Recent Updates
Recently added Catalysts

PF-04457845

Phase 2

Osteoarthritis, Knee | Small molecule | Musculoskeletal |Pfizer, Inc.|Last Updated: Sep 19, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment76
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00981357A Study To Investigate Whether PF-04457845 Is Effective In Treating Pain, Is Safe And Tolerable In Patients With Osteoarthritis Of The KneePHASE2 COMPLETED 76Nov 1, 2009May 1, 2010Sep 19, 20177 United States, Canada +1
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
To evaluate the efficacy of PF-04457845 (administered QD) versus placebo in relieving pain as measured by the WOMAC Pain sub-score in patients with osteoarthritis of the knee
8 weeks
To evaluate the safety and tolerability of PF-04457845 in patients with osteoarthritis.
10 weeks
Secondary Endpoints
Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Stiffness domain score (Likert scale for 2 items, overall score ranges from 0-8) in patients with osteoarthritis of the knee.
8 weeks
Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Physical Function domain score (Likert scale for 17 items, overall score ranges from 0-68) in patients with osteoarthritis of the knee.
8 weeks
Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Total Score in patients with osteoarthritis of the knee.
8 weeks
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PF-04457845 followed by placeboEXPERIMENTAL -
Placebo followed by PF-04457845EXPERIMENTAL -
Naproxen followed by placeboACTIVE_COMPARATOR -
Placebo followed by NaproxenACTIVE_COMPARATOR -
Interventions
NameTypeDescription
PF-04457845DRUGPF-04457845 4 mg tablet once daily / matched placebo
NaproxenDRUGNaproxen 500 mg tablet twice daily / matched placebo
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Subjects must have a diagnosis of Osteoarthritis (OA) of the knee confirmed by X-ray * Subjects must be willing and able to stop all current pain therapy for the duration of study. (Limited and specific pain therapy will be available throughout the study) * Subjects can be mal...

Countries:United StatesCanadaSweden
Unlock Eligibility Criteria