Phase 2
Completed N=250
A Dose-ranging Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy
Source: ClinicalTrials.gov NCT03764072 ↗Enrolled (actual)
250
Serious AEs
0.4%
Results posted
Feb 2022
Primary outcomePrimary: Time-weighted Sum of the Pain Intensity Difference as Recorded on Numeric Pain Rating Scale (NPRS) 0 to 24 Hours (SPID24) After First Dose — 19.1; 37.3; 32.3; 30.5 units on a scale — p=0.2107
Summary
This study will evaluate the dose-response relationship and safety of VX-150 in treating acute pain following bunionectomy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-weighted Sum of the Pain Intensity Difference as Recorded on Numeric Pain Rating Scale (NPRS) 0 to 24 Hours (SPID24) After First Dose |
19.1; 37.3; 32.3; 30.5; 27.5; 28.3 | 0.2107 |
| SECONDARY Time-weighted Sum of Pain Intensity Difference as Recorded on NPRS 0 to 48 Hours (SPID48) After First Dose |
77.4; 112.5; 106.1; 101.5; 90.9; 100.0 | — |
| SECONDARY Proportion of Participants With at Least 30 Percent (%) Reduction in NPRS at 24 Hours After First Dose of VX-150 Versus Placebo |
50.0; 59.5; 56.8; 55.6; 63.0; 51.9 | 0.3162 |
| SECONDARY Proportion of Participants With at Least 50% Reduction in NPRS at 24 Hours After the First Dose of VX-150 Versus Placebo |
41.3; 38.1; 45.5; 44.4; 45.7; 40.7 | 0.8714 |
| SECONDARY Proportion of Participants With at Least 70% Reduction in NPRS at 24 Hours After the First Dose of VX-150 Versus Placebo |
21.7; 21.4; 34.1; 22.2; 30.4; 18.5 | 0.6870 |
| SECONDARY Time to Onset of Confirmed Perceptible Pain Relief After First Dose of VX-150 Versus Placebo |
20.4; 29.6; 23.8; 20.2; 35.6; 25.2 | 0.5405 |
| SECONDARY Time to Onset of Meaningful Pain Relief After the First Dose of VX-150 Versus Placebo |
55.4; 58.7; 68.6; 49.9; 61.5; 64.5 | 0.5141 |
| SECONDARY Maximum Observed Concentration (Cmax) of VRT- 1207355 (Active Moiety) and VRT- 1268114 (Metabolite M5) |
4.97; 3.27; 1.71; 1.89; 0.794; 4.93 | — |
| SECONDARY Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VRT- 1207355 and VRT- 1268114 |
39.7; 25.7; 13.6; 14.6; 5.99; 46.1 | — |
| SECONDARY Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
15; 16; 19; 18; 19; 12 | — |
Eligibility Criteria
Key Inclusion Criteria
Before surgery:
- Body mass index (BMI) of 18.0 to 38.0 kilogram per meter square (kg/m^2)
- Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia (Mayo and popliteal sciatic block) not to include base wedge procedure
After surgery:
- Subject reported pain of greater than or equal to (>=) 4 on Numeric Pain Rating Scale (NPRS) and moderate or severe pain on the Verbal Categorical Rating Scale (VRS) within 9 hours after removal of the popliteal sciatic block on Day 1
- Subject is lucid and able to follow commands
- All analgesic guidelines were followed during and after the bunionectomy
Key Exclusion Criteria
Before surgery:
- History in the past 10 years of malignancy, except for squamous cell skin cancer, basal cell skin cancer, and Stage 0 cervical carcinoma in situ
- History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
- History of abnormal laboratory results >=2.5*upper limit of normal (ULN)
- History of peripheral neuropathy
- A known or clinically suspected infection with human immunodeficiency virus or hepatitis B or C viruses
- Prior medical history of bunionectomy or other foot surgery on the index foot
- History of peptic ulcer disease, or intolerance or unwillingness to receive ibuprofen
After surgery:
- Subject had a type 3 deformity requiring a base wedge osteotomy or concomitant surgery
Other protocol defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT03764072). 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. Informational only — not medical advice.