A Study of rhBMP-2/CPM in Closed Fractures of the Humerus
NCT ID: NCT00384852
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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COMPLETED
PHASE2
139 participants
INTERVENTIONAL
2007-01-31
2010-02-28
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
DOUBLE
Study Groups
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A
1.0 mg/mL rhBMP-2/CPM + SOC
rhBMP-2/CPM
B
2.0 mg/mL rhBMP-2/CPM + SOC
rhBMP-2/CPM
C
Buffer/CPM + SOC
rhBMP-2/CPM
D
Standard of Care Alone (SOC)
rhBMP-2/CPM
Interventions
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rhBMP-2/CPM
Eligibility Criteria
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Inclusion Criteria
* Subjects with either a closed proximal humeral fracture or a diaphyseal humeral fracture.
* Treatment plan that includes only conservative (nonoperative) therapy within 48 hours following injury.
Exclusion Criteria
* Planned procedure(s) at that would stimulate fracture union at the time of application of the initial immobilization device.
* Fractures located in the distal third of humerus.
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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Medical Monitor
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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Little Rock, Arkansas, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Clearwater, Florida, United States
St. Petersburg, Florida, United States
Brooklyn, New York, United States
Monroe, North Carolina, United States
Toledo, Ohio, United States
State College, Pennsylvania, United States
Herston, Queensland, Australia
Adelaide, South Australia, Australia
Melbourne, Victoria, Australia
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Vancouver, British Columbia, Canada
Ajax, Ontario, Canada
Chatham, Ontario, Canada
Oshawa, Ontario, Canada
Scarborough Village, Ontario, Canada
Windsor, Ontario, Canada
Montreal, Quebec, Canada
Charlottetown, , Canada
Oulu, , Finland
Turku, , Finland
Angers, , France
Créteil, , France
Berlin, , Germany
Münster, , Germany
Chihuahua City, Chihuahua, Mexico
Guadalajara, Jalisco, Mexico
Monterrey, Nuevo León, Mexico
D.f., , Mexico
Oslo, , Norway
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Linköping, , Sweden
Countries
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References
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Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
Other Identifiers
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3100N7-212
Identifier Type: -
Identifier Source: org_study_id
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