ACTiF- Assessment of Closed Tibial Fractures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00533377
First received: September 20, 2007
Last updated: February 15, 2012
Last verified: February 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ 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 ]

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

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
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, see Learn About Clinical Studies.

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

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00533377     History of Changes
Other Study ID Numbers: A3241010
Study First Received: September 20, 2007
Last Updated: February 15, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 18, 2014