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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00533377
Other study ID # A3241010
Secondary ID
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


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
See also
  Status Clinical Trial Phase
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Completed NCT02456194 - Management of Traumatic Bone Defects in Tibial Plateau Fractures With Antibiotic-Impregnated Biodegradable Calcium Sulfate Beads: A Prospective Clinical Trial N/A
Terminated NCT00667849 - Trial to Evaluate UltraSound in the Treatment of Tibial Fractures N/A
Completed NCT01132508 - Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures N/A
Completed NCT00512434 - Percutaneous Autologous Bone-marrow Grafting for Open Tibial Shaft Fracture N/A
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