A Randomized, Placebo-Controlled Study To Evaluate The Efficacy, Safety And Tolerability Of CP-533,536 In Subjects With Closed Fracture Of The Tibial Shaft

Pfizer1 site in 1 country276 target enrollmentJanuary 2008

ConditionsTibial Fractures

InterventionsCP-533, 536 Placebo Standard of Care CP-533,536

DrugsCP-533, 536 Placebo CP-533,536

Overview

Phase: Phase 2
Intervention: CP-533, 536
Conditions: Tibial Fractures
Sponsor: Pfizer
Enrollment: 276
Locations: 1
Primary Endpoint: Time to fracture healing compared with placebo
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

May 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

CP-533,536 Dose Level 2

Intervention: CP-533, 536

Placebo

Intervention: Placebo

Standard of Care

Intervention: Standard of Care

CP-533,536 Dose Level 1

Intervention: CP-533,536

CP-533,536 Dose Level 3

Intervention: CP-533,536

CP-533.536 Dose Level 4

Intervention: CP-533,536

Outcomes

Primary Outcomes

Time to fracture healing compared with placebo

Time Frame: 24 weeks

Secondary Outcomes

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)