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Efficacy and Safety of a Intra-articular Injection, ENKO1, in Patients With Symptomatic Knee Osteoarthritis.

NCT03762408 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2021-03-23

No results posted yet for this study

Summary

Clinical trial with medical device, multicenter, single-blind (blind third party evaluation), randomized, comparative and in two paralell groups, to demonstrate the treatment according to usual clinical practice, of the combination of 50 mg Sodium Hyaluronate and 50 mg Chondroitin Sulfate (ENKO 1) in a single administration, has non-inferiority efficacy vs the comparator (Durolane; 60 mg HA crosslinked) in patients with symptomatic knee osteoarthritis after three months of follow-up.

Conditions

  • Osteoarthritis, Knee

Interventions

DEVICE

ENKO 1

50 mg of HA/ 50 mg of CS in 5 ml

DEVICE

Durolane

60 mg HA crosslinked in 3 ml

Sponsors & Collaborators

  • Osteoarthritis Foundation International (OAFI)

    collaborator UNKNOWN

  • OPKO Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Luisa Varela, Ph, MSc · OPKO Health, Inc.

  • Jordi Monfort, MD, PhD · Hospital del Mar

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-15
Primary Completion
2020-05-29
Completion
2020-05-29

Countries

  • Spain

Study Locations

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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 NCT03762408 on ClinicalTrials.gov