Phase 3
Completed N=486
Study of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee
Source: ClinicalTrials.gov NCT02357459 ↗Enrolled (actual)
486
Serious AEs
2.5%
Results posted
Feb 2018
Primary outcomePrimary: Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain (ADP) Intensity Scores for 32 mg FX006 Versus Placebo — -3.12; -2.14 units on a scale — p=<0.0001
◆ Published Evidence
Established
37citations · ~5 / year
Efficacy of Triamcinolone Acetonide Extended-Release in Participants with Unilateral Knee Osteoarthritis: A Post Hoc Analysis.
Summary
The purpose of this study was to assess the safety and efficacy of FX006 for the treatment of pain in patients with osteoarthritis of the knee.
Linked Publications (2)
-
Efficacy of Triamcinolone Acetonide Extended-Release in Participants with Unilateral Knee Osteoarthritis: A Post Hoc Analysis.
-
Improved Treatment Effect of Triamcinolone Acetonide Extended-Release in Patients with Concordant Baseline Pain Scores on the Average Daily Pain and Western Ontario and McMaster Universities Osteoarthritis Index Pain Scales.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain (ADP) Intensity Scores for 32 mg FX006 Versus Placebo |
-3.12; -2.14 | <0.0001 sig |
| SECONDARY Area Under the Effect Curve (AUE) of Change From Baseline in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to Placebo |
-247.3; -145.3 | — |
| SECONDARY AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR |
-247.3; -231.9 | — |
| SECONDARY Change From Baseline to Week 12 in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR |
-3.12; -2.86 | — |
| SECONDARY AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 24 for FX006 Relative to Placebo |
-432.5; -297.0 | — |
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 symptoms associated with OA of the index knee for 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
- Index knee pain for > 15 days over the last month
- 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
- Any condition that could possibly confound the patient's assessment of index knee pain in judgement of the investigator (i.e., iIpsilateral hip OA, gout, 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 or greater than the index knee pain)
- Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease
- History of infection in the index knee
- Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening
- Unstable joint within 12 months of screening
- 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) or oral corticosteroids (investigational or marketed) within 1 month 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 (NCT02357459) and the linked publication. 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.