A Phase 2/3 Multicenter, Controlled Trial Of rhBMP-2/CPM In Tibial Fractures

Phase 2/3 Terminated 367 enrolled Wyeth is now a wholly owned subsidiary of Pfizer

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2006-11
Primary completion: 2009-07
Completion: 2010-03

Outcome

Outcome not reported

Stopped (Enrollment): “Decision was taken by Wyeth Sr. Management to early terminate the 3100N7-210 study (terminate enrollment but complete follow-up).”

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	rhBMP-2	Protein / enzyme biologic	1 mg/ml	Other
Subject	rhBMP-2	Protein / enzyme biologic	2 mg/ml	Other

Indications

No indication recorded.