Trials / Completed
CompletedNCT00533793
Adjunctive Therapy to Treat Tibial Shaft Fractures
A Phase II Randomized, Controlled, Open-labeled (Dose-blinded) Dose Finding Study of the Safety and Efficacy of I-040202 in the Treatment of Patients With Acute Open Tibial Shaft Fractures
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 201 (actual)
- Sponsor
- Kuros Biosurgery AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A phase 2, prospective, randomized, controlled, open-label (dose-blinded), parallel group, international multi-center study. The study will consist of four treatment groups - one control group (SoC) and three I-040202 groups receiving SoC plus 0.133 mg/mL, 0.4 mg/mL or 1.0 mg/mL I-040202.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | open fracture reduction | internal fracture fixation: osteosynthesis plates or intra-medullary nails |
Timeline
- Start date
- 2007-04-01
- Primary completion
- 2011-05-01
- Completion
- 2011-05-01
- First posted
- 2007-09-21
- Last updated
- 2012-03-16
Locations
49 sites across 12 countries: Bulgaria, Czechia, Finland, France, Germany, Hungary, Italy, Romania, Serbia, Slovakia, Slovenia, Switzerland
Source: ClinicalTrials.gov record NCT00533793. Inclusion in this directory is not an endorsement.