Status:
UNKNOWN
Post Marketing Clinical Follow up Study to Evaluate the Performance and Safety of HYALEXO
Lead Sponsor:
Yooyoung Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Opera CRO, a TIGERMED Group Company
Conditions:
Osteoarthritis
Degenerative Joint Disease
Eligibility:
All Genders
18+ years
Brief Summary
This trial is a post marketing clinical follow up study, aiming to evaluate the performance and safety of Hyalexo for pain relief in patients suffering from osteoarthritis or degenerative joint diseas...
Detailed Description
Design: Open, non-randomised, non-comparative, single group assignment, multicentre study. Chronogram of visits: The study foresees the following visits per patient: * Visit 1 day -3 to day -1: Sc...
Eligibility Criteria
Inclusion
- Patients older than 18 years old(inlcusive≥18years).
- Men or women.
- Patients suffering from painful chronic idiopathic symptomatic degenerative joint diseases(clinical evidence) OR knee osteoarthritis (as defined by the American College of Rheumatology (ACR) criteria); for patients with osteoarthritis at both knees, only the most painful one will be included in the study.
- VAS knee pain≥40mm at screening and 30 days before.
- Patients willing and able to comply with study terms.
- Patients willing to discontinue all other degenerative joint diseases or knee osteoarthritis treatments.
Exclusion
- Patients that are unable or unwilling to provide informed consent and/or patients participating in a concurrent clinical trial and/or patients that have participated in a similar clinical trial within the last 30 days.
- Patients with known hypersensitivity to any components of investigational product.
- Patients with infected or severely inflamed joints
- Patients with skin diseases or infections in the area of the injection site.
- Patients with hepatic failure or history thereof.
- Protected persons defined in the following articles of the French Public Health Code:
- L. 1121-5 pregnant women or breastfeeding.
- L. 1121-6: persons deprived of their liberty by a judicial or administrative decision, persons hospitalized without consent and persons admitted to a health or social establishment for purposes other than that of research.
- L. 1121-7: minors.
- L. 1121-8: adults who are subject to legal protection measures or out of state to express their consent.
- L. 1122-1-2: people in emergency situations who cannot give prior consent.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT05229458
Start Date
May 1 2022
End Date
December 1 2022
Last Update
April 19 2022
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