Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-30 @ 6:14 PM
Study NCT ID:
NCT01462435
Status:
COMPLETED
Last Update Posted:
2014-02-04
First Post:
2011-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Diclofenac Capsules to Treat Pain Following Bunionectomy
Sponsor:
Organization:
Raw JSON
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'organization': 'Iroko Pharmaceuticals, LLC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Celecoxib', 'description': 'Celecoxib : 200 mg Capsules', 'otherNumAtRisk': 106, 'otherNumAffected': 86, 'seriousNumAtRisk': 106, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Diclofenac Test (Lower Dose)', 'description': 'Diclofenac Test (lower dose) : Capsules', 'otherNumAtRisk': 109, 'otherNumAffected': 84, 'seriousNumAtRisk': 109, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Diclofenac Test (Upper Dose)', 'description': 'Diclofenac Test (upper dose) : Capsules', 'otherNumAtRisk': 107, 'otherNumAffected': 77, 'seriousNumAtRisk': 107, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Placebo : Capsules', 'otherNumAtRisk': 106, 'otherNumAffected': 63, 'seriousNumAtRisk': 106, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Postprocedural edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 34}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 39}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 16}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 17}], 'organSystem': 'Nervous system disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Postprocedural hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 11}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}], 'seriousEvents': [{'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}], '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), ANCOVA Model.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': 'Celecoxib : 200 mg Capsules'}, {'id': 'OG001', 'title': 'Diclofenac Test (Lower Dose)', 'description': 'Diclofenac Test (lower dose) : Capsules'}, {'id': 'OG002', 'title': 'Diclofenac Test (Upper Dose)', 'description': 'Diclofenac Test (upper dose) : Capsules'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo : Capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '390.468', 'spread': '925.1', 'groupId': 'OG000'}, {'value': '392.954', 'spread': '937.0', 'groupId': 'OG001'}, {'value': '524.315', 'spread': '1146.1', 'groupId': 'OG002'}, {'value': '76.887', 'spread': '340.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '446.946', 'ciLowerLimit': '206.567', 'ciUpperLimit': '687.324', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '122.2935', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.010', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '316.145', 'ciLowerLimit': '77.136', 'ciUpperLimit': '555.155', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '121.5971', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.011', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '313.119', 'ciLowerLimit': '72.202', 'ciUpperLimit': '554.037', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '122.5676', 'statisticalMethod': 'ANCOVA', '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".\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'}, {'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': '106', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': 'Celecoxib : 200 mg Capsules'}, {'id': 'OG001', 'title': 'Diclofenac Test (Lower Dose)', 'description': 'Diclofenac Test (lower dose) : Capsules'}, {'id': 'OG002', 'title': 'Diclofenac Test (Upper Dose)', 'description': 'Diclofenac Test (upper dose) : Capsules'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo : Capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '25.109', 'spread': '62.9', 'groupId': 'OG000'}, {'value': '27.450', 'spread': '64.9', 'groupId': 'OG001'}, {'value': '31.568', 'spread': '68.6', 'groupId': 'OG002'}, {'value': '14.406', 'spread': '53.5', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.043', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.109', 'groupIds': ['OG001', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.183', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', '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".\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'}, {'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': '106', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': 'Celecoxib : 200 mg Capsules'}, {'id': 'OG001', 'title': 'Diclofenac Test (Lower Dose)', 'description': 'Diclofenac Test (lower dose) : Capsules'}, {'id': 'OG002', 'title': 'Diclofenac Test (Upper Dose)', 'description': 'Diclofenac Test (upper dose) : Capsules'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo : Capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '51.675', 'spread': '122.4', 'groupId': 'OG000'}, {'value': '56.404', 'spread': '132.6', 'groupId': 'OG001'}, {'value': '64.689', 'spread': '138.5', 'groupId': 'OG002'}, {'value': '23.151', 'spread': '84.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.029', 'groupIds': ['OG001', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.050', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', '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".\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'}, {'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': '106', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': 'Celecoxib : 200 mg Capsules'}, {'id': 'OG001', 'title': 'Diclofenac Test (Lower Dose)', 'description': 'Diclofenac Test (lower dose) : Capsules'}, {'id': 'OG002', 'title': 'Diclofenac Test (Upper Dose)', 'description': 'Diclofenac Test (upper dose) : Capsules'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo : Capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '170.845', 'spread': '393.0', 'groupId': 'OG000'}, {'value': '177.101', 'spread': '418.3', 'groupId': 'OG001'}, {'value': '230.708', 'spread': '499.9', 'groupId': 'OG002'}, {'value': '48.811', 'spread': '186.5', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.004', 'groupIds': ['OG001', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', '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".\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'}, {'type': 'SECONDARY', 'title': 'Total Pain Relief (TOTPAR) Over 0 to 4 Hours. TOTPAR-4.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': 'Celecoxib : 200 mg Capsules'}, {'id': 'OG001', 'title': 'Diclofenac Test (Lower Dose)', 'description': 'Diclofenac Test (lower dose) : Capsules'}, {'id': 'OG002', 'title': 'Diclofenac Test (Upper Dose)', 'description': 'Diclofenac Test (upper dose) : Capsules'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo : Capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '2.226', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '2.112', 'spread': '3.5', 'groupId': 'OG001'}, {'value': '2.530', 'spread': '3.6', 'groupId': 'OG002'}, {'value': '1.387', 'spread': '2.7', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.091', 'groupIds': ['OG001', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.053', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0 - 4 hours', 'description': 'Pain relief was assessed using a 5-point categorical scale at all assessment time points 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.\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. In this way individual scores covering a longer time period were given more weight.The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 16 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 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': '106', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': 'Celecoxib : 200 mg Capsules'}, {'id': 'OG001', 'title': 'Diclofenac Test (Lower Dose)', 'description': 'Diclofenac Test (lower dose) : Capsules'}, {'id': 'OG002', 'title': 'Diclofenac Test (Upper Dose)', 'description': 'Diclofenac Test (upper dose) : Capsules'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo : Capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '3.840', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '3.690', 'spread': '6.8', 'groupId': 'OG001'}, {'value': '4.652', 'spread': '7.5', 'groupId': 'OG002'}, {'value': '1.943', 'spread': '4.4', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.026', 'groupIds': ['OG001', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.017', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0 - 8 hours', 'description': 'Pain relief was assessed using a 5-point categorical scale at all assessment time points 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.\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. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 32 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0.', 'unitOfMeasure': 'units on a scale*hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': 'Celecoxib : 200 mg Capsules'}, {'id': 'OG001', 'title': 'Diclofenac Test (Lower Dose)', 'description': 'Diclofenac Test (lower dose) : Capsules'}, {'id': 'OG002', 'title': 'Diclofenac Test (Upper Dose)', 'description': 'Diclofenac Test (upper dose) : Capsules'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo : Capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '10.670', 'spread': '22.2595', 'groupId': 'OG000'}, {'value': '10.186', 'spread': '21.3384', 'groupId': 'OG001'}, {'value': '13.325', 'spread': '25.9326', 'groupId': 'OG002'}, {'value': '3.566', 'spread': '10.8804', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.005', 'groupIds': ['OG001', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0 - 24 hours', 'description': 'Pain relief was assessed using a 5-point categorical scale at all assessment time points 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.\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. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 96 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0.', 'unitOfMeasure': 'units on a scale*hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': 'Celecoxib : 200 mg Capsules'}, {'id': 'OG001', 'title': 'Diclofenac Test (Lower Dose)', 'description': 'Diclofenac Test (lower dose) : Capsules'}, {'id': 'OG002', 'title': 'Diclofenac Test (Upper Dose)', 'description': 'Diclofenac Test (upper dose) : Capsules'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo : Capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '22.972', 'spread': '51.1', 'groupId': 'OG000'}, {'value': '21.635', 'spread': '48.', 'groupId': 'OG001'}, {'value': '28.054', 'spread': '58.1', 'groupId': 'OG002'}, {'value': '4.925', 'spread': '19.4', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0 - 48 hours', 'description': 'Pain relief was assessed using a 5-point categorical scale at all assessment time points 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.\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. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 192 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0.', 'unitOfMeasure': 'units on a scale*hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Celecoxib', 'description': 'Celecoxib : 200 mg Capsules'}, {'id': 'FG001', 'title': 'Diclofenac Test (Lower Dose)', 'description': 'Diclofenac Test (lower dose) : Capsules'}, {'id': 'FG002', 'title': 'Diclofenac Test (Upper Dose)', 'description': 'Diclofenac Test (upper dose) : Capsules'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Placebo : Capsules'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '109'}, {'groupId': 'FG002', 'numSubjects': '107'}, {'groupId': 'FG003', 'numSubjects': '106'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '109'}, {'groupId': 'FG002', 'numSubjects': '106'}, {'groupId': 'FG003', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}, {'value': '428', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Celecoxib', 'description': 'Celecoxib : 200 mg Capsules'}, {'id': 'BG001', 'title': 'Diclofenac Test (Lower Dose)', 'description': 'Diclofenac Test (lower dose) : Capsules'}, {'id': 'BG002', 'title': 'Diclofenac Test (Upper Dose)', 'description': 'Diclofenac Test (upper dose) : Capsules'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Placebo : Capsules'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.3', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '39.4', 'spread': '11.7', 'groupId': 'BG001'}, {'value': '39.3', 'spread': '11.8', 'groupId': 'BG002'}, {'value': '39.9', 'spread': '12.6', 'groupId': 'BG003'}, {'value': '39.7', 'spread': '12.0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '371', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '57', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}, {'value': '428', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, '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': 428}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-02', 'studyFirstSubmitDate': '2011-10-26', 'resultsFirstSubmitDate': '2013-02-20', 'studyFirstSubmitQcDate': '2011-10-27', 'lastUpdatePostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-21', 'studyFirstPostDateStruct': {'date': '2011-10-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', '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), ANCOVA Model.', '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".\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".\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".\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".\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': 'Total Pain Relief (TOTPAR) Over 0 to 4 Hours. TOTPAR-4.', 'timeFrame': '0 - 4 hours', 'description': 'Pain relief was assessed using a 5-point categorical scale at all assessment time points 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.\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. In this way individual scores covering a longer time period were given more weight.The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 16 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0.'}, {'measure': 'TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours', 'timeFrame': '0 - 8 hours', 'description': 'Pain relief was assessed using a 5-point categorical scale at all assessment time points 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.\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. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 32 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0.'}, {'measure': 'TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours', 'timeFrame': '0 - 24 hours', 'description': 'Pain relief was assessed using a 5-point categorical scale at all assessment time points 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.\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. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 96 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0.'}, {'measure': 'TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours', 'timeFrame': '0 - 48 hours', 'description': 'Pain relief was assessed using a 5-point categorical scale at all assessment time points 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.\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. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 192 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Other Acute Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '26995799', 'type': 'DERIVED', 'citation': 'Argoff C, McCarberg B, Gudin J, Nalamachu S, Young C. SoluMatrix(R) Diclofenac: Sustained Opioid-Sparing Effects in a Phase 3 Study in Patients with Postoperative Pain. Pain Med. 2016 Oct;17(10):1933-1941. doi: 10.1093/pm/pnw012. Epub 2016 Mar 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Diclofenac \\[Test\\] Capsules are safe and effective for the treatment of 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': 'NCT01462435', 'briefTitle': 'Study of Diclofenac Capsules to Treat Pain Following Bunionectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Iroko Pharmaceuticals, LLC'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Diclofenac [Test] Capsules for the Treatment of Acute Postoperative Pain After Bunionectomy', 'orgStudyIdInfo': {'id': 'DIC3-08-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diclofenac Test (lower dose)', 'interventionNames': ['Drug: Diclofenac Test (lower dose)']}, {'type': 'EXPERIMENTAL', 'label': 'Diclofenac Test (upper dose)', 'interventionNames': ['Drug: Diclofenac Test (upper dose)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Celecoxib', 'interventionNames': ['Drug: Celecoxib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Diclofenac Test (lower dose)', 'type': 'DRUG', 'description': 'Capsules', 'armGroupLabels': ['Diclofenac Test (lower dose)']}, {'name': 'Diclofenac Test (upper dose)', 'type': 'DRUG', 'description': 'Capsules', 'armGroupLabels': ['Diclofenac Test (upper dose)']}, {'name': 'Celecoxib', 'type': 'DRUG', 'description': '200 mg Capsules', 'armGroupLabels': ['Celecoxib']}, {'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': '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'}, {'name': 'S. Thomas Schiffgen, DPM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Premier Research Group Limited'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iroko Pharmaceuticals, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}