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ACTiF- Assessment of Closed Tibial Fractures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00533377
First Posted: September 21, 2007
Last Update Posted: February 17, 2012
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.
Information provided by (Responsible Party):
Pfizer
  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 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

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

Enrollment: 276
Study Start Date: January 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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.


Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00533377


  Show 56 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00533377     History of Changes
Other Study ID Numbers: A3241010
First Submitted: September 20, 2007
First Posted: September 21, 2007
Last Update Posted: February 17, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries