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Osteoarthritis Pain of the KneePhase 2NCT02847702

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

A Phase 2 study testing VM902A 200-mg Capsules, VM902A 400-mg Capsules and Naproxen 500-mg Capsules in people with Osteoarthritis Pain of the Knee, run by Purdue Pharma LP at 31 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Osteoarthritis Pain of the Knee
What is being tested?
VM902A 200-mg Capsules, VM902A 400-mg Capsules and Naproxen 500-mg Capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
31 sitesUnited States
Study dates
Aug 2016to 22 Nov 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • Other protocol-specific inclusion/exclusion criteria may apply.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

United States31 sites

  • Investigational Site

    Avon, Indiana, 46123

  • Investigational Site

    Bay City, Michigan, 48706

  • Investigational Site

    Birmingham, Alabama, 35216

  • Investigational Site

    Cincinnati, Ohio, 45219

  • Investigational Site

    Columbus, Georgia, 31904

  • Investigational Site

    Dayton, Ohio, 45417

  • Investigational Site

    DeLand, Florida, 32720

  • Investigational Site

    Dublin, Ohio, 43016

  • Investigational Site

    Duncansville, Pennsylvania, 16635

  • Investigational Site

    Hartsdale, New York, 10530

  • Investigational Site

    Hialeah, Florida, 33012

  • Investigational Site

    Homestead, Florida, 33030

  • Investigational Site

    Huntsville, Alabama, 35801

  • Investigational Site

    Jupiter, Florida, 33458

  • Investigational Site

    Kansas City, Missouri, 64114

  • Investigational Site

    Muncie, Indiana, 47304

  • Investigational Site

    New Bedford, Massachusetts, 02740

  • Investigational Site

    Newton, Kansas, 67114

  • Investigational Site

    Ogden, Utah, 84405

  • Investigational Site

    Orlando, Florida, 32806

  • Investigational Site

    Port Orange, Florida, 32129

  • Investigational Site

    Port Saint Lucie, Florida, 34952

  • Investigational Site

    Prairie Village, Kansas, 66206

  • Investigational Site

    Rosedale, New York, 11422

  • Investigational Site

    Salt Lake City, Utah, 84121

  • Investigational Site

    South Jordan, Utah, 84095

  • Investigational Site

    St Louis, Missouri, 63141

  • Investigational Site

    The Bronx, New York, 10467

  • Investigational Site

    The Villages, Florida, 32162

  • Investigational Site

    Troy, Michigan, 48098

  • Investigational Site

    West Palm Beach, Florida, 33409

Other trials in United States

About this study

Official title: 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.

Being tested
VM902A 200-mg Capsules, VM902A 400-mg Capsules, Naproxen 500-mg Capsules, Placebo
Keywords
Osteoarthritis, Pain, Osteoarthritis, knee
Medical subject headings
Osteoarthritis, Pain, Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VM902A 200-mg CapsulesDrug

    Taken orally with food twice daily

  • VM902A 400-mg CapsulesDrug

    Taken orally with food twice daily

  • Naproxen 500-mg CapsulesDrug

    Taken orally with food twice daily

  • PlaceboDrug

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

Study groups in NCT02847702
Study groupRoleWhat they receive
VM902A 200 mgExperimentalVM902A 200-mg Capsules
Receives: Drug: VM902A 200-mg Capsules; Drug: Placebo
VM902A 400 mgExperimentalVM902A 400-mg Capsules (2 x 200-mg capsules)
Receives: Drug: VM902A 400-mg Capsules; Drug: Placebo
NaproxenActive comparatorNaproxen 500-mg Capsules
Receives: Drug: Naproxen 500-mg Capsules; Drug: Placebo
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Week 4

Secondary outcomes (18)

  1. Weekly "Average Pain Over the Last 24 Hours" at Week 4

    Measured: Week 4

  2. Average Daily "Pain Right Now" Score at Week 4

    Measured: Week 4

  3. Western Ontario and McMaster OA Index (WOMAC) - Total Scores

    Measured: Week 4

  4. Western Ontario and McMaster OA Index (WOMAC) Pain Severity Subscale Score

    Measured: Week 4

  5. Western Ontario and McMaster OA Index (WOMAC) Physical Function Subscale Score

    Measured: Week 4

  6. Western Ontario and McMaster OA Index (WOMAC) Stiffness Subscale Score

    Measured: Week 4

  7. Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Scores

    Measured: Week 4

  8. Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score

    Measured: Week 4

  9. Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score

    Measured: Week 4

  10. Medical Outcomes Study 36-item Short-Form Health Survey (SF-36)

    Measured: Week 4

  11. EuroQol-5D (EQ-5D) to Measure Health Status

    Measured: Week 4

  12. Patient Global Impression of Change (PGIC) at the End of the Double-blind Period

    Measured: Week 4

  13. Supplemental Analgesic Medication Use

    The average daily number of tablets of supplemental pain medication taken during the study.

    Measured: Days 1 - 28

  14. Responder to Treatment

    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.

    Measured: Week 4

  15. Hospital Anxiety and Depression Scale (HADS) Score

    Safety assessment to evaluate the impact of VM902A on mood (anxiety and depression)

    Measured: Baseline to Week 4

  16. Columbia-Suicide Severity Rating Score (C-SSRS)

    Safety assessment to evaluate the occurrence of treatment-emergent suicidal ideation

    Measured: Baseline to Week 4

  17. Survey of Autonomic Symptoms (SAS) Score

    Safety assessment to evaluate symptoms of autonomic dysfunction

    Measured: Baseline to Week 4

  18. Kellgren-Lawrence Classification (K-L) Score

    Safety assessment to classify the severity of knee OA

    Measured: Baseline to Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2016 (estimated)
  2. Study startAug 2016
  3. Primary completion22 Nov 2016
  4. Study completion22 Nov 2016

Why it stopped: Company decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02847702
Sponsor's protocol ID
TKA2001
Status last verified
Nov 2017
First submitted
25 Jul 2016
Last updated
22 Nov 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VM902A 200-mg Capsules, VM902A 400-mg Capsules and Naproxen 500-mg Capsules in people with Osteoarthritis Pain of the Knee, run by Purdue Pharma LP at 31 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Company decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily "Average Pain Over the Last 24 Hours" Score at Week 4 (time frame: Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02847702.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2017.

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