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

June 10, 2026 updated by: PharmaResearch Co.,Ltd

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conjuran
Once a week for 5 injections
Device: Conjuran
Once a week for 5 injections
Other Names:
  • Polynucleotide sodium (PN)
Active Comparator: Hyruan
Once a week for 5 injections
Drug: Hyruan
Once a week for 5 injections
Other Names:
  • Sodium Hyaluronate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight-Bearing Pain (WBP) Visual Analog Scale (VAS)
Time Frame: Week 16
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
Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight-Bearing Pain (WBP), Resting Pain (RP), and Motion Pain (MP) VAS
Time Frame: Up to 56 weeks
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.
Up to 56 weeks
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
Time Frame: Up to 56 weeks
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.
Up to 56 weeks
EQ-5D (EuroQol 5-Dimension Health Questionnaire)
Time Frame: Up to 56 weeks
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.
Up to 56 weeks
Patient Global Assessment (PGA), Investigator Global Assessment (IGA)
Time Frame: Up to 56 weeks
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.
Up to 56 weeks
WBP and OMERACT-OARSI Responder Rate
Time Frame: Up to 56 weeks
Proportion of participants meeting WBP responder criteria or OMERACT-OARSI responder criteria
Up to 56 weeks
Rescue Medication Use
Time Frame: Up to 56 weeks
Proportion (%) of participants using rescue medication and amount of rescue medication consumed.
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
Incidence of adverse events, local adverse events, laboratory abnormalities, vital sign abnormalities, and physical examination findings.
Up to 56 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PharmaResearch Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

June 7, 2026

First Submitted That Met QC Criteria

June 10, 2026

First Posted (Actual)

June 12, 2026

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR-PRM002-P4-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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