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

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Pacira

Status and phase

Completed
Phase 2

Conditions

Osteoarthritis of the Knee

Treatments

Drug: FX006 16 mg
Drug: FX006 32 mg
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02116972
FX006-2014-006

Details and patient eligibility

About

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).

Full 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.

Enrollment

310 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

310 participants in 3 patient groups, including a placebo group

FX006 16 mg
Experimental group
Description:
Single 5 mL intra-articular (IA) injection Extended-release formulation
Treatment:
Drug: FX006 16 mg
FX006 32 mg
Experimental group
Description:
Single 5 mL intra-articular (IA) injection Extended-release formulation
Treatment:
Drug: FX006 32 mg
Placebo
Placebo Comparator group
Description:
Normal Saline Single 5 mL intra-articular (IA) injection
Treatment:
Drug: Placebo

Trial contacts and locations

44

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Data sourced from clinicaltrials.gov

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