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

• Status: Completed
• Trial end date: 2017-12-08
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated

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.