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The purpose of this study was to evaluate the efficacy and safety of Suzetrigine (SUZ) in treating acute pain after an abdominoplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received placebo matched to Suzetrigine (SUZ) and Hydrocodone bitartrate/acetaminophen (HB/APAP) for 48 hours. |
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| Hydrocodone bitartrate/acetaminophen (HB/APAP) | Active Comparator | Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 48 hours. |
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| Suzetrigine (SUZ) | Experimental | Participants received SUZ [100 mg as first dose, followed by 50 mg every 12 hours (q12h)] for 48 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suzetrigine (SUZ) | Drug | Tablets for oral administration. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 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). | 0 to 48 hours After First Dose of Study Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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). |
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Key Inclusion Criteria:
Before Surgery
After Surgery
Key Exclusion Criteria:
Before Surgery
After Surgery
Other protocol defined Inclusion/Exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shoals Medical Trials Inc. | Sheffield | Alabama | 35660 | United States | ||
| Arizona Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41689837 | Derived | Yuan S, Ji H, Lu Y, Zhang Z, Tang H. The Clinical Application of Suzetrigine. J Pain Palliat Care Pharmacother. 2026 Jun;40(2):311-320. doi: 10.1080/15360288.2026.2624502. Epub 2026 Feb 14. |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo matched to Suzetrigine (SUZ) and Hydrocodone bitartrate/acetaminophen (HB/APAP) for 48 hours. |
| FG001 | Hydrocodone Bitartrate/Acetaminophen (HB/APAP) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 12, 2023 | Jun 9, 2025 |
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| HB/APAP | Drug | Capsules for oral administration. |
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| Placebo (matched to SUZ) | Drug | Placebo matched to SUZ for oral administration. |
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| Placebo (matched to HB/APAP) | Drug | Placebo matched to HB/APAP for oral administration. |
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| 0 to 48 hours After First Dose of Study Drug |
| Time to Greater Than or Equal to (≥) 2-point Reduction in NPRS, SUZ Compared to Placebo | Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The 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. Participants who did not reach at least a 2-point reduction in NPRS from baseline by 48 hours were censored at 48 hours. | From Baseline Up to 48 Hours After First Dose of Study Drug |
| Time to ≥1-point Reduction in NPRS, SUZ Compared to Placebo | Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The 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 scores from baseline. Participants who did not reach at least a 1-point reduction in NPRS from baseline by 48 hours were censored at 48 hours. | From Baseline Up to 48 Hours After First Dose of Study Drug |
| Percentage of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Scale, SUZ Compared to Placebo | 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. Participants who discontinued study drug or had missing PGA at 48 hours were considered to not have reported good or excellent on the PGA. | At 48 hours |
| Incidence of Vomiting or Nausea, SUZ Compared to HB/APAP | The incidence with the events of vomiting or nausea during the specified time frame was reported. | From Baseline Up to Day 19 |
| Time-weighted SPID as Recorded on the NPRS From 0 to 24 Hours (SPID24), SUZ Compared to Placebo | SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference (PID) was calculated by subtracting the baseline pain intensity score from the pain intensity score at each post dose time point (NPRS range: 0 = no pain to 10 = worst possible pain). Time-weighted SPID was calculated as the sum of the PIDs at each post-dose time point multiplied by the time interval (in hours) between each time point. SPID 24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score). | 0 to 24 Hours After First Dose of Study Drug |
| Time to First Use of Rescue Medication, SUZ Compared to Placebo | Time to first use of rescue medication is the time from the first dose of study drug until the first use of rescue medication. Participants who did not take any rescue medication within 48 hours were censored at 48 hours. | 0 to 48 Hours After First Dose of Study Drug |
| Percentage of Participants Using Rescue Medication From 0 to 48 Hours, SUZ Compared to Placebo | 0 to 48 Hours After First Dose of Study Drug |
| Total Rescue Medication Usage, SUZ Compared to Placebo | 0 to 48 Hours After First Dose of Study Drug |
| Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Day 1 up to Day 19 |
| Phoenix |
| Arizona |
| 85053 |
| United States |
| Woodland International Research Group | Little Rock | Arkansas | 72211 | United States |
| Alliance Research Institute, LLC | Canoga Park | California | 91304 | United States |
| New Hope Research Development | Tarzana | California | 91356 | United States |
| Atlanta Center for Medical Research | Atlanta, GA | Atlanta | Georgia | 30331 | United States |
| Kansas Spine and Specialty Hospital | Wichita | Kansas | 67226 | United States |
| HD Research LLC | First Surgical Hospital | Bellaire | Texas | 77401 | United States |
| HD Research LLC | Houston Heights Hospital | Houston | Texas | 77008 | United States |
| Endeavor Clinical Trials | San Antonio | Texas | 78240 | United States |
| South Texas Spine & Surgical Hospital | San Antonio | Texas | 78258 | United States |
| JBR Clinical Research | Salt Lake City | Utah | 84107 | United States |
Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 48 hours.
| FG002 | Suzetrigine (SUZ) | Participants received SUZ [100 mg as first dose, followed by 50 mg every 12 hours (q12h)] for 48 hours. |
| Safety Set | Safety set included all participants who received at least 1 dose of study drug. |
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| NOT COMPLETED |
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Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo matched to SUZ and HB/APAP for 48 hours. |
| BG001 | Hydrocodone Bitartrate/Acetaminophen (HB/APAP) | Participants received HB 5 mg/ APAP 325 mg q6h for 48 hours. |
| BG002 | Suzetrigine (SUZ) | Participants received SUZ (100 mg as first dose, followed by 50 mg q12h) for 48 hours. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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 | 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 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). | Full analysis set (FAS) included all randomized participants who received at least 1 dose of study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | 0 to 48 hours After First Dose of Study Drug |
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| Secondary | 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 | 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). | FAS. | Posted | Least Squares Mean | Standard Error | units on a scale | 0 to 48 hours After First Dose of Study Drug |
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| Secondary | Time to Greater Than or Equal to (≥) 2-point Reduction in NPRS, SUZ Compared to Placebo | Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The 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. Participants who did not reach at least a 2-point reduction in NPRS from baseline by 48 hours were censored at 48 hours. | FAS. | Posted | Median | 95% Confidence Interval | minutes | From Baseline Up to 48 Hours After First Dose of Study Drug |
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| Secondary | Time to ≥1-point Reduction in NPRS, SUZ Compared to Placebo | Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The 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 scores from baseline. Participants who did not reach at least a 1-point reduction in NPRS from baseline by 48 hours were censored at 48 hours. | FAS. | Posted | Median | 95% Confidence Interval | minutes | From Baseline Up to 48 Hours After First Dose of Study Drug |
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| Secondary | Percentage of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Scale, SUZ Compared to Placebo | 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. Participants who discontinued study drug or had missing PGA at 48 hours were considered to not have reported good or excellent on the PGA. | FAS. | Posted | Number | percentage of participants | At 48 hours |
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| Secondary | Incidence of Vomiting or Nausea, SUZ Compared to HB/APAP | The incidence with the events of vomiting or nausea during the specified time frame was reported. | Safety set included all participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | From Baseline Up to Day 19 |
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| Secondary | Time-weighted SPID as Recorded on the NPRS From 0 to 24 Hours (SPID24), SUZ Compared to Placebo | SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference (PID) was calculated by subtracting the baseline pain intensity score from the pain intensity score at each post dose time point (NPRS range: 0 = no pain to 10 = worst possible pain). Time-weighted SPID was calculated as the sum of the PIDs at each post-dose time point multiplied by the time interval (in hours) between each time point. SPID 24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score). | FAS. | Posted | Least Squares Mean | Standard Error | units on a scale | 0 to 24 Hours After First Dose of Study Drug |
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| Secondary | Time to First Use of Rescue Medication, SUZ Compared to Placebo | Time to first use of rescue medication is the time from the first dose of study drug until the first use of rescue medication. Participants who did not take any rescue medication within 48 hours were censored at 48 hours. | FAS. | Posted | Median | 95% Confidence Interval | minutes | 0 to 48 Hours After First Dose of Study Drug |
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| Secondary | Percentage of Participants Using Rescue Medication From 0 to 48 Hours, SUZ Compared to Placebo | FAS. | Posted | Number | percentage of participants | 0 to 48 Hours After First Dose of Study Drug |
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| Secondary | Total Rescue Medication Usage, SUZ Compared to Placebo | FAS. | Posted | Median | Full Range | milligram | 0 to 48 Hours After First Dose of Study Drug |
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| Secondary | Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Safety set included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Day 1 up to Day 19 |
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Day 1 up to Day 19
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Placebo | Participants received Placebo matched to SUZ and HB/APAP for 48 hours. | 1 | 222 | 5 | 222 | 94 | 222 |
| EG001 | HB/APAP | Participants received HB 5 mg/ APAP 325 mg q6h for 48 hours. | 0 | 448 | 7 | 448 | 201 | 448 |
| EG002 | Suzetrigine (SUZ) | Participants received SUZ (100 mg as first dose, followed by 50 mg q12h) for 48 hours. | 0 | 448 | 11 | 448 | 146 | 448 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
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| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
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| Cardiogenic shock | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
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| Intra-abdominal haematoma | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Volvulus | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Impaired healing | General disorders | MedDRA 26.0 | Systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
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| Infected seroma | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Medical device site infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Monitor | Vertex Pharmaceuticals Incorporated | 617-341-6777 | medicalinfo@vrtx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 19, 2023 | Jun 9, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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