A study to evaluate the safety and effectiveness of an investigational drug in patients with hip osteoarthritis.
This is a randomized, double-blind, placebo-controlled, parallel-group study in patients with hip osteoarthritis. Enrolled patients will be randomized to one of two treatment groups (1:1) and treated with a single intra-articular injection of either 32 mg FX006 (study drug) or normal saline (placebo).
FX006 or saline placebo will be administered as a single intra-articular injection with a 12-week follow-up period in the double-blind phase.
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis
Study Type: Clinical Trial
Allocation: Randomized
Primary Purpose: Treatment
Inclusion Criteria:
· Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
· Patients 40 to 80 years of age, inclusive, on the day of randomization (Day 1)
· Body Mass Index (BMI) equal to or less than 40
· Symptoms associated with OA of the index hip for at least 3 months prior to Screening visit
· Agree to maintain the similar activity level throughout the study