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NCT03209362 · ClinicalTrials.gov registry record · Phase 2
SI-613 Study for Knee Osteoarthritis
A Phase 2 study, sponsored by Seikagaku Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT03209362: Completed Phase 2 study, sponsored by Seikagaku Corporation.
NCT03209362 is a Phase 2 study that has completed, run by Seikagaku Corporation. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03209362, a Phase 2 study, has completed, sponsored by Seikagaku Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
The objective of the study is to evaluate the efficacy and safety of intra-articular injections of SI-613 compared with placebo for knee OA.
Primary Outcome
Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Change in score from baseline over 12 weeks was analyzed using a repeated measures Analysis of Covariance (ANCOVA) model.
Interventions
- COMBINATION_PRODUCT Placebo
- COMBINATION_PRODUCT SI-613
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2017-10-19 |
| Est. Completion | 2018-11-13 |
| Phase | Phase 2 |
What the finished NCT03209362 record still lists
NCT03209362 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03209362 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03209362 about?
NCT03209362 is a clinical study titled "SI-613 Study for Knee Osteoarthritis". The objective of the study is to evaluate the efficacy and safety of intra-articular injections of SI-613 compared with placebo for knee OA.
What is the current status of trial NCT03209362?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2017-10-19. Estimated completion is 2018-11-13.
What interventions are being tested in trial NCT03209362?
The interventions under investigation include: Placebo (COMBINATION_PRODUCT), SI-613 (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03209362?
This trial is sponsored by Seikagaku Corporation, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03209362's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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