Tibial FracturesPhase 2NCT00533377
ACTiF- Assessment of Closed Tibial Fractures
A Phase 2 study testing CP-533, 536 and CP-533,536 in people with Tibial Fractures, run by Pfizer at 56 sites in 11 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Tibial Fractures
- What is being tested?
- CP-533, 536 and CP-533,536
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 276 participants
- Where
- 56 sitesin 11 countries
- Study dates
- Jan 2008to May 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
56 sites in 11 countries.
56 sites in 11 countries
Canada14 sites
Pfizer Investigational Site
Hamilton, Ontario, L8L 2X2
Pfizer Investigational Site
London, Ontario, N6A 4G5
Pfizer Investigational Site
London, Ontario, N6A 5W9
Pfizer Investigational Site
Ottawa, Ontario, K1Y 4E9
Pfizer Investigational Site
Red Deer, Alberta, T4N 4E7
Pfizer Investigational Site
Red Deer, Alberta, T4N 6V7
Pfizer Investigational Site
Sarnia, Ontario, N7T 4P3
Pfizer Investigational Site
Sarnia, Ontario, N7T 4R9
Pfizer Investigational Site
Sarnia, Ontario, N7T 6H3
Pfizer Investigational Site
Sarnia, Ontario, N7T 6H5
Pfizer Investigational Site
Sarnia, Ontario, N7T 6H6
Pfizer Investigational Site
Sarnia, Ontario, N7T 6S3
Pfizer Investigational Site
Sarnia, Ontario, N7T G6G
Pfizer Investigational Site
Toronto, Ontario, M5B 1W8
United States11 sites
Pfizer Investigational Site
Chattanooga, Tennessee, 37403
Pfizer Investigational Site
Columbia, Missouri, 65212
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Durham, North Carolina, 27710
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Minneapolis, Minnesota, 55415
Pfizer Investigational Site
Morgantown, West Virginia, 26505
Pfizer Investigational Site
Morgantown, West Virginia, 26506
Pfizer Investigational Site
Salt Lake City, Utah, 84108
Pfizer Investigational Site
Wichita, Kansas, 67214
Pfizer Investigational Site
Worcester, Massachusetts, 01655
Japan9 sites
Pfizer Investigational Site
Fujisawa-shi, Kanagawa
Pfizer Investigational Site
Kitakyushu-shi, Fukuoka
Pfizer Investigational Site
Kouchi, Kouchi-ken
Pfizer Investigational Site
Mizumaki-cho Onga-gun, Fukuoka
Pfizer Investigational Site
Nagoya, Aichi-ken
Pfizer Investigational Site
Okawa-shi, Fukuoka
Pfizer Investigational Site
Sasebo-Shi, Nagasaki
Pfizer Investigational Site
Shinagawa-ku, Tokyo
Pfizer Investigational Site
Toda-shi, Saitama
India7 sites
Pfizer Investigational Site
Bangalore, Karnataka, 560 001
Pfizer Investigational Site
Bangalore, Karnataka, 560 034
Pfizer Investigational Site
Lucknow, Uttar Pradesh, 226003
Pfizer Investigational Site
Ludhiana, Punjab, 141008
Pfizer Investigational Site
Mangalore, Karnataka, 575 001
Pfizer Investigational Site
Mumbai, Maharashtra, 400 012
Pfizer Investigational Site
Secunderabad, Andhra Pradesh, 500 003
South Africa4 sites
Pfizer Investigational Site
Glenwood, KwaZulu-Natal, 4000
Pfizer Investigational Site
Parktown, Gauteng, 2193
Pfizer Investigational Site
Soweto, 2013
Pfizer Investigational Site
Tygerberg, 7505
Turkey (Türkiye)3 sites
Pfizer Investigational Site
Ankara, 06100
Pfizer Investigational Site
Istanbul, 34098
Pfizer Investigational Site
Izmir, 35100
Australia2 sites
Pfizer Investigational Site
Adelaide, South Australia, 5000
Pfizer Investigational Site
Herston, Queensland, 4029
Croatia2 sites
Pfizer Investigational Site
Varaždin, 42000
Pfizer Investigational Site
Zagreb, 10000
Russia2 sites
Pfizer Investigational Site
Saint Petersburg, 193312
Pfizer Investigational Site
Saint Petersburg, 195427
Bosnia and Herzegovina1 site
Pfizer Investigational Site
Sarajevo, 71000
About this study
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
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
- Conditions
- Tibial Fractures
- Being tested
- CP-533, 536, Placebo, Standard of Care, CP-533,536
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-533, 536Drug
Active study drug
PlaceboDrug
Placebo vehicle
Standard of CareProcedure or surgery
Standard surgical procedure
CP-533,536Drug
Active study drug
CP-533,536Drug
Active study drug
CP-533,536Drug
Active study drug
| Study group | Role | What they receive |
|---|---|---|
| CP-533,536 Dose Level 2 | Experimental | Not described Receives: Drug: CP-533, 536 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Standard of Care | Other | Not described Receives: Procedure: Standard of Care |
| CP-533,536 Dose Level 1 | Experimental | Not described Receives: Drug: CP-533,536 |
| CP-533,536 Dose Level 3 | Experimental | Not described Receives: Drug: CP-533,536 |
| CP-533.536 Dose Level 4 | Experimental | Not described Receives: Drug: CP-533,536 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to fracture healing compared with placebo
Measured: 24 weeks
Secondary outcomes (5)
Proportion of subjects who require a secondary intervention to promote fracture healing
Measured: 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
Measured: 24 weeks
Time to fracture healing compared with Standard of Care
Measured: 24 weeks
Proportion of patients healed compared with placebo
Measured: 16 weeks
Time to regular callus formation compared with placebo
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startJan 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial FracturesStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533377
- Sponsor's protocol ID
- A3241010
- Status last verified
- Feb 2012
- First submitted
- 20 Sep 2007
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00533377
- Acronym / sponsor ID
- A3241010
- Conditions
- Tibial Fractures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 21 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| CP-533,536 Dose Level 2 | Experimental | Drug: CP-533, 536 |
| Placebo | Placebo comparator | Drug: Placebo |
| Standard of Care | Other | Procedure: Standard of Care |
| CP-533,536 Dose Level 1 | Experimental | Drug: CP-533,536 |
| CP-533,536 Dose Level 3 | Experimental | Drug: CP-533,536 |
| CP-533.536 Dose Level 4 | Experimental | Drug: CP-533,536 |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CP-533, 536Active study drug | Drug | CP-533,536 Dose Level 2 |
| PlaceboPlacebo vehicle | Drug | Placebo |
| Standard of CareStandard surgical procedure | Procedure or surgery | Standard of Care |
| CP-533,536Active study drug | Drug | CP-533,536 Dose Level 1 |
| CP-533,536Active study drug | Drug | CP-533,536 Dose Level 3 |
| CP-533,536Active study drug | Drug | CP-533.536 Dose Level 4 |
Primary outcome
Time to fracture healing compared with placebo
Time frame: 24 weeks
5 secondary outcomes
Proportion of subjects who require a secondary intervention to promote fracture healing
Time frame: 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
Time to fracture healing compared with Standard of Care
Time frame: 24 weeks
Proportion of patients healed compared with placebo
Time frame: 16 weeks
Time to regular callus formation compared with placebo
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2012.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Tibial Fractures
Not yet recruiting
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
Tibial Fracture, Femoral Fracture
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Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
RecruitingPhase 3
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
Open tíbia Fracture
Not yet recruiting
Personalized Weight-Bearing With Smart Crutch Tips After Surgery for Tibial Plateau Fractures
Tibial Plateau Fracture
Not yet recruiting
Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
56 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CP-533, 536 and CP-533,536 in people with Tibial Fractures, run by Pfizer at 56 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in Canada, United States, Japan, India, South Africa and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to fracture healing compared with placebo (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2012.