Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT01626118
Status:
COMPLETED
Last Update Posted:
2014-03-17
First Post:
2012-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Indomethacin Capsules to Treat Pain Following Bunionectomy
Sponsor:
Organization:
Raw JSON
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'Indomethacin Nanoformulation Capsules 40 mg BID', 'otherNumAtRisk': 93, 'otherNumAffected': 74, 'seriousNumAtRisk': 93, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Indomethacin 20 mg TID', 'description': 'Indomethacin Nanoformulation Capsules 20 mg TID', 'otherNumAtRisk': 92, 'otherNumAffected': 68, 'seriousNumAtRisk': 92, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Placebo Group', 'otherNumAtRisk': 94, 'otherNumAffected': 71, 'seriousNumAtRisk': 94, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 92, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 94, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Postprocedural edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 92, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 94, 'numAffected': 29}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 92, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 94, 'numAffected': 16}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 92, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 94, 'numAffected': 14}], 'organSystem': 'Nervous system disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 92, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 94, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 92, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 94, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 92, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 94, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Indomethacin 40 mg TID', 'description': 'Indomethacin Nanoformulation Capsules 40 mg TID'}, {'id': 'OG001', 'title': 'Indomethacin 40 mg BID', 'description': 'Indomethacin Nanoformulation Capsules 40 mg BID'}, {'id': 'OG002', 'title': 'Indomethacin 20 mg TID', 'description': 'Indomethacin Nanoformulation Capsules 20 mg TID'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo Group'}], 'classes': [{'categories': [{'measurements': [{'value': '598.670', 'spread': '1173.7863', 'groupId': 'OG000'}, {'value': '623.162', 'spread': '1182.0912', 'groupId': 'OG001'}, {'value': '342.779', 'spread': '858.6326', 'groupId': 'OG002'}, {'value': '280.517', 'spread': '817.6026', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.034', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '317.612', 'ciLowerLimit': '23.297', 'ciUpperLimit': '611.926', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '149.6694', 'groupDescription': 'The p value was obtained from an analysis of covariance (ANCOVA) model that included treatment effect as the factor and baseline pain intensity as the covariate. This was the primary analysis of the primary efficacy parameter.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.023', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '342.132', 'ciLowerLimit': '47.090', 'ciUpperLimit': '637.175', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '150.0397', 'groupDescription': 'The p value was obtained from an analysis of covariance (ANCOVA) model that included treatment effect as the factor and baseline pain intensity as the covariate. This was the primary analysis of the primary efficacy parameter.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.680', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '61.972', 'ciLowerLimit': '-233.527', 'ciUpperLimit': '357.471', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '150.2717', 'groupDescription': 'The p value was obtained from an analysis of covariance (ANCOVA) model that included treatment effect as the factor and baseline pain intensity as the covariate. This was the primary analysis of the primary efficacy parameter.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '503.008', 'ciLowerLimit': '301.930', 'ciUpperLimit': '704.086', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '102.3149', 'groupDescription': 'The p value was obtained from a mixed-model repeated-measure (MMRM) model that used all available data from all subjects to derive an estimate of pain intensity scores for subjects following study withdrawal, rather than "imputing" a score for individual subjects. The MMRM analysis was a sensitivity analysis of the primary efficacy parameter.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '511.357', 'ciLowerLimit': '309.749', 'ciUpperLimit': '712.965', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '102.5851', 'groupDescription': 'The p value was obtained from a mixed-model repeated-measure (MMRM) model that used all available data from all subjects to derive an estimate of pain intensity scores for subjects following study withdrawal, rather than "imputing" a score for individual subjects. The MMRM analysis was a sensitivity analysis of the primary efficacy parameter.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '341.232', 'ciLowerLimit': '139.249', 'ciUpperLimit': '543.215', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '102.7761', 'groupDescription': 'The p value was obtained from a mixed-model repeated-measure (MMRM) model that used all available data from all subjects to derive an estimate of pain intensity scores for subjects following study withdrawal, rather than "imputing" a score for individual subjects. The MMRM analysis was a sensitivity analysis of the primary efficacy parameter.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0-48 hours', 'description': 'The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". Pain intensity is assessed at baseline (time "0") and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40, and 48 hours.\n\nThe VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment.', 'unitOfMeasure': 'mm*hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.'}, {'type': 'SECONDARY', 'title': 'VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Indomethacin 40 mg TID', 'description': 'Indomethacin Nanoformulation Capsules 40 mg TID'}, {'id': 'OG001', 'title': 'Indomethacin 40 mg BID', 'description': 'Indomethacin Nanoformulation Capsules 40 mg BID'}, {'id': 'OG002', 'title': 'Indomethacin 20 mg TID', 'description': 'Indomethacin Nanoformulation Capsules 20 mg TID'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo Group'}], 'classes': [{'categories': [{'measurements': [{'value': '31.5', 'spread': '74.4', 'groupId': 'OG000'}, {'value': '35.3', 'spread': '79.6', 'groupId': 'OG001'}, {'value': '24.8', 'spread': '54.6', 'groupId': 'OG002'}, {'value': '18.4', 'spread': '62.1', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.191', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.108', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.461', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0-4 hours', 'description': 'The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". Pain intensity is assessed at baseline (time "0") and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, and 4 hours.\n\nThe VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment.', 'unitOfMeasure': 'mm*hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.'}, {'type': 'SECONDARY', 'title': 'VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Indomethacin 40 mg TID', 'description': 'Indomethacin Nanoformulation Capsules 40 mg TID'}, {'id': 'OG001', 'title': 'Indomethacin 40 mg BID', 'description': 'Indomethacin Nanoformulation Capsules 40 mg BID'}, {'id': 'OG002', 'title': 'Indomethacin 20 mg TID', 'description': 'Indomethacin Nanoformulation Capsules 20 mg TID'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo Group'}], 'classes': [{'categories': [{'measurements': [{'value': '69.7', 'spread': '151.7', 'groupId': 'OG000'}, {'value': '75.5', 'spread': '152.5', 'groupId': 'OG001'}, {'value': '47.6', 'spread': '109.9', 'groupId': 'OG002'}, {'value': '35.8', 'spread': '107.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.079', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.041', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.458', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0-8 hours', 'description': 'The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". Pain intensity is assessed at baseline (time "0") and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours.\n\nThe VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment.', 'unitOfMeasure': 'mm*hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.'}, {'type': 'SECONDARY', 'title': 'VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Indomethacin 40 mg TID', 'description': 'Indomethacin Nanoformulation Capsules 40 mg TID'}, {'id': 'OG001', 'title': 'Indomethacin 40 mg BID', 'description': 'Indomethacin Nanoformulation Capsules 40 mg BID'}, {'id': 'OG002', 'title': 'Indomethacin 20 mg TID', 'description': 'Indomethacin Nanoformulation Capsules 20 mg TID'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo Group'}], 'classes': [{'categories': [{'measurements': [{'value': '268.4', 'spread': '526.9', 'groupId': 'OG000'}, {'value': '265.2', 'spread': '516.2', 'groupId': 'OG001'}, {'value': '156.8', 'spread': '384.0', 'groupId': 'OG002'}, {'value': '115.5', 'spread': '346.5', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.020', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.021', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.441', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0-24 hours', 'description': 'The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". Pain intensity is assessed at baseline (time "0") and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, and 24 hours.\n\nThe VAS summed pain intensity difference (VASSPID) is calculated as a time-weighted sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment.', 'unitOfMeasure': 'mm*hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.'}, {'type': 'SECONDARY', 'title': 'Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Indomethacin 40 mg TID', 'description': 'Indomethacin Nanoformulation Capsules 40 mg TID'}, {'id': 'OG001', 'title': 'Indomethacin 40 mg BID', 'description': 'Indomethacin Nanoformulation Capsules 40 mg BID'}, {'id': 'OG002', 'title': 'Indomethacin 20 mg TID', 'description': 'Indomethacin Nanoformulation Capsules 20 mg TID'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo Group'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '3.8', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '2.9', 'groupId': 'OG002'}, {'value': '1.9', 'spread': '3.1', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.141', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.071', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.716', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0-4 hours', 'description': 'Pain relief was assessed with a 5-point categorical scale at all assessment timepoints after time 0. Subjects were asked "How much relief have you had since your starting pain?" with response choices of none=0, a little=1, some=2, a lot=3 and complete=4. Pain relief is assessed at the following points after time 0: 15, 30 \\& 45 minutes and 1, 1.5, 2, 3 \\& 4 hours.\n\nThe Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 16 units, which represents complete pain relief (4 on scale) at all points after 0.', 'unitOfMeasure': 'units on a scale*hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Indomethacin 40 mg TID', 'description': 'Indomethacin Nanoformulation Capsules 40 mg TID'}, {'id': 'OG001', 'title': 'Indomethacin 40 mg BID', 'description': 'Indomethacin Nanoformulation Capsules 40 mg BID'}, {'id': 'OG002', 'title': 'Indomethacin 20 mg TID', 'description': 'Indomethacin Nanoformulation Capsules 20 mg TID'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo Group'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '8.1', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '5.9', 'groupId': 'OG002'}, {'value': '3.0', 'spread': '5.8', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.049', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.020', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.593', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0-8 hours', 'description': 'Pain relief was assessed with a 5-point categorical scale at all assessment timepoints after time 0. Subjects were asked "How much relief have you had since your starting pain?" with response choices of none=0, a little=1, some=2, a lot=3 and complete=4. Pain relief is assessed at the following points after time 0: 15, 30 \\& 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7 \\& 8 hours.\n\nThe Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 32 units, which represents complete pain relief (4 on scale) at all points after 0.', 'unitOfMeasure': 'units on a scale*hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.'}, {'type': 'SECONDARY', 'title': 'TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Indomethacin 40 mg TID', 'description': 'Indomethacin Nanoformulation Capsules 40 mg TID'}, {'id': 'OG001', 'title': 'Indomethacin 40 mg BID', 'description': 'Indomethacin Nanoformulation Capsules 40 mg BID'}, {'id': 'OG002', 'title': 'Indomethacin 20 mg TID', 'description': 'Indomethacin Nanoformulation Capsules 20 mg TID'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo Group'}], 'classes': [{'categories': [{'measurements': [{'value': '16.2', 'spread': '29.1', 'groupId': 'OG000'}, {'value': '16.8', 'spread': '28.0', 'groupId': 'OG001'}, {'value': '10.1', 'spread': '21.8', 'groupId': 'OG002'}, {'value': '7.8', 'spread': '19.1', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.021', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.012', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.447', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0-24 hours', 'description': 'Pain relief was assessed with a 5-point categorical scale at all assessment timepoints after time 0. Subjects were asked "How much relief have you had since your starting pain?" with response choices of none=0, a little=1, some=2, a lot=3 and complete=4. Pain relief is assessed at the following points after time 0: 15, 30 \\& 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, \\& 24 hours.\n\nThe Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 96 units, which represents complete pain relief (4 on scale) at all points after 0.', 'unitOfMeasure': 'units on a scale*hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.'}, {'type': 'SECONDARY', 'title': 'TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Indomethacin 40 mg TID', 'description': 'Indomethacin Nanoformulation Capsules 40 mg TID'}, {'id': 'OG001', 'title': 'Indomethacin 40 mg BID', 'description': 'Indomethacin Nanoformulation Capsules 40 mg BID'}, {'id': 'OG002', 'title': 'Indomethacin 20 mg TID', 'description': 'Indomethacin Nanoformulation Capsules 20 mg TID'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo Group'}], 'classes': [{'categories': [{'measurements': [{'value': '34.7', 'spread': '65.1', 'groupId': 'OG000'}, {'value': '37.0', 'spread': '64.5', 'groupId': 'OG001'}, {'value': '21.2', 'spread': '49.3', 'groupId': 'OG002'}, {'value': '17.3', 'spread': '45.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.036', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.017', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.577', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0-48 hours', 'description': 'Pain relief was assessed with a 5-point categorical scale at all assessment timepoints after time 0. Subjects were asked "How much relief have you had since your starting pain?" with response choices of none=0, a little=1, some=2, a lot=3 and complete=4. Pain relief is assessed at the following points after time 0: 15, 30 \\& 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40 \\& 48 hours.\n\nThe Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 192 units, which represents complete pain relief (4 on scale) at all points after 0.', 'unitOfMeasure': 'units on a scale*hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Indomethacin 40 mg TID', 'description': 'Indomethacin Nanoformulation Capsules 40 mg TID'}, {'id': 'FG001', 'title': 'Indomethacin 40 mg BID', 'description': 'Indomethacin Nanoformulation Capsules 40 mg BID'}, {'id': 'FG002', 'title': 'Indomethacin 20 mg TID', 'description': 'Indomethacin Nanoformulation Capsules 20 mg TID'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Placebo Group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '93'}, {'groupId': 'FG002', 'numSubjects': '92'}, {'groupId': 'FG003', 'numSubjects': '94'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '91'}, {'groupId': 'FG002', 'numSubjects': '90'}, {'groupId': 'FG003', 'numSubjects': '91'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Investigator Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}, {'value': '373', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Indomethacin 40 mg TID', 'description': 'Indomethacin Nanoformulation Capsules 40 mg TID'}, {'id': 'BG001', 'title': 'Indomethacin 40 mg BID', 'description': 'Indomethacin Nanoformulation Capsules 40 mg BID'}, {'id': 'BG002', 'title': 'Indomethacin 20 mg TID', 'description': 'Indomethacin Nanoformulation Capsules 20 mg TID'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Placebo Group'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.2', 'spread': '12.27', 'groupId': 'BG000'}, {'value': '38.9', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '41.3', 'spread': '12.57', 'groupId': 'BG002'}, {'value': '40.7', 'spread': '11.32', 'groupId': 'BG003'}, {'value': '40.3', 'spread': '12.16', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}, {'value': '317', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '73', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}, {'value': '300', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}]}, {'title': 'White or Caucasian', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}, {'value': '282', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Subjects were allowed to select more than one race; therefore, some subjects are counted multiple times.', 'unitOfMeasure': 'participants'}, {'title': 'Weight (kg)', 'classes': [{'categories': [{'measurements': [{'value': '73.81', 'spread': '14.686', 'groupId': 'BG000'}, {'value': '72.77', 'spread': '15.761', 'groupId': 'BG001'}, {'value': '74.99', 'spread': '17.821', 'groupId': 'BG002'}, {'value': '71.22', 'spread': '14.607', 'groupId': 'BG003'}, {'value': '73.19', 'spread': '15.758', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Weight measured in kilogram', 'unitOfMeasure': 'KG', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height (cm)', 'classes': [{'categories': [{'measurements': [{'value': '166.28', 'spread': '8.059', 'groupId': 'BG000'}, {'value': '165.65', 'spread': '8.994', 'groupId': 'BG001'}, {'value': '166.52', 'spread': '9.761', 'groupId': 'BG002'}, {'value': '165.61', 'spread': '7.646', 'groupId': 'BG003'}, {'value': '166.01', 'spread': '8.621', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Height measured in centimeters', 'unitOfMeasure': 'CM', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI (kg/m^2)', 'classes': [{'categories': [{'measurements': [{'value': '26.5', 'spread': '4.49', 'groupId': 'BG000'}, {'value': '26.3', 'spread': '4.34', 'groupId': 'BG001'}, {'value': '26.7', 'spread': '4.73', 'groupId': 'BG002'}, {'value': '25.8', 'spread': '4.57', 'groupId': 'BG003'}, {'value': '26.3', 'spread': '4.52', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index measured in kilograms per meter squared.', 'unitOfMeasure': 'KG/M^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline pain intensity, mm', 'classes': [{'categories': [{'measurements': [{'value': '71.0', 'spread': '16.33', 'groupId': 'BG000'}, {'value': '71.2', 'spread': '16.11', 'groupId': 'BG001'}, {'value': '72.3', 'spread': '15.90', 'groupId': 'BG002'}, {'value': '73.9', 'spread': '16.6', 'groupId': 'BG003'}, {'value': '72.1', 'spread': '16.21', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain".', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Surgery duration, min', 'classes': [{'categories': [{'measurements': [{'value': '27.7', 'spread': '7.45', 'groupId': 'BG000'}, {'value': '27.6', 'spread': '7.95', 'groupId': 'BG001'}, {'value': '28.5', 'spread': '8.63', 'groupId': 'BG002'}, {'value': '27.2', 'spread': '6.59', 'groupId': 'BG003'}, {'value': '27.7', 'spread': '7.67', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Surgery duration, minutes', 'unitOfMeasure': 'minutes', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 373}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-17', 'studyFirstSubmitDate': '2012-06-20', 'resultsFirstSubmitDate': '2013-12-11', 'studyFirstSubmitQcDate': '2012-06-21', 'lastUpdatePostDateStruct': {'date': '2014-03-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-02-17', 'studyFirstPostDateStruct': {'date': '2012-06-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48)', 'timeFrame': '0-48 hours', 'description': 'The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". Pain intensity is assessed at baseline (time "0") and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40, and 48 hours.\n\nThe VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment.'}], 'secondaryOutcomes': [{'measure': 'VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry.', 'timeFrame': '0-4 hours', 'description': 'The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". Pain intensity is assessed at baseline (time "0") and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, and 4 hours.\n\nThe VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment.'}, {'measure': 'VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry.', 'timeFrame': '0-8 hours', 'description': 'The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". Pain intensity is assessed at baseline (time "0") and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours.\n\nThe VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment.'}, {'measure': 'VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry.', 'timeFrame': '0-24 hours', 'description': 'The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". Pain intensity is assessed at baseline (time "0") and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, and 24 hours.\n\nThe VAS summed pain intensity difference (VASSPID) is calculated as a time-weighted sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment.'}, {'measure': 'Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4).', 'timeFrame': '0-4 hours', 'description': 'Pain relief was assessed with a 5-point categorical scale at all assessment timepoints after time 0. Subjects were asked "How much relief have you had since your starting pain?" with response choices of none=0, a little=1, some=2, a lot=3 and complete=4. Pain relief is assessed at the following points after time 0: 15, 30 \\& 45 minutes and 1, 1.5, 2, 3 \\& 4 hours.\n\nThe Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 16 units, which represents complete pain relief (4 on scale) at all points after 0.'}, {'measure': 'TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours', 'timeFrame': '0-8 hours', 'description': 'Pain relief was assessed with a 5-point categorical scale at all assessment timepoints after time 0. Subjects were asked "How much relief have you had since your starting pain?" with response choices of none=0, a little=1, some=2, a lot=3 and complete=4. Pain relief is assessed at the following points after time 0: 15, 30 \\& 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7 \\& 8 hours.\n\nThe Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 32 units, which represents complete pain relief (4 on scale) at all points after 0.'}, {'measure': 'TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours', 'timeFrame': '0-24 hours', 'description': 'Pain relief was assessed with a 5-point categorical scale at all assessment timepoints after time 0. Subjects were asked "How much relief have you had since your starting pain?" with response choices of none=0, a little=1, some=2, a lot=3 and complete=4. Pain relief is assessed at the following points after time 0: 15, 30 \\& 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, \\& 24 hours.\n\nThe Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 96 units, which represents complete pain relief (4 on scale) at all points after 0.'}, {'measure': 'TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours', 'timeFrame': '0-48 hours', 'description': 'Pain relief was assessed with a 5-point categorical scale at all assessment timepoints after time 0. Subjects were asked "How much relief have you had since your starting pain?" with response choices of none=0, a little=1, some=2, a lot=3 and complete=4. Pain relief is assessed at the following points after time 0: 15, 30 \\& 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40 \\& 48 hours.\n\nThe Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 192 units, which represents complete pain relief (4 on scale) at all points after 0.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Other Acute Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Indomethacin \\[Test\\] Capsules are safe and effective for the treatment of postoperative bunionectomy pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient is male or female between 18 and 65 years of age\n* For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control\n* Has undergone primary, unilateral, first metatarsal bunionectomy with no additional collateral procedures\n* Patient must be willing to stay at the study site ≥ 72 hours\n\nExclusion Criteria:\n\n* Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs\n* Patient has a current disease or history of a disease that will impact the study or the patient's well-being\n* Patient has used or intends to use any of the medications that are prohibited by the protocol\n* Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test\n* Patient has taken another investigational drug within 30 days prior to screening"}, 'identificationModule': {'nctId': 'NCT01626118', 'briefTitle': 'Study of Indomethacin Capsules to Treat Pain Following Bunionectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Iroko Pharmaceuticals, LLC'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Placebo-Controlled Study of Indomethacin Nanoformulation Capsules for the Treatment of Acute Postoperative Pain After Bunionectomy', 'orgStudyIdInfo': {'id': 'IND3-10-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Indomethacin 40 mg TID', 'interventionNames': ['Drug: Indomethacin']}, {'type': 'EXPERIMENTAL', 'label': 'Indomethacin 40 mg BID', 'interventionNames': ['Drug: Indomethacin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Indomethacin 20 mg TID', 'interventionNames': ['Drug: Indomethacin']}], 'interventions': [{'name': 'Indomethacin', 'type': 'DRUG', 'description': 'capsules, 40 mg, TID', 'armGroupLabels': ['Indomethacin 40 mg TID']}, {'name': 'Indomethacin', 'type': 'DRUG', 'description': 'capsules, 40 mg, BID', 'armGroupLabels': ['Indomethacin 40 mg BID']}, {'name': 'Indomethacin', 'type': 'DRUG', 'description': 'capsules, 20 mg, TID', 'armGroupLabels': ['Indomethacin 20 mg TID']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'capsules', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85027', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Premier Research Group Limited', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '21122', 'city': 'Pasadena', 'state': 'Maryland', 'country': 'United States', 'facility': 'Chesapeake Research Group, LLC', 'geoPoint': {'lat': 39.119, 'lon': -76.57108}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Premier Research Group Limited', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Premier Research Group Limited', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Jason Dickerson, DPM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Premier Research Group Limited'}, {'name': 'Michael Golf, DPM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Premier Research Group Limited'}, {'name': 'Ira Gottlieb, DPM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chesapeake Research Group, LLC'}, {'name': 'Kyle Patrick, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Premier Research Group Limited'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iroko Pharmaceuticals, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}