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CP-533, 536

Phase 2

Tibial Fractures | Small molecule | Musculoskeletal |Pfizer, Inc.|Last Updated: Feb 17, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment276

FDA Designations

No designations recorded

Clinical trial landscape

CP-533, 536 · 1 trial · 1 indication

Phase 2 1
NCT00533377ACTiF- Assessment of Closed Tibial FracturesTibial Fractures
COMPLETED276 Analytics
PHASE2COMPLETED
ACTiF- Assessment of Closed Tibial Fractures
Tibial Fractures
NCT00533377276
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Study Endpoints

Primary Endpoints

Time to fracture healing compared with placebo
24 weeks

Secondary Endpoints

Proportion of subjects who require a secondary intervention to promote fracture healing
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
24 weeks
Time to fracture healing compared with Standard of Care
24 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CP-533,536 Dose Level 2EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Standard of CareOTHER -
CP-533,536 Dose Level 1EXPERIMENTAL -
CP-533,536 Dose Level 3EXPERIMENTAL -
CP-533.536 Dose Level 4EXPERIMENTAL -

Interventions

NameTypeDescription
CP-533, 536DRUGActive study drug
PlaceboDRUGPlacebo vehicle
Standard of CarePROCEDUREStandard surgical procedure
CP-533,536DRUGActive study drug
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Eligibility Criteria

Age Range17 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites56

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 tib...

Countries:United StatesAustraliaBosnia and HerzegovinaCanadaCroatiaIndiaJapanRussiaSouth AfricaSpainTurkey (Türkiye)
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Frequently asked questions about CP-533, 536

What is CP-533,536 used for?

CP-533,536 is an investigational small molecule being studied for the treatment of tibial fractures, a type of bone fracture in the lower leg. It is being developed as a potential therapy to aid in the healing of these fractures. The drug is currently in Phase 2 clinical development.

Who makes CP-533,536?

CP-533,536 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for tibial fractures.

What phase is CP-533,536 in?

CP-533,536 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness for treating tibial fractures.

What clinical trials is CP-533,536 in?

CP-533,536 has been studied in one completed Phase 2 clinical trial with the identifier NCT00533377. This trial, titled ACTiF- Assessment of Closed Tibial Fractures, enrolled 276 participants with tibial fractures and was conducted across multiple countries including the United States, Australia, Canada, Japan, and others.

Is CP-533,536 the same as any other drug?

CP-533,536 is the primary name for this investigational drug. No alternative names have been reported for this compound. It is being developed by Pfizer, Inc. for the treatment of tibial fractures and is currently in Phase 2 clinical trials.