A Dose-ranging 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: Placebo; Drug: VX-150

Study type: Interventional

Funder types: Industry

Identifiers

NCT03764072

VX18-150-104

Details and patient eligibility

About

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

Enrollment: 250 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received placebo matched to VX-150 for 2 days.

Treatment:

Drug: Placebo

VX-150 - Dose Level 1

Experimental group

Description:

Participants received VX-150 1500 milligrams (mg) as first dose, followed by VX-150 750 mg every 12 hours (q12h) for 2 days.

Treatment:

Drug: VX-150

VX-150 - Dose Level 2

Experimental group

Description:

Participants received VX-150 1000 mg once daily (qd) for 2 days.

Treatment:

Drug: VX-150

VX-150 - Dose Level 3

Experimental group

Description:

Participants received VX-150 500 mg q12h for 2 days.

Treatment:

Drug: VX-150

VX-150 - Dose Level 4

Experimental group

Description:

Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.

Treatment:

Drug: VX-150

VX-150 - Dose Level 5

Experimental group

Description:

Participants received VX-150 250 mg qd for 2 days.

Treatment:

Drug: VX-150