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Celebrex

Phase 3FDA approved 1998

Osteoarthritis,Knee | Small molecule | Musculoskeletal |Pfizer, Inc.|Trials Updated: Jun 10, 2008

Celebrex development status

FDA approval Dec 31, 1998
Approval holderUpjohn
ApplicationNDA020998
Highest phase Phase 3
Registered trials 2 across 2 sponsors since Aug 2005

Label indication CELEBREX is indicated CELEBREX is a nonsteroidal anti-inflammatory drug indicated for: • Osteoarthritis (OA) ( 1.1 ) • Rheumatoid Arthritis (RA) ( 1.2 ) • Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older ( 1.3 ) • Ankylosing Spondylitis (AS) ( 1.4 ) • Acute Pain (AP) ( 1.5 ) • Primary Dysmenorrhea (PD) ( 1.6 ) 1.1 Osteoarthritis (OA) For the management of the signs and symptoms of OA [see Clinical… FDA label

Celebrex target and mechanism

ModalitySmall molecule

Also known as Celebrex capsule

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

Celebrex clinical trials

Celebrex · 1 trial · 1 indication

Phase 3 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

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
CelebrexDRUG -
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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:Italy
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Competitive Landscape -Osteoarthritis 143 trials (matched to "Osteoarthritis,Knee")

Frequently asked questions about Celebrex

What is Celebrex?

Celebrex is a small molecule medicine developed by Pfizer, Inc. (ticker PFE) for musculoskeletal conditions. It has been studied in knee osteoarthritis, a degenerative joint condition. The clinical program includes a completed Phase 3 trial, NCT00137410, titled Celebrex Short Versus Long Therapy In Osteoarthritis Of The Knee, which enrolled 200 participants in Italy.

What is Celebrex used for in knee osteoarthritis?

Celebrex has been evaluated for the treatment of osteoarthritis of the knee. A completed Phase 3 study, NCT00137410, examined short versus long therapy with Celebrex in adults aged 50 years and older with knee osteoarthritis. The trial enrolled 200 participants in Italy and was randomized and double blind.

Who makes Celebrex?

Celebrex is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the company associated with the clinical development program for Celebrex in knee osteoarthritis.

What phase is Celebrex in?

Celebrex has been studied in Phase 3 clinical development for knee osteoarthritis. The program includes one completed Phase 3 trial, NCT00137410, with 200 participants. No active trials are currently listed for this asset.

What clinical trials is Celebrex in?

Celebrex has been studied in the Phase 3 trial NCT00137410, titled Celebrex Short Versus Long Therapy In Osteoarthritis Of The Knee. The trial was completed, enrolled 200 participants, was randomized and double blind, and was conducted in Italy in adults aged 50 years and older.

Is Celebrex the same as Celebrex capsule?

Yes, Celebrex capsule is another name for Celebrex. Both refer to the same medicine developed by Pfizer, Inc. (ticker PFE) that has been studied in Phase 3 for knee osteoarthritis.