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A Phase 1/2A, Single Dose Study Of PF-04383119 In Japanese Patients With Moderate To Severe Pain From Osteoarthritis Of The Knee

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Takasaki-shi, Gunma-ken, Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Knee Osteoarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
35-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Japanese Male or female, Age 35-65 (Part 1), Age 35-75 (Part 2)

- Diagnosis of osteoarthritis (OA) of the knee based on American College of Rheumatology
criteria

- Knee pain, and radiographic evidence of knee OA (Kellgren-Lawrence x-ray grade ≥2)
obtained within 1 year of enrollment

- At least one of the following: age >50, morning stiffness crepitus, and OA of the knee must involve the index tibiofemoral joint and must have
present for at least 6 months

- Patients who meet at least one of the following: unwilling to take non-opiate pain
medications, or for whom non-opiate pain medications have failed, or are candidates
for or seeking invasive interventions such as intraarticular injections, knee
arthroplasty, or total knee surgery

- Pain levels as required by the protocol at Screening and Baseline

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Diagnosis or history of RA, any inflammatory arthritis, gout, Paget's disease or any
other disease that in the Investigator's opinion would interfere with the assessment
of pain and other symptoms of OA

- Patients with regional pain syndromes suggestive of fibromyalgia or regional pain
caused by lumbar or cervical compressions with radiculopathy or at risk of developing
radiculopathy.

- Diagnosis or history of fibromyalgia

- Planned surgical procedure during the duration of the study

NCT00669409
Pfizer
Completed
A Phase 1/2A, Single Dose Study Of PF-04383119 In Japanese Patients With Moderate To Severe Pain From Osteoarthritis Of The Knee

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[email protected]

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