (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement in pain intensity. SPRID 0-12 score ranged from -12 to 84; higher score indicated better efficacy.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: Randomized participants with at least moderate baseline pain (score 2 on the pain severity rating \\[PSR\\] scale) confirmed by a score of at least 50 millimeter (mm) on the 100-mm visual analog scale (VAS)-PSR, within approximately 5 hours after surgery, provided a baseline assessment, and received study medication.'}, {'type': 'PRIMARY', 'title': 'Sum of Pain Relief and Pain Intensity Difference Scores From 8-12 Hours After the First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}, {'id': 'OG001', 'title': 'Ibuprofen', 'description': 'Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'spread': '12.0', 'groupId': 'OG000'}, {'value': '18.4', 'spread': '12.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.42', 'ciLowerLimit': '4.13', 'ciUpperLimit': '12.71', 'pValueComment': 'p-Value from ANOVA model, with treatment, baseline PSR, and gender terms. To protect type I error at 5% significance, 2 primary parameters tested sequentially: SPRID 8-12 not declared significant unless SPRID 0-12 was significant.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '8 to 12 hours', 'description': 'SPRID is time-weighted sum of PR plus PID (PRID) scores. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0=none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for pain intensity: "How much pain do you have at this time?" (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement (decrease) in pain intensity. SPRID 8-12 score ranged from -4 to 28; higher score indicated better efficacy.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Time-weighted Sum of Pain Intensity Difference (SPID) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}, {'id': 'OG001', 'title': 'Ibuprofen', 'description': 'Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}], 'classes': [{'title': 'SPID 0-12', 'categories': [{'measurements': [{'value': '4.1', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '9.5', 'groupId': 'OG001'}]}]}, {'title': 'SPID 8-12', 'categories': [{'measurements': [{'value': '2.5', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '5.2', 'groupId': 'OG001'}]}]}, {'title': 'SPID 12-24', 'categories': [{'measurements': [{'value': '12.5', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '18.7', 'spread': '11.7', 'groupId': 'OG001'}]}]}, {'title': 'SPID 20-24', 'categories': [{'measurements': [{'value': '8.8', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '10.7', 'spread': '7.3', 'groupId': 'OG001'}]}]}, {'title': 'SPID 0-24', 'categories': [{'measurements': [{'value': '15.5', 'spread': '19.3', 'groupId': 'OG000'}, {'value': '29.9', 'spread': '18.8', 'groupId': 'OG001'}]}]}, {'title': 'SPID 24-36', 'categories': [{'measurements': [{'value': '16.2', 'spread': '15.2', 'groupId': 'OG000'}, {'value': '21.6', 'spread': '13.9', 'groupId': 'OG001'}]}]}, {'title': 'SPID 32-36', 'categories': [{'measurements': [{'value': '7.0', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '10.2', 'spread': '7.4', 'groupId': 'OG001'}]}]}, {'title': 'SPID 36-48', 'categories': [{'measurements': [{'value': '17.4', 'spread': '14.2', 'groupId': 'OG000'}, {'value': '23.0', 'spread': '13.8', 'groupId': 'OG001'}]}]}, {'title': 'SPID 44-48', 'categories': [{'measurements': [{'value': '10.5', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '12.7', 'spread': '7.3', 'groupId': 'OG001'}]}]}, {'title': 'SPID 24-48', 'categories': [{'measurements': [{'value': '30.5', 'spread': '25.2', 'groupId': 'OG000'}, {'value': '40.7', 'spread': '23.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.95', 'ciLowerLimit': '5.94', 'ciUpperLimit': '11.95', 'pValueComment': 'p-Value from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'For SPID 0-12.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.15', 'ciLowerLimit': '1.45', 'ciUpperLimit': '4.85', 'pValueComment': 'p-Value from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'For SPID 8-12.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.56', 'ciLowerLimit': '2.84', 'ciUpperLimit': '10.27', 'pValueComment': 'p-Value from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'For SPID 12-24.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.091', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.02', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '4.37', 'pValueComment': 'p-Value from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'For SPID 20-24.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.95', 'ciLowerLimit': '9.12', 'ciUpperLimit': '20.79', 'pValueComment': 'p-Value from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'For SPID 0-24.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.87', 'ciLowerLimit': '1.42', 'ciUpperLimit': '10.33', 'pValueComment': 'p-Value from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'For SPID 24-36.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.48', 'ciLowerLimit': '1.13', 'ciUpperLimit': '5.83', 'pValueComment': 'p-Value from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'For SPID 32-36.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.09', 'ciLowerLimit': '1.82', 'ciUpperLimit': '10.36', 'pValueComment': 'p-Value from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'For SPID 36-48.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.042', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.41', 'ciLowerLimit': '0.09', 'ciUpperLimit': '4.73', 'pValueComment': 'p-Value from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'For SPID 44-48.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.97', 'ciLowerLimit': '3.49', 'ciUpperLimit': '18.45', 'pValueComment': 'p-Value from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'For SPID 24-48.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '0 to 12 hours, 8 to 12 hours, 12 to 24 hours, 20 to 24 hours, 0 to 24 hours, 24 to 36 hours, 32 to 36 hours, 36 to 48 hours, 44 to 48 hours, 24 to 48 hours', 'description': 'SPID is a derived endpoint from PID scores. For pain intensity, "How much pain do you have at this time?" answered on a 4-point categorical scale (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement (decrease) in pain intensity. SPID scores ranged as follows: 0 to 12 hour (-11.5 to 35.5), 8 to 12 hour (-6.0 to 18.0), 12 to 24 hour (-14.0 to 42.0), 20 to 24 hour (-8.0 to 24.0), 0 to 24 hour (-23.5 to 71.5), 24 to 36 hour (-16.0 to 48.0), 32 to 36 hour (-8.0 to 24.0), 36 to 48 hour (-16.0 to 48.0), 44 to 48 hour (-8.0 to 24.0), 24 to 48 hour (-28.0 to 84.0); higher positive values indicated improvement (decrease) in pain intensity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Time to First Dose of Rescue Medication After First Dose of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}, {'id': 'OG001', 'title': 'Ibuprofen', 'description': 'Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '2.2'}, {'value': 'NA', 'comment': 'Median time was more than 12 hours. 95% CI was not estimable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '0.10', 'ciUpperLimit': '0.34', 'statisticalMethod': 'proportional hazards model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 12 hours', 'description': 'During the first 12 hours of the study, participants not experiencing adequate relief after the 1-hour time point were allowed to take a single tablet (dose) of acetaminophen/hydrocodone hydrochloride (HCl) 500 mg/5 mg as a rescue medication (the only rescue medication allowed). The time at which rescue medication was taken was recorded.', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Here, "Number of participants analysed signifies those participants who were evaluable for this outcome measures".'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Taking Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}, {'id': 'OG001', 'title': 'Ibuprofen', 'description': 'Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}], 'classes': [{'title': 'First dosing interval (0 to 12 hours)', 'categories': [{'measurements': [{'value': '76.9', 'groupId': 'OG000'}, {'value': '29.6', 'groupId': 'OG001'}]}]}, {'title': 'Second dosing interval (12 to 24 hours)', 'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000'}, {'value': '5.6', 'groupId': 'OG001'}]}]}, {'title': 'Third dosing interval (24 to 36 hours)', 'categories': [{'measurements': [{'value': '32.7', 'groupId': 'OG000'}, {'value': '9.3', 'groupId': 'OG001'}]}]}, {'title': 'Fourth dosing interval (36 to 48 hours)', 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000'}, {'value': '5.6', 'groupId': 'OG001'}]}]}, {'title': 'Overall during the study (0 to 48 hours)', 'categories': [{'measurements': [{'value': '78.8', 'groupId': 'OG000'}, {'value': '31.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciPctValue': '95', 'paramValue': '-48.01', 'ciLowerLimit': '-64.46', 'ciUpperLimit': '-31.56', 'pValueComment': 'p-Values from the Cochran-Mantel-Haenszel (CMH) test, controlling for baseline PSR and gender.', 'groupDescription': 'During the first dosing interval (0 to 12 hours).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciPctValue': '95', 'paramValue': '-25.53', 'ciLowerLimit': '-39.78', 'ciUpperLimit': '-11.28', 'pValueComment': 'p-Values from the CMH test, controlling for baseline PSR and gender.', 'groupDescription': 'During the second dosing interval (12 to 24 hours).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciPctValue': '95', 'paramValue': '-24.05', 'ciLowerLimit': '-38.93', 'ciUpperLimit': '-9.18', 'pValueComment': 'p-Values from the CMH test, controlling for baseline PSR and gender.', 'groupDescription': 'During the third dosing interval (24 to 36 hours).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.035', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciPctValue': '95', 'paramValue': '-13.60', 'ciLowerLimit': '-26.41', 'ciUpperLimit': '-0.79', 'pValueComment': 'p-Values from the CMH test, controlling for baseline PSR and gender.', 'groupDescription': 'During the fourth dosing interval (36 to 48 hours).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciPctValue': '95', 'paramValue': '-48.01', 'ciLowerLimit': '-64.42', 'ciUpperLimit': '-31.60', 'pValueComment': 'p-Values from the CMH test, controlling for baseline PSR and gender.', 'groupDescription': 'During the study overall (0 to 48 hours).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox proportional hazard models', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.086', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.57', 'groupDescription': 'Time to First Dose Rescue Medication Over Entire Study Period (0-48 Hours)', 'statisticalMethod': 'Andersen-Gill (AG)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 48 hours', 'description': 'Participants not experiencing adequate relief after the 1-hour time point during each dosing interval were allowed to take a single tablet (dose) of acetaminophen/hydrocodone HCl 500 mg/5 mg as a rescue medication (the only rescue medication allowed) during each interval.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Pain Relief (PR) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}, {'id': 'OG001', 'title': 'Ibuprofen', 'description': 'Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}], 'classes': [{'title': '0.5 hours', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': '1 hour', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': '1.5 hours', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': '2 hours', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': '4 hours', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': '6 hours', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': '8 hours', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': '10 hours', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': '12 hours', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.50', 'ciUpperLimit': '1.19', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 0.5 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '1.53', 'ciLowerLimit': '1.11', 'ciUpperLimit': '1.94', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 1 hour.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '2.00', 'ciLowerLimit': '1.56', 'ciUpperLimit': '2.44', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 1.5 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '2.29', 'ciLowerLimit': '1.86', 'ciUpperLimit': '2.73', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 2 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '2.18', 'ciLowerLimit': '1.69', 'ciUpperLimit': '2.68', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 4 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.46', 'ciUpperLimit': '1.38', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline PSR, and gender terms.', 'estimateComment': 'Treatment difference (ibuprofen minus placebo) and corresponding 95% CI were calculated based on least-squares means from the ANOVA model.', 'groupDescription': 'Ibuprofen versus placebo at 6 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1.54', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 8 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.59', 'ciUpperLimit': '1.60', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 10 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.052', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '-0.00', 'ciUpperLimit': '1.01', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 12 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours', 'description': 'A 5-point categorical pain relief rating scale was used to rate pain relief in response to the question: "How much relief do you have from your starting pain?" Responses were scored as follows: 0=none, 1=a little, 2=some, 3=a lot, 4=complete. Higher score indicated more pain relief.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Pain Intensity Difference (PID) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}, {'id': 'OG001', 'title': 'Ibuprofen', 'description': 'Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}], 'classes': [{'title': '0.5 hours', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': '1 hour', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': '1.5 hours', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': '2 hours', 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': '4 hours', 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': '6 hours', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': '8 hours', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': '10 hours', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': '12 hours', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': '16 hours', 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': '20 hours', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': '24 hours', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': '28 hours', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': '32 hours', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': '36 hours', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': '40 hours', 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': '44 hours', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': '48 hours', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '0.37', 'ciLowerLimit': '0.16', 'ciUpperLimit': '0.59', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 0.5 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.63', 'ciUpperLimit': '1.18', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 1 hour.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.52', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 1.5 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '1.40', 'ciLowerLimit': '1.10', 'ciUpperLimit': '1.71', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 2 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '1.32', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.67', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 4 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '0.61', 'ciLowerLimit': '0.30', 'ciUpperLimit': '0.91', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 6 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.31', 'ciUpperLimit': '0.97', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 8 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.36', 'ciUpperLimit': '0.97', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 10 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.089', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.59', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 12 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.29', 'pValueComment': 'Ibuprofen versus placebo at 0.5 hours.', 'groupDescription': 'Ibuprofen versus placebo at 16 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '0.47', 'ciLowerLimit': '0.15', 'ciUpperLimit': '0.78', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 20 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.821', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.35', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 24 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '0.56', 'ciLowerLimit': '0.23', 'ciUpperLimit': '0.90', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 28 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '0.30', 'ciUpperLimit': '0.94', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 32 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.127', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.57', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 36 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '0.67', 'ciLowerLimit': '0.35', 'ciUpperLimit': '1.00', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 40 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.036', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '0.34', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.67', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 44 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.091', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.56', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 48 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 hours', 'description': 'For pain intensity, "How much pain do you have at this time?" answered on a 4-point categorical scale. Responses were scored as follows: 0=none, 1=mild, 2=moderate, 3=severe. PID score=baseline pain intensity score minus score at each time point. PID scores ranged from -1 to 3. Higher positive PID scores indicated greater improvement (decrease in pain intensity).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Pain Relief Combined With Pain Intensity (PRID) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}, {'id': 'OG001', 'title': 'Ibuprofen', 'description': 'Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}], 'classes': [{'title': '0.5 hours', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': '1 hour', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': '1.5 hours', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': '2 hours', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': '4 hours', 'categories': [{'measurements': [{'value': '0.8', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': '6 hours', 'categories': [{'measurements': [{'value': '2.5', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': '8 hours', 'categories': [{'measurements': [{'value': '1.8', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': '10 hours', 'categories': [{'measurements': [{'value': '1.3', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': '12 hours', 'categories': [{'measurements': [{'value': '2.0', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.74', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 0.5 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '2.43', 'ciLowerLimit': '1.77', 'ciUpperLimit': '3.09', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 1 hour.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '3.22', 'ciLowerLimit': '2.49', 'ciUpperLimit': '3.95', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 1.5 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '3.70', 'ciLowerLimit': '2.98', 'ciUpperLimit': '4.42', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 2 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '3.50', 'ciLowerLimit': '2.67', 'ciUpperLimit': '4.33', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 4 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '1.53', 'ciLowerLimit': '0.79', 'ciUpperLimit': '2.27', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 6 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '1.67', 'ciLowerLimit': '0.87', 'ciUpperLimit': '2.48', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 8 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '1.76', 'ciLowerLimit': '0.97', 'ciUpperLimit': '2.54', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 10 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.056', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '1.58', 'pValueComment': 'p-Values from ANOVA model with treatment, baseline PSR, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 12 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours', 'description': 'PRID score=PR plus PID. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0=none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for pain intensity: "How much pain do you have at this time?" (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; PID score ranged from -1 to 3; higher positive PID value=improvement. PRID scores ranged from -1 to 7. Higher PRID scores indicated better pain relief and decrease in pain intensity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Time-weighted Sum of Pain Relief Scores (TOTPAR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}, {'id': 'OG001', 'title': 'Ibuprofen', 'description': 'Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}], 'classes': [{'title': 'TOTPAR 0 to 12', 'categories': [{'measurements': [{'value': '14.1', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '28.7', 'spread': '12.3', 'groupId': 'OG001'}]}]}, {'title': 'TOTPAR 8 to 12', 'categories': [{'measurements': [{'value': '7.8', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '7.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.82', 'ciLowerLimit': '10.38', 'ciUpperLimit': '19.25', 'pValueComment': 'p-Value from ANOVA model with treatment, baseline pain severity, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo at 0 to 12 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.27', 'ciLowerLimit': '2.57', 'ciUpperLimit': '7.98', 'pValueComment': 'p-Value from ANOVA model with treatment, baseline pain severity, and gender terms.', 'groupDescription': 'Ibuprofen versus placebo from 8 to 12 hours.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '0-12 hours, 8-12 hours', 'description': 'TOTPAR is a derived endpoint from PR scores. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0=none, 1=a little, 2=some, 3=a lot, 4=complete). TOTPAR 0-12 scores ranged from 0 (worst) to 48 (best). TOTPAR 8-12 scores ranged from 0 (worst) to 16 (best).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Doses of Rescue Medication Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}, {'id': 'OG001', 'title': 'Ibuprofen', 'description': 'Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}], 'classes': [{'title': 'First dosing interval (0-12 hours)', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Second dosing interval (12-24 hours)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'Third dosing interval (24-36 hours)', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Fourth dosing interval (36-48 hours)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Overall during the study (0-48 hours)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'CMH-adjusted proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.73', 'ciLowerLimit': '-0.91', 'ciUpperLimit': '-0.55', 'pValueComment': 'p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.', 'groupDescription': 'For the first dosing interval.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'CMH-adjusted proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.72', 'ciLowerLimit': '-1.05', 'ciUpperLimit': '-0.40', 'pValueComment': 'Treatment difference (ibuprofen minus placebo) and corresponding 95% CI were calculated based on CMH-adjusted proportions and corresponding standard errors.', 'groupDescription': 'For the second dosing interval.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'CMH-adjusted proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.48', 'ciLowerLimit': '-0.90', 'ciUpperLimit': '-0.06', 'pValueComment': 'p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.', 'groupDescription': 'For the third dosing interval.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.021', 'groupIds': ['OG000'], 'paramType': 'CMH-adjusted proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.68', 'ciLowerLimit': '-1.02', 'ciUpperLimit': '-0.35', 'pValueComment': 'p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.', 'groupDescription': 'For the fourth dosing interval.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'CMH-adjusted proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.70', 'ciLowerLimit': '-0.89', 'ciUpperLimit': '-0.51', 'pValueComment': 'p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.', 'groupDescription': 'For the overall study duration.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '0-12, 12-24, 24-36, 36-48, 0-48 hours', 'unitOfMeasure': 'doses', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Time to Confirmed First Perceptible Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}, {'id': 'OG001', 'title': 'Ibuprofen', 'description': 'Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median time to first perceptible relief was more than 720 minutes. 95% CI was not estimable.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '20.1', 'upperLimit': '28.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 12 hours', 'description': 'The elapsed time from dosing until the participant indicated first perceptible pain relief by pressing the first stopwatch, provided the participant also indicated achieving meaningful relief by pressing the second stopwatch. Perceptible relief defined as when participant first began to feel any pain-relieving effect whatsoever of the drug. Did not necessarily mean the participant felt completely better, but when the participant first felt any difference in the pain he/she is currently feeling.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Here, "Number of participants analysed signifies those participants who were evaluable for this outcome measures".'}, {'type': 'SECONDARY', 'title': 'Time to Meaningful Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}, {'id': 'OG001', 'title': 'Ibuprofen', 'description': 'Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Time to meaningful relief was more than 720 minutes. 95% CI not calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '54.2', 'groupId': 'OG001', 'lowerLimit': '46.5', 'upperLimit': '79.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 12 hours', 'description': 'Participants evaluated the time to meaningful relief by depressing a second stopwatch at the moment they first began to experience meaningful relief, defined as relief from the pain that was considered meaningful to the participant.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Here, "Number of participants analysed signifies those participants who were evaluable for this outcome measures".'}, {'type': 'SECONDARY', 'title': 'Participant Global Evaluation Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}, {'id': 'OG001', 'title': 'Ibuprofen', 'description': 'Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}], 'classes': [{'title': '24 hours', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': '48 hours', 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Gamma statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.74', 'ciUpperLimit': '0.95', 'pValueComment': 'p-Value from the CMH test with modified ridit scores, controlling for baseline PSR score and gender.', 'groupDescription': 'Ibuprofen versus placebo at 24 hours', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Gamma statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.66', 'ciUpperLimit': '0.92', 'groupDescription': 'Ibuprofen versus placebo at 48 hours', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'p-Value from the CMH test with modified ridit scores, controlling for baseline PSR score and gender.'}], 'paramType': 'MEAN', 'timeFrame': '24 and 48 hours', 'description': 'Participants responded, on a 6-point categorical scale, to the following question: "How would you rate this medication as a pain-reliever?" Responses on this categorical scale ranged as follows: 0=very poor, 1=poor, 2=fair, 3=good, 4=very good, 5=excellent.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}, {'id': 'FG001', 'title': 'Ibuprofen', 'description': 'Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Vomited within 4 hours of dosing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}, {'id': 'BG001', 'title': 'Ibuprofen', 'description': 'Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '21.1', 'spread': '3.3', 'groupId': 'BG000'}, {'value': '21.3', 'spread': '3.6', 'groupId': 'BG001'}, {'value': '21.2', 'spread': '3.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pain Severity', 'classes': [{'title': 'Moderate', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'A 4-point categorical pain severity rating scale was used to rate the severity of baseline pain in response to the query " My starting pain is:" Responses ranged and were scored as follows: None (0), Mild (1), Moderate (2), Severe (3). A baseline pain intensity score of at least moderate was required for study enrollment.', 'unitOfMeasure': 'participants'}, {'title': 'Pain Intensity', 'classes': [{'categories': [{'measurements': [{'value': '73.8', 'spread': '12.25', 'groupId': 'BG000'}, {'value': '75.7', 'spread': '12.18', 'groupId': 'BG001'}, {'value': '74.8', 'spread': '12.20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'A 100-millimeter (mm) visual analog scale-pain severity rating (VAS-PSR) rated intensity of baseline pain. Participants were asked to "Draw a single vertical line on the scale that shows how much pain you have at this time." Scores on this 100-mm linear scale measured to nearest millimeter from left. Zero on the scale represented no pain and 100 represented the worst pain. Score of at least 50 mm required for enrolment.', 'unitOfMeasure': 'millimeter', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'dispFirstSubmitDate': '2012-04-19', 'completionDateStruct': {'date': '2011-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-13', 'studyFirstSubmitDate': '2010-12-22', 'dispFirstSubmitQcDate': '2012-04-19', 'resultsFirstSubmitDate': '2013-02-20', 'studyFirstSubmitQcDate': '2010-12-22', 'dispFirstPostDateStruct': {'date': '2012-04-24', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-13', 'studyFirstPostDateStruct': {'date': '2010-12-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores From 0 to 12 Hours After the First Dose (SPRID 0-12)', 'timeFrame': 'Baseline to 12 hours', 'description': 'SPRID is time-weighted sum of pain relief (PR) plus pain intensity (PI) difference (PID) (PRID) scores. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0 equals \\[=\\] none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for PI: "How much pain do you have at this time?" (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement in pain intensity. SPRID 0-12 score ranged from -12 to 84; higher score indicated better efficacy.'}, {'measure': 'Sum of Pain Relief and Pain Intensity Difference Scores From 8-12 Hours After the First Dose', 'timeFrame': '8 to 12 hours', 'description': 'SPRID is time-weighted sum of PR plus PID (PRID) scores. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0=none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for pain intensity: "How much pain do you have at this time?" (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement (decrease) in pain intensity. SPRID 8-12 score ranged from -4 to 28; higher score indicated better efficacy.'}], 'secondaryOutcomes': [{'measure': 'Time-weighted Sum of Pain Intensity Difference (SPID) Scores', 'timeFrame': '0 to 12 hours, 8 to 12 hours, 12 to 24 hours, 20 to 24 hours, 0 to 24 hours, 24 to 36 hours, 32 to 36 hours, 36 to 48 hours, 44 to 48 hours, 24 to 48 hours', 'description': 'SPID is a derived endpoint from PID scores. For pain intensity, "How much pain do you have at this time?" answered on a 4-point categorical scale (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement (decrease) in pain intensity. SPID scores ranged as follows: 0 to 12 hour (-11.5 to 35.5), 8 to 12 hour (-6.0 to 18.0), 12 to 24 hour (-14.0 to 42.0), 20 to 24 hour (-8.0 to 24.0), 0 to 24 hour (-23.5 to 71.5), 24 to 36 hour (-16.0 to 48.0), 32 to 36 hour (-8.0 to 24.0), 36 to 48 hour (-16.0 to 48.0), 44 to 48 hour (-8.0 to 24.0), 24 to 48 hour (-28.0 to 84.0); higher positive values indicated improvement (decrease) in pain intensity.'}, {'measure': 'Time to First Dose of Rescue Medication After First Dose of Study Drug', 'timeFrame': 'Baseline to 12 hours', 'description': 'During the first 12 hours of the study, participants not experiencing adequate relief after the 1-hour time point were allowed to take a single tablet (dose) of acetaminophen/hydrocodone hydrochloride (HCl) 500 mg/5 mg as a rescue medication (the only rescue medication allowed). The time at which rescue medication was taken was recorded.'}, {'measure': 'Percentage of Participants Taking Rescue Medication', 'timeFrame': 'Baseline to 48 hours', 'description': 'Participants not experiencing adequate relief after the 1-hour time point during each dosing interval were allowed to take a single tablet (dose) of acetaminophen/hydrocodone HCl 500 mg/5 mg as a rescue medication (the only rescue medication allowed) during each interval.'}, {'measure': 'Pain Relief (PR) Scores', 'timeFrame': '0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours', 'description': 'A 5-point categorical pain relief rating scale was used to rate pain relief in response to the question: "How much relief do you have from your starting pain?" Responses were scored as follows: 0=none, 1=a little, 2=some, 3=a lot, 4=complete. Higher score indicated more pain relief.'}, {'measure': 'Pain Intensity Difference (PID) Scores', 'timeFrame': '0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 hours', 'description': 'For pain intensity, "How much pain do you have at this time?" answered on a 4-point categorical scale. Responses were scored as follows: 0=none, 1=mild, 2=moderate, 3=severe. PID score=baseline pain intensity score minus score at each time point. PID scores ranged from -1 to 3. Higher positive PID scores indicated greater improvement (decrease in pain intensity).'}, {'measure': 'Pain Relief Combined With Pain Intensity (PRID) Scores', 'timeFrame': '0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours', 'description': 'PRID score=PR plus PID. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0=none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for pain intensity: "How much pain do you have at this time?" (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; PID score ranged from -1 to 3; higher positive PID value=improvement. PRID scores ranged from -1 to 7. Higher PRID scores indicated better pain relief and decrease in pain intensity.'}, {'measure': 'Time-weighted Sum of Pain Relief Scores (TOTPAR)', 'timeFrame': '0-12 hours, 8-12 hours', 'description': 'TOTPAR is a derived endpoint from PR scores. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0=none, 1=a little, 2=some, 3=a lot, 4=complete). TOTPAR 0-12 scores ranged from 0 (worst) to 48 (best). TOTPAR 8-12 scores ranged from 0 (worst) to 16 (best).'}, {'measure': 'Number of Doses of Rescue Medication Used', 'timeFrame': '0-12, 12-24, 24-36, 36-48, 0-48 hours'}, {'measure': 'Time to Confirmed First Perceptible Relief', 'timeFrame': 'Baseline to 12 hours', 'description': 'The elapsed time from dosing until the participant indicated first perceptible pain relief by pressing the first stopwatch, provided the participant also indicated achieving meaningful relief by pressing the second stopwatch. Perceptible relief defined as when participant first began to feel any pain-relieving effect whatsoever of the drug. Did not necessarily mean the participant felt completely better, but when the participant first felt any difference in the pain he/she is currently feeling.'}, {'measure': 'Time to Meaningful Relief', 'timeFrame': 'Baseline to 12 hours', 'description': 'Participants evaluated the time to meaningful relief by depressing a second stopwatch at the moment they first began to experience meaningful relief, defined as relief from the pain that was considered meaningful to the participant.'}, {'measure': 'Participant Global Evaluation Score', 'timeFrame': '24 and 48 hours', 'description': 'Participants responded, on a 6-point categorical scale, to the following question: "How would you rate this medication as a pain-reliever?" Responses on this categorical scale ranged as follows: 0=very poor, 1=poor, 2=fair, 3=good, 4=very good, 5=excellent.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dental pain', 'multiple dose', 'ibuprofen', 'third molar extraction'], 'conditions': ['Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3491001&StudyName=Multiple%20Dose%20Dental%20Pain%20Study%20Of%20Ibuprofen%20Extended%20Release', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The study hypothesis is that single and multiple doses of ibuprofen 600 mg ER caplets provide analgesic efficacy superior to placebo over 12-hour dosing intervals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females 16 to 40 years of age\n* Subjects who undergo surgical removal of at least two third molars\n* One of which must be a partial or full bony mandibular impaction\n* Subjects must have at least moderate baseline pain (a score of 2 on the categorical pain severity rating scale) confirmed by a score of at least 50 mm on the 100-mm visual analog scale-pain severity rating scale (VAS-PSR)\n\nExclusion Criteria:\n\n* Acute localized dental infection at the time of surgery that could confound the post-surgical evaluation\n* Presence or history of any significant organ disease\n* Use of prescription or OTC first generation antihistamines\n* Females who are pregnant, lactating or of childbearing potential and not using a medically approved method to prevent pregnancy'}, 'identificationModule': {'nctId': 'NCT01266161', 'briefTitle': 'Multiple Dose Dental Pain Study Of Ibuprofen Extended Release', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Multiple Dose Dental Pain Study Of An Ibuprofen 600 Mg Extended Release Caplet', 'orgStudyIdInfo': {'id': 'B3491001'}, 'secondaryIdInfos': [{'id': 'AK-10-13', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ibuprofen 600 mg extended release', 'interventionNames': ['Drug: Ibuprofen 600 mg ER']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ibuprofen 600 mg ER', 'type': 'DRUG', 'description': 'One 600 mg caplet dosed at 0, 12, 24 and 36 hours', 'armGroupLabels': ['Ibuprofen 600 mg extended release']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'One placebo caplet dosed at times 0, 12, 24 and 36 hours', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Central Texas Oral Surgery Associates', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Premier Research', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}