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

NCT03762408 | Completed DMC

• 1 other identifier: OPK-ENK-2017-01
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 18

Brief 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

Keywords

Osteoarthritis; Knee; Chondroitin Sulfate; Hyaluronic Acid; Intra-articular Injection; Viscosupplementation; Pain Relief; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Pain Relief

  Assessed using VAS (Visual Analogue Scale) Huskisson 0-100mm Pain relief scored on a scale of 0 to 10. 0 means No pain and 10 means worst possible pain.

  Change from baseline pain relief at 6 months.

Secondary Outcomes (11)

• Pain Relief

  0, 1, 6 and 12 weeks.

• Evaluation of functional WESTERN ONTARIO AND MCMASTER OSTEOARTHRITIS INDEX (WOMAC) index score (Pain subscale)

  -7, 0, 1, 6, 12 and 24 weeks.

• Evaluation of functional WESTERN ONTARIO AND MCMASTER OSTEOARTHRITIS INDEX (WOMAC) index score (Stiffness subscale)

  -7, 0, 1, 6, 12 and 24 weeks.

• Evaluation of functional WESTERN ONTARIO AND MCMASTER OSTEOARTHRITIS INDEX (WOMAC) index score (Functional capacity subscale)

  -7, 0, 1, 6, 12 and 24 weeks.

• Evaluation of percentage of patients who respond to treatment

  0, 1, 6, 12 and 24 weeks.

Study Arms (2)

ENKO 1

EXPERIMENTAL

ENKO 1 administered by single intra-articular injection.

Device: ENKO 1

Durolane

ACTIVE COMPARATOR

Durolane administered by single intra-articular injection.

Device: Durolane

Interventions

ENKO 1 DEVICE

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

ENKO 1

Durolane DEVICE

60 mg HA crosslinked in 3 ml

Durolane

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medial femorotibial compartment knee OA.
• Fulfilment of ACR criteria for knee OA (knee pain + grinding + stiffness in the morning \< 30 minutes).
• Patients with a clinical course of disease longer than 6 months.
• Global pain score greater than 60 mm on a 0-100 mm VAS on the knee under study.
• Grade II or III according to the Kellgren and Lawrence classification system for the knee under study (on a posteroanterior X-ray performed under weight-bearing and for 6 months before randomisation).
• Patients taking analgesics for at least 3 months before randomisation and whom are dissatisfied with their current therapy.
• Patients who have given their consent in writing to take part in the study.
• Woman of childbearing age must take a urine pregnancy test which must be negative at the randomisation visit and be currently using an effective contraceptive method for at least 2 menstrual cycles (oral contraceptives, intrauterine device, tubal ligation or other effective procedures).

You may not qualify if:

• Isolated symptomatic patellofemoral osteoarthritis.
• Microcrystalline osteoarthritis.
• Prosthesis in knee under study.
• Joint lavage or arthroscopy or any surgery on the knee under study in the 6 months before randomisation.
• Paget's disease of bone, chondromatosis or villonodular sinovitis.
• Inflammatory, infectious or metabolic arthritis (rheumatoid arthritis, spondyloarthropathy or connective tissue diseases).
• Haemochromatosis, ochronosis or haemophilia.
• History of diseases that the investigator considers likely to interfere with the functional disability assessment.
• Knee surgery planned during the study period.
• Other disease-related criteria:
• BMI greater than or equal to 30.
• Immunodeficiency or a serious or progressive disease (heart, lung, liver, kidney, haematological, neoplastic or infectious disease).
• Skin diseases or infections in the area of the injection site.
• Previous history of venous thromboembolism (including pulmonary embolism) or high risk of venous thromboembolism.
• Venous or lymphatic stasis of the leg under study.

Sponsors & Collaborators

• OPKO Health, Inc.: lead
• Osteoarthritis Foundation International (OAFI): collaborator

Study Sites (18)

Clínica Diagonal

Esplugues de Llobregat, Barceloma, 08950, Spain

Location

Consell calatà de l'Esport

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

Location

Clínica Novo Sancti Petri

Chiclana de la Frontera, Cádiz, 11139, Spain

Location

Clínica IQTRA

Torrejón de Ardoz, Madrid, 28002, Spain

Location

Hospital de Torrelodones

Torrelodones, Madrid, 28250, Spain

Location

Clínica Dr. Casermeiro

Mijas Costa, Málaga, 29651, Spain

Location

Instituto Médico Arriaza

A Coruña, 15009, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Instituto POAL del Reumatología

Barcelona, 08022, Spain

Location

Hospital Sant Rafael

Barcelona, 08035, Spain

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

BiClinic

Madrid, 28027, Spain

Location

AMS Centro Médico del Ejercicio

Málaga, 29004, Spain

Location

Clínica ISMEC

Seville, 41001, Spain

Location

Clínica Gastaldi

Valencia, 46015, Spain

Location

Clínica Traumatológica Dr. Baró

Valladolid, 47004, Spain

Location

Hospital Vithas San José

Vitoria-Gasteiz, 01008, Spain

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Luisa Varela, Ph, MSc

  OPKO Health, Inc.

  STUDY CHAIR

• Jordi Monfort, MD, PhD

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blinded (blind third party evaluation) The physician performing the infiltration will be different and cannot be related to the investigator evaluating the results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: December 3, 2018
• Study Start: December 15, 2017
• Primary Completion: May 29, 2020
• Study Completion: May 29, 2020
• Last Updated: March 23, 2021

Record last verified: 2021-03

Locations

ES (18)