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

• Status: Completed
• Trial end date: 2019-01-25
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated

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