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

Phase 2

Terminated

• Conditions: Fractures
• Interventions: Drug: rhBMP-2/CPM

• Registration Number: NCT00387686
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-10-11
• Study First Submitted QC: 2006-10-11
• Study First Posted: 2006-10-13
• Study Start: 2006-11
• Primary Completion: 2009-07
• Study Completion: 2010-03
• Status Verified: 2013-02
• Disposition First Submitted: 2013-02-21
• Disposition First Submitted QC: 2013-02-21
• Last Update Submitted: 2013-02-21
• Disposition First Posted: 2013-02-28
• Last Update Posted: 2013-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 367

Inclusion Criteria

• Skeletally mature, male and female subjects who are at least 18 years old.
• Closed diaphyseal tibial fracture.
• Closed reduction and definitive internal fixation by means of a reamed, locked intramedullary nail within 72 hours after injury.

Exclusion Criteria

• Concurrent fractures of the ipsilateral or contralateral lower extremity other than the ipsilateral fibula, that would impede performance on the functional assessment of weight bearing.
• Planned procedure(s) to stimulate fracture healing after intramedullary nailing.
• Neurovascular impairment of the fractured limb, deep vein thrombosis, or (impending) compartment syndrome.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	rhBMP-2/CPM	1.0 mg/mL rhBMP-2/CPM + surgical fixation
D	rhBMP-2/CPM	Standard of Care: Surgical fixation intervention
B	rhBMP-2/CPM	2.0 mg/mL rhBMP-2/CPM + surgical fixation
C	rhBMP-2/CPM	Buffer/CPM + surgical fixation Intervention

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to assess whether a single dose of rhBMP-2/CPM administered in combination with the SOC accelerates fracture union and return to normal function as indicated on radiographs and functional evaluations.	efficacy will be demonstrated if there is a greater than or equal to 4 week reduction in time to fra

Secondary Outcome Measures

Name	Time	Method
Demonstrate safety of rhBMP-2/CPM administration; demonstrate earlier return to function; assess feasibility of rhBMP-2CPM administration. Subject enrollment 12 months	12 months

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Norwich, United Kingdom