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

NCT00387686 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 367

Last updated 2013-02-28

No results posted yet for this study

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

  • Fractures

Interventions

DRUG

rhBMP-2/CPM

DRUG

rhBMP-2/CPM

DRUG

rhBMP-2/CPM

DRUG

rhBMP-2/CPM

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2009-07-31
Completion
2010-03-31

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • Finland
  • France
  • Germany
  • India
  • Latvia
  • Mexico
  • Poland
  • Romania
  • Serbia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00387686 on ClinicalTrials.gov