NCT02740231

A Study on Visco-antalgic Intra-articular Administration in Symptomatic Knee Osteoarthritis

A Two-stage 6-month Multicentre, Randomised, Double-blind, Controlled Study on the Safety and Efficacy Intra-articular Administration of JTA-004 in Patients With Symptomatic Knee Osteoarthritis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: Bone Therapeutics S.A · Industry
• Sex: All
• Age: 50 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

Osteoarthritis (OA) is the most common joint disease affecting millions of people around the world, for which there is unfortunately no cure. Among existing therapies, viscosupplementation, i.e., the injection of hyaluronic acid into the joint, has an established place in the symptomatic treatment of knee OA. The present Phase IIb/III aiming to assess the safety and efficacy of JTA-004 is organized in two phases. With results obtained in the first phase the best dose of JTA-004 is determined, and the efficacy of the selected dose will then be confirmed in the second phase.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	JTA-004 intra-articular injection	Each patient will undergo a single injection of JTA-004 into the knee joint
DEVICE	Reference product intra-articular injection	Each patient will undergo a single injection of Reference product into the knee joint

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-04-27
• Completion: 2018-04-27
• First posted: 2016-04-15
• Last updated: 2021-12-06
• Results posted: 2021-12-06