A Dose-ranging Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy
- Registration Number
- NCT03764072
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
This study will evaluate the dose-response relationship and safety of VX-150 in treating acute pain following bunionectomy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VX-150 - Dose Level 3 VX-150 Participants received VX-150 500 mg q12h for 2 days. VX-150 - Dose Level 1 VX-150 Participants received VX-150 1500 milligrams (mg) as first dose, followed by VX-150 750 mg every 12 hours (q12h) for 2 days. VX-150 - Dose Level 4 VX-150 Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days. Placebo Placebo Participants received placebo matched to VX-150 for 2 days. VX-150 - Dose Level 2 VX-150 Participants received VX-150 1000 mg once daily (qd) for 2 days. VX-150 - Dose Level 5 VX-150 Participants received VX-150 250 mg qd for 2 days.
- Primary Outcome Measures
Name Time Method Time-weighted Sum of the Pain Intensity Difference as Recorded on Numeric Pain Rating Scale (NPRS) 0 to 24 Hours (SPID24) After First Dose 0 to 24 Hours After First Dose 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).
- Secondary Outcome Measures
Name Time Method Time-weighted Sum of Pain Intensity Difference as Recorded on NPRS 0 to 48 Hours (SPID48) After First Dose 0 to 48 Hours After First Dose 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).
Proportion of Participants With at Least 50% Reduction in NPRS at 24 Hours After the First Dose of VX-150 Versus Placebo From Baseline at 24 Hours After First Dose Pain intensity was recorded on 11-point ordinal 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 24 hours after the first dose of VX-150 or placebo were reported.
Proportion of Participants With at Least 30 Percent (%) Reduction in NPRS at 24 Hours After First Dose of VX-150 Versus Placebo From Baseline at 24 Hours After First Dose Pain intensity was recorded on 11-point ordinal 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 24 hours after the first dose of VX-150 or placebo were reported.
Proportion of Participants With at Least 70% Reduction in NPRS at 24 Hours After the First Dose of VX-150 Versus Placebo From Baseline at 24 Hours After First Dose Pain intensity was recorded on 11-point ordinal 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 24 hours after the first dose of VX-150 or placebo were reported.
Time to Onset of Confirmed Perceptible Pain Relief After First Dose of VX-150 Versus Placebo Up to 6 hours After the First Dose Time to onset of confirmed perceptible pain relief (time to onset of perceptible pain relief \[any pain relief at all after the first dose\] for participants who had meaningful pain relief \[relief that is meaningful to participants after the first dose\] reported based on the stopwatch assessment.
Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VRT- 1207355 and VRT- 1268114 Day 1 and Day 2 Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Day 1 up to Day 10 Time to Onset of Meaningful Pain Relief After the First Dose of VX-150 Versus Placebo Up to 6 Hours After the First Dose Time to onset of meaningful pain relief (relief that is meaningful to participants after the first dose) reported based on the stopwatch assessment.
Maximum Observed Concentration (Cmax) of VRT- 1207355 (Active Moiety) and VRT- 1268114 (Metabolite M5) Day 1 and Day 2
Trial Locations
- Locations (6)
Lotus Clinical Research
🇺🇸Pasadena, California, United States
Chesapeake Research Group
🇺🇸Pasadena, Maryland, United States
Anaheim Clinical Trials
🇺🇸Anaheim, California, United States
Endeavor Clinical Trials
🇺🇸San Antonio, Texas, United States
JBR Clinical Research
🇺🇸Salt Lake City, Utah, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States