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TerminatedNCT03793010Updated Jan 24, 2024Results posted

Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis

A Phase 3 interventional study of FX006 and Normal saline in Osteoarthritis, Hip, sponsored by Pacira Pharmaceuticals, Inc. Terminated at 32 sites in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-01-24.

Sponsored by Pacira Pharmaceuticals, Inc · Phase 3, Interventional, and Treatment

Why this study was terminated
By Sponsor due to occurrences of incomplete study drug administration
Phase
Phase 3
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study summary

This is a two-part, multi-center, randomized, double-blind, placebo-controlled, parallel-group study in patients with hip OA. Approximately 70 patients will be enrolled in Part I and approximately 440 patients will be enrolled in Part II of the study. In each part, patients will be randomized to one of two treatment groups (1:1) and treated with a single IA injection of either 32 mg FX006 or normal saline.

Read the detailed description

This is a two-part, multi-center, randomized, double-blind, placebo-controlled, parallel-group study in patients with hip OA. Approximately 70 patients will be enrolled in Part I and approximately 440 patients will be enrolled in Part II of the study. In each part, patients will be randomized to one of two treatment groups (1:1) and treated with a single IA injection of either 32 mg FX006 or normal saline.

FX006 or saline placebo will be administered as a single IA injection with a 12-week follow-up period in the double-blind phase.

Patients participating in Part I of the study will be treated with a single IA injection of either 32 mg FX006 or normal saline and will return for follow up visits at Weeks 12, 16, 20, and 24. The patients will be discontinued at the time of notification by the Investigator.

Patients participating in Part II of the study will be treated with a single IA injection of either 32 mg FX006 or normal saline and will return for follow up visits at Weeks 12, 16, 20, and 24.

Patients participating in Part II of the study that are not clinically indicated for a second injection at Week 12 will return to the clinic at Weeks 16, 20, and 24 and will receive an open-label injection of FX006 at the first evaluation where the patient has been determined to meet all criteria. Patients will then return for follow-up visits every 4 weeks for 12 weeks post second injection and will complete the study 12 weeks post second injection (e.g., Week 24, 28, 32, or 36 depending on when the patient receives the open-label injection).

Patients participating in Part II of the study who are not eligible for a second injection after evaluation at Weeks 12, 16, 20, and 24 will complete the study at the Week 24 visit and complete the End of Study (EOS) assessments.

02

Conditions studied

  • Osteoarthritis, Hip

Keywords

  • Osteoarthritis
  • Hip
  • Pain
  • Intra-articular
  • Injection
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 70 is close to the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Pacira Pharmaceuticals, Inc is the lead sponsor of 100 studies on the registry; 3 are open to participants now.

Of its 26 completed or terminated interventional studies of FDA-regulated products, 17 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
  • Patients 40 to 80 years of age, inclusive, on the day of randomization (Day 1)
  • Body Mass Index (BMI) ≤ 40 kg/m2
  • Symptoms associated with OA of the index hip for ≥ 3 months prior to Screening visit
  • Currently meet the American College of Radiology (ACR) Criteria (clinical and radiological) for OA of the index hip
  • Kellgren-Lawrence (KL) Grade 2 or 3 in the index hip as confirmed by X-ray during Screening visit (centrally read)
  • Qualifying mean score on the WOMAC A and C (0-10 NRS scale)
  • Agree to maintain the similar activity level throughout the study
  • Willingness to abstain from use of restricted medications

Exclusion criteria

Exclusion Criteria:

  • Patients who cannot washout of prohibited medications
  • Diagnosed as secondary OA in the index hip including but not limited to articular fracture, major dysplasia or congenital abnormality, osteochondritis dissecans, acromegaly, ochronosis, hemochromatosis, Wilson's disease, or primary osteochondromatosis, etc.
  • Ipsilateral chronic knee pain
  • Sciatica
  • Atrophic osteoarthritis, femoral head necrosis and/or collapse, or subchondral bone insufficiency fracture in the index hip joint determined via central reading
  • Current or history of infection in the index hip (e.g. osteomyelitis) or current skin infection at injection site
  • Trauma or surgeries (e.g., arthroscopy, knee surgery) of lower limbs within 52 weeks with sequelae, etc.
  • History or current evidence of reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease, systemic lupus erythematosus or other autoimmune diseases
  • Any planned surgeries in the lower limbs during the study period, or any other surgery during the study period that would require use of a restricted medication
  • Presence of surgical hardware or other foreign body in the index hip
  • Planned/anticipated surgery of the index hip or any other surgery that would require use of a restricted medication during the study period
  • IA corticosteroid of any joint within 3 months of Screening visit (investigational or marketed, including FX006)
  • IA treatment of index hip with any of the following agents within 6 months of Screening: any biologic agent or hyaluronic acid (investigational or marketed)
  • IV or IM corticosteroids (investigational or marketed) within 3 months of Screening
  • Oral corticosteroids (investigational or marketed) within 1 month of Screening
  • Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening visit
  • Planned or expected changes to lifestyle with regard to physical activity, physical therapy, acupuncture, transcutaneous electrical nerve stimulation (TENS), or bracing within 1 month prior to Screening and changes throughout the duration of the study
  • Women of child-bearing potential (not surgically sterile or post-menopausal for at least 1 year as documented in medical history) not using a highly effective method or who are pregnant or nursing
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    FX006

    FX006 32mg

    Drug: FX006

  • Placebo comparator
    Normal Saline

    Normal Saline

    Drug: Normal saline

Interventions

  • DrugFX006

    Single Intra-articular injection

  • DrugNormal saline

    Single Intra-articular injection

06

What researchers measure

Primary outcomes

  1. Change in WOMAC A (Pain) Score at Week 12

    The change from baseline on the average Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A (pain) score at Week 12. The average WOMAC A score is calculated by taking the average of five questions with a range from 0 (no pain) to 10 (extreme pain).

    Time frame: Baseline and Week 12

Secondary outcomes

  1. Change in WOMAC C (Function) Score at Week 12

    Change from Baseline on the WOMAC C (function) score at Week 12. The average WOMAC C score is calculated by taking the average of seventeen questions with a range from 0 (no difficulty) to 10 (extreme difficulty).

    Time frame: Baseline and Week 12

  2. PGIC Score at Week 12

    PGIC (Patient Global Impression of Change) at Week 12. The PGIC score has a range from 1(very much improved) to 7 (very much worse) and indicates the overall status of the patient since baseline.

    Time frame: 12 Weeks

07

Results

Posted Sep 14, 2020
Limitations and caveats
This study was terminated early by the Sponsor due to occurrences of incomplete study drug administration. Only 15% of the planned study population had enrolled and no statistical evaluations reported due to insufficient sample size.

Participant flow

The recruitment period for this study was from December 2018 until August 2019. The patients were enrolled at medical clinics.

Participant flow — Overall Study
MilestoneFX006Normal Saline
Started3535
Randomized but not dosed20
Completed78
Not completed2827
Withdrew: Withdrawal by subject57
Withdrew: Withdrawn by investigator or sponsor1918
Withdrew: Lost to follow-up12
Withdrew: Patient couldn't sit still for injection10
Withdrew: Withdrew to pursue other treatment10
Withdrew: Did not meet eligibility criteria10

Outcome measures

PrimaryChange in WOMAC A (Pain) Score at Week 12

The change from baseline on the average Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A (pain) score at Week 12. The average WOMAC A score is calculated by taking the average of five questions with a range from 0 (no pain) to 10 (extreme pain).

Time frame:
Baseline and Week 12
Reported as:
Least squares mean · score on a scale
Change in WOMAC A (Pain) Score at Week 12
score on a scaleFX006Normal Saline
Change in WOMAC A (Pain) Score at Week 12-1.85 (-2.99 to -0.71)-2.16 (-3.22 to -1.09)
Statistical analysis
  • FX006 vs Normal Saline · Mean difference (final values): 0.31 · 95% CI -1.20 to 1.81
SecondaryChange in WOMAC C (Function) Score at Week 12

Change from Baseline on the WOMAC C (function) score at Week 12. The average WOMAC C score is calculated by taking the average of seventeen questions with a range from 0 (no difficulty) to 10 (extreme difficulty).

Time frame:
Baseline and Week 12
Reported as:
Least squares mean · score on a scale
Change in WOMAC C (Function) Score at Week 12
score on a scaleFX006Normal Saline
Change in WOMAC C (Function) Score at Week 12-1.56 (-2.73 to -0.40)-2.16 (-3.30 to -1.03)
Statistical analysis
  • FX006 vs Normal Saline · Mean difference (final values): 0.60 · 95% CI -1.05 to 2.24
SecondaryPGIC Score at Week 12

PGIC (Patient Global Impression of Change) at Week 12. The PGIC score has a range from 1(very much improved) to 7 (very much worse) and indicates the overall status of the patient since baseline.

Time frame:
12 Weeks
Reported as:
Least squares mean · score on a scale
PGIC Score at Week 12
score on a scaleFX006Normal Saline
PGIC Score at Week 123.4 (2.7 to 4.1)3.4 (2.8 to 4.1)
Statistical analysis
  • FX006 vs Normal Saline · Mean difference (final values): -0.0 · 95% CI -1.0 to 0.9

Adverse events

Collected over Adverse event data was collected for FX006 32 mg and Placebo from Baseline to Last Visit at Week 24.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
FX0060/33 (0%)0/33 (0%)21/33 (63.6%)
Normal Saline0/35 (0%)0/35 (0%)14/35 (40%)
Most frequent other events
Showing 10 of 41
Most frequent other events
EventFX006Normal Saline
ArthralgiaMusculoskeletal and connective tissue disorders8/331/35
DysphagiaGastrointestinal disorders2/330/35
Blood Pressure IncreasedInvestigations2/331/35
Weight IncreasedInvestigations2/330/35
Lumbar RadiculopathyNervous system disorders2/330/35
ThrombocytopeniaBlood and lymphatic system disorders1/330/35
Dry MouthGastrointestinal disorders1/330/35
Chest DiscomfortGeneral disorders1/330/35
BronchitisInfections and infestations1/331/35
Gastroenteritis ViralInfections and infestations1/330/35

Baseline characteristics

All patients who received a full dose of study drug assigned to the FX006 32 mg arm and the placebo arm were included in the analysis. 68 total patients were included in the safety population.

Age, Continuous
Age, Continuous(years)FX006Normal SalineTotal
Mean59.6 ± 9.4561.8 ± 7.9960.7 ± 8.73
Sex: Female, Male
Sex: Female, Male(Participants)FX006Normal SalineTotal
Female202141
Male131427
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)FX006Normal SalineTotal
Hispanic or Latino448
Not Hispanic or Latino283159
Unknown or Not Reported101
Race (NIH/OMB)
Race (NIH/OMB)(Participants)FX006Normal SalineTotal
American Indian or Alaska Native101
Asian011
Native Hawaiian or Other Pacific Islander000
Black or African American8816
White242650
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)FX006Normal SalineTotal
United States333568
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m2)FX006Normal SalineTotal
Mean30.50 ± 5.67931.29 ± 5.77530.91 ± 5.699
08

Study locations

32 sites
  • Arizona Research Center
    Phoenix, Arizona 85053, United States
  • Noble Clinical Research
    Tucson, Arizona 85704, United States
  • Hope Clinical Research
    Canoga Park, California 91303, United States
  • TriWest Research Associates, LLC
    El Cajon, California 92020, United States
  • BioSolutions Clinical Research Center
    La Mesa, California 91942, United States
  • Artemis Institute for Clinical Research
    San Diego, California 92103, United States
  • Mountain View Clinical Research, Inc.
    Denver, Colorado 80209, United States
  • Chase Medical Research, LLC
    Waterbury, Connecticut 06708, United States
  • Tampa Bay Medical Research
    Clearwater, Florida 33761, United States
  • Florida Research Associates, LLC
    DeLand, Florida 32720, United States
  • Advanced Research for Health Improvement
    Naples, Florida 34102, United States
  • Medallion Clinical Research Institute, LLC
    Naples, Florida 34102, United States
  • Oviedo Medical Research
    Oviedo, Florida 32765, United States
  • Progressive Medical Research
    Port Orange, Florida 32127, United States
  • Precision Clinical Research, LLC
    Sunrise, Florida 33351, United States
  • National Pain Research Institute
    Winter Park, Florida 32789, United States
  • Better Health Clinical Research, Inc
    Newnan, Georgia 30265, United States
  • Injury Care Research, LLC
    Boise, Idaho 83713, United States
  • Northwestern University Feinberg School of Medicine
    Chicago, Illinois 60611, United States
  • Heartland Research Associates
    Newton, Kansas 67114, United States
  • Excel Clinical Research
    Las Vegas, Nevada 89109, United States
  • Drug Trials America
    Hartsdale, New York 10530, United States
  • M3 Wake Research, Inc.
    Raleigh, North Carolina 27612, United States
  • PMG Research of Wilmington
    Wilmington, North Carolina 28401, United States
  • University Orthopedics Center
    Altoona, Pennsylvania 16602, United States
  • Altoona Center for Clinical Research
    Duncansville, Pennsylvania 16635, United States
  • Clinical Trials of South Carolina
    Charleston, South Carolina 29406, United States
  • Coastal Carolina Research Center
    Charleston, South Carolina 29406, United States
  • Wasatch Clinical Research, LLC
    Salt Lake City, Utah 84107, United States
  • Charlottesville Medical Research
    Charlottesville, Virginia 22911, United States
  • Spectrum Medical, Inc.
    Danville, Virginia 24541, United States
  • Northwest Clinical Research Center
    Bellevue, Washington 98007, United States
09

References and documents

Study documents

  • Study protocol · Jul 31, 2019
  • Statistical analysis plan · Sep 5, 2019

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03793010
Lead sponsor
Pacira Pharmaceuticals, Inc
Responsible party
Sponsor
First posted
Jan 4, 2019
Start date
Dec 12, 2018
Primary completion
Aug 7, 2019
Completion
Aug 7, 2019
Results posted
Sep 14, 2020
Last update
Jan 24, 2024

Study contacts

Scott Kelley, MD
study director · Pacira Pharmaceuticals, Inc

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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