Study of FX005 for the Treatment of Pain in Patients With Osteoarthritis of the Knee

Phase 1

Completed

Interventions: Drug: Placebo 2 (Diluent)
Drug: Placebo 1 (Carrier)
Drug: FX005

Brief Summary: The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of FX005 for the treatment of pain in patients with osteoarthritis of the knee.

Detailed Description: The objectives of the study are to assess FX005, as compared to placebo control, for:

* Safety and tolerability

* Analgesic effect

* Pharmacokinetics

Analgesic effect will be assessed using the Western Ontario \& McMaster University Osteoarthritis Index (WOMAC), the Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaire, and patient and clinical observer global assessments.

Recruitment & Eligibility

Inclusion Criteria

Male or female ≥40 years of age
Diagnosis of unilateral or bilateral osteoarthritis of the knee for at least 6 months; confirmation of osteoarthritis according to American College of Rheumatology Criteria (clinical and radiological)
Kellgren-Lawrence grades II or III
Mean score for the WOMAC A subscale (pain) between 2.0 and 3.5 for the index knee
Score of 2-3 for the WOMAC A1 score (pain on walking) for the index knee
Body mass index ≤ 40 kg/m2
Willingness to abstain from use of restricted medications during the study
Willingness and ability to comply with the study procedures and visit schedule

Exclusion Criteria

Kellgren-Lawrence Grade 0, I or IV radiographic stage of the index knee
Clinically apparent tense effusion in index knee
Presence of surgical hardware or other foreign body in the index knee
Clinical signs and symptoms of active knee infection or crystal disease
Intra-articular corticosteroid within 3 months of Screening
Intra-articular hyaluronic acid within 6 months of Screening
Other intra-articular therapy within 3 months 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 malignancy or other serious, non-malignant, significant, acute or chronic medical (e.g.. uncontrolled diabetes) or active psychiatric illness
Skin breakdown at the knee where the injection would take place
Women who are pregnant, nursing or likely to become pregnant during the time of the study
Women of child-bearing potential (not surgically sterile or post-menopausal for at least 1 year) not using effective contraception

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Change from baseline in the WOMAC A score (pain subscale)	at 4 weeks post treatment

Secondary Outcome Measures

Name	Time	Method
Incidence of treatment emergent adverse events	up to 12 weeks post treatment
Change from baseline for WOMAC A1 response (pain on walking)	over 4, 8 and 12 weeks post treatment
Average weekly consumption of analgesic medications	over 12 weeks post treatment
Change from baseline in WOMAC A score (pain subscale)	over 4, 8 and 12 weeks post treatment
Change from baseline for ICOAP constant pain score	at 2, 4, 8 and 12 weeks post treatment
Change in patient's global assessment score	at 4, 8 and 12 weeks post treatment
Change from baseline for ICOAP total score	at 2, 4, 8 and 12 weeks post treatment
Percent of responders according to the OMERACT-OARSI (Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International) criteria	at 4, 8 and 12 weeks post treatment
Change in clinical observer's global assessment score	at 4, 8 and 12 weeks post treatment
Change from baseline for WOMAC A score (pain subscale)	at 2, 8 and 12 weeks post treatment
Change from baseline for WOMAC B score (stiffness subscale)	at 2, 4, 8 and 12 weeks post treatment
Change from baseline for WOMAC C score (function subscale)	at 2, 4, 8 and 12 weeks post treatment
Change from baseline for WOMAC total score	at 2, 4, 8 and 12 weeks post treatment
Change from baseline for ICOAP intermittent pain score	at 2, 4, 8 and 12 weeks post treatment