A Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy
Completed · Phase 2 · Has a placebo group
Conditions studied: Acute Pain
In brief
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.
Key facts
- Study ID
- NCT03206749
- Run by
- Vertex Pharmaceuticals Incorporated
- People needed
- 243
- Starts
- 2017-06-29
- Expected to finish
- 2017-12-08
- Last updated by the study team
- 2021-02-03
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Arizona Research Center — Phoenix, Arizona, United States
- Anaheim Clinical Trials — Anaheim, California, United States
- Lotus Clinical Research — Pasadena, California, United States
- Jean Brown Research — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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