Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2026-01-24 @ 11:27 PM
Study NCT ID:
NCT03224403
Status:
COMPLETED
Last Update Posted:
2021-04-15
First Post:
2017-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized, Double-Blind, Single-Dose, Efficacy and Safety Study of Test Acetaminophen Tablet in Postoperative Dental Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'AMyers3@its.jnj.com', 'phone': '(215) 273-8421 USA EST', 'title': 'Andrew Myers, MD', 'organization': 'JNJWorldwide'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "Beginning with signing of the informed consent form and continuing within 7 days after dental surgery for non-serious adverse events, +30 days after the subject's last dose or exposure to the investigational product for serious adverse events.", 'description': 'AEs were systematically collected during the study and at the follow-up telephone interview within 7 days after surgery along with spontaneously reported AEs. Any clinically important abnormalities or causally-related AEs persisting were followed until resolution or until reaching a clinically stable endpoint. SAEs required immediate notification to the Sponsor. Any SAE occurring after the reporting period was to be promptly reported if a causal relationship to study product was suspected.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Two placebo caplets taken orally', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 9, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Test ACM 1000 mg', 'description': 'Two test acetaminophen 500 mg tablets taken orally', 'otherNumAtRisk': 249, 'deathsNumAtRisk': 249, 'otherNumAffected': 13, 'seriousNumAtRisk': 249, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Commercial ACM 1000 mg', 'description': 'Two test acetaminophen 500 mg tablets taken orally', 'otherNumAtRisk': 232, 'deathsNumAtRisk': 232, 'otherNumAffected': 16, 'seriousNumAtRisk': 232, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Commercial IBU 400 mg', 'description': 'Two commercial ibuprofen 400 mg liquid-filled capsules taken orally', 'otherNumAtRisk': 124, 'deathsNumAtRisk': 124, 'otherNumAffected': 7, 'seriousNumAtRisk': 124, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.0'}], 'seriousEvents': [{'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.0'}, {'term': 'Abortion Spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Confirmed Perceptible Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '124', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo caplets taken orally'}, {'id': 'OG001', 'title': 'Test ACM 1000 mg', 'description': 'Two test acetaminophen 500 mg tablets taken orally'}, {'id': 'OG002', 'title': 'Commercial ACM 1000 mg', 'description': 'Two commercial acetaminophen 500 mg caplets taken orally'}, {'id': 'OG003', 'title': 'Commercial IBU 400 mg', 'description': 'Two commercial ibuprofen 200 mg liquid-filled capsules taken orally'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median time to confirmed perceptible pain relief was not estimable since fewer than 50% of the participants treated with Placebo obtained confirmed perceptible pain relief.', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '240'}, {'value': '15.7', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '240'}, {'value': '20.2', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '240'}, {'value': '23.2', 'groupId': 'OG003', 'lowerLimit': '2.5', 'upperLimit': '240'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.', 'statisticalMethod': 'Wilcoxon test from SAS PROC LIFETEST', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.', 'statisticalMethod': 'Wilcoxon test from SAS PROC LIFETEST', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.', 'statisticalMethod': 'Wilcoxon test from SAS PROC LIFETEST', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.035', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'The significance threshold level was 0.049 (two-sided). P-values are from the comparison of median survival time using the bootstrap re-sampling method.', 'statisticalMethod': 'bootstrap re-sampling method', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'pValueComment': 'The significance threshold level was 0.049 (two-sided). P-values are from the comparison of median survival time using the bootstrap re-sampling method.', 'statisticalMethod': 'bootstrap re-sampling method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'within 4 hours', 'description': 'Minutes until confirmed perceptible pain relief is achieved. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Time to Meaningful Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '124', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo caplets taken orally'}, {'id': 'OG001', 'title': 'Test ACM 1000 mg', 'description': 'Two test acetaminophen 500 mg tablets taken orally'}, {'id': 'OG002', 'title': 'Commercial ACM 1000 mg', 'description': 'Two commercial acetaminophen 500 mg caplets taken orally'}, {'id': 'OG003', 'title': 'Commercial IBU 400 mg', 'description': 'Two commercial ibuprofen 200 mg liquid-filled capsules taken orally'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median time to meaningful pain relief was not estimable since fewer than 50% of the participants treated with this study medication obtained meaningful pain relief.', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '240'}, {'value': '46.1', 'groupId': 'OG001', 'lowerLimit': '8.7', 'upperLimit': '240'}, {'value': '44.2', 'groupId': 'OG002', 'lowerLimit': '12.6', 'upperLimit': '240'}, {'value': '43.9', 'groupId': 'OG003', 'lowerLimit': '16.7', 'upperLimit': '240'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.', 'statisticalMethod': 'Wilcoxon test from SAS PROC LIFETEST', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.', 'statisticalMethod': 'Wilcoxon test from SAS PROC LIFETEST', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.', 'statisticalMethod': 'Wilcoxon test from SAS PROC LIFETEST', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.671', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'The significance threshold level was 0.049 (two-sided). P-values are from the comparison of median survival time using the bootstrap re-sampling method.', 'statisticalMethod': 'bootstrap re-sampling method', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.487', 'groupIds': ['OG001', 'OG003'], 'pValueComment': 'The significance threshold level was 0.049 (two-sided). P-values are from the comparison of median survival time using the bootstrap re-sampling method.', 'statisticalMethod': 'bootstrap re-sampling method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 4 hours', 'description': 'Minutes until meaningful pain relief is achieved. Stopwatch is started after the participant takes the study medication. The participants are instructed to stop the stopwatch when the relief from the starting pain is meaningful to them.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 30 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo caplets taken orally'}, {'id': 'OG001', 'title': 'Test ACM 1000 mg', 'description': 'Two test acetaminophen 500 mg tablets taken orally'}], 'classes': [{'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}, {'value': '75.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by 30 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 30 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 29 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo caplets taken orally'}, {'id': 'OG001', 'title': 'Test ACM 1000 mg', 'description': 'Two test acetaminophen 500 mg tablets taken orally'}], 'classes': [{'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}, {'value': '73.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by 29 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 29 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 28 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo caplets taken orally'}, {'id': 'OG001', 'title': 'Test ACM 1000 mg', 'description': 'Two test acetaminophen 500 mg tablets taken orally'}], 'classes': [{'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}, {'value': '70.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by 28 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 28 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 27 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo caplets taken orally'}, {'id': 'OG001', 'title': 'Test ACM 1000 mg', 'description': 'Two test acetaminophen 500 mg tablets taken orally'}], 'classes': [{'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}, {'value': '70.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by 27 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 27 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 26 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo caplets taken orally'}, {'id': 'OG001', 'title': 'Test ACM 1000 mg', 'description': 'Two test acetaminophen 500 mg tablets taken orally'}], 'classes': [{'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}, {'value': '69.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by 26 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 26 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 25 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo caplets taken orally'}, {'id': 'OG001', 'title': 'Test ACM 1000 mg', 'description': 'Two test acetaminophen 500 mg tablets taken orally'}], 'classes': [{'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}, {'value': '69.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by 25 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 25 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 24 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo caplets taken orally'}, {'id': 'OG001', 'title': 'Test ACM 1000 mg', 'description': 'Two test acetaminophen 500 mg tablets taken orally'}], 'classes': [{'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}, {'value': '67.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by 24 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 24 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 23 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo caplets taken orally'}, {'id': 'OG001', 'title': 'Test ACM 1000 mg', 'description': 'Two test acetaminophen 500 mg tablets taken orally'}], 'classes': [{'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}, {'value': '66.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by 23 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 23 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 22 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo caplets taken orally'}, {'id': 'OG001', 'title': 'Test ACM 1000 mg', 'description': 'Two test acetaminophen 500 mg tablets taken orally'}], 'classes': [{'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000'}, {'value': '62.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by 22 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 22 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 21 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo caplets taken orally'}, {'id': 'OG001', 'title': 'Test ACM 1000 mg', 'description': 'Two test acetaminophen 500 mg tablets taken orally'}], 'classes': [{'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000'}, {'value': '60.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by 21 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 21 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 20 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo caplets taken orally'}, {'id': 'OG001', 'title': 'Test ACM 1000 mg', 'description': 'Two test acetaminophen 500 mg tablets taken orally'}], 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000'}, {'value': '58.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by 20 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 20 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 19 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo caplets taken orally'}, {'id': 'OG001', 'title': 'Test ACM 1000 mg', 'description': 'Two test acetaminophen 500 mg tablets taken orally'}], 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000'}, {'value': '56.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by 19 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 19 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 18 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo caplets taken orally'}, {'id': 'OG001', 'title': 'Test ACM 1000 mg', 'description': 'Two test acetaminophen 500 mg tablets taken orally'}], 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000'}, {'value': '55.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by 18 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 18 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 17 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo caplets taken orally'}, {'id': 'OG001', 'title': 'Test ACM 1000 mg', 'description': 'Two test acetaminophen 500 mg tablets taken orally'}], 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000'}, {'value': '53.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by 17 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 17 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 16 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo caplets taken orally'}, {'id': 'OG001', 'title': 'Test ACM 1000 mg', 'description': 'Two test acetaminophen 500 mg tablets taken orally'}], 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}, {'value': '52.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by 16 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 16 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 15 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo caplets taken orally'}, {'id': 'OG001', 'title': 'Test ACM 1000 mg', 'description': 'Two test acetaminophen 500 mg tablets taken orally'}], 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}, {'value': '41.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by 15 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 15 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 14 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo caplets taken orally'}, {'id': 'OG001', 'title': 'Test ACM 1000 mg', 'description': 'Two test acetaminophen 500 mg tablets taken orally'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000'}, {'value': '31.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by 14 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 14 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 13 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo caplets taken orally'}, {'id': 'OG001', 'title': 'Test ACM 1000 mg', 'description': 'Two test acetaminophen 500 mg tablets taken orally'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000'}, {'value': '25.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by 13 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 13 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 12 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo caplets taken orally'}, {'id': 'OG001', 'title': 'Test ACM 1000 mg', 'description': 'Two test acetaminophen 500 mg tablets taken orally'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000'}, {'value': '21.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.026', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by 12 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 12 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 11 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo caplets taken orally'}, {'id': 'OG001', 'title': 'Test ACM 1000 mg', 'description': 'Two test acetaminophen 500 mg tablets taken orally'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000'}, {'value': '18.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.080', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'by 11 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 11 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on the Intent-to-Treat (ITT) population, which included all participants who were randomized.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Two placebo caplets taken orally'}, {'id': 'FG001', 'title': 'Test ACM 1000 mg', 'description': 'Two test acetaminophen 500 mg tablets taken orally'}, {'id': 'FG002', 'title': 'Commercial ACM 1000 mg', 'description': 'Two commercial acetaminophen 500 mg caplets taken orally'}, {'id': 'FG003', 'title': 'Commercial IBU 400 mg', 'description': 'Two commercial ibuprofen 200 mg liquid-filled capsules taken orally'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '249'}, {'groupId': 'FG002', 'numSubjects': '232'}, {'groupId': 'FG003', 'numSubjects': '124'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '249'}, {'groupId': 'FG002', 'numSubjects': '232'}, {'groupId': 'FG003', 'numSubjects': '124'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '249', 'groupId': 'BG001'}, {'value': '232', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}, {'value': '664', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Two placebo caplets taken orally'}, {'id': 'BG001', 'title': 'Test ACM 1000 mg', 'description': 'Two test acetaminophen 500 mg tablets taken orally'}, {'id': 'BG002', 'title': 'Commercial ACM 1000 mg', 'description': 'Two commercial acetaminophen 500 mg caplets taken orally'}, {'id': 'BG003', 'title': 'Commercial IBU 400 mg', 'description': 'Two commercial ibuprofen 200 mg liquid-filled capsules taken orally'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '18.3', 'spread': '1.91', 'groupId': 'BG000'}, {'value': '19.0', 'spread': '2.31', 'groupId': 'BG001'}, {'value': '18.9', 'spread': '2.17', 'groupId': 'BG002'}, {'value': '19.2', 'spread': '2.56', 'groupId': 'BG003'}, {'value': '18.9', 'spread': '2.28', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '362', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '302', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}, {'value': '607', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '249', 'groupId': 'BG001'}, {'value': '232', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}, {'value': '664', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-16', 'size': 318299, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-03-22T05:40', 'hasProtocol': True}, {'date': '2018-04-25', 'size': 240760, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-03-22T05:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Post-operative dental pain following third molar extraction.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 664}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'dispFirstSubmitDate': '2019-04-02', 'completionDateStruct': {'date': '2018-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-22', 'studyFirstSubmitDate': '2017-07-07', 'dispFirstSubmitQcDate': '2019-04-02', 'resultsFirstSubmitDate': '2021-03-22', 'studyFirstSubmitQcDate': '2017-07-18', 'dispFirstPostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-22', 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Confirmed Perceptible Pain Relief', 'timeFrame': 'within 4 hours', 'description': 'Minutes until confirmed perceptible pain relief is achieved. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief.'}], 'secondaryOutcomes': [{'measure': 'Time to Meaningful Pain Relief', 'timeFrame': 'Within 4 hours', 'description': 'Minutes until meaningful pain relief is achieved. Stopwatch is started after the participant takes the study medication. The participants are instructed to stop the stopwatch when the relief from the starting pain is meaningful to them.'}, {'measure': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 30 Minutes', 'timeFrame': 'by 30 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 30 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.'}, {'measure': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 29 Minutes', 'timeFrame': 'by 29 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 29 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.'}, {'measure': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 28 Minutes', 'timeFrame': 'by 28 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 28 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.'}, {'measure': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 27 Minutes', 'timeFrame': 'by 27 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 27 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.'}, {'measure': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 26 Minutes', 'timeFrame': 'by 26 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 26 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.'}, {'measure': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 25 Minutes', 'timeFrame': 'by 25 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 25 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.'}, {'measure': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 24 Minutes', 'timeFrame': 'by 24 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 24 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.'}, {'measure': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 23 Minutes', 'timeFrame': 'by 23 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 23 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.'}, {'measure': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 22 Minutes', 'timeFrame': 'by 22 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 22 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.'}, {'measure': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 21 Minutes', 'timeFrame': 'by 21 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 21 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.'}, {'measure': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 20 Minutes', 'timeFrame': 'by 20 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 20 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.'}, {'measure': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 19 Minutes', 'timeFrame': 'by 19 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 19 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.'}, {'measure': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 18 Minutes', 'timeFrame': 'by 18 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 18 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.'}, {'measure': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 17 Minutes', 'timeFrame': 'by 17 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 17 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.'}, {'measure': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 16 Minutes', 'timeFrame': 'by 16 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 16 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.'}, {'measure': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 15 Minutes', 'timeFrame': 'by 15 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 15 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.'}, {'measure': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 14 Minutes', 'timeFrame': 'by 14 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 14 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.'}, {'measure': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 13 Minutes', 'timeFrame': 'by 13 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 13 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.'}, {'measure': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 12 Minutes', 'timeFrame': 'by 12 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 12 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.'}, {'measure': 'Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 11 Minutes', 'timeFrame': 'by 11 minutes', 'description': 'Percentage of participants with confirmed perceptible relief by 11 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-operative Dental Pain']}, 'referencesModule': {'references': [{'pmid': '38505928', 'type': 'DERIVED', 'citation': 'Myers A, Bertoch T, Zhang P, Cooper SA. Clinical validation of a fast-acting acetaminophen: a randomized, active and placebo controlled dental pain study. Curr Med Res Opin. 2024 May;40(5):839-848. doi: 10.1080/03007995.2024.2331159. Epub 2024 Mar 23.'}, {'pmid': '38124555', 'type': 'DERIVED', 'citation': 'Myers A, Gelotte C, Zuckerman A, Zimmerman B, Shenoy A, Qi D, Cooper SA. Analgesic onset and efficacy of a fast-acting formulation of acetaminophen in a postoperative dental impaction pain model. Curr Med Res Opin. 2024 Feb;40(2):267-277. doi: 10.1080/03007995.2023.2294946. Epub 2024 Jan 24.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate analgesic onset, efficacy, and safety of 1000 mg acetaminophen administered as two Test Acetaminophen 500 mg tablets (Test ACM) compared with 1000 mg acetaminophen administered as two commercial acetaminophen 500 mg caplets (ACM) and 400 mg ibuprofen administered as two commercial ibuprofen 200 mg liquid-filled capsules (IBU) in the dental pain model following third-molar extractions.', 'detailedDescription': 'This is a single-dose, randomized, double-blind, placebo- and active- controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of Test ACM 1000 mg compared with two commercial products over a four-hour period after third-molar extractions. Subjects will undergo dental extraction of three or four third molars.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 17 to 50 years old\n2. Weigh 100 lbs. or greater and have a body mass index (BMI) of 18 to 30 (inclusive)\n3. Dental extraction of three or four third molars\n4. Meets post-surgical pain criteria\n5. Females of childbearing age must be willing to use acceptable method of birth control\n\nExclusion Criteria:\n\n1. Currently pregnant or planning to be pregnant or nursing a baby\n2. Known allergy to acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs) including aspirin, as well as hydrocodone or other opioids\n3. Inability to swallow whole large tablets or capsules\n4. Have other conditions that the investigator feels may impact subject's safety and/or the integrity of the study\n5. Use of pain medications 5 or more times per week\n6. Have a history of chronic tranquilizer use, heavy drinking, or substance abuse in the last 5 years\n7. History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years\n8. Have a positive urine drug screen"}, 'identificationModule': {'nctId': 'NCT03224403', 'briefTitle': 'Randomized, Double-Blind, Single-Dose, Efficacy and Safety Study of Test Acetaminophen Tablet in Postoperative Dental Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Consumer and Personal Products Worldwide'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo- and Active- Controlled, Single-Dose, Efficacy and Safety Study of a Test Acetaminophen 500 mg Tablet in Postoperative Dental Pain', 'orgStudyIdInfo': {'id': 'CO-170317095828-PACT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test acetaminophen', 'description': 'Test acetaminophen 1000 mg dose', 'interventionNames': ['Drug: Test acetaminophen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Commercial acetaminophen', 'description': 'Commercial acetaminophen 1000 mg dose', 'interventionNames': ['Drug: Commercial acetaminophen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Commercial ibuprofen', 'description': 'Commercial ibuprofen, 400 mg dose', 'interventionNames': ['Drug: Commercial ibuprofen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Test acetaminophen', 'type': 'DRUG', 'otherNames': ['Test ACM'], 'description': 'single dose of 2 Test acetaminophen 500 mg tablets', 'armGroupLabels': ['Test acetaminophen']}, {'name': 'Commercial acetaminophen', 'type': 'DRUG', 'otherNames': ['Commercial ACM'], 'description': 'single dose of 2 acetaminophen 500 mg caplets', 'armGroupLabels': ['Commercial acetaminophen']}, {'name': 'Commercial ibuprofen', 'type': 'DRUG', 'otherNames': ['Commercial IBU'], 'description': 'Single dose of 2 ibuprofen 200 mg Liquid-filled Capsules', 'armGroupLabels': ['Commercial ibuprofen']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '2 placebo caplets', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Jean Brown Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Derek Muse', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jean Brown Research/ BB Holdings'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'YODA'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Johnson & Johnson Consumer and Personal Products Worldwide', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}