NCT07646483

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
25mo left

Started Jun 2026

Typical duration for not_applicable knee-osteoarthritis

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Jul 2028

Study Start

First participant enrolled

June 1, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

June 7, 2026

Last Update Submit

June 10, 2026

Conditions

Keywords

Polynucleotide sodiumOsteoarthritis

Outcome Measures

Primary Outcomes (1)

  • 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

    Week 16

Secondary Outcomes (7)

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

    Up to 56 weeks

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score

    Up to 56 weeks

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

    Up to 56 weeks

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

    Up to 56 weeks

  • WBP and OMERACT-OARSI Responder Rate

    Up to 56 weeks

  • +2 more secondary outcomes

Study Arms (2)

Conjuran

EXPERIMENTAL

Once a week for 5 injections

Device: Conjuran

Hyruan

ACTIVE COMPARATOR

Once a week for 5 injections

Drug: Hyruan

Interventions

ConjuranDEVICE

Once a week for 5 injections

Also known as: Polynucleotide sodium (PN)
Conjuran
HyruanDRUG

Once a week for 5 injections

Also known as: Sodium Hyaluronate
Hyruan

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥40 years
  • Knee osteoarthritis diagnosed according to ACR criteria
  • KL grade I-III
  • Weight-bearing pain VAS ≥40 mm
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2026

First Posted

June 12, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

June 12, 2026

Record last verified: 2026-06