Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2025-12-28 @ 1:10 PM
Study NCT ID:
NCT00740857
Status:
COMPLETED
Last Update Posted:
2011-06-06
First Post:
2008-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Comparing the Efficacy of Two Ibuprofen Formulations
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintrialresults@wyeth.com', 'title': 'U. S. Contact Center', 'organization': 'Wyeth'}, 'certainAgreement': {'otherDetails': 'The PI agreed to allow the sponsor 30 days to review and approve abstracts and 60 days to review and approve manuscripts prior to submission to protect against disclosure of confidential information.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': '2 placebo gel capsules delivered as a single dose up to 5 hours after surgery', 'otherNumAtRisk': 33, 'otherNumAffected': 13, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ibuprofen Formulation 1', 'description': '2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery', 'otherNumAtRisk': 88, 'otherNumAffected': 2, 'seriousNumAtRisk': 88, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Ibuprofen Formulation 2', 'description': '2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery', 'otherNumAtRisk': 90, 'otherNumAffected': 7, 'seriousNumAtRisk': 90, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry socket', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedural site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Meaningful Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 placebo gel capsules delivered as a single dose up to 5 hours after surgery'}, {'id': 'OG001', 'title': 'Ibuprofen Formulation 1', 'description': '2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery'}, {'id': 'OG002', 'title': 'Ibuprofen Formulation 2', 'description': '2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '45.4', 'groupId': 'OG001', 'lowerLimit': '41.5', 'upperLimit': '53.5'}, {'value': '63.6', 'groupId': 'OG002', 'lowerLimit': '58.6', 'upperLimit': '84.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '0-6 hours', 'description': 'Subjects evaluated the time to "First Perceptible" Relief by depressing a stopwatch at the moment they first began to experience "perceptible" relief and the time to "Meaningful" Relief by depressing a second stopwatch at the moment they first began to experience "meaningful" relief. These times were recorded up to 6 hrs after dosing. Range: up to 6 hrs, a lower number is better.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS). Median pain relief was not reached for the placebo participants within 360 minutes.', 'anticipatedPostingDate': '2009-10'}, {'type': 'SECONDARY', 'title': 'Pain Intensity Difference (PID) Scores at Each Individual Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 placebo gel capsules delivered as a single dose up to 5 hours after surgery'}, {'id': 'OG001', 'title': 'Ibuprofen Formulation 1', 'description': '2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery'}, {'id': 'OG002', 'title': 'Ibuprofen Formulation 2', 'description': '2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery'}], 'classes': [{'title': '15 minutes', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.3', 'groupId': 'OG002'}]}]}, {'title': '30 minutes', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': '45 minutes', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': '60 minutes', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': '90 minutes', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': '120 minutes', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': '180 minutes', 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': '240 minutes', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': '300 minutes', 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': '360 minutes', 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '0.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.118', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': '15 minutes', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With treatment, baseline Pain Severity Rating (PSR), and gender terms.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The 30, 45, 60....', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With treatment, baseline Pain Severity Rating (PSR), and gender terms.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0-6 hours', 'description': 'PID is based on the 4-point categorical pain severity score ranging from 0 (none) to 3 (severe), this value was derived by subtracting the score at each post-dosing time point from the baseline score, so that a higher positive value is indicative of greater improvement.', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).', 'anticipatedPostingDate': '2009-10'}, {'type': 'SECONDARY', 'title': 'Pain Relief (PR) Scores at Individual Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 placebo gel capsules delivered as a single dose up to 5 hours after surgery'}, {'id': 'OG001', 'title': 'Ibuprofen Formulation 1', 'description': '2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery'}, {'id': 'OG002', 'title': 'Ibuprofen Formulation 2', 'description': '2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery'}], 'classes': [{'title': '15 minutes', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': '30 minutes', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': '45 minutes', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': '60 minutes', 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': '90 minutes', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': '120 minutes', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': '180 minutes', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': '240 minutes', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': '300 minutes', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '1.3', 'groupId': 'OG002'}]}]}, {'title': '360 minutes', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '1.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.041', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': '15 minutes', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With treatment, baseline Pain Severity Rating (PSR), and gender terms.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The 30, 45, 60, 90, 120, 180, 240, 300 and 360 minute individual time points all have the same P-value score.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With treatment, baseline Pain Severity Rating (PSR), and gender terms.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0-6 hours', 'description': 'Response to the question "How much pain do you have from your starting pain?" was recorded on a 5-point categorical pain relief scale (None (0), A Little (1), Some (2), A Lot (3) or Complete (4)) at designated time points after study medication was taken.', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).', 'anticipatedPostingDate': '2009-10'}, {'type': 'SECONDARY', 'title': 'Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours and 0-6 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 placebo gel capsules delivered as a single dose up to 5 hours after surgery'}, {'id': 'OG001', 'title': 'Ibuprofen Formulation 1', 'description': '2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery'}, {'id': 'OG002', 'title': 'Ibuprofen Formulation 2', 'description': '2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery'}], 'classes': [{'title': '0-2 hours', 'categories': [{'measurements': [{'value': '1.8', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '2.9', 'groupId': 'OG001'}, {'value': '6.3', 'spread': '2.6', 'groupId': 'OG002'}]}]}, {'title': '0-6 hours', 'categories': [{'measurements': [{'value': '6.5', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '24.0', 'spread': '10.1', 'groupId': 'OG001'}, {'value': '23.0', 'spread': '9.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With treatment, baseline Pain Severity Rating (PSR), and gender terms.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0-2 and 0-6 hours', 'description': 'SPRID is a derived endpoint from the pain relief and pain intensity difference scores from 0-2 hours and 0-6 hours. PRID=PID+Pain Relief Score. SPRID-02 range: -2 (worst) to 14 (best); SPRID 06 range: -6 (worst) to 42 (best).', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).', 'anticipatedPostingDate': '2009-10'}, {'type': 'SECONDARY', 'title': 'Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 placebo gel capsules delivered as a single dose up to 5 hours after surgery'}, {'id': 'OG001', 'title': 'Ibuprofen Formulation 1', 'description': '2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery'}, {'id': 'OG002', 'title': 'Ibuprofen Formulation 2', 'description': '2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery'}], 'classes': [{'title': '15 minutes', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': '30 minutes', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': '45 minutes', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '1.7', 'groupId': 'OG002'}]}]}, {'title': '60 minutes', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '1.7', 'groupId': 'OG002'}]}]}, {'title': '90 minutes', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '1.7', 'groupId': 'OG002'}]}]}, {'title': '120 minutes', 'categories': [{'measurements': [{'value': '1.0', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '1.7', 'groupId': 'OG002'}]}]}, {'title': '180 minutes', 'categories': [{'measurements': [{'value': '1.2', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '1.8', 'groupId': 'OG002'}]}]}, {'title': '240 minutes', 'categories': [{'measurements': [{'value': '1.5', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '2.0', 'groupId': 'OG002'}]}]}, {'title': '300 minutes', 'categories': [{'measurements': [{'value': '1.0', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '2.2', 'groupId': 'OG002'}]}]}, {'title': '360 minutes', 'categories': [{'measurements': [{'value': '1.0', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '3.9', 'spread': '2.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.056', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': '15 minutes', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The 30, 45, 60, 90, 120, 180, 240, 300 and 360 minute individual time points all have the same P-value score.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0-6 hours', 'description': 'PRID (PRID=PID+PR) is a derived endpoint from the pain relief and pain intensity difference scores at each time point. Range: -1 (worst) to 7 (best).', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).', 'anticipatedPostingDate': '2009-10'}, {'type': 'SECONDARY', 'title': 'Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 placebo gel capsules delivered as a single dose up to 5 hours after surgery'}, {'id': 'OG001', 'title': 'Ibuprofen Formulation 1', 'description': '2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery'}, {'id': 'OG002', 'title': 'Ibuprofen Formulation 2', 'description': '2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery'}], 'classes': [{'title': '0-2 hours', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': '0-6 hours', 'categories': [{'measurements': [{'value': '1.4', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '4.8', 'groupId': 'OG001'}, {'value': '8.1', 'spread': '4.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0-2 and 0-6 hours', 'description': 'SPID is a derived endpoint from the pain intensity difference scores from 0-2 hours and 0-6 hours. Range: -2 (worst) to 6 (best); -6 (worst) to 18 (best).', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).', 'anticipatedPostingDate': '2009-10'}, {'type': 'SECONDARY', 'title': 'Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 placebo gel capsules delivered as a single dose up to 5 hours after surgery'}, {'id': 'OG001', 'title': 'Ibuprofen Formulation 1', 'description': '2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery'}, {'id': 'OG002', 'title': 'Ibuprofen Formulation 2', 'description': '2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery'}], 'classes': [{'title': '0-2 hours', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '1.6', 'groupId': 'OG002'}]}]}, {'title': '0-6 hours', 'categories': [{'measurements': [{'value': '5.1', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '15.4', 'spread': '5.7', 'groupId': 'OG001'}, {'value': '14.9', 'spread': '5.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0-2 and 0-6 hours', 'description': 'TOTPAR is a derived endpoint from the pain relief scores from 0-2 hours and 0-6 hours. Range: 0 (worst) - 8 (best); 0 (worst) - 24 (best)', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).', 'anticipatedPostingDate': '2009-10'}, {'type': 'SECONDARY', 'title': 'Time to First Perceptible Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 placebo gel capsules delivered as a single dose up to 5 hours after surgery'}, {'id': 'OG001', 'title': 'Ibuprofen Formulation 1', 'description': '2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery'}, {'id': 'OG002', 'title': 'Ibuprofen Formulation 2', 'description': '2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '23.7', 'groupId': 'OG001', 'lowerLimit': '20.6', 'upperLimit': '26.6'}, {'value': '28.6', 'groupId': 'OG002', 'lowerLimit': '25.9', 'upperLimit': '31.5'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '0-6 hours', 'description': 'The elapsed time from dosing until the patient indicated first perceptible relief, provided the subject also indicated achieving meaningful relief.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS). Median pain relief was not reached for the placebo participants within 360 minutes.', 'anticipatedPostingDate': '2009-10'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': '2 placebo gel capsules delivered as a single dose up to 5 hours after surgery'}, {'id': 'FG001', 'title': 'Ibuprofen Formulation 1', 'description': '2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery'}, {'id': 'FG002', 'title': 'Ibuprofen Formulation 2', 'description': '2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '88'}, {'groupId': 'FG002', 'numSubjects': '90'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '88'}, {'groupId': 'FG002', 'numSubjects': '90'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were recruited in the United States from August 2008 to October 2008.', 'preAssignmentDetails': "During the screening period, the Investigator or his/her designee examined each subject and completed a checklist of the inclusion/exclusion criteria in order to determine the patient's eligibility. Surgery occurred within 14 days of the screening visit."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '211', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': '2 placebo gel capsules delivered as a single dose up to 5 hours after surgery'}, {'id': 'BG001', 'title': 'Ibuprofen Formulation 1', 'description': '2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery'}, {'id': 'BG002', 'title': 'Ibuprofen Formulation 2', 'description': '2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'spread': '2.7', 'groupId': 'BG000'}, {'value': '18.5', 'spread': '2.5', 'groupId': 'BG001'}, {'value': '19.0', 'spread': '3.0', 'groupId': 'BG002'}, {'value': '18.8', 'spread': '2.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-01', 'studyFirstSubmitDate': '2008-08-22', 'resultsFirstSubmitDate': '2009-10-30', 'studyFirstSubmitQcDate': '2008-08-22', 'lastUpdatePostDateStruct': {'date': '2011-06-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-07-15', 'studyFirstPostDateStruct': {'date': '2008-08-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Meaningful Pain Relief', 'timeFrame': '0-6 hours', 'description': 'Subjects evaluated the time to "First Perceptible" Relief by depressing a stopwatch at the moment they first began to experience "perceptible" relief and the time to "Meaningful" Relief by depressing a second stopwatch at the moment they first began to experience "meaningful" relief. These times were recorded up to 6 hrs after dosing. Range: up to 6 hrs, a lower number is better.'}], 'secondaryOutcomes': [{'measure': 'Pain Intensity Difference (PID) Scores at Each Individual Time Points', 'timeFrame': '0-6 hours', 'description': 'PID is based on the 4-point categorical pain severity score ranging from 0 (none) to 3 (severe), this value was derived by subtracting the score at each post-dosing time point from the baseline score, so that a higher positive value is indicative of greater improvement.'}, {'measure': 'Pain Relief (PR) Scores at Individual Time Points', 'timeFrame': '0-6 hours', 'description': 'Response to the question "How much pain do you have from your starting pain?" was recorded on a 5-point categorical pain relief scale (None (0), A Little (1), Some (2), A Lot (3) or Complete (4)) at designated time points after study medication was taken.'}, {'measure': 'Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours and 0-6 Hours', 'timeFrame': '0-2 and 0-6 hours', 'description': 'SPRID is a derived endpoint from the pain relief and pain intensity difference scores from 0-2 hours and 0-6 hours. PRID=PID+Pain Relief Score. SPRID-02 range: -2 (worst) to 14 (best); SPRID 06 range: -6 (worst) to 42 (best).'}, {'measure': 'Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points', 'timeFrame': '0-6 hours', 'description': 'PRID (PRID=PID+PR) is a derived endpoint from the pain relief and pain intensity difference scores at each time point. Range: -1 (worst) to 7 (best).'}, {'measure': 'Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours', 'timeFrame': '0-2 and 0-6 hours', 'description': 'SPID is a derived endpoint from the pain intensity difference scores from 0-2 hours and 0-6 hours. Range: -2 (worst) to 6 (best); -6 (worst) to 18 (best).'}, {'measure': 'Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours', 'timeFrame': '0-2 and 0-6 hours', 'description': 'TOTPAR is a derived endpoint from the pain relief scores from 0-2 hours and 0-6 hours. Range: 0 (worst) - 8 (best); 0 (worst) - 24 (best)'}, {'measure': 'Time to First Perceptible Relief', 'timeFrame': '0-6 hours', 'description': 'The elapsed time from dosing until the patient indicated first perceptible relief, provided the subject also indicated achieving meaningful relief.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dental pain analgesia'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'This is a study of healthy volunteers to compare how quickly different ibuprofen products relieve dental pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria :\n\n* Outpatients with post-operative pain following surgical extraction of third molars,\n* examined by the attending dentist or physician and medically cleared to participate in the study,\n* in general good health and have no contraindications to the study or rescue medication.\n\nExclusions criteria:\n\n* any serious medical condition,\n* acute localized dental infection at the time of surgery ,\n* females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically approved method of contraception.'}, 'identificationModule': {'nctId': 'NCT00740857', 'briefTitle': 'Study Comparing the Efficacy of Two Ibuprofen Formulations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Study Comparing the Efficacy of Two Ibuprofen Formulations', 'orgStudyIdInfo': {'id': 'PV-08-24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: ibuprofen Formulation 1']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: ibuprofen Formulation 2']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'description': '2 placebo gels capsules delivered as a single dose.', 'armGroupLabels': ['1']}, {'name': 'ibuprofen Formulation 1', 'type': 'DRUG', 'description': '2 marketed ibuprofen gels', 'armGroupLabels': ['2']}, {'name': 'ibuprofen Formulation 2', 'type': 'DRUG', 'description': '2 marketed ibuprofen gels', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Wyeth (Registry Contact: Clinical Trial Registry Specialist)', 'oldOrganization': 'Wyeth'}}}}