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

February 21, 2013 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

A Phase 2/3, Multicenter, Double-Blind, Randomized, Controlled Study Of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) In Closed Diaphyseal Tibial Fracture

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

367

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Pfizer Investigational Site
  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Pfizer Investigational Site
      • New Lambton, New South Wales, Australia, 2305
        • Pfizer Investigational Site
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Pfizer Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Pfizer Investigational Site
  • Brazil
    • Sao Paolo
      • Cerequeira Cesar, Sao Paolo, Brazil, 05403-010
        • Pfizer Investigational Site
    • Sao Paulo
      • Vila Clemetino, Sao Paulo, Brazil, 04020-060
        • Pfizer Investigational Site
  • Canada
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J4
        • Pfizer Investigational Site
      • Oshawa, Ontario, Canada, L1G 2B9
        • Pfizer Investigational Site
      • Scarborough, Ontario, Canada, M1E 4B9
        • Pfizer Investigational Site
      • Windsor, Ontario, Canada, N8W 1L9
        • Pfizer Investigational Site
      • Windsor, Ontario, Canada, N9A 1E1
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
        • Pfizer Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Pfizer Investigational Site
  • Finland
      • Oulu, Finland, 90020
        • Pfizer Investigational Site
      • Turku, Finland, FIN-20520
        • Pfizer Investigational Site
  • France
      • Angers, France, 49100
        • Pfizer Investigational Site
      • Créteil, France, 94010
        • Pfizer Investigational Site
      • Marseille, France, 13009
        • Pfizer Investigational Site
      • Toulouse, France, 31400
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 13353
        • Pfizer Investigational Site
      • Mainz, Germany, D-55101
        • Pfizer Investigational Site
      • Muenster, Germany, 48149
        • Pfizer Investigational Site
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500063
        • Pfizer Investigational Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380006
        • Pfizer Investigational Site
    • Karnataka
      • Mangalore, Karnataka, India, 575001
        • Pfizer Investigational Site
    • Maharashtra
      • Nagpur, Maharashtra, India, 440010
        • Pfizer Investigational Site
      • Pune, Maharashtra, India, 411001
        • Pfizer Investigational Site
  • Latvia
      • Riga, Latvia, LV 1001
        • Pfizer Investigational Site
      • Riga, Latvia, LV 1005
        • Pfizer Investigational Site
  • Mexico
      • Chihuahua, Mexico, 31020
        • Pfizer Investigational Site
      • Guadalajara, Jal, Mexico, CP45235,
        • Pfizer Investigational Site
    • Del Miguel, Hidalgo
      • Col. Los Morales, Del Miguel, Hidalgo, Mexico, 11520
        • Pfizer Investigational Site
    • Guadalajara, Jal.
      • Col. el Retiro, Guadalajara, Jal., Mexico, 44280
        • Pfizer Investigational Site
    • Mexico D.F.
      • Mexico City, Mexico D.F., Mexico, CP 01030
        • Pfizer Investigational Site
  • Poland
      • Bielsk Podlaski, Poland, 17-100
        • Pfizer Investigational Site
      • Krakow, Poland, 30-901
        • Pfizer Investigational Site
  • Romania
      • Bucharest, Romania, 014461
        • Pfizer Investigational Site
      • Bucuresti, Romania, 014461
        • Pfizer Investigational Site
      • Bucuresti, Romania, 050098
        • Pfizer Investigational Site
      • Bucuresti, Romania, 021659
        • Pfizer Investigational Site
      • Iasi, Romania, 700483
        • Pfizer Investigational Site
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400132
        • Pfizer Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Pfizer Investigational Site
      • Nis, Serbia, 18000
        • Pfizer Investigational Site
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Pfizer Investigational Site
  • Spain
      • Alcala, Spain, 28805
        • Pfizer Investigational Site
      • Madrid, Spain, 28007
        • Pfizer Investigational Site
    • Madrid
      • Alcala de Henares, Madrid, Spain, 28805
        • Pfizer Investigational Site
  • Sweden
      • Uppsala, Sweden, 751 85
        • Pfizer Investigational Site
  • United Kingdom
      • Coventry, United Kingdom, CV2 2DX
        • Pfizer Investigational Site
      • Norwich, United Kingdom, NR4 7UY
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35294-3708
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Pfizer Investigational Site
      • Denver, Colorado, United States, 80204
        • Pfizer Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Pfizer Investigational Site
    • Florida
      • Pinellas Park, Florida, United States, 33781
        • Pfizer Investigational Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Pfizer Investigational Site
      • Indianapolis, Indiana, United States, 46202
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21201-1595
        • Pfizer Investigational Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49007
        • Pfizer Investigational Site
      • Portage, Michigan, United States, 49002
        • Pfizer Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Pfizer Investigational Site
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Pfizer Investigational Site
    • New York
      • Brooklyn, New York, United States, 11220
        • Pfizer Investigational Site
      • Elmhurst, New York, United States, 11373
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28203-5871
        • Pfizer Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
1.0 mg/mL rhBMP-2/CPM + surgical fixation
Drug: rhBMP-2/CPM
Experimental: B
2.0 mg/mL rhBMP-2/CPM + surgical fixation
Drug: rhBMP-2/CPM
Active Comparator: C
Buffer/CPM + surgical fixation Intervention
Drug: rhBMP-2/CPM
Other: D
Standard of Care: Surgical fixation intervention
Drug: rhBMP-2/CPM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: efficacy will be demonstrated if there is a greater than or equal to 4 week reduction in time to fra
efficacy will be demonstrated if there is a greater than or equal to 4 week reduction in time to fra

Secondary Outcome Measures

Outcome Measure
Time Frame
Demonstrate safety of rhBMP-2/CPM administration; demonstrate earlier return to function; assess feasibility of rhBMP-2CPM administration. Subject enrollment 12 months
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

October 11, 2006

First Submitted That Met QC Criteria

October 11, 2006

First Posted (Estimate)

October 13, 2006

Study Record Updates

Last Update Posted (Estimate)

February 28, 2013

Last Update Submitted That Met QC Criteria

February 21, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3100N7-210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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