Overview

Pharmacokinetic and Pharmacodynamic Study of FX006 in Patients With Osteoarthritis of the Knee

Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study was to evaluate the safety, pharmacokinetics and pharmacodynamics of FX006 in patients with osteoarthritis of the knee.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Flexion Therapeutics, Inc.
Treatments:
FX006
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
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 >=35 years of age

- Diagnosis of unilateral or bilateral OA of the knee for at least 6 months prior to
Screening with confirmation of OA according to American College of Rheumatology
Criteria for Classification of Idiopathic OA of the Knee (clinical and radiological)
based on an X-ray performed within 6 months prior to Screening or during the Screening
period

- Body mass index (BMI) ≤ 40 kg/m2

- Willingness to abstain from use of the protocol-specified restricted medications

Main Exclusion Criteria:

- 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 of infection in the index joint

- Clinical signs and symptoms of active knee infection or crystal disease of the index
knee

- Presence of surgical hardware or other foreign body in the index knee

- Unstable joint (such as a torn anterior cruciate ligament)

- 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

- Oral, inhaled or intranasal corticosteroids (investigational or marketed) within 1
month of Screening

- Prior arthroscopic or open surgery of the index knee within 12 months of Screening

- Planned/anticipated surgery of the index knee during the study period

- History of or active malignancy, with the exception of resected basal cell carcinoma,
squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ
within 5 years

- Insulin-dependent diabetes

- History of or active Cushing's syndrome

- Any other clinically significant acute or chronic medical conditions (e.g.,
uncontrolled diabetes)

- Skin breakdown at the knee where the injection would take place

- Women of child-bearing potential not using effective contraception or who are pregnant
or nursing