Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00387686
Status:
TERMINATED
Last Update Posted:
2013-02-28
First Post:
2006-10-11
Brief Title:
A Phase 23 Multicenter Controlled Trial Of rhBMP-2CPM In Tibial Fractures
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
A Phase 23 Multicenter Double-Blind Randomized Controlled Study Of Recombinant Human Bone Morphogenetic Protein-2 rhBMP-2Calcium Phosphate Matrix CPM In Closed Diaphyseal Tibial Fracture
Status:
TERMINATED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Decision was taken by Wyeth Sr Management to early terminate the 3100N7-210 study terminate enrollment but complete follow-up
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to assess whether a single dose of rhBMP-2CPM 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None