Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-01 @ 3:22 AM
Study NCT ID:
NCT03852459
Status:
COMPLETED
Last Update Posted:
2022-01-25
First Post:
2019-02-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Controlled Study to Assess the Efficacy and Safety of S-Ibuprofen Topical Gel 5% (AP0302) in the Treatment of DOMS
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kcorroon@aponialabs.com', 'phone': '917-574-5335', 'title': 'Kenneth Corroon', 'organization': 'Aponia Labs'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Day 7', 'description': 'TEAE was defined as an adverse event that was new or worsened in severity after the first dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Active Arm', 'description': 'S-Ibuprofen Topical Gel 5%\n\nS-Ibuprofen: Topical Gel 5%', 'otherNumAtRisk': 126, 'deathsNumAtRisk': 126, 'otherNumAffected': 123, 'seriousNumAtRisk': 126, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Arm', 'description': 'Vehicle Topical Gel\n\nVehicle: Vehicle Gel', 'otherNumAtRisk': 125, 'deathsNumAtRisk': 125, 'otherNumAffected': 117, 'seriousNumAtRisk': 125, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'application site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 123}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 117}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'application site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 76}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sum of the Time-weighted Differences From Baseline in Pain Intensity With Movement(SPIDMOVE) Over 24 Hours Post Time Zero', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'S-Ibuprofen Topical Gel 5%\n\nS-Ibuprofen: Topical Gel 5%'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Vehicle Topical Gel\n\nVehicle: Vehicle Gel'}], 'classes': [{'categories': [{'measurements': [{'value': '-33.09', 'spread': '31.311', 'groupId': 'OG000'}, {'value': '-29.09', 'spread': '29.763', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4272', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '0-24 hours.', 'description': 'The primary efficacy outcome is the sum of the time-weighted differences from baseline in muscle pain/soreness with movement over 0-24 hours post T0 (SPIDMOVE 0-24h), that is the area under the differences from baseline pain/soreness intensity difference curve. The pain intensity differences (PIDs) with movement from time point A to time point B was calculated using the trapezoid rule by subtracting each post-T0 pain score with movement from the pain score with movement at time point Ti. Positive and higher scores indicate greater reduction in pain. Measured by Pain Intensity Numerical Rating Scale (PI-NRS) where 0 = no pain and 10 = worst possible pain at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 20, 24, 26, 28, 30, 32, 34, 36, 40, 44, and 48 hours post-initial IP dose and immediately prior to the subsequent doses of investigational product (IP).', 'unitOfMeasure': 'score on a scale*hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'SPIDMOVE Over the Following Intervals: 0-6, 6-12, 0-12, 12-24, 24-36, 24-48, 0-36, 36-48 and 0-48 Hours Post-T0.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'S-Ibuprofen Topical Gel 5%\n\nS-Ibuprofen: Topical Gel 5%'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Vehicle Topical Gel\n\nVehicle: Vehicle Gel'}], 'classes': [{'title': '0-6 hours', 'categories': [{'measurements': [{'value': '-4.82', 'spread': '5.478', 'groupId': 'OG000'}, {'value': '-4.06', 'spread': '5.807', 'groupId': 'OG001'}]}]}, {'title': '6-12 hours', 'categories': [{'measurements': [{'value': '-8.98', 'spread': '8.583', 'groupId': 'OG000'}, {'value': '-7.73', 'spread': '8.412', 'groupId': 'OG001'}]}]}, {'title': '0-12 hours', 'categories': [{'measurements': [{'value': '-13.80', 'spread': '13.435', 'groupId': 'OG000'}, {'value': '-11.79', 'spread': '13.682', 'groupId': 'OG001'}]}]}, {'title': '12-24 hours', 'categories': [{'measurements': [{'value': '-19.29', 'spread': '18.868', 'groupId': 'OG000'}, {'value': '-17.30', 'spread': '17.338', 'groupId': 'OG001'}]}]}, {'title': '24-36 hours', 'categories': [{'measurements': [{'value': '-26.55', 'spread': '18.582', 'groupId': 'OG000'}, {'value': '-24.35', 'spread': '18.807', 'groupId': 'OG001'}]}]}, {'title': '24-48 hours', 'categories': [{'measurements': [{'value': '-60.37', 'spread': '38.168', 'groupId': 'OG000'}, {'value': '-54.61', 'spread': '38.604', 'groupId': 'OG001'}]}]}, {'title': '0-36 hours', 'categories': [{'measurements': [{'value': '-59.64', 'spread': '48.384', 'groupId': 'OG000'}, {'value': '-53.44', 'spread': '46.530', 'groupId': 'OG001'}]}]}, {'title': '36-48 hours', 'categories': [{'measurements': [{'value': '-33.82', 'spread': '20.293', 'groupId': 'OG000'}, {'value': '-30.26', 'spread': '20.794', 'groupId': 'OG001'}]}]}, {'title': '0-48 hours', 'categories': [{'measurements': [{'value': '-93.47', 'spread': '66.331', 'groupId': 'OG000'}, {'value': '-83.71', 'spread': '64.201', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From 0-6, 6-12, 0-12, 12-24, 24-36, 0-36, 24-28,36-48, and 0-48 hours post-T0. Time point i included 1, 2, 3, 4, 5, 6 (pre-dose), 7, 8, 9, 10, 11, 12 (pre-dose), 16, 18 (pre-dose), 20, and 24 (pre-dose) hours after the first dose.', 'description': 'Sum of the time-weighted differences from baseline in pain intensity with movement (SPIDMOVE) over the following intervals: 0-6, 6-12, 0-12, 12-24, 24-36, 0-36, 24-28, 36-48, and 0-48 hours post-T0, that is the area under the differences from baseline pain/soreness intensity difference curve. The PIDs with movement from time point A to time point B was calculated using the trapezoid rule by subtracting each post-T0 pain score with movement from the pain score with movement at time point Ti. Positive and higher scores indicate greater reduction in pain. Measured by Pain Intensity Numerical Rating Scale (PI-NRS) where 0 = no pain and 10 = worst possible pain at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 20, 24, 26, 28, 30, 32, 34, 36, 40, 44, and 48 hours post-initial IP dose and immediately prior to the subsequent doses of IP.', 'unitOfMeasure': 'score on a scale*hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Sum of Time Weighted Differences From Baseline in Muscle Stiffness (SSID) With Movement Over the Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'S-Ibuprofen Topical Gel 5%\n\nS-Ibuprofen: Topical Gel 5%'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Vehicle Topical Gel\n\nVehicle: Vehicle Gel'}], 'classes': [{'title': '0-6 hours', 'categories': [{'measurements': [{'value': '-3.81', 'spread': '6.218', 'groupId': 'OG000'}, {'value': '-3.33', 'spread': '5.957', 'groupId': 'OG001'}]}]}, {'title': '6-12 hours', 'categories': [{'measurements': [{'value': '-7.75', 'spread': '9.893', 'groupId': 'OG000'}, {'value': '-6.48', 'spread': '8.796', 'groupId': 'OG001'}]}]}, {'title': '0-12 hours', 'categories': [{'measurements': [{'value': '-11.55', 'spread': '15.446', 'groupId': 'OG000'}, {'value': '-9.81', 'spread': '14.302', 'groupId': 'OG001'}]}]}, {'title': '12-24 hours', 'categories': [{'measurements': [{'value': '-17.20', 'spread': '20.476', 'groupId': 'OG000'}, {'value': '-14.91', 'spread': '19.369', 'groupId': 'OG001'}]}]}, {'title': '0-24 hours', 'categories': [{'measurements': [{'value': '-28.75', 'spread': '34.920', 'groupId': 'OG000'}, {'value': '-24.72', 'spread': '32.365', 'groupId': 'OG001'}]}]}, {'title': '24-36 hours', 'categories': [{'measurements': [{'value': '-23.33', 'spread': '21.209', 'groupId': 'OG000'}, {'value': '-19.95', 'spread': '22.555', 'groupId': 'OG001'}]}]}, {'title': '24-48 hours', 'categories': [{'measurements': [{'value': '-53.58', 'spread': '44.528', 'groupId': 'OG000'}, {'value': '-44.77', 'spread': '44.732', 'groupId': 'OG001'}]}]}, {'title': '0-36 hours', 'categories': [{'measurements': [{'value': '-52.08', 'spread': '54.840', 'groupId': 'OG000'}, {'value': '-44.68', 'spread': '53.031', 'groupId': 'OG001'}]}]}, {'title': '36-48 hours', 'categories': [{'measurements': [{'value': '-30.25', 'spread': '23.947', 'groupId': 'OG000'}, {'value': '-24.82', 'spread': '23.171', 'groupId': 'OG001'}]}]}, {'title': '0-48 hours', 'categories': [{'measurements': [{'value': '-82.33', 'spread': '76.936', 'groupId': 'OG000'}, {'value': '-69.49', 'spread': '73.804', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-6, 6-12, 0-12, 12-24, 24-36, 24-48, 0-36, 36-48, and 0-48 post T0', 'description': 'Sum of the time-weighted differences from baseline in muscle stiffness with movement (SSIDMOVE) over the following intervals: 0-6, 6-12, 0-12, 12-24, 0-24, 24-36, 24-48, 0-36, 36-48, and 0-48 hours post-T0, that is the area under the differences from baseline stiffness difference curve. The muscle Stiffness Intensity Differences (SIDs) with movement from time point A to time point B was calculated using the trapezoid rule by subtracting each post-T0 stiffness score with movement from the stiffness score with movement at time point Ti. Positive and higher scores indicate greater reduction in stiffness. Measured by Muscle Stiffness Numerical Rating Scale (NRS) where 0 = No Stiffness and 10 = Worst Possible Stiffness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 20, 24, 26, 28, 30, 32, 34, 36, 40, 44, and 48 hours post-initial IP dose and immediately prior to the subsequent doses of IP.', 'unitOfMeasure': 'score on a scale*hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis set: All subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Total Relief With Movement (TOTPAR) 0-6 Hours Post Time Zero', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'S-Ibuprofen Topical Gel 5%\n\nS-Ibuprofen: Topical Gel 5%'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Vehicle Topical Gel\n\nVehicle: Vehicle Gel'}], 'classes': [{'categories': [{'measurements': [{'value': '4.06', 'spread': '3.435', 'groupId': 'OG000'}, {'value': '3.61', 'spread': '3.978', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-6 hours', 'description': 'Total relief with movement (TOTPAR) 0-6 hours post time zero\n\nTOTPAR was calculated as the sum of pain relief at time point i (PR i) times the weight for each PR i, where i referred to each pain relief scheduled assessment time point between A and B (not including B). The higher the number the better pain relief.\n\nCategorical Relief Rating Scale: Subjects rated relief from starting pain with movement using a 5-point categorical relief scale "0=no relief," "1=a little relief," "2=some relief," "3=a lot of relief," or "4=complete relief" at 1, 2, 3, 4, 5, and 6 hours post-initial IP dose and immediately prior to a subsequent dose of IP if one occurred prior to 6 hours.', 'unitOfMeasure': 'score on a scale*hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Subject Global Assessment of Study Medication Assessed at Approximately 48 Hours Post Time Zero', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'S-Ibuprofen Topical Gel 5%\n\nS-Ibuprofen: Topical Gel 5%'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Vehicle Topical Gel\n\nVehicle: Vehicle Gel'}], 'classes': [{'title': 'Original Categories - Poor', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Original Categories - Fair', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Original Categories - Good', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Original Categories - Very good', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Original Categories - Excellent', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Dichotomized Categories - Poor/fair', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}, {'title': 'Dichotomized Categories - Good/very good/excellent', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours post time zero', 'description': 'Global assessment of efficacy will be assessed at approximately 48 hours post-T0 (or upon early termination if the subject withdraws prior to the 48-hour assessment).\n\nSubject Global Assessment Using Original 5 Categories as 0=poor, 1=fair, 2=good, 3=very good, 4=excellent. In addition, the 5 categories were dichotomized into 2 categories (good/very good/excellent versus poor/fair). The proportion of good, very good, and excellent ratings were calculated for each treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Arm', 'description': 'S-Ibuprofen Topical Gel 5%\n\nS-Ibuprofen: Topical Gel 5%'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Vehicle Topical Gel\n\nVehicle: Vehicle Gel'}], 'classes': [{'title': 'Subjects with any TEAE', 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}]}, {'title': 'Subjects with any treatment-related TEAEs', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}]}, {'title': 'Subjects with TEAEs leading to discontinuation', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Subjects with SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TEAE with mild in severity', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}]}, {'title': 'TEAE with moderate in severity', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'TEAE with Severe in severity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 7', 'description': 'TEAE was defined as an adverse event that was new or worsened in severity after the first dose of study drug. A treatment-related TEAE was defined as a TEAE that was at least possibly related to the administration of study drug or was missing the relationship assessment. If a TEAE was recorded on multiple occasions, only the highest severity was presented.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: All subjects who received at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Arm', 'description': 'S-Ibuprofen Topical Gel 5%\n\nAP0302 (S-ibuprofen topical gel 5%)applied up to 7 times in 24 hours, over a 48-hour dosing period.'}, {'id': 'FG001', 'title': 'Placebo Arm', 'description': 'Vehicle Topical Gel\n\nPlacebo topical gel 5% applied up to 7 times in 24 hours, over a 48-hour dosing period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '125'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '122'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This was a Phase 2/3, single-center study conducted in USA', 'preAssignmentDetails': 'A total of 434 subjects were screened in the study of which 251 subjects were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Arm', 'description': 'S-Ibuprofen Topical Gel 5%\n\nS-Ibuprofen: Topical Gel 5%'}, {'id': 'BG001', 'title': 'Placebo Arm', 'description': 'Vehicle Topical Gel\n\nVehicle: Vehicle Gel'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.2', 'spread': '10.41', 'groupId': 'BG000'}, {'value': '30.6', 'spread': '10.37', 'groupId': 'BG001'}, {'value': '29.4', 'spread': '10.44', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '24.01', 'spread': '3.146', 'groupId': 'BG000'}, {'value': '24.55', 'spread': '3.082', 'groupId': 'BG001'}, {'value': '24.28', 'spread': '3.120', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-02', 'size': 1690537, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-06-10T18:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'active gel and matching vehicle control gel'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 251}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-29', 'studyFirstSubmitDate': '2019-02-20', 'resultsFirstSubmitDate': '2021-04-19', 'studyFirstSubmitQcDate': '2019-02-21', 'lastUpdatePostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-29', 'studyFirstPostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sum of the Time-weighted Differences From Baseline in Pain Intensity With Movement(SPIDMOVE) Over 24 Hours Post Time Zero', 'timeFrame': '0-24 hours.', 'description': 'The primary efficacy outcome is the sum of the time-weighted differences from baseline in muscle pain/soreness with movement over 0-24 hours post T0 (SPIDMOVE 0-24h), that is the area under the differences from baseline pain/soreness intensity difference curve. The pain intensity differences (PIDs) with movement from time point A to time point B was calculated using the trapezoid rule by subtracting each post-T0 pain score with movement from the pain score with movement at time point Ti. Positive and higher scores indicate greater reduction in pain. Measured by Pain Intensity Numerical Rating Scale (PI-NRS) where 0 = no pain and 10 = worst possible pain at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 20, 24, 26, 28, 30, 32, 34, 36, 40, 44, and 48 hours post-initial IP dose and immediately prior to the subsequent doses of investigational product (IP).'}], 'secondaryOutcomes': [{'measure': 'SPIDMOVE Over the Following Intervals: 0-6, 6-12, 0-12, 12-24, 24-36, 24-48, 0-36, 36-48 and 0-48 Hours Post-T0.', 'timeFrame': 'From 0-6, 6-12, 0-12, 12-24, 24-36, 0-36, 24-28,36-48, and 0-48 hours post-T0. Time point i included 1, 2, 3, 4, 5, 6 (pre-dose), 7, 8, 9, 10, 11, 12 (pre-dose), 16, 18 (pre-dose), 20, and 24 (pre-dose) hours after the first dose.', 'description': 'Sum of the time-weighted differences from baseline in pain intensity with movement (SPIDMOVE) over the following intervals: 0-6, 6-12, 0-12, 12-24, 24-36, 0-36, 24-28, 36-48, and 0-48 hours post-T0, that is the area under the differences from baseline pain/soreness intensity difference curve. The PIDs with movement from time point A to time point B was calculated using the trapezoid rule by subtracting each post-T0 pain score with movement from the pain score with movement at time point Ti. Positive and higher scores indicate greater reduction in pain. Measured by Pain Intensity Numerical Rating Scale (PI-NRS) where 0 = no pain and 10 = worst possible pain at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 20, 24, 26, 28, 30, 32, 34, 36, 40, 44, and 48 hours post-initial IP dose and immediately prior to the subsequent doses of IP.'}, {'measure': 'Sum of Time Weighted Differences From Baseline in Muscle Stiffness (SSID) With Movement Over the Interval', 'timeFrame': '0-6, 6-12, 0-12, 12-24, 24-36, 24-48, 0-36, 36-48, and 0-48 post T0', 'description': 'Sum of the time-weighted differences from baseline in muscle stiffness with movement (SSIDMOVE) over the following intervals: 0-6, 6-12, 0-12, 12-24, 0-24, 24-36, 24-48, 0-36, 36-48, and 0-48 hours post-T0, that is the area under the differences from baseline stiffness difference curve. The muscle Stiffness Intensity Differences (SIDs) with movement from time point A to time point B was calculated using the trapezoid rule by subtracting each post-T0 stiffness score with movement from the stiffness score with movement at time point Ti. Positive and higher scores indicate greater reduction in stiffness. Measured by Muscle Stiffness Numerical Rating Scale (NRS) where 0 = No Stiffness and 10 = Worst Possible Stiffness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 20, 24, 26, 28, 30, 32, 34, 36, 40, 44, and 48 hours post-initial IP dose and immediately prior to the subsequent doses of IP.'}, {'measure': 'Total Relief With Movement (TOTPAR) 0-6 Hours Post Time Zero', 'timeFrame': '0-6 hours', 'description': 'Total relief with movement (TOTPAR) 0-6 hours post time zero\n\nTOTPAR was calculated as the sum of pain relief at time point i (PR i) times the weight for each PR i, where i referred to each pain relief scheduled assessment time point between A and B (not including B). The higher the number the better pain relief.\n\nCategorical Relief Rating Scale: Subjects rated relief from starting pain with movement using a 5-point categorical relief scale "0=no relief," "1=a little relief," "2=some relief," "3=a lot of relief," or "4=complete relief" at 1, 2, 3, 4, 5, and 6 hours post-initial IP dose and immediately prior to a subsequent dose of IP if one occurred prior to 6 hours.'}, {'measure': 'Subject Global Assessment of Study Medication Assessed at Approximately 48 Hours Post Time Zero', 'timeFrame': '48 hours post time zero', 'description': 'Global assessment of efficacy will be assessed at approximately 48 hours post-T0 (or upon early termination if the subject withdraws prior to the 48-hour assessment).\n\nSubject Global Assessment Using Original 5 Categories as 0=poor, 1=fair, 2=good, 3=very good, 4=excellent. In addition, the 5 categories were dichotomized into 2 categories (good/very good/excellent versus poor/fair). The proportion of good, very good, and excellent ratings were calculated for each treatment.'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to Day 7', 'description': 'TEAE was defined as an adverse event that was new or worsened in severity after the first dose of study drug. A treatment-related TEAE was defined as a TEAE that was at least possibly related to the administration of study drug or was missing the relationship assessment. If a TEAE was recorded on multiple occasions, only the highest severity was presented.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Acute']}, 'descriptionModule': {'briefSummary': 'Phase 2 study designed to evaluated analgesic efficacy and safety of S-Ibuprofen Topical Gel 5%', 'detailedDescription': 'The purpose of this randomized, double-blind study is to evaluate the efficacy and safety of S-Ibuprofen Topical Gel 5% in reducing pain/soreness associated with delayed onset muscle soreness (DOMS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* history of pain/soreness after exercise\n* BMI between 18-30\n* negative drug, alcohol, pregnancy screens\n* other protocol-defined inclusion criteria may apply\n\nExclusion Criteria:\n\n* upper extremity workout in last 3 months\n* job or hobby requiring heavy lifting\n* history of muscle disorders\n* allergy or intolerance to NSAID or study drug\n* history of recent pain medication use\n* other protocol-defined exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT03852459', 'briefTitle': 'Controlled Study to Assess the Efficacy and Safety of S-Ibuprofen Topical Gel 5% (AP0302) in the Treatment of DOMS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aponia Laboratories, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind,Vehicle-Controlled Study to Determine the Efficacy and Safety of AP0302 in the Treatment of Delayed Onset Muscle Soreness (DOMS)', 'orgStudyIdInfo': {'id': 'AP-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Arm', 'description': 'S-Ibuprofen Topical Gel 5%', 'interventionNames': ['Drug: S-Ibuprofen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Arm', 'description': 'Vehicle Topical Gel', 'interventionNames': ['Drug: Vehicle']}], 'interventions': [{'name': 'S-Ibuprofen', 'type': 'DRUG', 'description': 'Topical Gel 5%', 'armGroupLabels': ['Active Arm']}, {'name': 'Vehicle', 'type': 'DRUG', 'description': 'Vehicle Gel', 'armGroupLabels': ['Placebo Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'JBR Clinical Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Todd Bertoch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'JBR Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aponia Laboratories, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}