Trial Outcomes & Findings for A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty (NCT NCT05034952)
NCT ID: NCT05034952
Last Updated: 2024-12-27
Results Overview
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). SPIDr0-48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
303 participants
Primary outcome timeframe
0 to 48 Hours After First Dose of Study Drug
Results posted on
2024-12-27
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received placebos matched to VX-548 and Hydrocodone bitartrate/acetaminophen (HB/APAP) for 2 days.
|
HB/APAP
Participants received HB 5 milligrams (mg) / APAP 325 mg every 6 hours for 2 days.
|
VX-548: Low Dose
Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg every 12 hours (q12h) for 2 days.
|
VX-548: High Dose
Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
77
|
76
|
74
|
76
|
|
Overall Study
COMPLETED
|
75
|
70
|
70
|
72
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
4
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebos matched to VX-548 and Hydrocodone bitartrate/acetaminophen (HB/APAP) for 2 days.
|
HB/APAP
Participants received HB 5 milligrams (mg) / APAP 325 mg every 6 hours for 2 days.
|
VX-548: Low Dose
Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg every 12 hours (q12h) for 2 days.
|
VX-548: High Dose
Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal of consent (not due to AE)
|
0
|
2
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
3
|
3
|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty
Baseline characteristics by cohort
| Measure |
Placebo
n=77 Participants
Participants received placebo matched to VX-548 and HB/APAP for 2 days.
|
HB/APAP
n=76 Participants
Participants received HB 5 mg / APAP 325 mg q6h for 2 days.
|
VX-548: Low Dose
n=74 Participants
Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days.
|
VX-548: High Dose
n=76 Participants
Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
|
Total
n=303 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.6 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
45.4 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
41.5 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
43.1 years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
43.2 years
STANDARD_DEVIATION 9.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
298 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
223 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
57 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
224 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Pain Intensity at Baseline (at 0 hours) as Recorded on Numeric Pain Rating Scale (NPRS)
|
7.4 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
7.3 units on a scale
STANDARD_DEVIATION 1.8 • n=7 Participants
|
7.4 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
7.2 units on a scale
STANDARD_DEVIATION 1.7 • n=4 Participants
|
7.3 units on a scale
STANDARD_DEVIATION 1.7 • n=21 Participants
|
PRIMARY outcome
Timeframe: 0 to 48 Hours After First Dose of Study DrugPopulation: Full analysis set (FAS) included all randomized participants who received at least 1 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). SPIDr0-48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).
Outcome measures
| Measure |
Placebo
n=77 Participants
Participants received placebo matched to VX-548 and HB/APAP for 2 days.
|
HB/APAP
n=76 Participants
Participants received HB 5 mg / APAP 325 mg q6h for 2 days.
|
VX-548: Low Dose
n=74 Participants
Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days.
|
VX-548: High Dose
n=76 Participants
Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
|
|---|---|---|---|---|
|
Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) at Rest 0 to 48 Hours (SPIDr0-48) After the First Dose of Study Drug
|
72.73 units on a scale
Standard Error 10.23
|
85.20 units on a scale
Standard Error 10.30
|
95.11 units on a scale
Standard Error 10.44
|
110.53 units on a scale
Standard Error 10.30
|
SECONDARY outcome
Timeframe: 0 to 24 Hours After First Dose of Study DrugPopulation: FAS.
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). SPIDr0-24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score).
Outcome measures
| Measure |
Placebo
n=77 Participants
Participants received placebo matched to VX-548 and HB/APAP for 2 days.
|
HB/APAP
n=76 Participants
Participants received HB 5 mg / APAP 325 mg q6h for 2 days.
|
VX-548: Low Dose
n=74 Participants
Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days.
|
VX-548: High Dose
n=76 Participants
Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
|
|---|---|---|---|---|
|
Time-weighted SPID as Recorded on an NPRS at Rest 0 to 24 Hours (SPIDr0-24) After the First Dose of Study Drug
|
25.96 units on a scale
Standard Error 4.70
|
29.98 units on a scale
Standard Error 4.73
|
37.65 units on a scale
Standard Error 4.79
|
45.54 units on a scale
Standard Error 4.73
|
SECONDARY outcome
Timeframe: From Baseline At 48 Hours After First Dose of Study DrugPopulation: FAS.
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 or placebo were reported.
Outcome measures
| Measure |
Placebo
n=77 Participants
Participants received placebo matched to VX-548 and HB/APAP for 2 days.
|
HB/APAP
n=76 Participants
Participants received HB 5 mg / APAP 325 mg q6h for 2 days.
|
VX-548: Low Dose
n=74 Participants
Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days.
|
VX-548: High Dose
n=76 Participants
Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least 30 Percent (%),Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug
|
48.1 percentage of participants
|
53.9 percentage of participants
|
59.5 percentage of participants
|
60.5 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline At 48 Hours After First Dose of Study DrugPopulation: FAS.
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.
Outcome measures
| Measure |
Placebo
n=77 Participants
Participants received placebo matched to VX-548 and HB/APAP for 2 days.
|
HB/APAP
n=76 Participants
Participants received HB 5 mg / APAP 325 mg q6h for 2 days.
|
VX-548: Low Dose
n=74 Participants
Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days.
|
VX-548: High Dose
n=76 Participants
Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least 50% Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug
|
33.8 percentage of participants
|
42.1 percentage of participants
|
43.2 percentage of participants
|
44.7 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline at 48 Hours After First Dose of Study DrugPopulation: FAS.
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.
Outcome measures
| Measure |
Placebo
n=77 Participants
Participants received placebo matched to VX-548 and HB/APAP for 2 days.
|
HB/APAP
n=76 Participants
Participants received HB 5 mg / APAP 325 mg q6h for 2 days.
|
VX-548: Low Dose
n=74 Participants
Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days.
|
VX-548: High Dose
n=76 Participants
Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least 70% Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug
|
14.3 percentage of participants
|
23.7 percentage of participants
|
18.9 percentage of participants
|
25.0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 16Population: Safety set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Placebo
n=77 Participants
Participants received placebo matched to VX-548 and HB/APAP for 2 days.
|
HB/APAP
n=76 Participants
Participants received HB 5 mg / APAP 325 mg q6h for 2 days.
|
VX-548: Low Dose
n=74 Participants
Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days.
|
VX-548: High Dose
n=76 Participants
Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
|
|---|---|---|---|---|
|
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with TEAEs
|
54 Participants
|
46 Participants
|
45 Participants
|
42 Participants
|
|
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with SAEs
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
HB/APAP
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
VX-548 Low Dose
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
VX-548 High Dose
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=77 participants at risk
Participants received placebo matched to VX-548 and HB/APAP for 2 days.
|
HB/APAP
n=76 participants at risk
Participants received HB 5 mg / APAP 325 mg q6h for 2 days.
|
VX-548 Low Dose
n=74 participants at risk
Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days.
|
VX-548 High Dose
n=76 participants at risk
Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
|
|---|---|---|---|---|
|
Infections and infestations
Incision site cellulitis
|
1.3%
1/77 • Day 1 up to Day 16
|
0.00%
0/76 • Day 1 up to Day 16
|
0.00%
0/74 • Day 1 up to Day 16
|
0.00%
0/76 • Day 1 up to Day 16
|
|
Infections and infestations
Sepsis
|
1.3%
1/77 • Day 1 up to Day 16
|
0.00%
0/76 • Day 1 up to Day 16
|
0.00%
0/74 • Day 1 up to Day 16
|
0.00%
0/76 • Day 1 up to Day 16
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.00%
0/77 • Day 1 up to Day 16
|
1.3%
1/76 • Day 1 up to Day 16
|
0.00%
0/74 • Day 1 up to Day 16
|
0.00%
0/76 • Day 1 up to Day 16
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/77 • Day 1 up to Day 16
|
0.00%
0/76 • Day 1 up to Day 16
|
1.4%
1/74 • Day 1 up to Day 16
|
0.00%
0/76 • Day 1 up to Day 16
|
Other adverse events
| Measure |
Placebo
n=77 participants at risk
Participants received placebo matched to VX-548 and HB/APAP for 2 days.
|
HB/APAP
n=76 participants at risk
Participants received HB 5 mg / APAP 325 mg q6h for 2 days.
|
VX-548 Low Dose
n=74 participants at risk
Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days.
|
VX-548 High Dose
n=76 participants at risk
Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
5.2%
4/77 • Day 1 up to Day 16
|
11.8%
9/76 • Day 1 up to Day 16
|
9.5%
7/74 • Day 1 up to Day 16
|
9.2%
7/76 • Day 1 up to Day 16
|
|
Gastrointestinal disorders
Nausea
|
36.4%
28/77 • Day 1 up to Day 16
|
30.3%
23/76 • Day 1 up to Day 16
|
29.7%
22/74 • Day 1 up to Day 16
|
18.4%
14/76 • Day 1 up to Day 16
|
|
Gastrointestinal disorders
Vomiting
|
6.5%
5/77 • Day 1 up to Day 16
|
10.5%
8/76 • Day 1 up to Day 16
|
1.4%
1/74 • Day 1 up to Day 16
|
2.6%
2/76 • Day 1 up to Day 16
|
|
Nervous system disorders
Dizziness
|
18.2%
14/77 • Day 1 up to Day 16
|
10.5%
8/76 • Day 1 up to Day 16
|
14.9%
11/74 • Day 1 up to Day 16
|
7.9%
6/76 • Day 1 up to Day 16
|
|
Nervous system disorders
Headache
|
6.5%
5/77 • Day 1 up to Day 16
|
6.6%
5/76 • Day 1 up to Day 16
|
8.1%
6/74 • Day 1 up to Day 16
|
14.5%
11/76 • Day 1 up to Day 16
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.2%
4/77 • Day 1 up to Day 16
|
1.3%
1/76 • Day 1 up to Day 16
|
2.7%
2/74 • Day 1 up to Day 16
|
2.6%
2/76 • Day 1 up to Day 16
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.6%
2/77 • Day 1 up to Day 16
|
2.6%
2/76 • Day 1 up to Day 16
|
5.4%
4/74 • Day 1 up to Day 16
|
1.3%
1/76 • Day 1 up to Day 16
|
|
Vascular disorders
Hypotension
|
3.9%
3/77 • Day 1 up to Day 16
|
3.9%
3/76 • Day 1 up to Day 16
|
5.4%
4/74 • Day 1 up to Day 16
|
1.3%
1/76 • Day 1 up to Day 16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place