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Trial record 1 of 1 for:    NCT00533377
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ACTiF- Assessment of Closed Tibial Fractures

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ClinicalTrials.gov Identifier: NCT00533377
Recruitment Status : Completed
First Posted : September 21, 2007
Last Update Posted : February 17, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 20, 2007
First Posted Date  ICMJE September 21, 2007
Last Update Posted Date February 17, 2012
Study Start Date  ICMJE January 2008
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2008)
Time to fracture healing compared with placebo [ Time Frame: 24 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 20, 2007)
The primary efficacy endpoint is the time to fracture healing during 24 weeks as assessed by the central orthopedic panel read radiographic measurements, compared with placebo.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2007)
  • Time to fracture healing as assessed by the central orthopedic panel read radiographic measurements, compared with SOC;
  • Time to fracture healing as assessed by the treating physician, compared with placebo;
  • Proportion of patients healed at 16 weeks, compared with placebo;
  • Time to regular callus formation as assessed by the central orthopedic panel read radiographic measurements, compared with placebo;
  • 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 SOC groups;
  • The proportion of subjects who require a secondary intervention to promote fracture healing within 48 weeks of the study period, including:
  • Bone graft;
  • Revision of intramedullary (IM) nail;
  • IM nail removal and plating or external fixation;
  • Nail dynamization to promote healing.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ACTiF- Assessment of Closed Tibial Fractures
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tibial Fractures
Intervention  ICMJE
  • Drug: CP-533, 536
    Active study drug
  • Drug: Placebo
    Placebo vehicle
  • Procedure: Standard of Care
    Standard surgical procedure
  • Drug: CP-533,536
    Active study drug
Study Arms  ICMJE
  • Experimental: CP-533,536 Dose Level 2
    Intervention: Drug: CP-533, 536
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Standard of Care
    Intervention: Procedure: Standard of Care
  • Experimental: CP-533,536 Dose Level 1
    Intervention: Drug: CP-533,536
  • Experimental: CP-533,536 Dose Level 3
    Intervention: Drug: CP-533,536
  • Experimental: CP-533.536 Dose Level 4
    Intervention: Drug: CP-533,536
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 9, 2010)
276
Original Enrollment  ICMJE
 (submitted: September 20, 2007)
264
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Bosnia and Herzegovina,   Canada,   Croatia,   India,   Japan,   Russian Federation,   South Africa,   Spain,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00533377
Other Study ID Numbers  ICMJE A3241010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP