Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-07 @ 7:10 AM
Study NCT ID:
NCT05553366
Status:
COMPLETED
Last Update Posted:
2025-08-01
First Post:
2022-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-07-01', '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': 'medicalinfo@vrtx.com', 'phone': '617-341-6777', 'title': 'Medical Monitor', 'organization': 'Vertex Pharmaceuticals Incorporated'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 up to Day 19', 'description': 'Safety Set included all participants who received at least 1 dose of the study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to SUZ and HB/APAP for 2 days.', 'otherNumAtRisk': 216, 'deathsNumAtRisk': 216, 'otherNumAffected': 51, 'seriousNumAtRisk': 216, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Hydrocodone Bitartrate/Acetaminophen (HB/APAP)', 'description': 'Participants received HB 5 mg/ APAP 325 mg q6h for 2 days.', 'otherNumAtRisk': 431, 'deathsNumAtRisk': 431, 'otherNumAffected': 113, 'seriousNumAtRisk': 431, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Suzetrigine (SUZ)', 'description': 'Participants received SUZ \\[100 mg as first dose, followed by 50 mg q12h\\] for 2 days.', 'otherNumAtRisk': 426, 'deathsNumAtRisk': 426, 'otherNumAffected': 72, 'seriousNumAtRisk': 426, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 431, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 426, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 431, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 426, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 431, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 426, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 431, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 426, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48), SUZ Compared to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to SUZ and HB/APAP for 2 days.'}, {'id': 'OG001', 'title': 'Suzetrigine (SUZ)', 'description': 'Participants received SUZ \\[100 mg as first dose, followed by 50 mg q12h\\] for 2 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.6', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '99.9', 'spread': '4.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0 to 48 hours After First Dose of Study Drug', 'description': 'SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated subtracting the baseline pain intensity score from the pain intensity score at each postdose time point (using pain rating score range: 0= no pain to 10= worst possible pain). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48), SUZ Compared to HB/APAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydrocodone Bitartrate/Acetaminophen (HB/APAP)', 'description': 'Participants received HB 5 mg/ APAP 325 mg q6h for 2 days.'}, {'id': 'OG001', 'title': 'Suzetrigine (SUZ)', 'description': 'Participants received SUZ \\[100 mg as first dose, followed by 50 mg q12h\\] for 2 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '120.1', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '99.9', 'spread': '4.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0016', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0 to 48 hours After First Dose of Study Drug', 'description': 'SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the baseline pain intensity score from the pain intensity score at each post dose time point(using pain rating score range: 0= no pain to 10= worst possible pain). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Greater Than or Equal to (≥)2-Point Reduction in NPRS,SUZ Compared to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to SUZ and HB/APAP for 2 days.'}, {'id': 'OG001', 'title': 'Suzetrigine (SUZ)', 'description': 'Participants received SUZ \\[100 mg as first dose, followed by 50 mg q12h\\] for 2 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '480', 'groupId': 'OG000', 'lowerLimit': '476', 'upperLimit': '716'}, {'value': '240', 'groupId': 'OG001', 'lowerLimit': '117', 'upperLimit': '477'}]}]}], 'analyses': [{'pValue': '0.0016', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline Up to 48 Hours After First Dose of Study Drug', 'description': 'Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.\n\nThe time to ≥ 2-point reduction in NPRS from baseline was the time elapsed from the first dose of study drug until the first time the participant had at least a 2-point reduction in NPRS scores from baseline.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure. Data for this outcome measure was planned to be collected and analyzed only for the Placebo and SUZ group.'}, {'type': 'SECONDARY', 'title': 'Time to ≥1-Point Reduction in NPRS, SUZ Compared to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to SUZ and HB/APAP for 2 days.'}, {'id': 'OG001', 'title': 'Suzetrigine (SUZ)', 'description': 'Participants received SUZ \\[100 mg as first dose, followed by 50 mg q12h\\] for 2 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000', 'lowerLimit': '34', 'upperLimit': '121'}, {'value': '60', 'groupId': 'OG001', 'lowerLimit': '58', 'upperLimit': '65'}]}]}], 'analyses': [{'pValue': '0.1315', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline Up to 48 Hours After First Dose of Study Drug', 'description': 'Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.\n\nThe time to ≥1-point reduction in NPRS from baseline was the time elapsed from the first dose of study drug until the first time the participant had at least a 1-point reduction in NPRS from baseline.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure. Data for this outcome measure was planned to be collected and analyzed only for the Placebo and SUZ group.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Scale, SUZ Compared to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to SUZ and HB/APAP for 2 days.'}, {'id': 'OG001', 'title': 'Suzetrigine (SUZ)', 'description': 'Participants received SUZ \\[100 mg as first dose, followed by 50 mg q12h\\] for 2 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.2', 'groupId': 'OG000'}, {'value': '61.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0343', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At 48 Hours After First Dose of Study Drug', 'description': 'The PGA is a single-item assessment of patient perceptions of the method of pain control with the study drug and is evaluated on a 4-point Likert scale as: (poor, fair, good, or excellent). Percentage of participants who reported good or excellent on the PGA scale were reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure. Data for this outcome measure was planned to be collected and analyzed only for the Placebo and SUZ group.'}, {'type': 'SECONDARY', 'title': 'Incidence of Vomiting or Nausea, SUZ Compared to HB/APAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydrocodone Bitartrate/Acetaminophen (HB/APAP)', 'description': 'Participants received HB 5 mg/ APAP 325 mg q6h for 2 days.'}, {'id': 'OG001', 'title': 'Suzetrigine (SUZ)', 'description': 'Participants received SUZ \\[100 mg as first dose, followed by 50 mg q12h\\] for 2 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'groupId': 'OG000'}, {'value': '9.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0014', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Pearson's chi-squared test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline up to Day 19', 'description': 'The percentage of participants with the events of vomiting or nausea during the specified time frame was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set included all participants who received at least 1 dose of study drug. Data for this outcome measure was planned to be collected and analyzed only for the HB/APAP and SUZ group.'}, {'type': 'SECONDARY', 'title': 'Time-weighted SPID as Recorded on the NPRS From 0 to 24 Hours (SPID24), SUZ Compared to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to SUZ and HB/APAP for 2 days.'}, {'id': 'OG001', 'title': 'Suzetrigine (SUZ)', 'description': 'Participants received SUZ \\[100 mg as first dose, followed by 50 mg q12h\\] for 2 days'}], 'classes': [{'categories': [{'measurements': [{'value': '19.8', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '30.6', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0032', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0 to 24 Hours After First Dose of Study Drug', 'description': 'SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the baseline pain intensity score from the pain intensity score at each post dose time point (using pain rating score range: 0= no pain to 10= worst possible pain). SPID24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure. Data for this outcome measure was planned to be collected and analyzed only for the Placebo and SUZ group.'}, {'type': 'SECONDARY', 'title': 'Time to First Use of Rescue Medication, SUZ Compared to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to SUZ and HB/APAP for 2 days.'}, {'id': 'OG001', 'title': 'Suzetrigine (SUZ)', 'description': 'Participants received SUZ \\[100 mg as first dose, followed by 50 mg q12h\\] for 2 days'}], 'classes': [{'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000', 'lowerLimit': '143', 'upperLimit': '210'}, {'value': '157', 'groupId': 'OG001', 'lowerLimit': '145', 'upperLimit': '192'}]}]}], 'analyses': [{'pValue': '0.8592', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '0 to 48 Hours After First Dose of Study Drug', 'description': 'Time to first use of rescue medication is the time from the first dose of study drug until the first use of rescue medication.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure. Data for this outcome measure was planned to be collected and analyzed only for the Placebo and SUZ group.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Using Rescue Medication From 0 to 48 Hours, SUZ Compared to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to SUZ and HB/APAP for 2 days.'}, {'id': 'OG001', 'title': 'Suzetrigine (SUZ)', 'description': 'Participants received SUZ \\[100 mg as first dose, followed by 50 mg q12h\\] for 2 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.6', 'groupId': 'OG000'}, {'value': '85.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9143', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '0 to 48 Hours After First Dose of Study Drug', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure. Data for this outcome measure was planned to be collected and analyzed only for the Placebo and SUZ group.'}, {'type': 'SECONDARY', 'title': 'Total Rescue Medication Usage, SUZ Compared to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to SUZ and HB/APAP for 2 days.'}, {'id': 'OG001', 'title': 'Suzetrigine (SUZ)', 'description': 'Participants received SUZ \\[100 mg as first dose, followed by 50 mg q12h\\] for 2 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '800', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3200'}, {'value': '800', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3200'}]}]}], 'analyses': [{'pValue': '0.0205', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon rank-sum', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '0 to 48 Hours After First Dose of Study Drug', 'unitOfMeasure': 'milligram', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure. Data for this outcome measure was planned to be collected and analyzed only for the Placebo and SUZ group.'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}, {'value': '426', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to SUZ and HB/APAP for 2 days.'}, {'id': 'OG001', 'title': 'Hydrocodone Bitartrate/Acetaminophen (HB/APAP)', 'description': 'Participants received HB 5 mg/ APAP 325 mg q6h for 2 days'}, {'id': 'OG002', 'title': 'Suzetrigine (SUZ)', 'description': 'Participants received SUZ \\[100 mg as first dose, followed by 50 mg q12h\\] for 2 days'}], 'classes': [{'title': 'Participants with TEAEs', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}]}, {'title': 'Participants with SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to Day 19', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set included all participants who received at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to suzetrigine (SUZ) and hydrocodone bitartrate/acetaminophen (HB/APAP) for 2 days.'}, {'id': 'FG001', 'title': 'Hydrocodone Bitartrate/Acetaminophen (HB/APAP)', 'description': 'Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 2 days.'}, {'id': 'FG002', 'title': 'Suzetrigine (SUZ)', 'description': 'Participants received SUZ \\[100 mg as first dose, followed by 50 mg every 12 hours (q12h)\\] for 2 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '216'}, {'groupId': 'FG001', 'numSubjects': '431'}, {'groupId': 'FG002', 'numSubjects': '428'}]}, {'type': 'Safety Set', 'comment': 'Safety Set included all participants who received at least 1 dose of the study drug.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '216'}, {'groupId': 'FG001', 'numSubjects': '431'}, {'groupId': 'FG002', 'numSubjects': '426'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '419'}, {'groupId': 'FG002', 'numSubjects': '418'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Withdrawal of Consent (not due to AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Other non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Randomized but not dosed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}, {'value': '431', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}, {'value': '1073', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to SUZ and HB/APAP for 2 days.'}, {'id': 'BG001', 'title': 'Hydrocodone Bitartrate/Acetaminophen (HB/APAP)', 'description': 'Participants received HB 5 mg/ APAP 325 mg q6h for 2 days.'}, {'id': 'BG002', 'title': 'Suzetrigine (SUZ)', 'description': 'Participants received SUZ \\[100 mg as first dose, followed by 50 mg q12h\\] for 2 days.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.1', 'spread': '13.5', 'groupId': 'BG000'}, {'value': '48.3', 'spread': '12.6', 'groupId': 'BG001'}, {'value': '47.7', 'spread': '13.3', 'groupId': 'BG002'}, {'value': '48.0', 'spread': '13.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '187', 'groupId': 'BG000'}, {'value': '359', 'groupId': 'BG001'}, {'value': '366', 'groupId': 'BG002'}, {'value': '912', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '161', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '364', 'groupId': 'BG003'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}, {'value': '709', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '314', 'groupId': 'BG001'}, {'value': '285', 'groupId': 'BG002'}, {'value': '759', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '260', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'Multiracial', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-12', 'size': 796234, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-13T05:47', 'hasProtocol': True}, {'date': '2023-12-19', 'size': 626793, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-13T05:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1075}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'dispFirstSubmitDate': '2024-12-13', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2022-09-20', 'resultsFirstSubmitDate': '2025-06-13', 'studyFirstSubmitQcDate': '2022-09-20', 'dispFirstPostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-14', 'studyFirstPostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48), SUZ Compared to Placebo', 'timeFrame': '0 to 48 hours After First Dose of Study Drug', 'description': 'SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated subtracting the baseline pain intensity score from the pain intensity score at each postdose time point (using pain rating score range: 0= no pain to 10= worst possible pain). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).'}], 'secondaryOutcomes': [{'measure': 'Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48), SUZ Compared to HB/APAP', 'timeFrame': '0 to 48 hours After First Dose of Study Drug', 'description': 'SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the baseline pain intensity score from the pain intensity score at each post dose time point(using pain rating score range: 0= no pain to 10= worst possible pain). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).'}, {'measure': 'Time to Greater Than or Equal to (≥)2-Point Reduction in NPRS,SUZ Compared to Placebo', 'timeFrame': 'From Baseline Up to 48 Hours After First Dose of Study Drug', 'description': 'Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.\n\nThe time to ≥ 2-point reduction in NPRS from baseline was the time elapsed from the first dose of study drug until the first time the participant had at least a 2-point reduction in NPRS scores from baseline.'}, {'measure': 'Time to ≥1-Point Reduction in NPRS, SUZ Compared to Placebo', 'timeFrame': 'From Baseline Up to 48 Hours After First Dose of Study Drug', 'description': 'Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.\n\nThe time to ≥1-point reduction in NPRS from baseline was the time elapsed from the first dose of study drug until the first time the participant had at least a 1-point reduction in NPRS from baseline.'}, {'measure': 'Percentage of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Scale, SUZ Compared to Placebo', 'timeFrame': 'At 48 Hours After First Dose of Study Drug', 'description': 'The PGA is a single-item assessment of patient perceptions of the method of pain control with the study drug and is evaluated on a 4-point Likert scale as: (poor, fair, good, or excellent). Percentage of participants who reported good or excellent on the PGA scale were reported.'}, {'measure': 'Incidence of Vomiting or Nausea, SUZ Compared to HB/APAP', 'timeFrame': 'From Baseline up to Day 19', 'description': 'The percentage of participants with the events of vomiting or nausea during the specified time frame was reported.'}, {'measure': 'Time-weighted SPID as Recorded on the NPRS From 0 to 24 Hours (SPID24), SUZ Compared to Placebo', 'timeFrame': '0 to 24 Hours After First Dose of Study Drug', 'description': 'SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the baseline pain intensity score from the pain intensity score at each post dose time point (using pain rating score range: 0= no pain to 10= worst possible pain). SPID24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score).'}, {'measure': 'Time to First Use of Rescue Medication, SUZ Compared to Placebo', 'timeFrame': '0 to 48 Hours After First Dose of Study Drug', 'description': 'Time to first use of rescue medication is the time from the first dose of study drug until the first use of rescue medication.'}, {'measure': 'Percentage of Participants Using Rescue Medication From 0 to 48 Hours, SUZ Compared to Placebo', 'timeFrame': '0 to 48 Hours After First Dose of Study Drug'}, {'measure': 'Total Rescue Medication Usage, SUZ Compared to Placebo', 'timeFrame': '0 to 48 Hours After First Dose of Study Drug'}, {'measure': 'Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Day 1 up to Day 19'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of suzetrigine for acute pain after a bunionectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Before Surgery\n\n * Participants scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia (Mayo and popliteal sciatic block)\n* After Surgery\n\n * Participant is lucid and able to follow commands\n * All analgesic guidelines were followed during and after the bunionectomy\n\nKey Exclusion Criteria:\n\n* Before Surgery\n\n * Prior history of bunionectomy or or other foot surgery on the index foot; or bunionectomy on the opposite foot\n * History of cardiac dysrhythmias within the last 2 years requiring anti-arrhythmia treatment(s)\n * Any prior surgery within 1 month before the first study drug dose\n* After Surgery\n\n * Participant had a type 3 deformity requiring a base wedge osteotomy, concomitant surgery such as hammertoe repair; or experienced medical complications during the bunionectomy\n * Participant had a medical complication during the bunionectomy that, in the opinion of the investigator, should preclude randomization\n\nOther protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05553366', 'briefTitle': 'Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vertex Pharmaceuticals Incorporated'}, 'officialTitle': 'A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy', 'orgStudyIdInfo': {'id': 'VX22-548-104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo matched to suzetrigine (SUZ) and hydrocodone bitartrate/acetaminophen (HB/APAP) for 2 days.', 'interventionNames': ['Drug: Placebo (matched to SUZ)', 'Drug: Placebo (matched to HB/APAP)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hydrocodone bitartrate/acetaminophen (HB/APAP)', 'description': 'Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 2 days.', 'interventionNames': ['Drug: HB/APAP', 'Drug: Placebo (matched to SUZ)']}, {'type': 'EXPERIMENTAL', 'label': 'Suzetrigine (SUZ)', 'description': 'Participants received SUZ \\[100 mg as first dose, followed by 50 mg every 12 hours (q12h)\\] for 2 days.', 'interventionNames': ['Drug: SUZ', 'Drug: Placebo (matched to HB/APAP)']}], 'interventions': [{'name': 'SUZ', 'type': 'DRUG', 'otherNames': ['VX-548'], 'description': 'Tablets for oral administration.', 'armGroupLabels': ['Suzetrigine (SUZ)']}, {'name': 'HB/APAP', 'type': 'DRUG', 'description': 'Capsules for oral administration.', 'armGroupLabels': ['Hydrocodone bitartrate/acetaminophen (HB/APAP)']}, {'name': 'Placebo (matched to SUZ)', 'type': 'DRUG', 'description': 'Placebo matched to SUZ for oral administration.', 'armGroupLabels': ['Hydrocodone bitartrate/acetaminophen (HB/APAP)', 'Placebo']}, {'name': 'Placebo (matched to HB/APAP)', 'type': 'DRUG', 'description': 'Placebo matched to HB/APAP for oral administration.', 'armGroupLabels': ['Placebo', 'Suzetrigine (SUZ)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35660', 'city': 'Sheffield', 'state': 'Alabama', 'country': 'United States', 'facility': 'Shoals Medical Trials Inc.', 'geoPoint': {'lat': 34.76509, 'lon': -87.69864}}, {'zip': '85053', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Research Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Woodland International Research Group', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '93301', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Trovare Clinical Research', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Research Network Inc', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '91356', 'city': 'Tarzana', 'state': 'California', 'country': 'United States', 'facility': 'New Hope Research Development', 'geoPoint': {'lat': 34.17334, 'lon': -118.55397}}, {'zip': '91790', 'city': 'West Covina', 'state': 'California', 'country': 'United States', 'facility': 'New Hope Research Development', 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'Oklahoma', 'country': 'United States', 'facility': 'Center for Orthopaedic Reconstruction and Excellence', 'geoPoint': {'lat': 36.02287, 'lon': -95.96833}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'facility': 'HD Research LLC | First Surgical Hospital', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '75006', 'city': 'Carrollton', 'state': 'Texas', 'country': 'United States', 'facility': 'HD Research LLC | Legent Orthopedic Hospital', 'geoPoint': {'lat': 32.95373, 'lon': -96.89028}}, {'zip': '77008', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'HD Research LLC | Houston Heights Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78501', 'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'facility': 'Futuro Clinical Trials', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Endeavor Clinical Trials', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77598', 'city': 'Webster', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Physicians Hospital', 'geoPoint': {'lat': 29.53773, 'lon': -95.11826}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'JBR Clinical Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vertex Pharmaceuticals Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}