ACTiF- Assessment of Closed Tibial Fractures

February 15, 2012 updated by: Pfizer

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
276

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Pfizer Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Pfizer Investigational Site
  • Bosnia and Herzegovina
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Pfizer Investigational Site
  • Canada
    • Alberta
      • Red Deer, Alberta, Canada, T4N 6V7
        • Pfizer Investigational Site
      • Red Deer, Alberta, Canada, T4N 4E7
        • Pfizer Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Pfizer Investigational Site
      • London, Ontario, Canada, N6A 4G5
        • Pfizer Investigational Site
      • London, Ontario, Canada, N6A 5W9
        • Pfizer Investigational Site
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Pfizer Investigational Site
      • Sarnia, Ontario, Canada, N7T 4P3
        • Pfizer Investigational Site
      • Sarnia, Ontario, Canada, N7T 4R9
        • Pfizer Investigational Site
      • Sarnia, Ontario, Canada, N7T 6H3
        • Pfizer Investigational Site
      • Sarnia, Ontario, Canada, N7T 6H5
        • Pfizer Investigational Site
      • Sarnia, Ontario, Canada, N7T 6H6
        • Pfizer Investigational Site
      • Sarnia, Ontario, Canada, N7T 6S3
        • Pfizer Investigational Site
      • Sarnia, Ontario, Canada, N7T G6G
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M5B 1W8
        • Pfizer Investigational Site
  • Croatia
      • Varazdin, Croatia, 42000
        • Pfizer Investigational Site
      • Zagreb, Croatia, 10000
        • Pfizer Investigational Site
  • India
    • Andhra Pradesh
      • Secunderabad, Andhra Pradesh, India, 500 003
        • Pfizer Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560 034
        • Pfizer Investigational Site
      • Bangalore, Karnataka, India, 560 001
        • Pfizer Investigational Site
      • Mangalore, Karnataka, India, 575 001
        • Pfizer Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400 012
        • Pfizer Investigational Site
    • Punjab
      • Ludhiana, Punjab, India, 141008
        • Pfizer Investigational Site
    • UttarPradesh
      • Lucknow, UttarPradesh, India, 226003
        • Pfizer Investigational Site
  • Japan
    • Aichi-ken
      • Nagoya-shi, Aichi-ken, Japan
        • Pfizer Investigational Site
    • Fukuoka-ken
      • Kitakyushu-shi, Fukuoka-ken, Japan
        • Pfizer Investigational Site
      • Mizumaki-cho Onga-gun, Fukuoka-ken, Japan
        • Pfizer Investigational Site
      • Okawa-shi, Fukuoka-ken, Japan
        • Pfizer Investigational Site
    • Kanagawa-ken
      • Fujisawa-shi, Kanagawa-ken, Japan
        • Pfizer Investigational Site
    • Kouchi-ken
      • Kouchi City, Kouchi-ken, Japan
        • Pfizer Investigational Site
    • Nagasaki-ken
      • Sasebo-Shi, Nagasaki-ken, Japan
        • Pfizer Investigational Site
    • Saitama-ken
      • Toda-shi, Saitama-ken, Japan
        • Pfizer Investigational Site
    • Tokyo
      • Shinagawa-ku, Tokyo, Japan
        • Pfizer Investigational Site
  • Russian Federation
      • St. Petersburg, Russian Federation, 193312
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation, 195427
        • Pfizer Investigational Site
  • South Africa
      • Soweto, South Africa, 2013
        • Pfizer Investigational Site
      • Tygerberg, South Africa, 7505
        • Pfizer Investigational Site
    • Gauteng Province
      • Parktown, Gauteng Province, South Africa, 2193
        • Pfizer Investigational Site
    • Kwazulu Natal
      • Glenwood, Kwazulu Natal, South Africa, 4000
        • Pfizer Investigational Site
  • Spain
      • Sevilla, Spain, 41013
        • Pfizer Investigational Site
  • Turkey
      • Ankara, Turkey, 06100
        • Pfizer Investigational Site
      • Istanbul, Turkey, 34098
        • Pfizer Investigational Site
      • Izmir, Turkey, 35100
        • Pfizer Investigational Site
  • United States
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Pfizer Investigational Site
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Pfizer Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Pfizer Investigational Site
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Pfizer Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Pfizer Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75246
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Pfizer Investigational Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Pfizer Investigational Site
      • Morgantown, West Virginia, United States, 26505
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Placebo vehicle
EXPERIMENTAL: CP-533,536 Dose Level 2
Drug: CP-533, 536
Active study drug
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Time to fracture healing compared with placebo
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of subjects who require a secondary intervention to promote fracture healing
Time Frame: 48 weeks
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
24 weeks
Time to fracture healing compared with Standard of Care
Time Frame: 24 weeks
24 weeks
Proportion of patients healed compared with placebo
Time Frame: 16 weeks
16 weeks
Time to regular callus formation compared with placebo
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2007

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A3241010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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