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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00533377




Registration number
NCT00533377
Ethics application status
Date submitted
20/09/2007
Date registered
21/09/2007
Date last updated
17/02/2012

Titles & IDs
Public title
ACTiF- Assessment of Closed Tibial Fractures
Scientific 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
Secondary ID [1] 0 0
A3241010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tibial Fractures 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CP-533, 536
Treatment: Drugs - Placebo
Treatment: Surgery - Standard of Care
Treatment: Drugs - CP-533,536
Treatment: Drugs - CP-533,536
Treatment: Drugs - CP-533,536

Experimental: CP-533,536 Dose Level 2 -

Placebo comparator: Placebo -

Other: Standard of Care -

Experimental: CP-533,536 Dose Level 1 -

Experimental: CP-533,536 Dose Level 3 -

Experimental: CP-533.536 Dose Level 4 -


Treatment: Drugs: CP-533, 536
Active study drug

Treatment: Drugs: Placebo
Placebo vehicle

Treatment: Surgery: Standard of Care
Standard surgical procedure

Treatment: Drugs: CP-533,536
Active study drug

Treatment: Drugs: CP-533,536
Active study drug

Treatment: Drugs: CP-533,536
Active study drug
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to fracture healing compared with placebo
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
Proportion of subjects who require a secondary intervention to promote fracture healing
Timepoint [1] 0 0
48 weeks
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
24 weeks
Secondary outcome [3] 0 0
Time to fracture healing compared with Standard of Care
Timepoint [3] 0 0
24 weeks
Secondary outcome [4] 0 0
Proportion of patients healed compared with placebo
Timepoint [4] 0 0
16 weeks
Secondary outcome [5] 0 0
Time to regular callus formation compared with placebo
Timepoint [5] 0 0
24 weeks

Eligibility
Key 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.
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2010
Sample size
Target
Accrual to date
Final
276
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Herston
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Adelaide
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Kansas
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Utah
Country [9] 0 0
United States of America
State/province [9] 0 0
West Virginia
Country [10] 0 0
Bosnia and Herzegovina
State/province [10] 0 0
Sarajevo
Country [11] 0 0
Canada
State/province [11] 0 0
Alberta
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Croatia
State/province [13] 0 0
Varazdin
Country [14] 0 0
Croatia
State/province [14] 0 0
Zagreb
Country [15] 0 0
India
State/province [15] 0 0
Andhra Pradesh
Country [16] 0 0
India
State/province [16] 0 0
Karnataka
Country [17] 0 0
India
State/province [17] 0 0
Maharashtra
Country [18] 0 0
India
State/province [18] 0 0
Punjab
Country [19] 0 0
India
State/province [19] 0 0
UttarPradesh
Country [20] 0 0
Japan
State/province [20] 0 0
Aichi-ken
Country [21] 0 0
Japan
State/province [21] 0 0
Fukuoka-ken
Country [22] 0 0
Japan
State/province [22] 0 0
Kanagawa-ken
Country [23] 0 0
Japan
State/province [23] 0 0
Kouchi-ken
Country [24] 0 0
Japan
State/province [24] 0 0
Nagasaki-ken
Country [25] 0 0
Japan
State/province [25] 0 0
Saitama-ken
Country [26] 0 0
Japan
State/province [26] 0 0
Tokyo
Country [27] 0 0
Russian Federation
State/province [27] 0 0
St. Petersburg
Country [28] 0 0
South Africa
State/province [28] 0 0
Gauteng Province
Country [29] 0 0
South Africa
State/province [29] 0 0
Kwazulu Natal
Country [30] 0 0
South Africa
State/province [30] 0 0
Soweto
Country [31] 0 0
South Africa
State/province [31] 0 0
Tygerberg
Country [32] 0 0
Spain
State/province [32] 0 0
Sevilla
Country [33] 0 0
Turkey
State/province [33] 0 0
Ankara
Country [34] 0 0
Turkey
State/province [34] 0 0
Istanbul
Country [35] 0 0
Turkey
State/province [35] 0 0
Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT00533377
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00533377