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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Flexion Therapeutics, Inc.

Criteria

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