NCT03852914

Brief Summary

A Phase III, prospective, multicentre, non-controlled, with consecutive participant enrollment in order to evaluate the efficacy, safety and duration of the effects of the viscosupplementation with a preparation of sodium hyaluronate 2% (SH2%) from Tedec-Meiji Farma S.A. over 12 months. Adult patients diagnosed with primary osteoarthritis of the knee according to American College of Rheumatology (ACR) criteria with radiological grades II and III according to Kellgren-Lawrence scale (KL) will receive a single injection of SH2% and will be followed for 1 year with follow up visits at 6 and 12 months. At 6 months patients could be offered a second injection whenever and when they comply with the criteria established for re-treatment and will be followed for additional 6 months

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 22, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

March 1, 2019

Status Verified

February 1, 2019

Enrollment Period

9 months

First QC Date

February 22, 2019

Last Update Submit

February 27, 2019

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

  • Change in pain intensity according to VAS (0-100mm)

    The VAS to be used in the study consists of a horizontal line marked from 0 to 100 mm, where 0 means no pain and 100 is the greatest possible pain. Patients must draw a vertical line at the point that they believe that represents the pain intensity at that time.

    6 and 12 months after treatment

Secondary Outcomes (5)

  • Change in function from baseline in the target knee

    6 and 12 months after treatment

  • Change in function from baseline in the target knee

    6 and 12 months after treatment

  • Percentage of patients achieving the Minimally Clinical Important Improvement (MCII)

    6 and 12 months after treatment

  • Percentage of patients achieving the Patient Acceptable Symptoms State (PASS)

    6 and 12 months after treatment

  • Patient and investigator global assessments

    6 and 12 months after treatment

Study Arms (1)

Experimental: Sodium Hyaluronate 2%

EXPERIMENTAL

Each patient will receive a single injection of SH2%

Device: Sodium hyaluronate 2%

Interventions

Sodium hyaluronate 2%DEVICE

Each patient will receive a single injection of SH 2% and will be followed for 6 months. At 6 months follow up visit patients could be offered a second injection whenever and when they comply with the criteria established for re-treatment and will be followed for additional 6 months.

Experimental: Sodium Hyaluronate 2%

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient ≥ 45 years of age of either sex.
  • Primary knee OA of the medial or lateral femoro-tibial compartment documented according to ACR criteria with symptoms, at screening, from at least 3 months.
  • KL radiological grade 2-3.
  • Antero-posterior view X-Ray image of the target knee
  • Pain intensity at screening in the target knee ≥40 mm and \<80 mm measured by Visual Analogue Scale (VAS), and ≤ 20 mm in the contralateral knee.
  • Able to understand and willing to comply with study procedures.
  • Able to provide informed consent.

You may not qualify if:

  • BMI ≥ 30 kg/m2.
  • Pregnant or lactating women. Women of child-bearing age not using effective contraception.
  • Severe inflammation of the target knee.
  • Previous surgery in the target knee, including arthroscopy.
  • Subjects with any musculoskeletal condition affecting the target knee that would impair the proper evaluation
  • Patients with joint inflammatory disease, microcrystalline arthropathies and significant osteoarthritis symptoms in other joints apart from the knee, and which require pharmacological treatment.
  • Underlying disease considered by the investigator that might interfere with the development and evaluation study.
  • Subjects with venous or lymphatic stasis in the relevant limb.
  • Previous administration of any of the following treatments: hyaluronic acid i.a. (last year); steroids i.a. or joint lavage (last 3 months), glucosamine sulfate, chondroitin sulfate or diacerein (last 3 months), NSAIDs (last 14 days), any investigational drug (last month) or its administration during this study.
  • Pain in other parts of the body greater than the knee pain that could interfere with the evaluation.
  • Any pathology that, under investigator judgement, interfere with the administration or assessment.
  • Patients with known hypersensitivity to SH or paracetamol.
  • Patients in waiting list for surgery.
  • Patients awaiting disablement assessment.
  • Previous participation in this protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Hospital General de Elche

Elche, Alicánte, 03203, Spain

RECRUITING

Hospital de la Marina Baixa de Villajoyosa

Villajoyosa, Alicánte, 03570, Spain

RECRUITING

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, 28922, Spain

RECRUITING

Complejo Hospitalario La Coruña

A Coruña, 15006, Spain

RECRUITING

Hospital Universitario Reina Sofia

Córdoba, 10004, Spain

RECRUITING

Clinica Universitaria de Navarra

Madrid, 28027, Spain

RECRUITING

Hospital Clínico San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Related Publications (1)

  • Gavin C, J Blanco F, L Pablos J, Caracuel MA, Rosas J, Gomez-Barrena E, Navarro F, Coronel MP, Gimeno M. One-Year, Efficacy and Safety Open Label Study, with a Single Injection of a New Hyaluronan for Knee OA: The SOYA Trial. J Pain Res. 2021 Jul 21;14:2229-2237. doi: 10.2147/JPR.S321841. eCollection 2021.

    PMID: 34321921DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Mercedes Gimeno, PhD

    Tedec Meiji

    STUDY CHAIR

  • Carlos Gavin, PhD

    Hospital Uiversitario Fundacion Alcorcón

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alicia Navarro, MSc

CONTACT

34 91 745 25 20alicia.navarro@alphabioresearch.com

Roger Daga, MSc

CONTACT

34 91 745 25 20roger.daga@alphabioresearch.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2019

First Posted

February 25, 2019

Study Start

January 17, 2019

Primary Completion

October 1, 2019

Study Completion

April 1, 2020

Last Updated

March 1, 2019

Record last verified: 2019-02

Locations

ES(10)