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PF-04136309

Phase 2

Osteoarthritis, Knee | Small molecule | Musculoskeletal |Pfizer, Inc.|Trials Updated: Jul 13, 2021

PF-04136309 development status

Highest phase Phase 2
Registered trials 4 across 1 sponsor since Jun 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment159

FDA Designations

No designations recorded

PF-04136309 clinical trials

PF-04136309 · 1 trial · 1 indication

Phase 2 1
NCT00689273Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study In Subjects With Osteoarthritic Pain Of The KneeOsteoarthritis, Knee
COMPLETED159 Analytics
PHASE2COMPLETED
Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study In Subjects With Osteoarthritic Pain Of The Knee
Osteoarthritis, KneeUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Domain Score at Week 2
Baseline, Week 2

WOMAC: self-administered, disease-specific 24 item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness, and physical function in participants with osteoarthritis (OA) of the hip and/or knee. It consists of 3 domains: pain, stiffness and physical function. WOMAC pain domain consists of 5 questions scored on 5 point Likert scale (0=minimum pain to 4=maximum pain) where higher score indicates higher pain. It assesses amount of pain experienced due to OA in the study joint in past 48 hours. Total possible pain domain score calculated by addition of scores of each 5 questions ranged from: 0 (minimum) - 20 (maximum), higher scores indicate higher pain.

Secondary Endpoints

Change From Baseline in WOMAC Pain Domain Score at Week 1
Baseline, Week 1
Change From Baseline in WOMAC Stiffness Domain Score at Week 1 and Week 2
Baseline, Weeks 1, 2
Change From Baseline in WOMAC Physical Function Domain Score at Week 1 and Week 2
Baseline, Weeks 1, 2
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PF-04136309EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PF-04136309DRUG125 mg capsules. Dose will be 4 capsules BID for 2 weeks for a total of 500 mg for each dosing interval.
PlaceboDRUGPlacebo will be matched to PF-04136309. Dose, frequency, and duration same as PF-04136309.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: * Male or female of any race, between the ages of 18 and 75 years inclusive * Female subjects must be of non-childbearing potential and have a negative pregnancy test at Screening. * Osteoarthritis of the knee of at least 6 months duration and meeting the American College of Rhe...

Countries:United StatesSouth Korea
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Competitive Landscape -Osteoarthritis 143 trials (matched to "Osteoarthritis, Knee")

Frequently asked questions about PF-04136309

What is PF-04136309 used for?

PF-04136309 was studied for the treatment of osteoarthritic pain of the knee. It was evaluated in a Phase 2 clinical trial in adults with knee osteoarthritis. It is an investigational small molecule and is not an approved therapy for osteoarthritis or any other indication.

Who is developing PF-04136309?

PF-04136309 was developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 2 study of the compound in knee osteoarthritis. The program is a Pfizer musculoskeletal asset.

What phase is PF-04136309 in?

PF-04136309 reached Phase 2 clinical development. Its single recorded trial, NCT00689273, was a Phase 2 study in subjects with osteoarthritic pain of the knee, and that trial is completed. No active trials of PF-04136309 are ongoing, and the drug is not approved.

What clinical trials is PF-04136309 in?

PF-04136309 was evaluated in one clinical trial, NCT00689273, titled a randomized, double-blind, placebo-controlled Phase 2 study in subjects with osteoarthritic pain of the knee. The trial enrolled 159 participants across the United States and South Korea and is completed.

How was the PF-04136309 knee osteoarthritis trial designed?

NCT00689273 was a randomized, double-blind, placebo-controlled Phase 2 study of PF-04136309 in adults with osteoarthritic pain of the knee. It enrolled 159 participants aged 18 years and older of all sexes, across sites in the United States and South Korea, and did not select patients by biomarker.