drugset
drugset / Trial / NCT00161616

Study Evaluating InductOs in Diaphyseal Tibia Fractures

NCT00161616 ↗

Phase 4 Completed 277 enrolled Wyeth is now a wholly owned subsidiary of Pfizer
RandomizedSingle-groupSingle-blindTreatment

Summary

Demonstrate a larger proportion of subjects with healed fractures among subjects treated with InductOs and reamed, locked intramedullary nailing compared to subjects treated with reamed, locked intramedullary nailing alone.

Timeline

Start
2003-09
Primary completion
2008-07
Completion
2008-08

Outcome

Missed primary endpoint

registry analysis (superiority or other test); rhBMP-2/ACS vs Standard of Care; p = 0.0541; Fisher Exact NCT00161616 ↗

registry analysis (superiority or other test); rhBMP-2/ACS vs Standard of Care; p = 0.7983; Fisher Exact NCT00161616 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject rhBMP-2 Protein / enzyme biologic 1.5 mg/ml Other

Indications

No indication recorded.