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NCT00449696 · ClinicalTrials.gov registry record · Phase 3
Gel-200 Versus Placebo in Osteoarthritis of the Knee
A Phase 3 study, sponsored by Seikagaku Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 379
- Enrollment target
NCT00449696: Completed Phase 3 study, sponsored by Seikagaku Corporation.
NCT00449696 is a Phase 3 study that has completed, run by Seikagaku Corporation. The registered enrollment target is 379 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00449696, a Phase 3 study, has completed, sponsored by Seikagaku Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 379 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if a single intra-articular injection of Gel-200 is superior to a single injection of Phosphate Buffered Saline (PBS) in subjects with symptomatic osteoarthritis of the knee.
Primary Outcome
Observed WOMAC pain subscore on VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.
Interventions
- DEVICE Placebo
- DEVICE Gel-200
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 379 participants |
| Start Date | 2006-09 |
| Est. Completion | 2007-12 |
| Phase | Phase 3 |
What the finished NCT00449696 record still lists
NCT00449696 is an interventional study that assigns participants to a tested intervention. The registered 379 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00449696 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00449696 about?
NCT00449696 is a clinical study titled "Gel-200 Versus Placebo in Osteoarthritis of the Knee". The purpose of this study is to determine if a single intra-articular injection of Gel-200 is superior to a single injection of Phosphate Buffered Saline (PBS) in subjects with symptomatic osteoarthritis of the knee.
What is the current status of trial NCT00449696?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 379 participants. The study started on 2006-09. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00449696?
The interventions under investigation include: Placebo (DEVICE), Gel-200 (DEVICE).
Who is sponsoring clinical trial NCT00449696?
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 NCT00449696's enrollment target sits among peer trials
379 987th of 2000 higher than 1,013 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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