Status:
COMPLETED
A Dose-ranging Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Acute Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study will evaluate the dose-response relationship and safety of VX-150 in treating acute pain following bunionectomy.
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
December 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2019
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT03764072
Start Date
December 12 2018
End Date
January 25 2019
Last Update
February 9 2022
Active Locations (6)
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1
Arizona Research Center
Phoenix, Arizona, United States, 85053
2
Anaheim Clinical Trials
Anaheim, California, United States, 92801
3
Lotus Clinical Research
Pasadena, California, United States, 91105
4
Chesapeake Research Group
Pasadena, Maryland, United States, 21122