Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
276 participants
INTERVENTIONAL
2008-01-31
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CP-533,536 Dose Level 2
CP-533, 536
Active study drug
Placebo
Placebo
Placebo vehicle
Standard of Care
Standard of Care
Standard surgical procedure
CP-533,536 Dose Level 1
CP-533,536
Active study drug
CP-533,536 Dose Level 3
CP-533,536
Active study drug
CP-533.536 Dose Level 4
CP-533,536
Active study drug
Interventions
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CP-533, 536
Active study drug
Placebo
Placebo vehicle
Standard of Care
Standard surgical procedure
CP-533,536
Active study drug
CP-533,536
Active study drug
CP-533,536
Active study drug
Eligibility Criteria
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Inclusion Criteria
* Closed tibial fractures Types A, B \& C (See OTA fracture classification) can be included.
Exclusion Criteria
* 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.
17 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Wichita, Kansas, United States
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
Sarnia, Ontario, Canada
Pfizer Investigational Site
Sarnia, Ontario, Canada
Pfizer Investigational Site
Toronto, Ontario, Canada
Pfizer Investigational Site
Varaždin, , Croatia
Pfizer Investigational Site
Zagreb, , Croatia
Pfizer Investigational Site
Secunderabad, Andhra Pradesh, India
Pfizer Investigational Site
Bangalore, Karnataka, India
Pfizer Investigational Site
Bangalore, Karnataka, India
Pfizer Investigational Site
Mangalore, Karnataka, India
Pfizer Investigational Site
Mumbai, Maharashtra, India
Pfizer Investigational Site
Ludhiana, Punjab, India
Pfizer Investigational Site
Lucknow, Uttar Pradesh, India
Pfizer Investigational Site
Nagoya, Aichi-ken, Japan
Pfizer Investigational Site
Kitakyushu-shi, Fukuoka, Japan
Pfizer Investigational Site
Mizumaki-cho Onga-gun, Fukuoka, Japan
Pfizer Investigational Site
Okawa-shi, Fukuoka, Japan
Pfizer Investigational Site
Fujisawa-shi, Kanagawa, Japan
Pfizer Investigational Site
Kouchi, Kouchi-ken, Japan
Pfizer Investigational Site
Sasebo-Shi, Nagasaki, Japan
Pfizer Investigational Site
Toda-shi, Saitama, Japan
Pfizer Investigational Site
Shinagawa-ku, Tokyo, Japan
Pfizer Investigational Site
Saint Petersburg, , Russia
Pfizer Investigational Site
Saint Petersburg, , Russia
Pfizer Investigational Site
Parktown, Gauteng, South Africa
Pfizer Investigational Site
Glenwood, KwaZulu-Natal, South Africa
Pfizer Investigational Site
Soweto, , South Africa
Pfizer Investigational Site
Tygerberg, , South Africa
Pfizer Investigational Site
Seville, Sevilla, Spain
Pfizer Investigational Site
Ankara, , Turkey (Türkiye)
Pfizer Investigational Site
Istanbul, , Turkey (Türkiye)
Pfizer Investigational Site
Izmir, , Turkey (Türkiye)
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3241010
Identifier Type: -
Identifier Source: org_study_id
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