A Study to Evaluate the Analgesic Efficacy and Safety of V120083 in Subjects With Osteoarthritis (OA) of the Knee

Purdue Pharma

Status and phase: Completed; Phase 2

Conditions: Osteo Arthritis Knee

Treatments: Drug: V120083; Drug: Placebo; Drug: Naproxen

Study type: Interventional

Funder types: Industry

Identifiers

NCT03028870

VAN2001

Details and patient eligibility

About

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.

Enrollment: 291 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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291 participants in 4 patient groups, including a placebo group

V120083 30 mg

Experimental group

Description:

V120083 30-mg capsules taken orally twice daily

Treatment:

Drug: Placebo

Drug: V120083

V120083 60 mg

Experimental group

Description:

V120083 60-mg (2 x 30 mg) capsules taken orally twice daily

Treatment:

Drug: Placebo

Drug: V120083

Naproxen

Active Comparator group

Description:

Naproxen 500-mg capsules taken orally twice daily

Treatment:

Drug: Naproxen

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Capsules to match V120083 and/or naproxen taken orally twice daily

Treatment:

Drug: Placebo