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A Study to Evaluate the Efficacy, Safety and Tolerability of EVI-01 Intra-Articular Injection in Osteoarthritis of the Knee

NCT05337540 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-12-08

No results posted yet for this study

Summary

Objective: Identifying the dose of EVI-01 with the best clinical response, balancing the efficacy, safety, and tolerability of the investigational product.

Study design: Interventional, dose-finding, three arms, randomized (1:1:1), parallel assignment, double-blind, controlled by an active comparator.

Conditions

Interventions

DEVICE

EVI-01

Single intra-articular injection of high molecular weight hyaluronic acid

DEVICE

Active comparator Synvisc-One

Single intra-articular injection of active comparator Synvisc-One

Sponsors & Collaborators

  • Azidus Brasil

    collaborator INDUSTRY

  • Aptissen SA

    lead INDUSTRY

Principal Investigators

  • Guilherme Gracitelli, MD · C.E.P.O.T. - Centro de Estudos e Pesquisas em Ortopedia e Traumatologia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-17
Primary Completion
2025-10-29
Completion
2025-10-29

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

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 NCT05337540 on ClinicalTrials.gov