Expired Study
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Clinical Trial 41391

Chicago, IL 60611

Study Summary:

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

Qualified Participants May Receive:

Qualified participants of the study will be compensated.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.