ACTiF- Assessment of Closed Tibial Fractures

Pfizer

Status and phase: Completed; Phase 2

Conditions: Tibial Fractures

Treatments: Drug: Placebo; Drug: CP-533, 536; Drug: CP-533,536; Procedure: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT00533377

A3241010

Details and patient eligibility

About

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

Enrollment: 276 patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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276 participants in 6 patient groups, including a placebo group

CP-533,536 Dose Level 2

Experimental group

Treatment:

Drug: CP-533, 536

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Standard of Care

Other group

Treatment:

Procedure: Standard of Care

CP-533,536 Dose Level 1

Experimental group

Treatment:

Drug: CP-533,536

Drug: CP-533,536

Drug: CP-533,536

CP-533,536 Dose Level 3

Experimental group

Treatment:

Drug: CP-533,536

Drug: CP-533,536

Drug: CP-533,536

CP-533.536 Dose Level 4

Experimental group

Treatment:

Drug: CP-533,536

Drug: CP-533,536

Drug: CP-533,536