A Dose-ranging Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy
Status: | Completed |
---|---|
Conditions: | Chronic Pain |
Therapuetic Areas: | Musculoskeletal |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 2/20/2019 |
Start Date: | November 30, 2018 |
End Date: | January 25, 2019 |
A Phase 2B Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel-design Study of the Efficacy and Safety of VX-150 for Acute Pain Following Bunionectomy
This study will evaluate the dose-response relationship and safety of VX-150 in treating
acute pain following bunionectomy.
acute pain following bunionectomy.
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
We found this trial at
5
sites
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