The purpose of this study is to evaluate the analgesic efficacy, safety, and tolerability of VM902A twice daily compared to placebo in subjects with moderate to severe chronic pain due to OA of the knee.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
75
Taken orally with food twice daily
Taken orally with food twice daily
Taken orally with food twice daily
Daily "Average Pain Over the Last 24 Hours" Score at Week 4
Time frame: Week 4
Weekly "Average Pain Over the Last 24 Hours" at Week 4
Time frame: Week 4
Average Daily "Pain Right Now" Score at Week 4
Time frame: Week 4
Western Ontario and McMaster OA Index (WOMAC) - Total Scores
Time frame: Week 4
Western Ontario and McMaster OA Index (WOMAC) Pain Severity Subscale Score
Time frame: Week 4
Western Ontario and McMaster OA Index (WOMAC) Physical Function Subscale Score
Time frame: Week 4
Western Ontario and McMaster OA Index (WOMAC) Stiffness Subscale Score
Time frame: Week 4
Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Scores
Time frame: Week 4
Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score
Time frame: Week 4
Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score
Time frame: Week 4
Medical Outcomes Study 36-item Short-Form Health Survey (SF-36)
Time frame: Week 4
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Capsules to match VM902A and/or naproxen taken orally with food twice daily
Investigational Site
Birmingham, Alabama, United States
Investigational Site
Huntsville, Alabama, United States
Investigational Site
DeLand, Florida, United States
Investigational Site
Hialeah, Florida, United States
Investigational Site
Homestead, Florida, United States
Investigational Site
Jupiter, Florida, United States
Investigational Site
Orlando, Florida, United States
Investigational Site
Port Orange, Florida, United States
Investigational Site
Port Saint Lucie, Florida, United States
Investigational Site
The Villages, Florida, United States
...and 21 more locations
EuroQol-5D (EQ-5D) to Measure Health Status
Time frame: Week 4
Patient Global Impression of Change (PGIC) at the End of the Double-blind Period
Time frame: Week 4
Supplemental Analgesic Medication Use
The average daily number of tablets of supplemental pain medication taken during the study.
Time frame: Days 1 - 28
Responder to Treatment
The percentage reduction from the baseline mean "average pain over the last 24 hours" score to the week 4 mean pain score from the mBPI-SF pain severity subscale.
Time frame: Week 4
Hospital Anxiety and Depression Scale (HADS) Score
Safety assessment to evaluate the impact of VM902A on mood (anxiety and depression)
Time frame: Baseline to Week 4
Columbia-Suicide Severity Rating Score (C-SSRS)
Safety assessment to evaluate the occurrence of treatment-emergent suicidal ideation
Time frame: Baseline to Week 4
Survey of Autonomic Symptoms (SAS) Score
Safety assessment to evaluate symptoms of autonomic dysfunction
Time frame: Baseline to Week 4
Kellgren-Lawrence Classification (K-L) Score
Safety assessment to classify the severity of knee OA
Time frame: Baseline to Week 4