Tibial Fractures
Conditions
Brief summary
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
Interventions
DRUGCP-533, 536
Active study drug
DRUGPlacebo
Placebo vehicle
PROCEDUREStandard of Care
Standard surgical procedure
DRUGCP-533,536
Active study drug
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or females 17 years or older with confirmed closure of the tibial epiphyses, with a closed fracture of the tibial diaphysis undergoing treatment with reamed locked IM nailing procedure and the absence of an associated compartment syndrome or vascular injury; * Closed tibial fractures Types A, B & C (See OTA fracture classification) can be included.
Exclusion criteria
* Previous fractures of the same tibia that may impact nailing procedure or impaired visibility of current fracture or a history of osteomyelitis; * Subjects with any other clinically significant injuries, which may significantly impair weight bearing of the affected limb; * Subjects with a fracture gap of \>1cm after initial surgery and prior to drug administration; * Any other planned invasive or non invasive interventions intended to promote bone healing of the tibial fracture under study are not allowed in the first 24 weeks after treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to fracture healing compared with placebo | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects who require a secondary intervention to promote fracture healing | 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 | 24 weeks |
| Time to fracture healing compared with Standard of Care | 24 weeks |
| Proportion of patients healed compared with placebo | 16 weeks |
| Time to regular callus formation compared with placebo | 24 weeks |
Countries
Australia, Bosnia and Herzegovina, Canada, Croatia, India, Japan, Russia, South Africa, Spain, Turkey (Türkiye), United States
Outcome results
None listed