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



Status:Terminated
Conditions:Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:40 - 75
Updated:11/24/2017
Start Date:August 2016
End Date:November 22, 2016

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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

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.


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.
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