A Study to Evaluate the Analgesic Efficacy and Safety of VM902A in Subjects With Osteoarthritis (OA) of the Knee

Osteoarthritis Pain of the Knee Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02847702
• Other study ID #: TKA2001
• Status: Terminated
• Phase: Phase 2
• First received: July 25, 2016
• Last updated: November 20, 2017
• Start date: August 2016
• Est. completion date: November 22, 2016

Study information

• Verified date: November 2017
• Source: Purdue Pharma LP
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: November 22, 2016
• Est. primary completion date: November 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Pain of the Knee

Intervention

Drug:
• VM902A 200-mg Capsules
Taken orally with food twice daily
• VM902A 400-mg Capsules
Taken orally with food twice daily
• Naproxen 500-mg Capsules
Taken orally with food twice daily
• Placebo
Capsules to match VM902A and/or naproxen taken orally with food twice daily

Locations

Country	Name	City	State
United States	Investigational Site	Avon	Indiana
United States	Investigational Site	Bay City	Michigan
United States	Investigational Site	Birmingham	Alabama
United States	Investigational Site	Bronx	New York
United States	Investigational Site	Cincinnati	Ohio
United States	Investigational Site	Columbus	Georgia
United States	Investigational Site	Dayton	Ohio
United States	Investigational Site	DeLand	Florida
United States	Investigational Site	Dublin	Ohio
United States	Investigational Site	Duncansville	Pennsylvania
United States	Investigational Site	Hartsdale	New York
United States	Investigational Site	Hialeah	Florida
United States	Investigational Site	Homestead	Florida
United States	Investigational Site	Huntsville	Alabama
United States	Investigational Site	Jupiter	Florida
United States	Investigational Site	Kansas City	Missouri
United States	Investigational Site	Muncie	Indiana
United States	Investigational Site	New Bedford	Massachusetts
United States	Investigational Site	Newton	Kansas
United States	Investigational Site	Ogden	Utah
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	Prairie Village	Kansas
United States	Investigational Site	Rosedale	New York
United States	Investigational Site	Saint Louis	Missouri
United States	Investigational Site	Salt Lake City	Utah
United States	Investigational Site	South Jordan	Utah
United States	Investigational Site	The Villages	Florida
United States	Investigational Site	Troy	Michigan
United States	Investigational Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Purdue Pharma LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily "Average Pain Over the Last 24 Hours" Score at Week 4		Week 4
Secondary	Weekly "Average Pain Over the Last 24 Hours" at Week 4		Week 4
Secondary	Average Daily "Pain Right Now" Score at Week 4		Week 4
Secondary	Western Ontario and McMaster OA Index (WOMAC) - Total Scores		Week 4
Secondary	Western Ontario and McMaster OA Index (WOMAC) Pain Severity Subscale Score		Week 4
Secondary	Western Ontario and McMaster OA Index (WOMAC) Physical Function Subscale Score		Week 4
Secondary	Western Ontario and McMaster OA Index (WOMAC) Stiffness Subscale Score		Week 4
Secondary	Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Scores		Week 4
Secondary	Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score		Week 4
Secondary	Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score		Week 4
Secondary	Medical Outcomes Study 36-item Short-Form Health Survey (SF-36)		Week 4
Secondary	EuroQol-5D (EQ-5D) to Measure Health Status		Week 4
Secondary	Patient Global Impression of Change (PGIC) at the End of the Double-blind Period		Week 4
Secondary	Supplemental Analgesic Medication Use	The average daily number of tablets of supplemental pain medication taken during the study.	Days 1 - 28
Secondary	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.	Week 4
Secondary	Hospital Anxiety and Depression Scale (HADS) Score	Safety assessment to evaluate the impact of VM902A on mood (anxiety and depression)	Baseline to Week 4
Secondary	Columbia-Suicide Severity Rating Score (C-SSRS)	Safety assessment to evaluate the occurrence of treatment-emergent suicidal ideation	Baseline to Week 4
Secondary	Survey of Autonomic Symptoms (SAS) Score	Safety assessment to evaluate symptoms of autonomic dysfunction	Baseline to Week 4
Secondary	Kellgren-Lawrence Classification (K-L) Score	Safety assessment to classify the severity of knee OA	Baseline to Week 4