Clinical trial NCT03028870: A Study to Evaluate the Analgesic Efficacy and Safety of V120083 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 V120083 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteo Arthritis Knee
Keywords: Osteoarthritis
Pain
Osteoarthritis Knee
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
Collaborators: name: Shionogi
First posted: 2017-01-23
Enrollment: 291
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
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 of V120083 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 ≤ 80 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, morning stiffness \< 30 minutes, 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. If a radiograph is not available, one must be taken and the diagnostic criteria must be confirmed before randomization.
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 ≥ 4 and ≤ 9 on an 11-point numerical rating scale (NRS) for the index knee on ≥ 3 consecutive days during the pain assessment period and come in for randomization within 96 hours after the latest qualifying pain score entry
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 study, 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 with chronic pain conditions other than OA of the knee as their predominant pain condition, including gout, 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
3. Subjects scheduled for surgical interventions of the disease site or any other major surgery during the study conduct period
4. Subjects with a history of a prior joint replacement of the index knee
5. 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
6. Subjects with a history of significant trauma to a knee, hip or shoulder within the previous year
7. Subjects who have significant pain, other than or more than knee pain, including significant hip, back pain, that may confound the analgesic efficacy assessments of this study.

Primary outcomes:
measure: Daily "Average Pain Over the Last 24 Hours" Score at Week 4
timeFrame: Week 4
Secondary outcomes:
measure: Weekly Change From Baseline Score of "Average Pain Over the Last 24 Hours" From the mBPI-SF Pain Severity Subscale
timeFrame: Weeks 1, 2 and 4
measure: Average Daily "Pain Right Now" Score Collected by e-Diary
timeFrame: 4 Weeks
measure: Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale
timeFrame: 4 Weeks
measure: Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale
timeFrame: 4 Weeks
measure: Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale
timeFrame: 4 Weeks
measure: Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score
timeFrame: 4 Weeks
measure: Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Score (All Parts of 6 Questions)
timeFrame: 4 Weeks
measure: Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score
timeFrame: 4 Weeks
measure: Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score
timeFrame: 4 Weeks
measure: Responder to Treatment (Calculated as the Percentage Reduction of "Average Pain Over the Last 24 Hours") at Week 4
timeFrame: Week 4
measure: Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary
timeFrame: 4 Weeks
measure: Medical Outcomes Study Short Form-36 (SF-36) - Mental Component Summary
timeFrame: 4 Weeks
measure: European Quality of Life Scale - 5 Dimensions (EQ-5D-5L) to Measure Health Status
timeFrame: 4 Weeks
measure: Patient Global Impression of Change (PGIC)
timeFrame: 4 Weeks
measure: Supplemental Analgesic Medication Use
timeFrame: Up to 28 days
measure: Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS)
timeFrame: Baseline up to 4 Weeks
measure: Change From Baseline to Week 4 in Hospital Anxiety and Depression Scale (HADS) Score
timeFrame: Week 4
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Tuscumbia
country: United States
facility: Terence T. Hart, MD
state: Alabama
city: North Hollywood
country: United States
facility: Providence Clinical Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Marcos
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Miami
country: United States
facility: Future Care Solution, LLC
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare, LLC
state: Florida
city: Orlando
country: United States
facility: Omega Research Consultants, LLC
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Valparaiso
country: United States
facility: Buynak Clinical Research, P.C.
state: Indiana
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Saint Louis
country: United States
facility: St. Louis Center for Clinical Research
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Clinical Trials, LC
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research, LLC
state: Missouri
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Hartsdale
country: United States
facility: Drug Trials America
state: New York
city: Greensboro
country: United States
facility: Medication Management, LLC
state: North Carolina
city: Mooresville
country: United States
facility: Research Institute of the Carolinas of Piedmont Healthcare, PA
state: North Carolina
city: Morganton
country: United States
facility: Burke Primary Care
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: New Horizons Clinical Research
state: Ohio
city: Dayton
country: United States
facility: Providence Health Partners - Center for Clinical Research
state: Ohio
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Greer
country: United States
facility: Mountain View Clinical Research, Inc.
state: South Carolina
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
Study officials:
References: