Trial · NCT05553366
Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
NCT05553366, Phase 3, Completed, Vertex Pharmaceuticals Incorporated; results first posted 2025-08-01
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy. Trials, record NCT05553366. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05553366
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
- NCT number
- NCT05553366
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,075 participants, actual
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Conditions
- Acute Pain
- Interventions
- SUZ, HB/APAP, Placebo (matched to SUZ), Placebo (matched to HB/APAP)
- First posted
- 2022-09-23
- Last updated
- 2025-08-01
- Results first posted
- 2025-08-01
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 0 to 48 hours After First Dose of Study Drug | 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). |
| 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 | 0 to 48 hours After First Dose of Study Drug | 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). |
| Secondary | Time to Greater Than or Equal to (≥)2-Point Reduction in NPRS,SUZ Compared to Placebo | From Baseline Up to 48 Hours After First Dose of Study Drug | 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. |
| Secondary | Time to ≥1-Point Reduction in NPRS, SUZ Compared to Placebo | From Baseline Up to 48 Hours After First Dose of Study Drug | 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 from baseline. |
| Secondary | Percentage of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Scale, SUZ Compared to Placebo | At 48 Hours After First Dose of Study Drug | 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. |
| Secondary | Incidence of Vomiting or Nausea, SUZ Compared to HB/APAP | From Baseline up to Day 19 | The percentage of participants with the events of vomiting or nausea during the specified time frame was reported. |
| Secondary | Time-weighted SPID as Recorded on the NPRS From 0 to 24 Hours (SPID24), SUZ Compared to Placebo | 0 to 24 Hours After First Dose of Study Drug | 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). |
| Secondary | Time to First Use of Rescue Medication, SUZ Compared to Placebo | 0 to 48 Hours After First Dose of Study Drug | Time to first use of rescue medication is the time from the first dose of study drug until the first use of rescue medication. |
| Secondary | 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 | |
| Secondary | Total Rescue Medication Usage, SUZ Compared to Placebo | 0 to 48 Hours After First Dose of Study Drug |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | 0 to 48 hours After First Dose of Study Drug | 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. | units on a scale | LEAST_SQUARES_MEAN |
| 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 | 0 to 48 hours After First Dose of Study Drug | FAS. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this specific outcome measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Time to Greater Than or Equal to (≥)2-Point Reduction in NPRS,SUZ Compared to Placebo | From Baseline Up to 48 Hours After First Dose of Study Drug | 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. | minutes | MEDIAN |
| SECONDARY | Time to ≥1-Point Reduction in NPRS, SUZ Compared to Placebo | From Baseline Up to 48 Hours After First Dose of Study Drug | 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. | minutes | MEDIAN |
| SECONDARY | Percentage of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Scale, SUZ Compared to Placebo | At 48 Hours After First Dose of Study Drug | 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. | percentage of participants | NUMBER |
| SECONDARY | Incidence of Vomiting or Nausea, SUZ Compared to HB/APAP | From Baseline up to Day 19 | 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. | percentage of participants | NUMBER |
| SECONDARY | Time-weighted SPID as Recorded on the NPRS From 0 to 24 Hours (SPID24), SUZ Compared to Placebo | 0 to 24 Hours After First Dose of Study Drug | 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. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Time to First Use of Rescue Medication, SUZ Compared to Placebo | 0 to 48 Hours After First Dose of Study Drug | 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. | minutes | MEDIAN |
| SECONDARY | 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 | 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. | percentage of participants | NUMBER |
| SECONDARY | Total Rescue Medication Usage, SUZ Compared to Placebo | 0 to 48 Hours After First Dose of Study Drug | 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. | milligram | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Placebo | 70.6 | Standard Error 6.3 | units on a scale | |
| 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 | Suzetrigine (SUZ) | 99.9 | Standard Error 4.5 | units on a scale | |
| 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 | Hydrocodone Bitartrate/Acetaminophen (HB/APAP) | 120.1 | Standard Error 4.5 | units on a scale | |
| 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 | Suzetrigine (SUZ) | 99.9 | Standard Error 4.5 | units on a scale | |
| Time to Greater Than or Equal to (≥)2-Point Reduction in NPRS,SUZ Compared to Placebo | Placebo | 480 | 95% Confidence Interval 476 to 716 | minutes | |
| Time to Greater Than or Equal to (≥)2-Point Reduction in NPRS,SUZ Compared to Placebo | Suzetrigine (SUZ) | 240 | 95% Confidence Interval 117 to 477 | minutes | |
| Time to ≥1-Point Reduction in NPRS, SUZ Compared to Placebo | Placebo | 61 | 95% Confidence Interval 34 to 121 | minutes | |
| Time to ≥1-Point Reduction in NPRS, SUZ Compared to Placebo | Suzetrigine (SUZ) | 60 | 95% Confidence Interval 58 to 65 | minutes | |
| Percentage of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Scale, SUZ Compared to Placebo | Placebo | 53.2 | percentage of participants | ||
| Percentage of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Scale, SUZ Compared to Placebo | Suzetrigine (SUZ) | 61.7 | percentage of participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 216 | |
| Overall Study | STARTED | Hydrocodone Bitartrate/Acetaminophen (HB/APAP) | 431 | |
| Overall Study | STARTED | Suzetrigine (SUZ) | 428 | |
| Overall Study | Safety Set | Placebo | 216 | |
| Overall Study | Safety Set | Hydrocodone Bitartrate/Acetaminophen (HB/APAP) | 431 | |
| Overall Study | Safety Set | Suzetrigine (SUZ) | 426 | |
| Overall Study | COMPLETED | Placebo | 208 | |
| Overall Study | COMPLETED | Hydrocodone Bitartrate/Acetaminophen (HB/APAP) | 419 | |
| Overall Study | COMPLETED | Suzetrigine (SUZ) | 418 | |
| Overall Study | NOT COMPLETED | Placebo | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Placebo | 9 | 216 | |
| other | Constipation | Gastrointestinal disorders | Hydrocodone Bitartrate/Acetaminophen (HB/APAP) | 22 | 431 | |
| other | Constipation | Gastrointestinal disorders | Suzetrigine (SUZ) | 15 | 426 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 23 | 216 | |
| other | Nausea | Gastrointestinal disorders | Hydrocodone Bitartrate/Acetaminophen (HB/APAP) | 62 | 431 | |
| other | Nausea | Gastrointestinal disorders | Suzetrigine (SUZ) | 35 | 426 | |
| other | Dizziness | Nervous system disorders | Placebo | 11 | 216 | |
| other | Dizziness | Nervous system disorders | Hydrocodone Bitartrate/Acetaminophen (HB/APAP) | 23 | 431 | |
| other | Dizziness | Nervous system disorders | Suzetrigine (SUZ) | 15 | 426 | |
| other | Headache | Nervous system disorders | Placebo | 20 | 216 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 216 |
| Total, all-cause mortality | Hydrocodone Bitartrate/Acetaminophen (HB/APAP) | 0 | 431 |
| Total, all-cause mortality | Suzetrigine (SUZ) | 0 | 426 |
| Total, other adverse events | Placebo | 51 | 216 |
| Total, other adverse events | Hydrocodone Bitartrate/Acetaminophen (HB/APAP) | 113 | 431 |
| Total, other adverse events | Suzetrigine (SUZ) | 72 | 426 |
| Total, serious adverse events | Placebo | 0 | 216 |
| Total, serious adverse events | Hydrocodone Bitartrate/Acetaminophen (HB/APAP) | 0 | 431 |
| Total, serious adverse events | Suzetrigine (SUZ) | 0 | 426 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05553366
GET https://conductscience.org/api/trials/v1/NCT05553366/results?page=2