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

NCT02847702 | Terminated Phase 2 DMC

• 1 other identifier: TKA2001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 31

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.

Conditions

Osteoarthritis Pain of the Knee

Keywords

Osteoarthritis; Pain; Osteoarthritis, knee

Outcome Measures

Primary Outcomes (1)

• Daily "Average Pain Over the Last 24 Hours" Score at Week 4

  Week 4

Secondary Outcomes (18)

• 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

Study Arms (4)

VM902A 200 mg

EXPERIMENTAL

VM902A 200-mg Capsules

Drug: VM902A 200-mg Capsules; Drug: Placebo

VM902A 400 mg

EXPERIMENTAL

VM902A 400-mg Capsules (2 x 200-mg capsules)

Drug: VM902A 400-mg Capsules; Drug: Placebo

Naproxen

ACTIVE COMPARATOR

Naproxen 500-mg Capsules

Drug: Naproxen 500-mg Capsules; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

VM902A 200-mg Capsules DRUG

Taken orally with food twice daily

VM902A 200 mg

VM902A 400-mg Capsules DRUG

Taken orally with food twice daily

VM902A 400 mg

Naproxen 500-mg Capsules DRUG

Taken orally with food twice daily

Naproxen

Placebo DRUG

Capsules to match VM902A and/or naproxen taken orally with food twice daily

Naproxen; Placebo; VM902A 200 mg; VM902A 400 mg

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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
• 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
• 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.

You may not qualify if:

• Subjects with radiographic evidence of OA with K-L grade 0, 1, or 4
• 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
• 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
• 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
• Subjects scheduled for surgical interventions of the disease site or any other major surgery during the study conduct period
• Subjects with a history of a prior joint replacement of the index knee
• 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.

Sponsors & Collaborators

• Purdue Pharma LP: lead

Study Sites (31)

Investigational Site

Birmingham, Alabama, 35216, United States

Location

Investigational Site

Huntsville, Alabama, 35801, United States

Location

Investigational Site

DeLand, Florida, 32720, United States

Location

Investigational Site

Hialeah, Florida, 33012, United States

Location

Investigational Site

Homestead, Florida, 33030, United States

Location

Investigational Site

Jupiter, Florida, 33458, United States

Location

Investigational Site

Orlando, Florida, 32806, United States

Location

Investigational Site

Port Orange, Florida, 32129, United States

Location

Investigational Site

Port Saint Lucie, Florida, 34952, United States

Location

Investigational Site

The Villages, Florida, 32162, United States

Location

Investigational Site

West Palm Beach, Florida, 33409, United States

Location

Investigational Site

Columbus, Georgia, 31904, United States

Location

Investigational Site

Avon, Indiana, 46123, United States

Location

Investigational Site

Muncie, Indiana, 47304, United States

Location

Investigational Site

Newton, Kansas, 67114, United States

Location

Investigational Site

Prairie Village, Kansas, 66206, United States

Location

Investigational Site

New Bedford, Massachusetts, 02740, United States

Location

Investigational Site

Bay City, Michigan, 48706, United States

Location

Investigational Site

Troy, Michigan, 48098, United States

Location

Investigational Site

Kansas City, Missouri, 64114, United States

Location

Investigational Site

St Louis, Missouri, 63141, United States

Location

Investigational Site

Hartsdale, New York, 10530, United States

Location

Investigational Site

Rosedale, New York, 11422, United States

Location

Investigational Site

The Bronx, New York, 10467, United States

Location

Investigational Site

Cincinnati, Ohio, 45219, United States

Location

Investigational Site

Dayton, Ohio, 45417, United States

Location

Investigational Site

Dublin, Ohio, 43016, United States

Location

Investigational Site

Duncansville, Pennsylvania, 16635, United States

Location

Investigational Site

Ogden, Utah, 84405, United States

Location

Investigational Site

Salt Lake City, Utah, 84121, United States

Location

Investigational Site

South Jordan, Utah, 84095, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Pain; Osteoarthritis, Knee

Interventions

Naproxen

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: July 28, 2016
• Study Start: August 1, 2016
• Primary Completion: November 22, 2016
• Study Completion: November 22, 2016
• Last Updated: November 22, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (31)