Phase 2
N=303
A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty
Acute Pain
Bottom Line
View on ClinicalTrials.gov: NCT05034952 ↗Enrolled (actual)
303
Serious AEs
1.0%
Results posted
Dec 2024
Primary outcome: Primary: 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; 85.20; 95.11; 110.53 units on a scale — p=0.3914
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VX-548 (Drug); HB/APAP (Drug); Placebo (matched to VX-548) (Drug); Placebo (matched to HB/APAP) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vertex Pharmaceuticals Incorporated
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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; 85.20; 95.11; 110.53 | 0.3914 |
| SECONDARY 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; 29.98; 37.65; 45.54 | 0.5476 |
| SECONDARY 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; 53.9; 59.5; 60.5 | 0.4712 |
| SECONDARY Percentage of Participants With at Least 50% Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug |
33.8; 42.1; 43.2; 44.7 | 0.2882 |
| SECONDARY Percentage of Participants With at Least 70% Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug |
14.3; 23.7; 18.9; 25.0 | 0.1343 |
| SECONDARY Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
54; 46; 45; 42; 1; 1 | — |
Summary
The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating acute pain after an abdominoplasty.
Eligibility Criteria
Key Inclusion Criteria
- Before Surgery:
- Participant scheduled to undergo an abdominoplasty without collateral procedures
- After Surgery:
- Participant is lucid and able to follow commands
- All analgesic guidelines were followed during and after the abdominoplasty
- Abdominoplasty procedure duration <=3 hours without collateral procedures (for example., liposuction)
Key Exclusion Criteria
- Before Surgery:
- Prior history of abdominoplasty, intra-abdominal and/or pelvic surgery
- History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
- Any prior surgery within 1 month before the first study drug
- After Surgery:
- Participant had medical complications during the abdominoplasty that, in the opinion of the investigator, should preclude randomization
- Participant had collateral procedures during the abdominoplasty
Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT05034952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.