Phase 2
Completed N=310
Study of FX006 vs Normal Saline in Patients With Osteoarthritis of the Knee
Source: ClinicalTrials.gov NCT02116972 ↗Enrolled (actual)
310
Serious AEs
1.3%
Results posted
Mar 2018
Primary outcomePrimary: 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 — -3.08; -2.50 units on a scale — p=0.0821
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
-3.08; -2.50 | 0.0821 |
| SECONDARY Change From Baseline to Week 12 for WOMAC C (Function Subscale) |
-0.83; -0.79 | — |
| SECONDARY Change From Baseline to Week 12 for Patient Global Impression of Change (PGIC) |
2.5; 2.7 | — |
| SECONDARY 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 |
-2.83; -2.46; -2.81; -2.34; -2.51; -2.24 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02116972). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.