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

This study has been terminated.
(Decision was taken by Wyeth Sr. Management to early terminate the 3100N7-210 study (terminate enrollment but complete follow-up).)
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00387686
First received: October 11, 2006
Last updated: February 21, 2013
Last verified: February 2013
History of Changes

October 11, 2006
February 21, 2013
November 2006
July 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
The primary objective of this study is to assess whether a single dose of rhBMP-2/CPM amdinistered in combination with the SOC accellerates fracture union and return to normal function as indicated on radiographs and functional evaluations.
Complete list of historical versions of study NCT00387686 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Brazil,   Canada,   Finland,   France,   Germany,   India,   Latvia,   Mexico,   Poland,   Romania,   Serbia,   Slovenia,   Spain,   Sweden,   United Kingdom
 
NCT00387686
3100N7-210
No
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