search
Back to results

ACTiF- Assessment of Closed Tibial Fractures

Primary Purpose

Tibial Fractures

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CP-533, 536
Placebo
Standard of Care
CP-533,536
CP-533,536
CP-533,536
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tibial Fractures

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Other

Experimental

Experimental

Experimental

Arm Label

CP-533,536 Dose Level 2

Placebo

Standard of Care

CP-533,536 Dose Level 1

CP-533,536 Dose Level 3

CP-533.536 Dose Level 4

Arm Description

Outcomes

Primary Outcome Measures

Time to fracture healing compared with placebo

Secondary Outcome Measures

Proportion of subjects who require a secondary intervention to promote fracture healing
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 to fracture healing compared with Standard of Care
Proportion of patients healed compared with placebo
Time to regular callus formation compared with placebo

Full Information

First Posted
September 20, 2007
Last Updated
February 15, 2012
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00533377
Brief Title
ACTiF- Assessment of Closed Tibial Fractures
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
276 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CP-533,536 Dose Level 2
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Standard of Care
Arm Type
Other
Arm Title
CP-533,536 Dose Level 1
Arm Type
Experimental
Arm Title
CP-533,536 Dose Level 3
Arm Type
Experimental
Arm Title
CP-533.536 Dose Level 4
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CP-533, 536
Intervention Description
Active study drug
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo vehicle
Intervention Type
Procedure
Intervention Name(s)
Standard of Care
Intervention Description
Standard surgical procedure
Intervention Type
Drug
Intervention Name(s)
CP-533,536
Intervention Description
Active study drug
Intervention Type
Drug
Intervention Name(s)
CP-533,536
Intervention Description
Active study drug
Intervention Type
Drug
Intervention Name(s)
CP-533,536
Intervention Description
Active study drug
Primary Outcome Measure Information:
Title
Time to fracture healing compared with placebo
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Proportion of subjects who require a secondary intervention to promote fracture healing
Time Frame
48 weeks
Title
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
Title
Time to fracture healing compared with Standard of Care
Time Frame
24 weeks
Title
Proportion of patients healed compared with placebo
Time Frame
16 weeks
Title
Time to regular callus formation compared with placebo
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Pfizer Investigational Site
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Pfizer Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Pfizer Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Pfizer Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Pfizer Investigational Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Facility Name
Pfizer Investigational Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Pfizer Investigational Site
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Pfizer Investigational Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Pfizer Investigational Site
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
Pfizer Investigational Site
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4N 4E7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4N 6V7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Pfizer Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Pfizer Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4P3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4R9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 6H3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 6H5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 6H6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 6S3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T G6G
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Varazdin
ZIP/Postal Code
42000
Country
Croatia
Facility Name
Pfizer Investigational Site
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Pfizer Investigational Site
City
Secunderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 003
Country
India
Facility Name
Pfizer Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 001
Country
India
Facility Name
Pfizer Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 034
Country
India
Facility Name
Pfizer Investigational Site
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575 001
Country
India
Facility Name
Pfizer Investigational Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400 012
Country
India
Facility Name
Pfizer Investigational Site
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141008
Country
India
Facility Name
Pfizer Investigational Site
City
Lucknow
State/Province
UttarPradesh
ZIP/Postal Code
226003
Country
India
Facility Name
Pfizer Investigational Site
City
Nagoya-shi
State/Province
Aichi-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kitakyushu-shi
State/Province
Fukuoka-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Mizumaki-cho Onga-gun
State/Province
Fukuoka-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Okawa-shi
State/Province
Fukuoka-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fujisawa-shi
State/Province
Kanagawa-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kouchi City
State/Province
Kouchi-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sasebo-Shi
State/Province
Nagasaki-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Toda-shi
State/Province
Saitama-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shinagawa-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
St. Petersburg
ZIP/Postal Code
193312
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
ZIP/Postal Code
195427
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Parktown
State/Province
Gauteng Province
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Glenwood
State/Province
Kwazulu Natal
ZIP/Postal Code
4000
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Soweto
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Tygerberg
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Pfizer Investigational Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Izmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3241010&StudyName=ACTiF-%20Assessment%20of%20Closed%20Tibial%20Fractures
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

ACTiF- Assessment of Closed Tibial Fractures

We'll reach out to this number within 24 hrs