The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of V116517 versus placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
105
Taken orally twice daily
Taken orally twice daily
1-2 capsules taken orally twice daily
"Pain on the average in the last 24 hours" score from the Modified Brief Pain Inventory - Short Form (mBPI-SF)
Time frame: Week 4
mBPI-SF severity of pain (parameters including average pain, worst pain, least pain, pain right now) and interference of pain (all parts of question 6)
Time frame: Week 4
Neuropathic Pain Symptom Inventory (NPSI)
Time frame: Week 4
Patient Global Impression of Change (PGIC)
Time frame: Week 4
Supplemental Analgesic Medication Use
Time frame: Over 4 weeks
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Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily
Investigational Site
Tucson, Arizona, United States
Investigational Site
La Jolla, California, United States
Investigational Site
North Hollywood, California, United States
Investigational Site
Boca Raton, Florida, United States
Investigational Site
Bradenton, Florida, United States
Investigational Site
DeLand, Florida, United States
Investigational Site
Fort Myers, Florida, United States
Investigational Site
Lynn Haven, Florida, United States
Investigational Site
North Miami, Florida, United States
Investigational Site
Orlando, Florida, United States
...and 18 more locations