Knee OsteoarthritisNCT07646483
Clinical Trial to Evaluate the Efficacy and Safety of Conjuran® After First and Second Cycle (Repeat) Administration in Patients With Knee Osteoarthritis
A study testing Conjuran and Hyruan in people with Knee Osteoarthritis, run by PharmaResearch Co.,Ltd.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Conjuran and Hyruan
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥40 years
- Knee osteoarthritis diagnosed according to ACR criteria
- KL grade I-III
- Weight-bearing pain VAS ≥40 mm
- Written informed consent
Who cannot join
- 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
About this study
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
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Conjuran, Hyruan
- Keywords
- Polynucleotide sodium, Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConjuranDevice
Also called Polynucleotide sodium (PN)
Once a week for 5 injections
HyruanDrug
Also called Sodium Hyaluronate
Once a week for 5 injections
| Study group | Role | What they receive |
|---|---|---|
| Conjuran | Experimental | Once a week for 5 injections Receives: Device: Conjuran |
| Hyruan | Active comparator | Once a week for 5 injections Receives: Drug: Hyruan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 16
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 56 weeks
WBP and OMERACT-OARSI Responder Rate
Proportion of participants meeting WBP responder criteria or OMERACT-OARSI responder criteria
Measured: Up to 56 weeks
Rescue Medication Use
Proportion (%) of participants using rescue medication and amount of rescue medication consumed.
Measured: Up to 56 weeks
Incidence of Adverse Events, Laboratory Abnormalities, Vital Sign Abnormalities, and Physical Examination Findings [Safety Evaluation]
Incidence of adverse events, local adverse events, laboratory abnormalities, vital sign abnormalities, and physical examination findings.
Measured: Up to 56 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PharmaResearch Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646483
- Sponsor's protocol ID
- PR-PRM002-P4-01
- Status last verified
- Jun 2026
- First submitted
- 7 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07646483
- Acronym / sponsor ID
- PR-PRM002-P4-01
- Conditions
- Knee Osteoarthritis
- Keywords
- Polynucleotide sodium, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- PharmaResearch Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conjuran | Experimental | Device: ConjuranOnce a week for 5 injections |
| Hyruan | Active comparator | Drug: HyruanOnce a week for 5 injections |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥40 years
- Knee osteoarthritis diagnosed according to ACR criteria
- KL grade I-III
- Weight-bearing pain VAS ≥40 mm
- Written informed consent
Key exclusion criteria (6 listed)
- Inflammatory or secondary arthritis
- Recent treatment in the target knee
- Significant uncontrolled medical conditions
- Hypersensitivity to study device components
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ConjuranAlso: Polynucleotide sodium (PN)Once a week for 5 injections | Device | Conjuran |
| HyruanAlso: Sodium HyaluronateOnce a week for 5 injections | Drug | Hyruan |
Primary outcome
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
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Conjuran and Hyruan in people with Knee Osteoarthritis, run by PharmaResearch Co.,Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight-Bearing Pain (WBP) Visual Analog Scale (VAS) (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.