MedDataX Logo

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

NCT02740231 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2021-12-06

Study results available
· View outcomes & findings →

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

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

Sponsors & Collaborators

  • Bone Therapeutics S.A

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-04-27
Completion
2018-04-27

Related Clinical Trials

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02740231 on ClinicalTrials.gov