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

NCT03028870 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: VAN2001
• Study Type: interventional
• Target: 291
• Locations: 1 country
• Sites: 30

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.

Conditions

Osteo Arthritis Knee

Keywords

Osteoarthritis; Pain; Osteoarthritis Knee

Outcome Measures

Primary Outcomes (1)

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

  At week 4, subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.

  Week 4

Secondary Outcomes (17)

• Weekly Change From Baseline Score of "Average Pain Over the Last 24 Hours" From the mBPI-SF Pain Severity Subscale

  Weeks 1, 2 and 4

• Average Daily "Pain Right Now" Score Collected by e-Diary

  4 Weeks

• Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale

  4 Weeks

• Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale

  4 Weeks

• Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale

  4 Weeks

Study Arms (4)

V120083 30 mg

EXPERIMENTAL

V120083 30-mg capsules taken orally twice daily

Drug: V120083; Drug: Placebo

V120083 60 mg

EXPERIMENTAL

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

Drug: V120083; Drug: Placebo

Naproxen

ACTIVE COMPARATOR

Naproxen 500-mg capsules taken orally twice daily

Drug: Naproxen; Drug: Placebo

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

V120083 DRUG

Capsules

V120083 30 mg; V120083 60 mg

Naproxen DRUG

Capsules

Naproxen

Placebo DRUG

Capsules to match V120083 and/or naproxen

Naproxen; Placebo; V120083 30 mg; V120083 60 mg

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• 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 ≥ 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
• 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.

You may not qualify if:

• Subjects with radiographic evidence of OA with K-L grade 0,1 or 4
• 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
• 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
• Subjects with a history of significant trauma to a knee, hip or shoulder within the previous year
• 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.

Sponsors & Collaborators

• Purdue Pharma LP: lead
• Shionogi: collaborator

Study Sites (30)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35235, United States

Location

Terence T. Hart, MD

Tuscumbia, Alabama, 35674, United States

Location

Providence Clinical Research

North Hollywood, California, 91606, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Artemis Institute for Clinical Research

San Marcos, California, 92078, United States

Location

Future Care Solution, LLC

Miami, Florida, 33165, United States

Location

New Horizon Research Center

Miami, Florida, 33175, United States

Location

Sensible Healthcare, LLC

Ocoee, Florida, 34761, United States

Location

Omega Research Consultants, LLC

Orlando, Florida, 32810, United States

Location

Clinical Research of West Florida, Inc.

Tampa, Florida, 33603, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Buynak Clinical Research, P.C.

Valparaiso, Indiana, 46383, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Location

Clinical Pharmacology Study Group

Worcester, Massachusetts, 01605, United States

Location

St. Louis Center for Clinical Research

St Louis, Missouri, 63128, United States

Location

St. Louis Clinical Trials, LC

St Louis, Missouri, 63141, United States

Location

Sundance Clinical Research, LLC

St Louis, Missouri, 63141, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Drug Trials America

Hartsdale, New York, 10530, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Medication Management, LLC

Greensboro, North Carolina, 27408, United States

Location

Research Institute of the Carolinas of Piedmont Healthcare, PA

Mooresville, North Carolina, 28117, United States

Location

Burke Primary Care

Morganton, North Carolina, 28655, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

New Horizons Clinical Research

Cincinnati, Ohio, 45242, United States

Location

Providence Health Partners - Center for Clinical Research

Dayton, Ohio, 45439, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Mountain View Clinical Research, Inc.

Greer, South Carolina, 29651, United States

Location

FutureSearch Trials of Neurology

Austin, Texas, 78731, United States

Location

Diagnostics Research Group

San Antonio, Texas, 78229, 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

Results Point of Contact

• Title: Clinical Leader
• Organization: Purdue Pharma L.P.

steven.ripa@pharma.com

1-800-733-1333

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: January 19, 2017
• First Posted: January 23, 2017
• Study Start: March 14, 2017
• Primary Completion: November 10, 2017
• Study Completion: November 21, 2017
• Last Updated: February 12, 2019
• Results First Posted: November 15, 2018

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (30)