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OpenTrials
Completed

NCT Number: NCT00533377

ACTiF- Assessment of Closed Tibial Fractures

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

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Key information

Conditions

Tibial Fractures Fractures, Bone Leg Injuries Wounds and Injuries

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Herston, Queensland, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CP-533, 536

Drug

Active study drug

Placebo

Drug

Placebo vehicle

Standard of care

Procedure

Standard surgical procedure

CP-533,536

Drug

Active study drug

Primary outcomes

  1. Time to fracture healing compared with placebo

    Time frame: 24 weeks

Secondary outcomes

  1. Proportion of subjects who require a secondary intervention to promote fracture healing

    Time frame: 48 weeks

  2. 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

    Time frame: 24 weeks

  3. Time to fracture healing compared with Standard of Care

    Time frame: 24 weeks

  4. Proportion of patients healed compared with placebo

    Time frame: 16 weeks

  5. Time to regular callus formation compared with placebo

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 21, 2007
Registry last updated
Feb 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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