Clinical trial NCT03206749: A Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy
Official title: A Phase 2 Randomized, Double-blind, Placebo-controlled, 3-arm, 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: 2017-07-02
Enrollment: 243
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 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.

Primary outcomes:
measure: 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
timeFrame: 0 to 24 hours after the first dose
Secondary outcomes:
measure: 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
timeFrame: 2 to 24 hours after the first dose
measure: 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
timeFrame: 0 to 48 hours after the first dose
measure: Time to Onset of Perceptible Pain Relief After the 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: Time to First Rescue Medication After the First Dose of VX-150 Versus Placebo
timeFrame: up to 48 hours after the first dose
measure: Percentage of Participants Using Rescue Medication After the First Dose VX-150 Versus Placebo
timeFrame: 0 to 24 hours after the first dose and 24 to 48 hours after the first dose
measure: Total Rescue Medication Used After the First Dose of VX-150 Versus Placebo
timeFrame: 0 to 24 hours after the first dose and 24 to 48 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: Time to Reach Maximum Observed Plasma Concentration (Tmax) of VRT- 1207355 and VRT- 1268114
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 Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From 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: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
References: