Clinical trial NCT03764072: A Dose-ranging Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy
Official title: A Phase 2B Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel-design Study of the Efficacy and Safety of VX-150 for Acute Pain Following Bunionectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2018-12-04
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the dose-response relationship and safety of VX-150 in treating acute pain following bunionectomy.


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

Primary outcomes:
measure: Time-weighted Sum of the Pain Intensity Difference as Recorded on Numeric Pain Rating Scale (NPRS) 0 to 24 Hours (SPID24) After First Dose
timeFrame: 0 to 24 Hours After First Dose
Secondary outcomes:
measure: Time-weighted Sum of Pain Intensity Difference as Recorded on NPRS 0 to 48 Hours (SPID48) After First Dose
timeFrame: 0 to 48 Hours After First Dose
measure: Proportion of Participants With at Least 30 Percent (%) Reduction in NPRS at 24 Hours After First Dose of VX-150 Versus Placebo
timeFrame: From Baseline at 24 Hours After First Dose
measure: Proportion of Participants With at Least 50% Reduction in NPRS at 24 Hours After the First Dose of VX-150 Versus Placebo
timeFrame: From Baseline at 24 Hours After First Dose
measure: Proportion of Participants With at Least 70% Reduction in NPRS at 24 Hours After the First Dose of VX-150 Versus Placebo
timeFrame: From Baseline at 24 Hours After First Dose
measure: Time to Onset of Confirmed Perceptible Pain Relief After First Dose of VX-150 Versus Placebo
timeFrame: Up to 6 hours After the First Dose
measure: Time to Onset of Meaningful Pain Relief After the First Dose of VX-150 Versus Placebo
timeFrame: Up to 6 Hours After the First Dose
measure: Maximum Observed Concentration (Cmax) of VRT- 1207355 (Active Moiety) and VRT- 1268114 (Metabolite M5)
timeFrame: Day 1 and Day 2
measure: Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VRT- 1207355 and VRT- 1268114
timeFrame: Day 1 and Day 2
measure: Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 up to Day 10
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Pasadena
country: United States
facility: Lotus Clinical Research
state: California
city: Pasadena
country: United States
facility: Chesapeake Research Group
state: Maryland
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
Study officials:
References: