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

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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.


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
8042 Wurzbach Road
San Antonio, Texas 78229
210-949-0807
1137
mi
from 43215
San Antonio, TX
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8028 Ritchie Highway
Pasadena, Maryland 21122
443-557-0374
347
mi
from 43215
Pasadena, MD
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1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
1960
mi
from 43215
Anaheim, CA
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Phoenix, Arizona 85023
1658
mi
from 43215
Phoenix, AZ
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1045 East 3900 South
Salt Lake City, Utah 84124
1512
mi
from 43215
Salt Lake City, UT
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