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

November 20, 2017 updated by: Purdue Pharma LP

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Investigational Site
      • Huntsville, Alabama, United States, 35801
        • Investigational Site
    • Florida
      • DeLand, Florida, United States, 32720
        • Investigational Site
      • Hialeah, Florida, United States, 33012
        • Investigational Site
      • Homestead, Florida, United States, 33030
        • Investigational Site
      • Jupiter, Florida, United States, 33458
        • Investigational Site
      • Orlando, Florida, United States, 32806
        • Investigational Site
      • Port Orange, Florida, United States, 32129
        • Investigational Site
      • Port Saint Lucie, Florida, United States, 34952
        • Investigational Site
      • The Villages, Florida, United States, 32162
        • Investigational Site
      • West Palm Beach, Florida, United States, 33409
        • Investigational Site
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Investigational Site
    • Indiana
      • Avon, Indiana, United States, 46123
        • Investigational Site
      • Muncie, Indiana, United States, 47304
        • Investigational Site
    • Kansas
      • Newton, Kansas, United States, 67114
        • Investigational Site
      • Prairie Village, Kansas, United States, 66206
        • Investigational Site
    • Massachusetts
      • New Bedford, Massachusetts, United States, 02740
        • Investigational Site
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Investigational Site
      • Troy, Michigan, United States, 48098
        • Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Investigational Site
      • Saint Louis, Missouri, United States, 63141
        • Investigational Site
    • New York
      • Bronx, New York, United States, 10467
        • Investigational Site
      • Hartsdale, New York, United States, 10530
        • Investigational Site
      • Rosedale, New York, United States, 11422
        • Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Investigational Site
      • Dayton, Ohio, United States, 45417
        • Investigational Site
      • Dublin, Ohio, United States, 43016
        • Investigational Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Investigational Site
    • Utah
      • Ogden, Utah, United States, 84405
        • Investigational Site
      • Salt Lake City, Utah, United States, 84121
        • Investigational Site
      • South Jordan, Utah, United States, 84095
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Capsules to match VM902A and/or naproxen taken orally with food twice daily
Experimental: VM902A 200 mg
VM902A 200-mg Capsules
Drug: VM902A 200-mg Capsules
Taken orally with food twice daily
Drug: Placebo
Capsules to match VM902A and/or naproxen taken orally with food twice daily
Experimental: VM902A 400 mg
VM902A 400-mg Capsules (2 x 200-mg capsules)
Drug: Placebo
Capsules to match VM902A and/or naproxen taken orally with food twice daily
Drug: VM902A 400-mg Capsules
Taken orally with food twice daily
Active Comparator: Naproxen
Naproxen 500-mg Capsules
Drug: Placebo
Capsules to match VM902A and/or naproxen taken orally with food twice daily
Drug: Naproxen 500-mg Capsules
Taken orally with food twice daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Daily "Average Pain Over the Last 24 Hours" Score at Week 4
Time Frame: Week 4
Week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Weekly "Average Pain Over the Last 24 Hours" at Week 4
Time Frame: Week 4
Week 4
Average Daily "Pain Right Now" Score at Week 4
Time Frame: Week 4
Week 4
Western Ontario and McMaster OA Index (WOMAC) - Total Scores
Time Frame: Week 4
Week 4
Western Ontario and McMaster OA Index (WOMAC) Pain Severity Subscale Score
Time Frame: Week 4
Week 4
Western Ontario and McMaster OA Index (WOMAC) Physical Function Subscale Score
Time Frame: Week 4
Week 4
Western Ontario and McMaster OA Index (WOMAC) Stiffness Subscale Score
Time Frame: Week 4
Week 4
Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Scores
Time Frame: Week 4
Week 4
Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score
Time Frame: Week 4
Week 4
Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score
Time Frame: Week 4
Week 4
Medical Outcomes Study 36-item Short-Form Health Survey (SF-36)
Time Frame: Week 4
Week 4
EuroQol-5D (EQ-5D) to Measure Health Status
Time Frame: Week 4
Week 4
Patient Global Impression of Change (PGIC) at the End of the Double-blind Period
Time Frame: Week 4
Week 4
Supplemental Analgesic Medication Use
Time Frame: Days 1 - 28
The average daily number of tablets of supplemental pain medication taken during the study.
Days 1 - 28
Responder to Treatment
Time Frame: Week 4
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
Hospital Anxiety and Depression Scale (HADS) Score
Time Frame: Baseline to Week 4
Safety assessment to evaluate the impact of VM902A on mood (anxiety and depression)
Baseline to Week 4
Columbia-Suicide Severity Rating Score (C-SSRS)
Time Frame: Baseline to Week 4
Safety assessment to evaluate the occurrence of treatment-emergent suicidal ideation
Baseline to Week 4
Survey of Autonomic Symptoms (SAS) Score
Time Frame: Baseline to Week 4
Safety assessment to evaluate symptoms of autonomic dysfunction
Baseline to Week 4
Kellgren-Lawrence Classification (K-L) Score
Time Frame: Baseline to Week 4
Safety assessment to classify the severity of knee OA
Baseline to Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Purdue Pharma LP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 22, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 22, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TKA2001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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