Status:
UNKNOWN
Post Marketing Clinical Follow up Study to Evaluate the Performance and Safety of ORTHIX PLUS
Lead Sponsor:
Yooyoung Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Opera CRO, a TIGERMED Group Company
Conditions:
Osteoarthritis, Knee
Degenerative Joint Disease of Knee
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 ORTHIX PLUS for pain relief in patients suffering from osteoarthritis or degenerative joint di...
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: Scre...
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.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT05348525
Start Date
July 1 2022
End Date
March 1 2023
Last Update
April 27 2022
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