ACTiF- Assessment of Closed Tibial Fractures

Completed · Phase 2 · Has a placebo group

Conditions studied: Tibial Fractures

In brief

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

Key facts

Study ID

NCT00533377

Run by

Pfizer

People needed

276

Starts

2008-01-01

Expected to finish

2010-05-01

Last updated by the study team

2012-02-17

Who can join

Age: 17 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Pfizer Investigational Site — Morgantown, West Virginia, United States
• Pfizer Investigational Site — Herston, Queensland, Australia
• Pfizer Investigational Site — Adelaide, South Australia, Australia
• Pfizer Investigational Site — Sarajevo, Bosnia and Herzegovina
• Pfizer Investigational Site — Red Deer, Alberta, Canada
• Pfizer Investigational Site — Red Deer, Alberta, Canada
• Pfizer Investigational Site — Hamilton, Ontario, Canada
• Pfizer Investigational Site — London, Ontario, Canada
• Pfizer Investigational Site — London, Ontario, Canada
• Pfizer Investigational Site — Ottawa, Ontario, Canada
• Pfizer Investigational Site — Sarnia, Ontario, Canada
• Pfizer Investigational Site — Sarnia, Ontario, Canada
• Pfizer Investigational Site — Sarnia, Ontario, Canada
• Pfizer Investigational Site — Sarnia, Ontario, Canada
• Pfizer Investigational Site — Sarnia, Ontario, Canada
• Pfizer Investigational Site — Wichita, Kansas, United States

Full record on ClinicalTrials.gov

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