Phase 2
N=243
A Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy
Acute Pain
Bottom Line
View on ClinicalTrials.gov: NCT03206749 ↗Enrolled (actual)
243
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Time-weighted Sum of the Pain Intensity Difference (SPID) Between VX-150 Versus Placebo as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 24 Hours After the First Dose — 36.14; 6.64 units on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VX-150 (Drug); HB/APAP (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vertex Pharmaceuticals Incorporated
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-weighted Sum of the Pain Intensity Difference (SPID) Between VX-150 Versus Placebo as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 24 Hours After the First Dose |
36.14; 6.64 | <0.0001 sig |
| SECONDARY Time-weighted Sum of the Pain Intensity Difference Between VX-150 Versus Placebo as Recorded on a NPRS 2 to 24 Hours After the First Dose |
34.95; 6.43 | <0.0001 sig |
| SECONDARY Time-weighted Sum of the Pain Intensity Difference Between VX-150 Versus Placebo as Recorded on a NPRS 0 to 48 Hours After the First Dose |
112.22; 49.43 | <0.0001 sig |
| SECONDARY Time to Onset of Perceptible Pain Relief After the First Dose of VX-150 Versus Placebo |
26.8; 28.3 | 0.0469 sig |
| SECONDARY Time to Onset of Meaningful Pain Relief After the First Dose of VX-150 Versus Placebo |
53.4; 75.9 | 0.3294 |
| SECONDARY Time to First Rescue Medication After the First Dose of VX-150 Versus Placebo |
2.7; 2.3 | 0.2341 |
| SECONDARY Percentage of Participants Using Rescue Medication After the First Dose VX-150 Versus Placebo |
83.8; 89.0; 56.3; 69.5 | 0.3358 |
| SECONDARY Total Rescue Medication Used After the First Dose of VX-150 Versus Placebo |
800; 1084.9; 577.8; 786.0 | 0.0004 sig |
| SECONDARY Maximum Observed Concentration (Cmax) of VRT- 1207355 (Active Moiety) and VRT- 1268114 (Metabolite M5) |
4.95; 4.92; 1.65; 2.53 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of VRT- 1207355 and VRT- 1268114 |
5.58; 4.03; 8.10; 4.03 | — |
| SECONDARY Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VRT- 1207355 and VRT- 1268114 |
38.8; 45.7; 12.9; 25.0 | — |
| SECONDARY Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
25; 30; 29; 0; 0; 0 | — |
Summary
This is a Phase 2 randomized, double-blind, placebo-controlled, 3-arm, parallel design study to evaluate the efficacy and safety of VX-150 in treating acute pain following bunionectomy.
Eligibility Criteria
Inclusion Criteria
Prior to Surgery:
- Body mass index (BMI) of 18.0 to 38.0 kg/m2, inclusive
- 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 ≥4 on the 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
Exclusion Criteria
Prior to 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
- Intolerant of or unwilling to receive hydrocodone, acetaminophen, or ibuprofen
- For female subjects: Pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last study drug dose
- For male subjects: Male subjects with a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last study drug dose
After Surgery:
- Subject had a type 3 deformity requiring a base wedge osteotomy or concomitant surgery such as hammertoe repair; or experienced medical complications during the bunionectomy that, in the opinion of the investigator, should preclude randomization
Other protocol defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03206749). 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.