Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of VX-548 for acute pain after a bunionectomy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: VX-548 Participants will be randomized to receive VX-548. |
Drug: VX-548
Tablets for oral administration.
Drug: Placebo (matched to HB/APAP)
Placebo matched to HB/APAP for oral administration.
|
| Active Comparator: Hydrocodone bitartrate/acetaminophen (HB/APAP) Participants will be randomized to receive HB/APAP. |
Drug: HB/APAP
Capsules for oral administration.
Drug: Placebo (matched to VX-548)
Placebo matched to VX-548 for oral administration.
|
| Placebo Comparator: Placebo Participants will be randomized to receive placebo matched to VX-548 and HB/APAP. |
Drug: Placebo (matched to VX-548)
Placebo matched to VX-548 for oral administration.
Drug: Placebo (matched to HB/APAP)
Placebo matched to HB/APAP for oral administration.
|
Outcome Measures
Primary Outcome Measures
- Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48) Compared to Placebo [Baseline to 48 Hours]
Secondary Outcome Measures
- SPID48 Compared to HB/APAP [Baseline to 48 Hours]
- Time to Greater than or Equal to (≥)2-Point Reduction in NPRS from Baseline Compared to Placebo [Baseline to 48 Hours]
- Time to ≥1-Point Reduction in NPRS from Baseline Compared to Placebo [Baseline to 48 Hours]
- Proportion of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Compared to Placebo [At 48 Hours]
- Incidence of Vomiting or Nausea Compared to HB/APAP [Baseline to Day 17]
- Time-weighted SPID as Recorded on the NPRS from 0 to 24 hours (SPID24) Compared to Placebo [Baseline to 24 hours]
- Time to First Use of Rescue Medication Compared to Placebo [Baseline to 48 hours]
- Proportion of Participants using Rescue Medication Compared to Placebo [Baseline to 48 hours]
- Total Rescue Medication Usage Compared to Placebo [Baseline to 48 hours]
- Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline to Day 17]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
-
Before Surgery
-
Participants scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia (Mayo and popliteal sciatic block)
-
After Surgery
-
Participant is lucid and able to follow commands
-
All analgesic guidelines were followed during and after the bunionectomy
Key Exclusion Criteria:
-
Before Surgery
-
Prior history of bunionectomy or or other foot surgery on the index foot; or bunionectomy on the opposite foot
-
History of cardiac dysrhythmias within the last 2 years requiring anti-arrhythmia treatment(s)
-
Any prior surgery within 1 month before the first study drug dose
-
After Surgery
-
Participant had a type 3 deformity requiring a base wedge osteotomy, concomitant surgery such as hammertoe repair; or experienced medical complications during the bunionectomy
-
Participant had a medical complication during the bunionectomy that, in the opinion of the investigator, should preclude randomization
Other protocol defined Inclusion/Exclusion criteria may apply.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Vertex Pharmaceuticals Incorporated
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VX22-548-104