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
230
Taken orally twice daily
Taken orally twice daily
Taken orally twice daily
Genova Clinical Research, Inc.
Tucson, Arizona, United States
Orthopedic Research Institute
Boynton Beach, Florida, United States
Western Ontario and McMaster OA Index (WOMAC) Pain Score
Time frame: Week 4
WOMAC Physical Function Score
Time frame: Week 4
WOMAC Stiffness Score
Time frame: Week 4
Modified Brief Pain Inventory - Short Form (mBPI-SF) Severity of Pain and Interference of Pain
Time frame: Week 4
Patient Global Impression of Change (PGIC)
Time frame: Week 4
Supplemental Analgesic Medication Use
Time frame: Over 4 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tablets to match V116517 and/or placebo capsules to match naproxen taken orally twice daily
Avail Clinical Research, LLC
DeLand, Florida, United States
Westside Center for Clinical Research
Jacksonville, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Health Awareness, Inc.
Jupiter, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Compass Research East, LLC
Oviedo, Florida, United States
Northwest Indiana Center for Clinical Research
Valparaiso, Indiana, United States
Analgesic Solutions
Natick, Massachusetts, United States
...and 8 more locations