Osteoarthritis Pain of the Knee
Conditions
Keywords
Osteoarthritis, Pain, Osteoarthritis, knee
Brief summary
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.
Interventions
DRUGVM902A 200-mg Capsules
Taken orally with food twice daily
DRUGVM902A 400-mg Capsules
Taken orally with food twice daily
Taken orally with food twice daily
DRUGPlacebo
Capsules to match VM902A and/or naproxen taken orally with food twice daily
Sponsors
Purdue Pharma LP
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria Include: 1. Males and females ≥ 40 and ≤ 75 years of age with moderate to severe chronic OA pain of the knee (lasting several hours daily) as their predominant pain condition for at least 6 months prior to screening 2. Diagnostic criteria for primary pain condition (American College of Rheumatology \[ACR\] clinical and radiographic criteria): * At least 1 of the following in addition to knee pain: age \> 50, stiffness \< 30 min, crepitus on active motion, and * Kellgren-Lawrence (K-L) grade 2 or 3 radiographic evidence at the screening visit as determined by a local radiologist or rheumatologist. Note that K-L grades 2 to 3 require the presence of osteophytes, which is required to meet ACR clinical and radiographic criteria for knee OA 3. Subjects whose OA pain of the index knee is not adequately treated prior to the screening visit: • Subjects must have a self-reported average pain intensity rating of moderate or severe on a verbal rating scale (ie, none, mild, moderate, and severe) over the 7 days prior to the screening visit 4. The subjects must have average pain over the last 24 hours scores ≥ 5 and ≤ 9 on an 11-point numerical rating scale (NRS) for the index knee on ≥ 3 consecutive days during the screening period and come in for randomization within 72 hours after qualification is met 5. Subjects who are willing and able to stop taking any/all analgesic medications, including over-the-counter pain medications, opioids, marijuana, and topical analgesics for OA pain for the duration of the treatment period, with the exception of study-specific rescue medication. Key
Exclusion criteria
Include: 1. Subjects with radiographic evidence of OA with K-L grade 0, 1, or 4 2. Subjects at risk for destructive arthropathy, subjects with a history of osteonecrosis, osteoporotic fracture, rapidly progressive osteoarthritis (RPOA 1 and 2), subchondral insufficiency fracture, and hip/knee dislocations 3. Subjects considered high risk for surgery based upon American Society of Anesthesiologists physical classification system for surgery grading, or subjects who would not be willing to undergo joint replacement surgery if required 4. Subjects with chronic pain conditions other than OA of the knee as their predominant pain condition, including gout (except for subjects with gout that is controlled with diet and/or with stable suppressive treatment with uric acid reducing medication(s) and/or colchicine, and who have not had any attack within the past 2 years), pseudogout, psoriatic arthritis, active Lyme disease, rheumatoid arthritis or any other inflammatory arthritis, fibromyalgia, neuropathic pain conditions, bursitis, or acute injury or signs of active infection in the target pain area 5. Subjects scheduled for surgical interventions of the disease site or any other major surgery during the study conduct period 6. Subjects with a history of a prior joint replacement of the index knee 7. Subjects who have had arthroscopy on either knee or hip within 6 months of entering the study, or open surgery on either knee or hip within 12 months of entering the study. Other protocol-specific inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Daily Average Pain Over the Last 24 Hours Score at Week 4 | Week 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster OA Index (WOMAC) Stiffness Subscale Score | Week 4 | — |
| Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Scores | Week 4 | — |
| Weekly Average Pain Over the Last 24 Hours at Week 4 | Week 4 | — |
| Average Daily Pain Right Now Score at Week 4 | Week 4 | — |
| Western Ontario and McMaster OA Index (WOMAC) - Total Scores | Week 4 | — |
| Western Ontario and McMaster OA Index (WOMAC) Pain Severity Subscale Score | Week 4 | — |
| Western Ontario and McMaster OA Index (WOMAC) Physical Function Subscale Score | Week 4 | — |
| Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score | Week 4 | — |
| Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score | Week 4 | — |
| EuroQol-5D (EQ-5D) to Measure Health Status | Week 4 | — |
| Patient Global Impression of Change (PGIC) at the End of the Double-blind Period | Week 4 | — |
| Supplemental Analgesic Medication Use | Days 1 - 28 | The average daily number of tablets of supplemental pain medication taken during the study. |
| Responder to Treatment | Week 4 | 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. |
| Hospital Anxiety and Depression Scale (HADS) Score | Baseline to Week 4 | Safety assessment to evaluate the impact of VM902A on mood (anxiety and depression) |
| Columbia-Suicide Severity Rating Score (C-SSRS) | Baseline to Week 4 | Safety assessment to evaluate the occurrence of treatment-emergent suicidal ideation |
| Survey of Autonomic Symptoms (SAS) Score | Baseline to Week 4 | Safety assessment to evaluate symptoms of autonomic dysfunction |
| Kellgren-Lawrence Classification (K-L) Score | Baseline to Week 4 | Safety assessment to classify the severity of knee OA |
| Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) | Week 4 | — |
Countries
United States
Outcome results
None listed