A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
- Conditions
- Acute Pain
- Interventions
- Registration Number
- NCT04977336
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating acute pain after a bunionectomy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 274
-
Before Surgery:
- Participant 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
-
Before Surgery:
- Prior history of bunionectomy or other foot surgery on the index foot
- History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
- Any prior surgery within 1 month before the first study drug
-
After Surgery:
- Participant had a Type 3 deformity requiring a base wedge osteotomy or concomitant surgery such as hammertoe repair, or had medical complications during the bunionectomy that, in the opinion of the investigator, should preclude randomization
Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo (matched to VX-548) Participants received placebo matched to VX-548 and Hydrocodone bitartrate/acetaminophen (HB/APAP) for 2 days. Placebo Placebo (matched to HB/APAP) Participants received placebo matched to VX-548 and Hydrocodone bitartrate/acetaminophen (HB/APAP) for 2 days. HB/APAP HB/APAP Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 2 days. VX-548: Low Dose VX-548 Participants received VX-548 20 mg as first dose, followed by VX-548 10 mg tablet every 12 hours (q12h) for 2 days. VX-548: Mid Dose VX-548 Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days. VX-548: High Dose VX-548 Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
- Primary Outcome Measures
Name Time Method Time-Weighted Sum of Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 48 Hours (SPID48) After the First Dose of Study Drug 0 to 48 hours After First 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). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).
- Secondary Outcome Measures
Name Time Method Time-Weighted SPID as Recorded on a NPRS 0 to 24 Hours (SPID24) After the First Dose of Study Drug 0 to 24 hours After First 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). SPID24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score).
Percentage of Participants With at Least 30 Percent (%) Reduction in NPRS at 48 Hours After the First Dose of Study Drug From Baseline at 48 Hours After First Dose of Study Drug 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, HB/APAP or placebo was reported.
Percentage of Participants With at Least 50% Reduction in NPRS at 48 Hours After the First Dose of Study Drug From Baseline at 48 Hours After First Dose of Study Drug 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.
Percentage of Participants With at Least 70% Reduction in NPRS at 48 Hours After the First Dose of Study Drug From Baseline at 48 Hours After First Dose of Study Drug 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.
Maximum Observed Plasma Concentration (Cmax) of VX-548 and M6-548 (Metabolite) Day 1 and Day 2 Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-548 and M6-548 (Metabolite) Day 1 and Day 2 Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VX-548 and M6-548 (Metabolite) Day 1 and Day 2 Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Day 1 up to Day 16
Trial Locations
- Locations (12)
Shoals Medical Trials Inc.
🇺🇸Sheffield, Alabama, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Anaheim Clinical Trials
🇺🇸Anaheim, California, United States
Lotus Clinical Research
🇺🇸Pasadena, California, United States
New Hope Research Development
🇺🇸Tarzana, California, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Chesapeake Research Group
🇺🇸Pasadena, Maryland, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
First Surgical Hospital
🇺🇸Bellaire, Texas, United States
Legent Orthopedic Hospital
🇺🇸Carrollton, Texas, United States
Scroll for more (2 remaining)Shoals Medical Trials Inc.🇺🇸Sheffield, Alabama, United States