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

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NCT00387686

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35294-3708, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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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.

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NCT00387686
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Aurora, Colorado
  4. Denver, Colorado
  5. New Haven, Connecticut
  6. Pinellas Park, Florida
  7. Fort Wayne, Indiana
  8. Indianapolis, Indiana
  9. Baltimore, Maryland
  10. Kalamazoo, Michigan
  11. Portage, Michigan
  12. Lebanon, New Hampshire
  13. New Brunswick, New Jersey
  14. Brooklyn, New York
  15. Elmhurst, New York
  16. Charlotte, North Carolina
  17. Memphis, Tennessee
  18. Buenos Aires,
  19. Liverpool, New South Wales
  20. New Lambton, New South Wales
  21. Herston, Queensland
  22. Adelaide, South Australia
  23. Cerequeira Cesar, Sao Paolo
  24. Vila Clemetino, Sao Paulo
  25. Ajax, Ontario
  26. Oshawa, Ontario
  27. Scarborough, Ontario
  28. Windsor, Ontario
  29. Windsor, Ontario
  30. Montreal, Quebec
  31. Sherbrooke, Quebec
  32. Oulu,
  33. Turku,
  34. Angers,
  35. Créteil,
  36. Marseille,
  37. Toulouse,
  38. Berlin,
  39. Mainz,
  40. Muenster,
  41. Hyderabad, Andhra Pradesh
  42. Ahmedabad, Gujarat
  43. Mangalore, Karnataka
  44. Nagpur, Maharashtra
  45. Pune, Maharashtra
  46. Riga,
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  48. Col. Los Morales, Del Miguel, Hidalgo
  49. Col. el Retiro, Guadalajara, Jal.
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  60. Iasi,
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Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase 2/3 Multicenter, Controlled Trial Of rhBMP-2/CPM In Tibial Fractures
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Fractures
Intervention  ICMJE Drug: rhBMP-2/CPM
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 31, 2009)		367
Original Enrollment  ICMJE
 (submitted: October 11, 2006)		600
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Brazil,   Canada,   Finland,   France,   Germany,   India,   Latvia,   Mexico,   Poland,   Romania,   Serbia,   Slovenia,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00387686
Other Study ID Numbers  ICMJE 3100N7-210
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP