ACTiF- Assessment of Closed Tibial Fractures - Full Text View

Purpose

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

Condition	Intervention	Phase
Tibial Fractures	Drug: CP-533, 536 Drug: Placebo Procedure: Standard of Care Drug: CP-533,536	Phase II

MedlinePlus related topics:

Fractures

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Time to fracture healing compared with placebo [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects who require a secondary intervention to promote fracture healing [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Time to fracture healing compared with Standard of Care [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Proportion of patients healed compared with placebo [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Time to regular callus formation compared with placebo [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	264
Study Start Date:	October 2007
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
CP-533,536 Dose Level 2: Experimental	Drug: CP-533, 536 Active study drug
Placebo: Placebo Comparator	Drug: Placebo Placebo vehicle
Standard of Care	Procedure: Standard of Care Standard surgical procedure
CP-533,536 Dose Level 1: Experimental	Drug: CP-533,536 Active study drug

Eligibility

Ages Eligible for Study:	17 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533377

Contacts


Contact: Pfizer CT.gov Call Center	1-800-718-1021

Show 61 Study Locations

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3241010
First Received:	September 20, 2007
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00533377
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Fractures, Bone

Wounds and Injuries

Disorders of Environmental Origin

Fractures, Closed

Leg Injuries

Tibial Fractures

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00533377