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NCT Number: NCT07646483

Clinical Trial to Evaluate the Efficacy and Safety of 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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conjuran

Device

Once a week for 5 injections

Other names: Polynucleotide sodium (PN)

Hyruan

Drug

Once a week for 5 injections

Other names: Sodium Hyaluronate

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. WBP and OMERACT-OARSI Responder Rate

    Time frame: Up to 56 weeks

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

  6. Rescue Medication Use

    Time frame: Up to 56 weeks

    Proportion (%) of participants using rescue medication and amount of rescue medication consumed.

  7. 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.

Sponsors and collaborators

Lead sponsor

PharmaResearch Co.,Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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