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

Last updated on December 15, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35294-3708 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fractures
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00387686
Pfizer
Terminated
A Phase 2/3 Multicenter, Controlled Trial Of rhBMP-2/CPM In Tibial Fractures

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A Phase 2/3 Multicenter, Controlled Trial Of rhBMP-2/CPM In Tibial Fractures
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Fractures
Drug: rhBMP-2/CPM
  • Experimental: A
    1.0 mg/mL rhBMP-2/CPM + surgical fixation
    Intervention: Drug: rhBMP-2/CPM
  • Experimental: B
    2.0 mg/mL rhBMP-2/CPM + surgical fixation
    Intervention: Drug: rhBMP-2/CPM
  • Active Comparator: C
    Buffer/CPM + surgical fixation Intervention
    Intervention: Drug: rhBMP-2/CPM
  • D
    Standard of Care: Surgical fixation intervention
    Intervention: Drug: rhBMP-2/CPM
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
367
March 2010
July 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Brazil,   Canada,   Finland,   France,   Germany,   India,   Latvia,   Mexico,   Poland,   Romania,   Serbia,   Slovenia,   Spain,   Sweden,   United Kingdom,   United States
 
 
NCT00387686
3100N7-210
No
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
February 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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