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NCT00387686 Clinical Trial

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

Fractures Clinical Trial

Official 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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00387686
Other study ID # 3100N7-210
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received October 11, 2006
Last updated February 21, 2013
Start date November 2006
Est. completion date March 2010

Study information
Verified date February 2013
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 367
Est. completion date March 2010
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• rhBMP-2/CPM

• rhBMP-2/CPM

• rhBMP-2/CPM

• rhBMP-2/CPM

Locations
Country Name City State
Argentina Pfizer Investigational Site Buenos Aires
Australia Pfizer Investigational Site Adelaide South Australia
Australia Pfizer Investigational Site Herston Queensland
Australia Pfizer Investigational Site Liverpool New South Wales
Australia Pfizer Investigational Site New Lambton New South Wales
Brazil Pfizer Investigational Site Cerequeira Cesar Sao Paolo
Brazil Pfizer Investigational Site Vila Clemetino Sao Paulo
Canada Pfizer Investigational Site Ajax Ontario
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Oshawa Ontario
Canada Pfizer Investigational Site Scarborough Ontario
Canada Pfizer Investigational Site Sherbrooke Quebec
Canada Pfizer Investigational Site Windsor Ontario
Canada Pfizer Investigational Site Windsor Ontario
Finland Pfizer Investigational Site Oulu
Finland Pfizer Investigational Site Turku
France Pfizer Investigational Site Angers
France Pfizer Investigational Site Créteil
France Pfizer Investigational Site Marseille
France Pfizer Investigational Site Toulouse
Germany Pfizer Investigational Site Berlin
Germany Pfizer Investigational Site Mainz
Germany Pfizer Investigational Site Muenster
India Pfizer Investigational Site Ahmedabad Gujarat
India Pfizer Investigational Site Hyderabad Andhra Pradesh
India Pfizer Investigational Site Mangalore Karnataka
India Pfizer Investigational Site Nagpur Maharashtra
India Pfizer Investigational Site Pune Maharashtra
Latvia Pfizer Investigational Site Riga
Latvia Pfizer Investigational Site Riga
Mexico Pfizer Investigational Site Chihuahua
Mexico Pfizer Investigational Site Col. el Retiro Guadalajara, Jal.
Mexico Pfizer Investigational Site Col. Los Morales Del Miguel, Hidalgo
Mexico Pfizer Investigational Site Guadalajara, Jal
Mexico Pfizer Investigational Site Mexico City Mexico D.F.
Poland Pfizer Investigational Site Bielsk Podlaski
Poland Pfizer Investigational Site Krakow
Romania Pfizer Investigational Site Bucharest
Romania Pfizer Investigational Site Bucuresti
Romania Pfizer Investigational Site Bucuresti
Romania Pfizer Investigational Site Bucuresti
Romania Pfizer Investigational Site Cluj-Napoca Cluj
Romania Pfizer Investigational Site Iasi
Serbia Pfizer Investigational Site Belgrade
Serbia Pfizer Investigational Site Nis
Slovenia Pfizer Investigational Site Ljubljana
Spain Pfizer Investigational Site Alcala
Spain Pfizer Investigational Site Alcala de Henares Madrid
Spain Pfizer Investigational Site Madrid
Sweden Pfizer Investigational Site Uppsala
United Kingdom Pfizer Investigational Site Coventry
United Kingdom Pfizer Investigational Site Norwich
United States Pfizer Investigational Site Aurora Colorado
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Brooklyn New York
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site Elmhurst New York
United States Pfizer Investigational Site Fort Wayne Indiana
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Kalamazoo Michigan
United States Pfizer Investigational Site Lebanon New Hampshire
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site New Brunswick New Jersey
United States Pfizer Investigational Site New Haven Connecticut
United States Pfizer Investigational Site Pinellas Park Florida
United States Pfizer Investigational Site Portage Michigan

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  Finland,  France,  Germany,  India,  Latvia,  Mexico,  Poland,  Romania,  Serbia,  Slovenia,  Spain,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. efficacy will be demonstrated if there is a greater than or equal to 4 week reduction in time to fra No
Secondary Demonstrate safety of rhBMP-2/CPM administration; demonstrate earlier return to function; assess feasibility of rhBMP-2CPM administration. Subject enrollment 12 months 12 months Yes
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