Trials / Terminated
TerminatedNCT00387686
A Phase 2/3 Multicenter, Controlled Trial Of rhBMP-2/CPM In Tibial Fractures
A Phase 2/3, Multicenter, Double-Blind, Randomized, Controlled Study Of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) In Closed Diaphyseal Tibial Fracture
- Status
- Terminated
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 367 (actual)
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to assess whether a single dose of rhBMP-2/CPM administered at the fracture site via percutaneous injection, in combination with standard of care, accelerates fracture union and return to normal function in subjects who have a closed diaphyseal tibial fracture when compared to standard of care alone.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | rhBMP-2/CPM | |
| DRUG | rhBMP-2/CPM | |
| DRUG | rhBMP-2/CPM | |
| DRUG | rhBMP-2/CPM |
Timeline
- Start date
- 2006-11-01
- Primary completion
- 2009-07-01
- Completion
- 2010-03-01
- First posted
- 2006-10-13
- Last updated
- 2013-02-28
Locations
68 sites across 18 countries: United States, Argentina, Australia, Brazil, Canada, Finland, France, Germany, India, Latvia, Mexico, Poland, Romania, Serbia, Slovenia, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT00387686. Inclusion in this directory is not an endorsement.