ACTiF- Assessment of Closed Tibial Fractures

February 15, 2012 updated by: Pfizer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

276

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Pfizer Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Pfizer Investigational Site
  • Bosnia and Herzegovina
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Pfizer Investigational Site
  • Canada
    • Alberta
      • Red Deer, Alberta, Canada, T4N 6V7
        • Pfizer Investigational Site
      • Red Deer, Alberta, Canada, T4N 4E7
        • Pfizer Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Pfizer Investigational Site
      • London, Ontario, Canada, N6A 4G5
        • Pfizer Investigational Site
      • London, Ontario, Canada, N6A 5W9
        • Pfizer Investigational Site
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Pfizer Investigational Site
      • Sarnia, Ontario, Canada, N7T 4P3
        • Pfizer Investigational Site
      • Sarnia, Ontario, Canada, N7T 4R9
        • Pfizer Investigational Site
      • Sarnia, Ontario, Canada, N7T 6H3
        • Pfizer Investigational Site
      • Sarnia, Ontario, Canada, N7T 6H5
        • Pfizer Investigational Site
      • Sarnia, Ontario, Canada, N7T 6H6
        • Pfizer Investigational Site
      • Sarnia, Ontario, Canada, N7T 6S3
        • Pfizer Investigational Site
      • Sarnia, Ontario, Canada, N7T G6G
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M5B 1W8
        • Pfizer Investigational Site
  • Croatia
      • Varazdin, Croatia, 42000
        • Pfizer Investigational Site
      • Zagreb, Croatia, 10000
        • Pfizer Investigational Site
  • India
    • Andhra Pradesh
      • Secunderabad, Andhra Pradesh, India, 500 003
        • Pfizer Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560 034
        • Pfizer Investigational Site
      • Bangalore, Karnataka, India, 560 001
        • Pfizer Investigational Site
      • Mangalore, Karnataka, India, 575 001
        • Pfizer Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400 012
        • Pfizer Investigational Site
    • Punjab
      • Ludhiana, Punjab, India, 141008
        • Pfizer Investigational Site
    • UttarPradesh
      • Lucknow, UttarPradesh, India, 226003
        • Pfizer Investigational Site
  • Japan
    • Aichi-ken
      • Nagoya-shi, Aichi-ken, Japan
        • Pfizer Investigational Site
    • Fukuoka-ken
      • Kitakyushu-shi, Fukuoka-ken, Japan
        • Pfizer Investigational Site
      • Mizumaki-cho Onga-gun, Fukuoka-ken, Japan
        • Pfizer Investigational Site
      • Okawa-shi, Fukuoka-ken, Japan
        • Pfizer Investigational Site
    • Kanagawa-ken
      • Fujisawa-shi, Kanagawa-ken, Japan
        • Pfizer Investigational Site
    • Kouchi-ken
      • Kouchi City, Kouchi-ken, Japan
        • Pfizer Investigational Site
    • Nagasaki-ken
      • Sasebo-Shi, Nagasaki-ken, Japan
        • Pfizer Investigational Site
    • Saitama-ken
      • Toda-shi, Saitama-ken, Japan
        • Pfizer Investigational Site
    • Tokyo
      • Shinagawa-ku, Tokyo, Japan
        • Pfizer Investigational Site
  • Russian Federation
      • St. Petersburg, Russian Federation, 193312
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation, 195427
        • Pfizer Investigational Site
  • South Africa
      • Soweto, South Africa, 2013
        • Pfizer Investigational Site
      • Tygerberg, South Africa, 7505
        • Pfizer Investigational Site
    • Gauteng Province
      • Parktown, Gauteng Province, South Africa, 2193
        • Pfizer Investigational Site
    • Kwazulu Natal
      • Glenwood, Kwazulu Natal, South Africa, 4000
        • Pfizer Investigational Site
  • Spain
      • Sevilla, Spain, 41013
        • Pfizer Investigational Site
  • Turkey
      • Ankara, Turkey, 06100
        • Pfizer Investigational Site
      • Istanbul, Turkey, 34098
        • Pfizer Investigational Site
      • Izmir, Turkey, 35100
        • Pfizer Investigational Site
  • United States
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Pfizer Investigational Site
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Pfizer Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Pfizer Investigational Site
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Pfizer Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Pfizer Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75246
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Pfizer Investigational Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Pfizer Investigational Site
      • Morgantown, West Virginia, United States, 26505
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Placebo vehicle
EXPERIMENTAL: CP-533,536 Dose Level 2
Drug: CP-533, 536
Active study drug
OTHER: Standard of Care
Procedure: Standard of Care
Standard surgical procedure
EXPERIMENTAL: CP-533,536 Dose Level 1
Drug: CP-533,536
Active study drug
EXPERIMENTAL: CP-533,536 Dose Level 3
Drug: CP-533,536
Active study drug
EXPERIMENTAL: CP-533.536 Dose Level 4
Drug: CP-533,536
Active study drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to fracture healing compared with placebo
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects who require a secondary intervention to promote fracture healing
Time Frame: 48 weeks
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
Time Frame: 24 weeks
24 weeks
Time to fracture healing compared with Standard of Care
Time Frame: 24 weeks
24 weeks
Proportion of patients healed compared with placebo
Time Frame: 16 weeks
16 weeks
Time to regular callus formation compared with placebo
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

September 20, 2007

First Submitted That Met QC Criteria

September 20, 2007

First Posted (ESTIMATE)

September 21, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

February 17, 2012

Last Update Submitted That Met QC Criteria

February 15, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3241010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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