Diclofenac-hyaluronate conjugate (diclofenac etalhyaluronate) intra-articular injection for hip, ankle, shoulder, and elbow osteoarthritis: a randomized controlled trial.

ABSTRACT:

Background

To evaluate the efficacy and safety of intra-articular injection of diclofenac etalhyaluronate (DF-HA) in patients with osteoarthritis (OA) of the hip, ankle, shoulder, or elbow.

Methods

In this randomized, placebo-controlled, double-blind study in Japan, Japanese patients aged ≥20 years diagnosed with OA of the hip, ankle, shoulder, or elbow were randomly assigned 1:1 to DF-HA 30 mg or placebo (citric acid-sodium citrate buffered solution). Subjects received three injections of the study drug in each joint cavity every 4 weeks and were assessed for 12 weeks after the first injection. The primary endpoint was the mean change from baseline in a diary-based 11-point numerical rating scale (NRS) for pain over 12 weeks, analyzed for each joint. Treatment-emergent adve

SUBMITTER: Kubo T 

PROVIDER: S-EPMC9022275 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature