ACTiF- Assessment of Closed Tibial Fractures


Tracking Information

Start Date  ICMJEOctober 2007
Estimated Primary Completion DateJune 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 ] [ Designated as safety issue: No ]
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 HistoryComplete list of historical versions of study NCT00533377 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: February 5, 2008)
  • 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 ]
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.

Descriptive Information

Brief Title  ICMJEACTiF- Assessment of Closed Tibial Fractures
Official Title  ICMJEA 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 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Condition  ICMJETibial 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 / Comparison Groups
  • CP-533,536 Dose Level 2: Experimental
    Intervention: Drug: CP-533, 536
  • Placebo: Placebo Comparator
    Intervention: Drug: Placebo
  • Standard of Care
    Intervention: Procedure: Standard of Care
  • CP-533,536 Dose Level 1: Experimental
    Intervention: Drug: CP-533,536
  • CP-533,536 Dose Level 3: Experimental
    Intervention: Drug: CP-533,536
  • CP-533.536 Dose Level 4: Experimental
    Intervention: Drug: CP-533,536

Recruitment Information

Estimated Enrollment  ICMJE339
Estimated Completion DateJune 2010
Estimated Primary Completion DateJune 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.
GenderBoth
Ages17 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021
Location Countries  ICMJEUnited States,   Australia,   Bosnia and Herzegovina,   Canada,   Croatia,   India,   Japan,   Russian Federation,   South Africa,   Spain,   Turkey

Administrative Information

NCT ID  ICMJENCT00533377
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study ID Numbers  ICMJEA3241010
Study Sponsor  ICMJEPfizer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Information Provided ByPfizer