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Osteoarthritis of the KneePhase 2NCT02116972

Study of FX006 vs Normal Saline in Patients With Osteoarthritis of the Knee

A Phase 2 study testing FX006 32 mg and FX006 16 mg in people with Osteoarthritis of the Knee, run by Pacira Pharmaceuticals, Inc at 44 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study was to assess the magnitude and duration of pain relief of a single IA injection of 2 doses (16 and 32 mg) of FX006, an extended-release formulation of TCA, relative to normal saline (placebo control). Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Osteoarthritis of the Knee
What is being tested?
FX006 32 mg and FX006 16 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
310 participants
Where
44 sitesin 2 countries
Study dates
Apr 2014to Nov 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Main Inclusion Criteria:

  • Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
  • Male or female >=40 years of age
  • Has documented diagnosis of OA of the index knee made at least 6 months prior to Screening
  • Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA
  • Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee per Screening X-ray
  • Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)
  • Body mass index (BMI) ≤ 40 kg/m2
  • Willingness to abstain from use of restricted medications

Main Exclusion Criteria:

  • Ipsilateral hip OA
  • Fibromyalgia, chronic pain syndrome or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee
  • History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
  • History of arthritides due to crystals (e.g., gout, pseudogout)
  • History or clinical signs and symptoms of infection in the index joint
  • Knee pain that is not clinically attributable to OA of the knee (e.g., radicular low back pain and hip pain that is referred to the knee that could cause misclassification)
  • Pain in any other area of the lower extremities or back that is equal to or greater than the index knee pain
  • IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
  • IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
  • Intramuscular (IM) corticosteroids (investigational or marketed) within 3 months of Screening
  • Oral corticosteroids (investigational or marketed) within 1 month of Screening
  • Inhaled, intranasal and topical corticosteroids (investigational or marketed) within 2 weeks of Screening
  • Any other IA investigational drug/biologic within 6 months of Screening
  • Prior use of FX006
  • Women of child-bearing potential not using effective contraception or who are pregnant or nursing

Trial locations and contacts

44 sites in 2 countries.

44 sites in 2 countries

United States39 sites

  • Study site

    Albuquerque, New Mexico, 87102

  • Study site

    Altoona, Pennsylvania, 16602

  • Study site

    Anaheim, California, 92801

  • Study site

    Anniston, Alabama, 36207

  • Study site

    Birmingham, Alabama, 35216

  • Study site

    Canoga Park, California, 91303

  • Study site

    Dallas, Texas, 75231

  • Study site

    Danville, Virginia, 24541

  • Study site

    DeLand, Florida, 32720

  • Study site

    Duncansville, Pennsylvania, 16635

  • Study site

    El Cajon, California, 92020

  • Study site

    Evansville, Indiana, 47713

  • Study site

    Fort Lauderdale, Florida, 33316

  • Study site

    Hot Springs, Arkansas, 71913

  • Study site

    Houston, Texas, 77055

  • Study site

    Kansas City, Missouri, 64114

  • Study site

    Las Vegas, Nevada, 89106

  • Study site

    Los Angeles, California, 90036

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Mobile, Alabama, 36608

  • Study site

    Mt. Pleasant, South Carolina, 29464

  • Study site

    New Bedford, Massachusetts, 02740

  • Study site

    New York, New York, 10018

  • Study site

    North Hollywood, California, 91606

  • Study site

    Oklahoma City, Oklahoma, 73112

  • Study site

    Orlando, Florida, 32825

  • Study site

    Paducah, Kentucky, 42003

  • Study site

    Phoenix, Arizona, 85023

  • Study site

    Pinellas Park, Florida, 33781

  • Study site

    Raleigh, North Carolina, 27612

  • Study site

    Rochester, New York, 14609

  • Study site

    San Antonio, Texas, 78258

  • Study site

    San Diego, California, 92103

  • Study site

    Stamford, Connecticut, 06905

  • Study site

    Tampa, Florida, 33613

  • Study site

    Troy, Michigan, 48085

  • Study site

    Tucson, Arizona, 85704

  • Study site

    Victoria, Texas, 77901

  • Study site

    Wheaton, Maryland, 20902

Other trials in United States

Canada5 sites

  • Study site

    Kitchener, Ontario

  • Study site

    Québec

  • Study site

    Sarnia, Ontario

  • Study site

    Toronto, Ontario

  • Study site

    Windsor, Ontario

Other trials in Canada

About this study

Official title: A Double-Blind, Randomized, Parallel Group, Dose-Ranging Study to Assess the Safety and Efficacy of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee

The purpose of this study was to assess the magnitude and duration of pain relief of a single IA injection of 2 doses (16 and 32 mg) of FX006, an extended-release formulation of TCA, relative to normal saline (placebo control).

Read the detailed description

This was a double-blind, randomized, parallel group, dose-ranging, single-dose study. The study was conducted in male and female patients ≥40 years of age with OA of the knee.

Approximately 300 patients with OA of the knee were randomized, using a centralized randomization procedure, to 1 of 3 treatment groups (1:1:1) and treated with a single IA injection of:

  • 16 mg FX006,
  • 32 mg FX006, or
  • normal saline (placebo).

Each patient was evaluated for a total of 24 weeks following a single IA injection. Following screening, safety and efficacy were evaluated at 7 out-patient visits (Days 1 [Baseline], Weeks 4, 8, 12, 16, 20, and 24).

The study was expected to enroll over approximately 6 to 7 months.

Being tested
FX006 32 mg, Placebo, FX006 16 mg
Keywords
osteoarthritis, knee, pain, corticosteroid, intra-articular, injection
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis, Pain

What participants receive

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

  • FX006 32 mgDrug

    Also called Zilretta

    Single 5 mL IA injection

  • PlaceboDrug

    Also called Normal Saline

    Single 5 mL IA injection

  • FX006 16 mgDrug

    Single 5 mL IA injection

Study groups in NCT02116972
Study groupRoleWhat they receive
FX006 16 mgExperimentalSingle 5 mL intra-articular (IA) injection Extended-release formulation
Receives: Drug: FX006 16 mg
FX006 32 mgExperimentalSingle 5 mL intra-articular (IA) injection Extended-release formulation
Receives: Drug: FX006 32 mg
PlaceboPlacebo comparatorNormal Saline Single 5 mL intra-articular (IA) injection
Receives: Drug: Placebo

What is being measured

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

  1. Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores for 32 mg FX006 Versus Placebo

    The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain"and 10 indicates "pain as bad as you can imagine."

    Measured: Baseline and Week 12

Secondary outcomes (3)

  1. Change From Baseline to Week 12 for WOMAC C (Function Subscale)

    The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

    Measured: Baseline and Week 12

  2. Change From Baseline to Week 12 for Patient Global Impression of Change (PGIC)

    The Patient Global Impression of Change is a scale that aims to evaluate all aspects of participants' (patients') health and determining if there has been an improvement or not. The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.

    Measured: Baseline and Week 12

  3. Change From Baseline to Week 16 and Then Week 20 and Then Week 24 in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores

    The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."

    Measured: Baseline and Weeks 16, 20 and 24

Timeline

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

  1. First posted17 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionNov 2015
  4. Study completionNov 2015

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
310 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02116972
Sponsor's protocol ID
FX006-2014-006
Status last verified
Jan 2024
First submitted
15 Apr 2014
Last updated
24 Jan 2024
Data monitoring committee
No

Publications

  • Conaghan PG, Cohen SB, Berenbaum F, Lufkin J, Johnson JR, Bodick N. Brief Report: A Phase IIb Trial of a Novel Extended-Release Microsphere Formulation of Triamcinolone Acetonide for Intraarticular Injection in Knee Osteoarthritis. Arthritis Rheumatol. 2018 Feb;70(2):204-211. doi: 10.1002/art.40364. Epub 2017 Dec 20.

    PubMed 29088579

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FX006 32 mg and FX006 16 mg in people with Osteoarthritis of the Knee, run by Pacira Pharmaceuticals, Inc at 44 sites in 2 countries.

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

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, Canada. 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?

Yes. Results are posted in the registry (first posted 20 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores for 32 mg FX006 Versus Placebo (time frame: Baseline and Week 12). 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 NCT02116972, which also lists 1 linked publication.

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 24 Jan 2024.

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