NCT03200288

A Study to Evaluate the Clinical Performance and Safety of an Intra-articular Hyaluronic Acid in Knee Osteoarthritis

A Phase 3,Randomized,Double-blind,Placebo-controlled Study to Evaluate the Clinical Performance and Safety of an Intra-articular Solution of High and Low Molecular Weight Hyaluronic Acid (HL-01) in the Treatment of Pain in Symptomatic Knee Osteoarthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 692 (actual)
• Sponsor: IBSA Institut Biochimique SA · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a study to evaluate the Clinical Performance and Safety of a single intra-articular (i.a.) injection of hyaluronic acid product (as HL-01) in the treatment of pain due to osteoarthritis (OA) of the knee.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	HL-01: high and low molecular weight hyaluronic acid	2 ml intra-articular single injection
DEVICE	Placebo	2 ml intra-articular single injection

Timeline

• Start date: 2017-06-29
• Primary completion: 2018-06-27
• Completion: 2018-10-30
• First posted: 2017-06-27
• Last updated: 2021-11-16

Locations

31 sites across 5 countries: Belgium, Germany, Hungary, Italy, Poland