ACTiF- Assessment of Closed Tibial Fractures

NCT ID: NCT00533377

Last Updated: 2012-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-05-31

Brief Summary

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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

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Conditions

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Tibial Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CP-533,536 Dose Level 2

Group Type EXPERIMENTAL

CP-533, 536

Intervention Type DRUG

Active study drug

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo vehicle

Standard of Care

Group Type OTHER

Standard of Care

Intervention Type PROCEDURE

Standard surgical procedure

CP-533,536 Dose Level 1

Group Type EXPERIMENTAL

CP-533,536

Intervention Type DRUG

Active study drug

CP-533,536 Dose Level 3

Group Type EXPERIMENTAL

CP-533,536

Intervention Type DRUG

Active study drug

CP-533.536 Dose Level 4

Group Type EXPERIMENTAL

CP-533,536

Intervention Type DRUG

Active study drug

Interventions

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CP-533, 536

Active study drug

Intervention Type DRUG

Placebo

Placebo vehicle

Intervention Type DRUG

Standard of Care

Standard surgical procedure

Intervention Type PROCEDURE

CP-533,536

Active study drug

Intervention Type DRUG

CP-533,536

Active study drug

Intervention Type DRUG

CP-533,536

Active study drug

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Wichita, Kansas, United States

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Worcester, Massachusetts, United States

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Minneapolis, Minnesota, United States

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Columbia, Missouri, United States

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Durham, North Carolina, United States

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Chattanooga, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Salt Lake City, Utah, United States

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Morgantown, West Virginia, United States

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Morgantown, West Virginia, United States

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Herston, Queensland, Australia

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Adelaide, South Australia, Australia

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Sarajevo, , Bosnia and Herzegovina

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Red Deer, Alberta, Canada

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Red Deer, Alberta, Canada

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Hamilton, Ontario, Canada

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London, Ontario, Canada

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London, Ontario, Canada

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Ottawa, Ontario, Canada

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Sarnia, Ontario, Canada

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Sarnia, Ontario, Canada

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Sarnia, Ontario, Canada

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Sarnia, Ontario, Canada

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Sarnia, Ontario, Canada

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Sarnia, Ontario, Canada

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Sarnia, Ontario, Canada

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Toronto, Ontario, Canada

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Varaždin, , Croatia

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Zagreb, , Croatia

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Secunderabad, Andhra Pradesh, India

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Bangalore, Karnataka, India

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Bangalore, Karnataka, India

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Mangalore, Karnataka, India

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Mumbai, Maharashtra, India

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Ludhiana, Punjab, India

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Lucknow, Uttar Pradesh, India

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Nagoya, Aichi-ken, Japan

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Kitakyushu-shi, Fukuoka, Japan

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Mizumaki-cho Onga-gun, Fukuoka, Japan

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Okawa-shi, Fukuoka, Japan

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Fujisawa-shi, Kanagawa, Japan

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Kouchi, Kouchi-ken, Japan

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Sasebo-Shi, Nagasaki, Japan

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Toda-shi, Saitama, Japan

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Shinagawa-ku, Tokyo, Japan

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Parktown, Gauteng, South Africa

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Glenwood, KwaZulu-Natal, South Africa

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Soweto, , South Africa

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Tygerberg, , South Africa

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Seville, Sevilla, Spain

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Ankara, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Countries

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United States Australia Bosnia and Herzegovina Canada Croatia India Japan Russia South Africa Spain Turkey (Türkiye)

Related Links

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Other Identifiers

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A3241010

Identifier Type: -

Identifier Source: org_study_id

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