Clinical trial NCT02847702: A Study to Evaluate the Analgesic Efficacy and Safety of VM902A in Subjects With Osteoarthritis (OA) of the Knee
Official title: A Phase 2a, Multicenter, Randomized, Double-blind, Placebo Controlled and Active-controlled, Parallel-group Study Evaluating the Analgesic Efficacy and Safety of VM902A in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Osteoarthritis Pain of the Knee
Keywords: Osteoarthritis
Pain
Osteoarthritis, knee
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2016-07-28
Enrollment: 75
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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/exclusion criteria may apply.

Primary outcomes:
measure: Daily "Average Pain Over the Last 24 Hours" Score at Week 4
timeFrame: Week 4
Secondary outcomes:
measure: Weekly "Average Pain Over the Last 24 Hours" at Week 4
timeFrame: Week 4
measure: Average Daily "Pain Right Now" Score at Week 4
timeFrame: Week 4
measure: Western Ontario and McMaster OA Index (WOMAC) - Total Scores
timeFrame: Week 4
measure: Western Ontario and McMaster OA Index (WOMAC) Pain Severity Subscale Score
timeFrame: Week 4
measure: Western Ontario and McMaster OA Index (WOMAC) Physical Function Subscale Score
timeFrame: Week 4
measure: Western Ontario and McMaster OA Index (WOMAC) Stiffness Subscale Score
timeFrame: Week 4
measure: Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Scores
timeFrame: Week 4
measure: Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score
timeFrame: Week 4
measure: Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score
timeFrame: Week 4
measure: Medical Outcomes Study 36-item Short-Form Health Survey (SF-36)
timeFrame: Week 4
measure: EuroQol-5D (EQ-5D) to Measure Health Status
timeFrame: Week 4
measure: Patient Global Impression of Change (PGIC) at the End of the Double-blind Period
timeFrame: Week 4
measure: Supplemental Analgesic Medication Use
timeFrame: Days 1 - 28
measure: Responder to Treatment
timeFrame: Week 4
measure: Hospital Anxiety and Depression Scale (HADS) Score
timeFrame: Baseline to Week 4
measure: Columbia-Suicide Severity Rating Score (C-SSRS)
timeFrame: Baseline to Week 4
measure: Survey of Autonomic Symptoms (SAS) Score
timeFrame: Baseline to Week 4
measure: Kellgren-Lawrence Classification (K-L) Score
timeFrame: Baseline to Week 4
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: Investigational Site
state: Alabama
city: DeLand
country: United States
facility: Investigational Site
state: Florida
city: Hialeah
country: United States
facility: Investigational Site
state: Florida
city: Homestead
country: United States
facility: Investigational Site
state: Florida
city: Jupiter
country: United States
facility: Investigational Site
state: Florida
city: Orlando
country: United States
facility: Investigational Site
state: Florida
city: Port Orange
country: United States
facility: Investigational Site
state: Florida
city: Port Saint Lucie
country: United States
facility: Investigational Site
state: Florida
city: The Villages
country: United States
facility: Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Investigational Site
state: Florida
city: Columbus
country: United States
facility: Investigational Site
state: Georgia
city: Avon
country: United States
facility: Investigational Site
state: Indiana
city: Muncie
country: United States
facility: Investigational Site
state: Indiana
city: Newton
country: United States
facility: Investigational Site
state: Kansas
city: Prairie Village
country: United States
facility: Investigational Site
state: Kansas
city: New Bedford
country: United States
facility: Investigational Site
state: Massachusetts
city: Bay City
country: United States
facility: Investigational Site
state: Michigan
city: Troy
country: United States
facility: Investigational Site
state: Michigan
city: Kansas City
country: United States
facility: Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Investigational Site
state: Missouri
city: Bronx
country: United States
facility: Investigational Site
state: New York
city: Hartsdale
country: United States
facility: Investigational Site
state: New York
city: Rosedale
country: United States
facility: Investigational Site
state: New York
city: Cincinnati
country: United States
facility: Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Investigational Site
state: Ohio
city: Dublin
country: United States
facility: Investigational Site
state: Ohio
city: Duncansville
country: United States
facility: Investigational Site
state: Pennsylvania
city: Ogden
country: United States
facility: Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Investigational Site
state: Utah
city: South Jordan
country: United States
facility: Investigational Site
state: Utah
Study officials:
References: