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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00387686




Registration number
NCT00387686
Ethics application status
Date submitted
11/10/2006
Date registered
13/10/2006
Date last updated
28/02/2013

Titles & IDs
Public title
A Phase 2/3 Multicenter, Controlled Trial Of rhBMP-2/CPM In Tibial Fractures
Scientific title
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
Secondary ID [1] 0 0
3100N7-210
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fractures 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: A - 1.0 mg/mL rhBMP-2/CPM + surgical fixation

Experimental: B - 2.0 mg/mL rhBMP-2/CPM + surgical fixation

Active comparator: C - Buffer/CPM + surgical fixation Intervention

Other: D - Standard of Care: Surgical fixation intervention
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
efficacy will be demonstrated if there is a greater than or equal to 4 week reduction in time to fra
Secondary outcome [1] 0 0
Demonstrate safety of rhBMP-2/CPM administration; demonstrate earlier return to function; assess feasibility of rhBMP-2CPM administration. Subject enrollment 12 months
Timepoint [1] 0 0
12 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2010
Sample size
Target
Accrual to date
Final
367
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Liverpool
Recruitment hospital [2] 0 0
Pfizer Investigational Site - New Lambton
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Herston
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Adelaide
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2305 - New Lambton
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Colorado
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United States of America
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Connecticut
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Florida
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Indiana
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Maryland
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Michigan
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New Hampshire
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New Jersey
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New York
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North Carolina
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United States of America
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Tennessee
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Argentina
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Buenos Aires
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Brazil
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Sao Paolo
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Brazil
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Sao Paulo
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Canada
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Ontario
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Canada
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Quebec
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Finland
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Oulu
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Finland
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Turku
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France
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Angers
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France
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Créteil
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France
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Marseille
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France
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Toulouse
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Germany
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Berlin
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Germany
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Mainz
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Germany
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Muenster
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India
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Andhra Pradesh
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India
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Gujarat
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India
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Karnataka
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India
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Maharashtra
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Latvia
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Riga
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Mexico
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Del Miguel, Hidalgo
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Mexico
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Guadalajara, Jal.
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Mexico
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Mexico D.F.
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Mexico
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Chihuahua
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Mexico
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Guadalajara, Jal
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Poland
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Bielsk Podlaski
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Poland
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Krakow
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Romania
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Cluj
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Romania
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Bucharest
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Romania
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Bucuresti
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Romania
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Iasi
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Serbia
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Belgrade
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Serbia
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Nis
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Slovenia
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Ljubljana
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Spain
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Madrid
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Spain
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Alcala
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Sweden
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Uppsala
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United Kingdom
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Coventry
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United Kingdom
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Norwich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Wyeth is now a wholly owned subsidiary of Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00387686
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00387686