Trials / Active Not Recruiting
Active Not RecruitingNCT06399042
Pivotal Study to Evaluate Efficacy and Safety of SP5M002 Inj. as Compared to Synovian Inj. in Patients With Mild to Moderate Knee Osteoarthritis
A Multi-center, Randomized, Double-Blinded, Active Controlled, Phase III Study to Evaluate Efficacy and Safety of SP5M002 Injection Compared With Synovian Injection in Patients With Mild to Moderate Knee Osteoarthritis
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 297 (actual)
- Sponsor
- Shin Poong Pharmaceutical Co. Ltd. · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, double-blind, multicenter, Active Controlled, pivotal clinical trial to assess the efficacy and safety of the novel hexamethylenediamine (HMDA) cross-linked hyaluronate intra-articular injection (SP5M002) compared with an active comparator, the 1,4-butanediol diglycidyl ether (BDDE) cross-linked hyaluronate (Synovian) in patients with knee osteoarthritis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SP5M002 inj | pre-filled syringe |
| DEVICE | Synovian inj | pre-filled syringe |
Timeline
- Start date
- 2023-06-14
- Primary completion
- 2024-06-01
- Completion
- 2024-09-01
- First posted
- 2024-05-03
- Last updated
- 2024-05-03
Locations
16 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT06399042. Inclusion in this directory is not an endorsement.