The purpose of this study is to find out the good and bad effects of an investigational drug called CP-533,536 in patients with closed fracture of the tibial shaft undergoing internal fixation using reamed inter-locked IM nailing procedure
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
276
Active study drug
Placebo vehicle
Standard surgical procedure
Time to fracture healing compared with placebo
Time frame: 24 weeks
Proportion of subjects who require a secondary intervention to promote fracture healing
Time frame: 48 weeks
Impact on the subject's ability to return to normal function, general health status, work productivity, and degree of pain at fracture site compared with placebo and Standard of Care groups
Time frame: 24 weeks
Time to fracture healing compared with Standard of Care
Time frame: 24 weeks
Proportion of patients healed compared with placebo
Time frame: 16 weeks
Time to regular callus formation compared with placebo
Time frame: 24 weeks
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Active study drug
Active study drug
Active study drug
Pfizer Investigational Site
Wichita, Kansas, United States
Pfizer Investigational Site
Worcester, Massachusetts, United States
Pfizer Investigational Site
Minneapolis, Minnesota, United States
Pfizer Investigational Site
Columbia, Missouri, United States
Pfizer Investigational Site
Durham, North Carolina, United States
Pfizer Investigational Site
Chattanooga, Tennessee, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
Salt Lake City, Utah, United States
Pfizer Investigational Site
Morgantown, West Virginia, United States
...and 46 more locations