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Celebrex

Phase 3

Osteoarthritis,Knee | Small molecule | Musculoskeletal |Pfizer, Inc.|Last Updated: Feb 2, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment200

FDA Designations

No designations recorded

Clinical trial landscape

Celebrex · 2 trials · 2 indications

Phase 3 1Phase 1 1
NCT00137410Celebrex Short Versus Long Therapy In Osteoarthritis Of The KneeOsteoarthritis,Knee
COMPLETED200 Analytics
PHASE3COMPLETED
Celebrex Short Versus Long Therapy In Osteoarthritis Of The Knee
Osteoarthritis,KneeUnlock trial analytics

Study Endpoints

Primary Endpoints

Time elapsing between the last drug administration and a new flare, if any, occurring within a 12 months FU and proportion pts with a new flare
AUCinf, AUCt, Cmax
1.5 month
Visual inspection of median plasma concentration versus time profiles resulting from each formulation
1.5 month

Secondary Endpoints

Flare intensity WOMAC OA index Psycho-affective Index Pt's assessment of OA pain (VAS) Pt's & Physician's global assessment disease severity Incidence of total AEs Incidence of GI AEs: Incidence of changes in: hematology, renal function, liver function
Tmax, half-life
1.5 month
adverse events, laboratory tests, vital signs
1.5 month
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Celebrex capsuleACTIVE_COMPARATORCommercial capsule
D1EXPERIMENTALTest formulation D1
D2EXPERIMENTALTest formulation D2
D3EXPERIMENTALTest formulation D3

Interventions

NameTypeDescription
CelebrexDRUG -
Celebrex capsuleDRUGSingle dose 200 mg commercial Celebrex capsule
Test formulation D1DRUGSingle dose 150 mg celecoxib as formulation D1
Test formulation D2DRUGSingle dose 150 mg celecoxib as formulation D2
Test formulation D3DRUGSingle dose 150 mg celecoxib as formulation D3
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * diagnosis of OA of the knee according to the ACR Classification Criteria for osteoarthritis; * patients in flare Exclusion Criteria: * any concomitant inflammatory rheumatic condition which may interfere with the assessment of OA * clinical or radiological evidence of chondr...

Countries:ItalyUnited States
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Frequently asked questions about Celebrex

What is Celebrex used for?

Celebrex is used for osteoarthritis of the knee and is also studied in healthy volunteers. It is a small molecule developed by Pfizer, Inc. (NYSE: PFE). The drug is currently in Phase 1 clinical development, though completed trials include a Phase 3 study in knee osteoarthritis.

Who makes Celebrex?

Celebrex is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The company is conducting clinical trials of Celebrex in osteoarthritis of the knee and in healthy volunteers.

What phase is Celebrex in?

Celebrex is in Phase 1 clinical development. While a Phase 3 trial in osteoarthritis of the knee has been completed, the current development stage is Phase 1. Celebrex is investigational and still in clinical development.

What clinical trials is Celebrex in?

Celebrex has two completed clinical trials. NCT00137410 was a Phase 3 study of short versus long therapy in osteoarthritis of the knee, enrolling 200 participants in Italy. NCT00925106 was a Phase 1 pharmacokinetics study of celecoxib test formulations in 16 healthy volunteers in the United States.

Is Celebrex FDA approved?

Celebrex is not FDA approved based on the available data. It is an investigational drug still in clinical development, currently in Phase 1 trials. The completed trials include a Phase 3 study in knee osteoarthritis and a Phase 1 pharmacokinetics study.