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Completed

NCT Number: NCT02116972

Study of FX006 vs Normal Saline 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).

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kitchener, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FX006 32 mg

Drug

Single 5 mL IA injection

Other names: Zilretta

Placebo

Drug

Single 5 mL IA injection

Other names: Normal Saline

FX006 16 mg

Drug

Single 5 mL IA injection

Primary outcomes

  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

    Time frame: Baseline and Week 12

    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."

Secondary outcomes

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

    Time frame: Baseline and Week 12

    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.

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

    Time frame: Baseline and Week 12

    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.

  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

    Time frame: Baseline and Weeks 16, 20 and 24

    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."

Other outcomes

  1. Percent of Responders According to Outcomes Measures in OMERACT-OARSI Strict Criteria

    Time frame: Weeks 4, 8 and 12

    Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International. (OMERACT-OARSI) Responders are defined as participants with high improvement in pain or function.

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

    Time frame: Baseline and Week 12

    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.

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

    Time frame: Baseline and Week 12

    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.

  4. Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores

    Time frame: Baseline and Up to Week 24

    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."Weeks 12, 16, 20, and 24 are specified as the primary and secondary endpoints for the 32 mg group and the placebo group

  5. Change From Baseline to Each of Weeks 4, 8, 16, 20, and 24 in WOMAC-C-function

    Time frame: Baseline and Weeks 4, 8, 16, 20 and 24 (Week 12 data is represented in the secondary outcome measure)

    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.

  6. Change From Baseline to Each of Weeks 4, 8, 12, 16, 20, and 24 in WOMAC-A Pain

    Time frame: Baseline and Weeks 4, 8, 12, 16, 20 and 24

    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.

  7. Change From Baseline to Each of Weeks 4, 8, 16, 20, and 24 in PGIC

    Time frame: Baseline and Weeks 4, 8, 16, 20, and 24 (Week 12 data reported in secondary outcome measure)

    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.

  8. Proportion of Patients Experiencing a >20%, 30% and 50% Decrease in Pain From Baseline in Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores at Week 12

    Time frame: 12 weeks

    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."

  9. Time to Onset of Pain Relief

    Time frame: Baseline up to 24 Weeks after administration of study treatment

    Time to onset of pain relief in days is defined as the time from administration of study treatment to the first pain assessment showing >30% improvement from the weekly average daily pain score at baseline.

Sponsors and collaborators

Lead sponsor

Pacira Pharmaceuticals, Inc

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 17, 2014
Registry last updated
Jan 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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