Clinical Trial to Evaluate the Efficacy and Safety of Conjuran® After First and Second Cycle (Repeat) Administration in Patients With Knee Osteoarthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conjuran, Hyruan.
- Who it may be relevant to
- Registry conditions: Knee Osteoarthritis. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Randomized, Double-Blind, Active-Controlled, Non-Inferiority Clinical Trial to Evaluate the Efficacy and Safety of Intra-Articular Conjuran® After First and Second Cycle (Repeat) Administration in Patients With Knee Osteoarthritis
Overview
This clinical trial aims to evaluate and compare the efficacy and safety of Conjuran® and Hyruan in patients with knee osteoarthritis following first and second cycle (repeat) administration.
Interventions
- Device Conjuran
Once a week for 5 injections - Drug Hyruan
Once a week for 5 injections
Primary outcome measures
- Weight-Bearing Pain (WBP) Visual Analog Scale (VAS) [Time frame: Week 16]
Secondary outcome measures (7)
- Weight-Bearing Pain (WBP), Resting Pain (RP), and Motion Pain (MP) VAS [Time frame: Up to 56 weeks]
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score [Time frame: Up to 56 weeks]
- EQ-5D (EuroQol 5-Dimension Health Questionnaire) [Time frame: Up to 56 weeks]
- Patient Global Assessment (PGA), Investigator Global Assessment (IGA) [Time frame: Up to 56 weeks]
- WBP and OMERACT-OARSI Responder Rate [Time frame: Up to 56 weeks]
- Rescue Medication Use [Time frame: Up to 56 weeks]
- Incidence of Adverse Events, Laboratory Abnormalities, Vital Sign Abnormalities, and Physical Examination Findings [Safety Evaluation] [Time frame: Up to 56 weeks]
Eligibility criteria
Inclusion criteria
- Age ≥40 years
- Knee osteoarthritis diagnosed according to ACR criteria
- KL grade I-III
- Weight-bearing pain VAS ≥40 mm
- Written informed consent
Exclusion criteria
- Inflammatory or secondary arthritis
- Recent treatment in the target knee
- Significant uncontrolled medical conditions
- Hypersensitivity to study device components
- Pregnancy or breastfeeding
- Participation in another clinical trial
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07646483 · PR-PRM002-P4-01