Clinical trial NCT00533377: ACTiF- Assessment of Closed Tibial Fractures
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tibial Fractures
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-09-21
Enrollment: 276
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: Time to fracture healing compared with placebo
timeFrame: 24 weeks
Secondary outcomes:
measure: Proportion of subjects who require a secondary intervention to promote fracture healing
timeFrame: 48 weeks
measure: 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
timeFrame: 24 weeks
measure: Time to fracture healing compared with Standard of Care
timeFrame: 24 weeks
measure: Proportion of patients healed compared with placebo
timeFrame: 16 weeks
measure: Time to regular callus formation compared with placebo
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Worcester
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Chattanooga
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Morgantown
country: United States
facility: Pfizer Investigational Site
state: West Virginia
city: Morgantown
country: United States
facility: Pfizer Investigational Site
state: West Virginia
city: Herston
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Adelaide
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Sarajevo
country: Bosnia and Herzegovina
facility: Pfizer Investigational Site
city: Red Deer
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Red Deer
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Varazdin
country: Croatia
facility: Pfizer Investigational Site
city: Zagreb
country: Croatia
facility: Pfizer Investigational Site
city: Secunderabad
country: India
facility: Pfizer Investigational Site
state: Andhra Pradesh
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Mangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Mumbai
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Ludhiana
country: India
facility: Pfizer Investigational Site
state: Punjab
city: Lucknow
country: India
facility: Pfizer Investigational Site
state: UttarPradesh
city: Nagoya-shi
country: Japan
facility: Pfizer Investigational Site
state: Aichi-ken
city: Kitakyushu-shi
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka-ken
city: Mizumaki-cho Onga-gun
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka-ken
city: Okawa-shi
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka-ken
city: Fujisawa-shi
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa-ken
city: Kouchi City
country: Japan
facility: Pfizer Investigational Site
state: Kouchi-ken
city: Sasebo-Shi
country: Japan
facility: Pfizer Investigational Site
state: Nagasaki-ken
city: Toda-shi
country: Japan
facility: Pfizer Investigational Site
state: Saitama-ken
city: Shinagawa-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Parktown
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng Province
city: Glenwood
country: South Africa
facility: Pfizer Investigational Site
state: Kwazulu Natal
city: Soweto
country: South Africa
facility: Pfizer Investigational Site
city: Tygerberg
country: South Africa
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
city: Izmir
country: Turkey
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: