Clinical Trial to Evaluate the Efficacy and Safety of Conjuran® After First and Second Cycle (Repeat) Administration in Patients With Knee Osteoarthritis
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
1 other identifier
interventional
180
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable knee-osteoarthritis
Started Jun 2026
Typical duration for not_applicable knee-osteoarthritis
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 Start
First participant enrolled
June 1, 2026
CompletedFirst Submitted
Initial submission to the registry
June 7, 2026
CompletedFirst Posted
Study publicly available on registry
June 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
June 12, 2026
June 1, 2026
1.3 years
June 7, 2026
June 10, 2026
Conditions
Keywords
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
EXPERIMENTALOnce a week for 5 injections
Hyruan
ACTIVE COMPARATOROnce a week for 5 injections
Interventions
Eligibility Criteria
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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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