Clinical trial
Safety and Efficacy of I 0401 in the Treatment of Tibial Plateau Fractures…
NCT00409799 · Kuros Biosurgery AG, Industry · Completed
Key facts
| NCT number | NCT00409799 |
|---|---|
| Title | Safety and Efficacy of I 0401 in the Treatment of Tibial Plateau Fractures Requiring Grafting |
| Official title | A Phase 2 Randomized, Controlled, Open-label (Dose-blinded), Multi-center, Dose-finding Study of the Safety and Efficacy of I-0401 in the Treatment of Patients With Fractures of the Tibial Plateau Requiring Grafting. |
| Lead sponsor | Kuros Biosurgery AG, Industry |
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Tibia Plateau Fractures |
| Intervention type | Drug |
| Interventions | I-0401 (a new bone graft substitute) |
| Enrollment | 208 |
| Start date | Nov 1, 2006 |
| Primary completion | Sep 1, 2011 |
| Completion | Sep 1, 2011 |
| First posted | Dec 11, 2006 |
| Last update posted | Mar 16, 2012 |
| Countries | Australia, France, Germany, Hungary, Italy, Poland, Spain, Switzerland, United Kingdom |
At a glance
- 10–99 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: