A Dose-ranging Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy
NCT ID: NCT03764072
Last Updated: 2022-02-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
250 participants
INTERVENTIONAL
2018-12-12
2019-01-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Participants received placebo matched to VX-150 for 2 days.
Placebo
Capsules for oral administration.
VX-150 - Dose Level 1
Participants received VX-150 1500 milligrams (mg) as first dose, followed by VX-150 750 mg every 12 hours (q12h) for 2 days.
VX-150
Capsules for oral administration.
VX-150 - Dose Level 2
Participants received VX-150 1000 mg once daily (qd) for 2 days.
VX-150
Capsules for oral administration.
VX-150 - Dose Level 3
Participants received VX-150 500 mg q12h for 2 days.
VX-150
Capsules for oral administration.
VX-150 - Dose Level 4
Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.
VX-150
Capsules for oral administration.
VX-150 - Dose Level 5
Participants received VX-150 250 mg qd for 2 days.
VX-150
Capsules for oral administration.
Interventions
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VX-150
Capsules for oral administration.
Placebo
Capsules for oral administration.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Locations
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Arizona Research Center
Phoenix, Arizona, United States
Anaheim Clinical Trials
Anaheim, California, United States
Lotus Clinical Research
Pasadena, California, United States
Chesapeake Research Group
Pasadena, Maryland, United States
Endeavor Clinical Trials
San Antonio, Texas, United States
JBR Clinical Research
Salt Lake City, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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VX18-150-104
Identifier Type: -
Identifier Source: org_study_id
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