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
Overview
- Phase
- Phase 2
- Intervention
- FX006 16 mg
- Conditions
- Osteoarthritis of the Knee
- Sponsor
- Pacira Pharmaceuticals, Inc
- Enrollment
- 310
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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).
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.
Investigators
Eligibility Criteria
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
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
Arms & Interventions
FX006 16 mg
Single 5 mL intra-articular (IA) injection Extended-release formulation
Intervention: FX006 16 mg
FX006 32 mg
Single 5 mL intra-articular (IA) injection Extended-release formulation
Intervention: FX006 32 mg
Placebo
Normal Saline Single 5 mL intra-articular (IA) injection
Intervention: Placebo
Outcomes
Primary Outcomes
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
- Change From Baseline to Week 12 for WOMAC C (Function Subscale)(Baseline and Week 12)
- Change From Baseline to Week 12 for Patient Global Impression of Change (PGIC)(Baseline and Week 12)
- 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(Baseline and Weeks 16, 20 and 24)