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ACTiF- Assessment of Closed Tibial Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00533377
Recruitment Status : Completed
First Posted : September 21, 2007
Last Update Posted : February 17, 2012
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Tibial Fractures Drug: CP-533, 536 Drug: Placebo Procedure: Standard of Care Drug: CP-533,536 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: CP-533,536 Dose Level 2 Drug: CP-533, 536
Active study drug

Placebo Comparator: Placebo Drug: Placebo
Placebo vehicle

Standard of Care Procedure: Standard of Care
Standard surgical procedure

Experimental: CP-533,536 Dose Level 1 Drug: CP-533,536
Active study drug

Experimental: CP-533,536 Dose Level 3 Drug: CP-533,536
Active study drug

Experimental: CP-533.536 Dose Level 4 Drug: CP-533,536
Active study drug

Primary Outcome Measures :
  1. Time to fracture healing compared with placebo [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Proportion of subjects who require a secondary intervention to promote fracture healing [ Time Frame: 48 weeks ]
  2. 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 ]
  3. Time to fracture healing compared with Standard of Care [ Time Frame: 24 weeks ]
  4. Proportion of patients healed compared with placebo [ Time Frame: 16 weeks ]
  5. Time to regular callus formation compared with placebo [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00533377

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Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer Identifier: NCT00533377    
Other Study ID Numbers: A3241010
First Posted: September 21, 2007    Key Record Dates
Last Update Posted: February 17, 2012
Last Verified: February 2012
Additional relevant MeSH terms:
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Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries