A Phase 2/3 Multicenter, Controlled Trial Of rhBMP-2/CPM In Tibial Fractures
NCT00387686
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- 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.
- 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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Descriptive Information | ||||
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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 |
| |||
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 | 367 | |||
Original Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
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 |
| |||
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 |