ACTiF- Assessment of Closed Tibial Fractures

Tibial Fractures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00533377
• Other study ID #: A3241010
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2007
• Last updated: February 15, 2012
• Start date: January 2008
• Est. completion date: May 2010

Study information

• Verified date: February 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Tibial Fractures

Intervention

Drug:
• CP-533, 536
Active study drug
• Placebo
Placebo vehicle

Procedure:
• Standard of Care
Standard surgical procedure

Drug:
• CP-533,536
Active study drug
• CP-533,536
Active study drug
• CP-533,536
Active study drug

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Adelaide	South Australia
Australia	Pfizer Investigational Site	Herston	Queensland
Bosnia and Herzegovina	Pfizer Investigational Site	Sarajevo
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	Red Deer	Alberta
Canada	Pfizer Investigational Site	Red Deer	Alberta
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
Croatia	Pfizer Investigational Site	Varazdin
Croatia	Pfizer Investigational Site	Zagreb
India	Pfizer Investigational Site	Bangalore	Karnataka
India	Pfizer Investigational Site	Bangalore	Karnataka
India	Pfizer Investigational Site	Lucknow	UttarPradesh
India	Pfizer Investigational Site	Ludhiana	Punjab
India	Pfizer Investigational Site	Mangalore	Karnataka
India	Pfizer Investigational Site	Mumbai	Maharashtra
India	Pfizer Investigational Site	Secunderabad	Andhra Pradesh
Japan	Pfizer Investigational Site	Fujisawa-shi	Kanagawa-ken
Japan	Pfizer Investigational Site	Kitakyushu-shi	Fukuoka-ken
Japan	Pfizer Investigational Site	Kouchi City	Kouchi-ken
Japan	Pfizer Investigational Site	Mizumaki-cho Onga-gun	Fukuoka-ken
Japan	Pfizer Investigational Site	Nagoya-shi	Aichi-ken
Japan	Pfizer Investigational Site	Okawa-shi	Fukuoka-ken
Japan	Pfizer Investigational Site	Sasebo-Shi	Nagasaki-ken
Japan	Pfizer Investigational Site	Shinagawa-ku	Tokyo
Japan	Pfizer Investigational Site	Toda-shi	Saitama-ken
Russian Federation	Pfizer Investigational Site	St. Petersburg
Russian Federation	Pfizer Investigational Site	St. Petersburg
South Africa	Pfizer Investigational Site	Glenwood	Kwazulu Natal
South Africa	Pfizer Investigational Site	Parktown	Gauteng Province
South Africa	Pfizer Investigational Site	Soweto
South Africa	Pfizer Investigational Site	Tygerberg
Spain	Pfizer Investigational Site	Sevilla
Turkey	Pfizer Investigational Site	Ankara
Turkey	Pfizer Investigational Site	Istanbul
Turkey	Pfizer Investigational Site	Izmir
United States	Pfizer Investigational Site	Chattanooga	Tennessee
United States	Pfizer Investigational Site	Columbia	Missouri
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Durham	North Carolina
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Minneapolis	Minnesota
United States	Pfizer Investigational Site	Morgantown	West Virginia
United States	Pfizer Investigational Site	Morgantown	West Virginia
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	Wichita	Kansas
United States	Pfizer Investigational Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Bosnia and Herzegovina,  Canada,  Croatia,  India,  Japan,  Russian Federation,  South Africa,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to fracture healing compared with placebo		24 weeks	No
Secondary	Proportion of subjects who require a secondary intervention to promote fracture healing		48 weeks	No
Secondary	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		24 weeks	No
Secondary	Time to fracture healing compared with Standard of Care		24 weeks	No
Secondary	Proportion of patients healed compared with placebo		16 weeks	No
Secondary	Time to regular callus formation compared with placebo		24 weeks	No

External Links

•   To obtain contact information for a study center near you, click here.