A Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy

Vertex Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Acute Pain

Treatments: Drug: HB/APAP; Drug: VX-150; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03206749

VX16-150-103

Details and patient eligibility

About

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.

Enrollment: 243 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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243 participants in 3 patient groups, including a placebo group

VX-150

Experimental group

Treatment:

Drug: VX-150

Hydrocodone Bitartrate/Acetaminophen (HB/APAP)

Active Comparator group

Treatment:

Drug: HB/APAP

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo