Pivotal Clinical Trial to Evaluate the Efficacy and Safety After NPNP-001 Application in Patients with Knee Osteoarthritis.

Sponsor
PharmaResearch Co.,Ltd
Study ID
NCT06779071
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NPNP-001 — DEVICE
    Description: NPNP-001 2ml per injection, once a week for 3 injections. Placebo(saline) 2ml per injection, once a week for 2 injections.
  • Conjuran — DEVICE
    Description: Conjuran 2ml per injection, once a week for 5 injections.

Study Details

This study was designed to demonstrate non-inferiority and safety in pain reduction after NPNP-001 application in patients with knee osteoarthritis.

Key Dates

Start date
Jan 8, 2025
Status verified
Jan 2025
Primary completion
May 31, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
260 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NPNP-001
  • Active Comparator: Conjuran

Primary Outcome Measure

Change from baseline of Weight-bearing pain (WBP) - 100mm visual analogue scale (VAS) [ Time Frame: 20 weeks ]

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