A Phase 2/3 Multicenter, Controlled Trial Of rhBMP-2/CPM In Tibial Fractures
NCT ID: NCT00387686
Last Updated: 2013-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
367 participants
INTERVENTIONAL
2006-11-30
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
1.0 mg/mL rhBMP-2/CPM + surgical fixation
rhBMP-2/CPM
B
2.0 mg/mL rhBMP-2/CPM + surgical fixation
rhBMP-2/CPM
C
Buffer/CPM + surgical fixation Intervention
rhBMP-2/CPM
D
Standard of Care: Surgical fixation intervention
rhBMP-2/CPM
Interventions
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rhBMP-2/CPM
rhBMP-2/CPM
rhBMP-2/CPM
rhBMP-2/CPM
Eligibility Criteria
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Inclusion Criteria
* 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
* Planned procedure(s) to stimulate fracture healing after intramedullary nailing.
* Neurovascular impairment of the fractured limb, deep vein thrombosis, or (impending) compartment syndrome.
18 Years
ALL
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Aurora, Colorado, United States
Pfizer Investigational Site
Denver, Colorado, United States
Pfizer Investigational Site
New Haven, Connecticut, United States
Pfizer Investigational Site
Pinellas Park, Florida, United States
Pfizer Investigational Site
Fort Wayne, Indiana, United States
Pfizer Investigational Site
Indianapolis, Indiana, United States
Pfizer Investigational Site
Baltimore, Maryland, United States
Pfizer Investigational Site
Kalamazoo, Michigan, United States
Pfizer Investigational Site
Portage, Michigan, United States
Pfizer Investigational Site
Lebanon, New Hampshire, United States
Pfizer Investigational Site
New Brunswick, New Jersey, United States
Pfizer Investigational Site
Brooklyn, New York, United States
Pfizer Investigational Site
Elmhurst, New York, United States
Pfizer Investigational Site
Charlotte, North Carolina, United States
Pfizer Investigational Site
Memphis, Tennessee, United States
Pfizer Investigational Site
Buenos Aires, , Argentina
Pfizer Investigational Site
Liverpool, New South Wales, Australia
Pfizer Investigational Site
New Lambton, New South Wales, Australia
Pfizer Investigational Site
Herston, Queensland, Australia
Pfizer Investigational Site
Adelaide, South Australia, Australia
Pfizer Investigational Site
Cerequeira Cesar, São Paulo, Brazil
Pfizer Investigational Site
Vila Clemetino, São Paulo, Brazil
Pfizer Investigational Site
Ajax, Ontario, Canada
Pfizer Investigational Site
Oshawa, Ontario, Canada
Pfizer Investigational Site
Scarborough Village, Ontario, Canada
Pfizer Investigational Site
Windsor, Ontario, Canada
Pfizer Investigational Site
Windsor, Ontario, Canada
Pfizer Investigational Site
Montreal, Quebec, Canada
Pfizer Investigational Site
Sherbrooke, Quebec, Canada
Pfizer Investigational Site
Oulu, , Finland
Pfizer Investigational Site
Turku, , Finland
Pfizer Investigational Site
Angers, , France
Pfizer Investigational Site
Créteil, , France
Pfizer Investigational Site
Marseille, , France
Pfizer Investigational Site
Toulouse, , France
Pfizer Investigational Site
Berlin, , Germany
Pfizer Investigational Site
Mainz, , Germany
Pfizer Investigational Site
Münster, , Germany
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India
Pfizer Investigational Site
Ahmedabad, Gujarat, India
Pfizer Investigational Site
Mangalore, Karnataka, India
Pfizer Investigational Site
Nagpur, Maharashtra, India
Pfizer Investigational Site
Pune, Maharashtra, India
Pfizer Investigational Site
Riga, , Latvia
Pfizer Investigational Site
Riga, , Latvia
Pfizer Investigational Site
Chihuahua City, Chihuahua, Mexico
Pfizer Investigational Site
Col. Los Morales, Del Miguel, Hidalgo, Mexico
Pfizer Investigational Site
Col. El Retiro, Guadalajara, Jal., Mexico
Pfizer Investigational Site
Mexico City, Mexico City, Mexico
Pfizer Investigational Site
Guadalajara, Jal, , Mexico
Pfizer Investigational Site
Bielsk Podlaski, , Poland
Pfizer Investigational Site
Krakow, , Poland
Pfizer Investigational Site
Cluj-Napoca, Cluj, Romania
Pfizer Investigational Site
Iași, Iaşi, Romania
Pfizer Investigational Site
Bucharest, , Romania
Pfizer Investigational Site
Bucharest, , Romania
Pfizer Investigational Site
Bucharest, , Romania
Pfizer Investigational Site
Belgrade, , Serbia
Pfizer Investigational Site
Niš, , Serbia
Pfizer Investigational Site
Ljubljana, , Slovenia
Pfizer Investigational Site
Alcalá de Henares, Madrid, Spain
Pfizer Investigational Site
Madrid, Madrid, Spain
Pfizer Investigational Site
Alcalá, , Spain
Pfizer Investigational Site
Uppsala, , Sweden
Pfizer Investigational Site
Coventry, , United Kingdom
Pfizer Investigational Site
Norwich, , United Kingdom
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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3100N7-210
Identifier Type: -
Identifier Source: org_study_id
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