Last reviewed · How we verify
NCT06399042
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
Phase 3 trial testing SP5M002 inj in Osteoarthritis in 297 participants. Status unknown.
1 June 2024
Quick facts
| Lead sponsor | Shin Poong Pharmaceutical Co. Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 297 |
| Start date | 14 June 2023 |
| Primary completion | 1 June 2024 |
| Estimated completion | 1 September 2024 |
| Sites | 16 locations across South Korea |
Drugs / interventions tested
- SP5M002 inj
- Synovian inj — full drug profile →
Conditions studied
- Osteoarthritis — all drugs for Osteoarthritis →
Sponsor
Shin Poong Pharmaceutical Co. Ltd. — full company profile →
Who can join
40 and older, any sex, with Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Change in [Weight-Bearing Pain (WBP)-100mm-visual analogue scale (VAS)] at Week 12 from baseline (visit 2)
Time frame: 12 weeks
\* Weight Bearing Pain (WBP) - 100mm-visual analogue scale (VAS) -
Change in [Weight-Bearing Pain (WBP)-100mm-visual analogue scale (VAS)] at Week 6 from baseline (visit 2)
Time frame: 6 weeks
\* Weight Bearing Pain (WBP) - 100mm-visual analogue scale (VAS)
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06399042
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Osteoarthritis
Currently open trials in the same condition.
- NCT07404891 — Clinical Trial on the Efficacy and Safety of ALT001 in Osteoarthritis · NA · recruiting
- NCT07118501 — A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System · recruiting
- NCT06631638 — EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) · NA · recruiting
- NCT07198750 — "Bimodal vs Unimodal High-Intensity Pulsed Electromagnetic Field Therapy in Older Adults With Knee Osteoarthritis" · NA · recruiting
- NCT07006714 — Preoperative Correction of Vitamin D Deficiency in Total Joint Arthroplasty (TJA) · Phase 4 · active not recruiting
Other Shin Poong Pharmaceutical Co. Ltd. trials
Trials by the same sponsor.
- NCT06660719 — Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Receiving Thrombolytic Standard of · Phase 3 · recruiting
- NCT07064525 — Evaluate the Efficacy and Safety of SPC1001 Low in Patients With Essential Hypertension · Phase 2 · enrolling by invitation
- NCT06826872 — Efficacy and Safety of SPC1001 in Patients With Essential Hypertension · Phase 2 · recruiting
- NCT05633420 — Pilot Clinical Trial to Explore Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients · Phase 2 · completed
- NCT06212648 — Evaluate the Efficacy and Safety of SPC1001 and Monotherapy in Patients With Essential Hypertension · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06399042 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shin Poong Pharmaceutical Co. Ltd.
- Last refreshed: 30 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06399042.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing