Trial · NCT04977336
A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
NCT04977336, Phase 2, Completed, Vertex Pharmaceuticals Incorporated; results first posted 2025-06-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy. Trials, record NCT04977336. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04977336
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
- NCT number
- NCT04977336
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 274 participants, actual
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Conditions
- Acute Pain
- Interventions
- VX-548, HB/APAP, Placebo (matched to VX-548), Placebo (matched to HB/APAP)
- First posted
- 2021-07-26
- Last updated
- 2025-06-25
- Results first posted
- 2025-06-25
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time-Weighted Sum of Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 48 Hours (SPID48) After the First Dose of Study Drug | 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 pain intensity score at given post-dose time points from the baseline pain intensity scores (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 SPID as Recorded on a NPRS 0 to 24 Hours (SPID24) After the First Dose of Study Drug | 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 pain intensity score at given post-dose time points from the baseline pain intensity scores (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 | Percentage of Participants With at Least 30 Percent (%) Reduction in NPRS at 48 Hours After the First Dose of Study Drug | From Baseline at 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 percentage of participants with at least 30% reduction from baseline in NPRS at 48 hours after the first dose of VX-548, HB/APAP or placebo was reported. |
| Secondary | Percentage of Participants With at Least 50% Reduction in NPRS at 48 Hours After the First Dose of Study Drug | From Baseline at 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 percentage of participants with at least 50% reduction from baseline in NPRS at 48 hours after the first dose of VX-548, HB/APAP or placebo were reported. |
| Secondary | Percentage of Participants With at Least 70% Reduction in NPRS at 48 Hours After the First Dose of Study Drug | From Baseline at 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 percentage of participants with at least 70% reduction from baseline in NPRS at 48 hours after the first dose of VX-548, HB/APAP or placebo were reported. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of VX-548 and M6-548 (Metabolite) | Day 1 and Day 2 | |
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-548 and M6-548 (Metabolite) | Day 1 and Day 2 | |
| Secondary | Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VX-548 and M6-548 (Metabolite) | Day 1 and Day 2 | |
| Secondary | Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to Day 16 |
Source ClinicalTrials.gov
Outcomes9
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 Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 48 Hours (SPID48) After the First Dose of Study Drug | 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. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Time-Weighted SPID as Recorded on a NPRS 0 to 24 Hours (SPID24) After the First Dose of Study Drug | 0 to 24 hours After First Dose of Study Drug | FAS. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With at Least 30 Percent (%) Reduction in NPRS at 48 Hours After the First Dose of Study Drug | From Baseline at 48 Hours After First Dose of Study Drug | FAS. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least 50% Reduction in NPRS at 48 Hours After the First Dose of Study Drug | From Baseline at 48 Hours After First Dose of Study Drug | FAS. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least 70% Reduction in NPRS at 48 Hours After the First Dose of Study Drug | From Baseline at 48 Hours After First Dose of Study Drug | FAS. | percentage of participants | NUMBER |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of VX-548 and M6-548 (Metabolite) | Day 1 and Day 2 | Pharmacokinetic (PK) analysis set included participants who received at least 1 dose of VX-548. Here, Number Analyzed signifies those participants who were evaluable at specified time points. | micrograms/milliliter (mcg/mL) | MEAN |
| SECONDARY | Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-548 and M6-548 (Metabolite) | Day 1 and Day 2 | PK analysis set included participants who received at least 1 dose of VX-548. Here, Number Analyzed signifies those participants who were evaluable at specified time points. | hours (h) | MEDIAN |
| SECONDARY | Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VX-548 and M6-548 (Metabolite) | Day 1 and Day 2 | PK analysis set included participants who received at least 1 dose of VX-548. Here, Number Analyzed signifies those participants who were evaluable at specified time points. | hour*mcg/ml (h*mcg/mL) | MEAN |
| SECONDARY | Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to Day 16 | Safety set included all participants who had received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group71
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 Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 48 Hours (SPID48) After the First Dose of Study Drug | Placebo | 100.98 | Standard Error 11.60 | units on a scale | |
| Time-Weighted Sum of Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 48 Hours (SPID48) After the First Dose of Study Drug | HB/APAP | 115.64 | Standard Error 11.49 | units on a scale | |
| Time-Weighted Sum of Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 48 Hours (SPID48) After the First Dose of Study Drug | VX-548: Low Dose | 112.92 | Standard Error 15.52 | units on a scale | |
| Time-Weighted Sum of Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 48 Hours (SPID48) After the First Dose of Study Drug | VX-548: Mid Dose | 86.87 | Standard Error 11.33 | units on a scale | |
| Time-Weighted Sum of Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 48 Hours (SPID48) After the First Dose of Study Drug | VX-548: High Dose | 137.77 | Standard Error 11.50 | units on a scale | |
| Time-Weighted SPID as Recorded on a NPRS 0 to 24 Hours (SPID24) After the First Dose of Study Drug | Placebo | 31.54 | Standard Error 5.57 | units on a scale | |
| Time-Weighted SPID as Recorded on a NPRS 0 to 24 Hours (SPID24) After the First Dose of Study Drug | HB/APAP | 40.95 | Standard Error 5.52 | units on a scale | |
| Time-Weighted SPID as Recorded on a NPRS 0 to 24 Hours (SPID24) After the First Dose of Study Drug | VX-548: Low Dose | 34.36 | Standard Error 7.45 | units on a scale | |
| Time-Weighted SPID as Recorded on a NPRS 0 to 24 Hours (SPID24) After the First Dose of Study Drug | VX-548: Mid Dose | 24.78 | Standard Error 5.44 | units on a scale | |
| Time-Weighted SPID as Recorded on a NPRS 0 to 24 Hours (SPID24) After the First Dose of Study Drug | VX-548: High Dose | 45.22 | Standard Error 5.52 | units on a scale |
1 to 10 of 71Source ClinicalTrials.gov
See all 71 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 59 | |
| Overall Study | STARTED | HB/APAP | 60 | |
| Overall Study | STARTED | VX-548: Low Dose | 33 | |
| Overall Study | STARTED | VX-548: Mid Dose | 62 | |
| Overall Study | STARTED | VX-548: High Dose | 60 | |
| Overall Study | COMPLETED | Placebo | 58 | |
| Overall Study | COMPLETED | HB/APAP | 60 | |
| Overall Study | COMPLETED | VX-548: Low Dose | 32 | |
| Overall Study | COMPLETED | VX-548: Mid Dose | 61 | |
| Overall Study | COMPLETED | VX-548: High Dose | 58 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events15
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 | Nausea | Gastrointestinal disorders | Placebo | 5 | 59 | |
| other | Nausea | Gastrointestinal disorders | HB/APAP | 11 | 60 | |
| other | Nausea | Gastrointestinal disorders | VX-548: Low Dose | 2 | 33 | |
| other | Nausea | Gastrointestinal disorders | VX-548: Mid Dose | 3 | 62 | |
| other | Nausea | Gastrointestinal disorders | VX-548: High Dose | 5 | 60 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 1 | 59 | |
| other | Vomiting | Gastrointestinal disorders | HB/APAP | 3 | 60 | |
| other | Vomiting | Gastrointestinal disorders | VX-548: Low Dose | 0 | 33 | |
| other | Vomiting | Gastrointestinal disorders | VX-548: Mid Dose | 0 | 62 | |
| other | Vomiting | Gastrointestinal disorders | VX-548: High Dose | 0 | 60 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 59 |
| Total, all-cause mortality | HB/APAP | 0 | 60 |
| Total, all-cause mortality | VX-548: Low Dose | 0 | 33 |
| Total, all-cause mortality | VX-548: Mid Dose | 0 | 62 |
| Total, all-cause mortality | VX-548: High Dose | 0 | 60 |
| Total, other adverse events | Placebo | 12 | 59 |
| Total, other adverse events | HB/APAP | 13 | 60 |
| Total, other adverse events | VX-548: Low Dose | 2 | 33 |
| Total, other adverse events | VX-548: Mid Dose | 7 | 62 |
| Total, other adverse events | VX-548: High Dose | 9 | 60 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT04977336
GET https://conductscience.org/api/trials/v1/NCT04977336/results?page=2