ACTiF- Assessment of Closed Tibial Fractures

Phase 2

Completed

• Conditions: Tibial Fractures
• Interventions: Drug: CP-533, 536; Drug: Placebo; Procedure: Standard of Care; Drug: CP-533,536

• Registration Number: NCT00533377
• Lead Sponsor: Pfizer

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-09-20
• Study First Submitted QC: 2007-09-20
• Study First Posted: 2007-09-21
• Study Start: 2008-01
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2012-02
• Disposition First Submitted: 2012-02-15
• Disposition First Submitted QC: 2012-02-15
• Last Update Submitted: 2012-02-15
• Disposition First Posted: 2012-02-17
• Last Update Posted: 2012-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 276

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CP-533,536 Dose Level 2	CP-533, 536	-
Placebo	Placebo	-
Standard of Care	Standard of Care	-
CP-533,536 Dose Level 1	CP-533,536	-
CP-533,536 Dose Level 3	CP-533,536	-
CP-533.536 Dose Level 4	CP-533,536	-

Primary Outcome Measures

Name	Time	Method
Time to fracture healing compared with placebo	24 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇹🇷 Izmir, Turkey