Clinical Trial to Evaluate the Efficacy and Safety of Conjuran® After First and Second Cycle (Repeat) Administration in Patients With Knee Osteoarthritis

N/ANot Yet RecruitingNCT07646483

PharmaResearch Co.,Ltd180 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

180

Conditions

Knee Osteoarthritis

Interventions

ConjuranDEVICE

Once a week for 5 injections

HyruanDRUG

Once a week for 5 injections

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Weight-Bearing Pain (WBP) Visual Analog Scale (VAS)

Change from baseline in WBP after the first treatment assessed using a 100-mm Visual Analog Scale (VAS), ranging from 0 to 100. Higher scores indicate worse pain

Time frame: Week 16

Secondary Outcomes

Weight-Bearing Pain (WBP), Resting Pain (RP), and Motion Pain (MP) VAS

Change from baseline in WBP, RP, and MP after the first and second treatment cycles, assessed using a 100-mm VAS (0-100). Higher scores indicate worse pain.

Time frame: Up to 56 weeks

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score

Change from baseline in WOMAC total and subscale scores after the first and second treatment cycles. WOMAC is a 24-item questionnaire with scores ranging from 0 to 96. Higher scores indicate worse symptoms.

Time frame: Up to 56 weeks

EQ-5D (EuroQol 5-Dimension Health Questionnaire)

Change from baseline in EQ-5D score after the first and second treatment cycles. EQ-5D consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and an EQ Visual Analog Scale (EQ VAS; 0-100). Higher scores indicate better health status.

Time frame: Up to 56 weeks

Patient Global Assessment (PGA), Investigator Global Assessment (IGA)

Change from baseline in PGA and IGA after the first and second treatment cycles, assessed using a 100-mm Visual Analog Scale (VAS) (0-100). Higher scores indicate worse disease status.

Time frame: Up to 56 weeks

WBP and OMERACT-OARSI Responder Rate

Proportion of participants meeting WBP responder criteria or OMERACT-OARSI responder criteria

Data from ClinicalTrials.gov

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