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A Study Comparing 4 Dose Regimens of PLA-695, Naproxen, and Placebo In Subjects With Osteoarthritis Of The Knee

Last updated on March 14, 2019

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Study Location
Huntsville, Alabama, 35801 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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criteria is in the protocol.

- Men or women 50 to 75 years of age. Women must be of non-childbearing potential.
Sexually active men who are not surgically sterile must agree and commit to use of
barrier contraception during the study and for at least 12 weeks after the last dose
of PLA.

- Diagnosed with idiopathic OA of the knee for at least 3 months duration in accordance
with [1986] American College of Rheumatology (ACR) clinical and radiographic criteria:
knee pain, the presence of osteophytes, and any one of the following: age >50 years,
crepitus, or morning stiffness

- Radiographic confirmation of OA at the target joint (weight-bearing anteroposterior
and lateral views) within 1 year of screening.

- Must be currently treated for OA with a stable daily dose of 1 NSAID, including COX-2
inhibitors, not exceeding the maximum recommended dose in the product label, and taken
as prescribed by the physician, starting at least 4 weeks before the screening visit.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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Additional exclusion are included in the protocol.

- History of or suspected current esophageal or gastrointestinal bleeding, ulcers,
obstruction, or perforation, or pancreatitis.

- Grade 4 severity on the Kellgren-Lawrence Scale on the screening target knee
radiograph.

- Any significant cardiovascular, hematologic, blood dyscrasia, endocrine, respiratory,
neurologic, psychiatric, metabolic, immunologic, infectious, hepatic, or renal
condition that the investigator considers detrimental to the subject's participating
in the study or that may prevent the successful completion of the study.

- Any clinically significant laboratory abnormality.

NCT00396955
Pfizer
Terminated
A Study Comparing 4 Dose Regimens of PLA-695, Naproxen, and Placebo In Subjects With Osteoarthritis Of The Knee

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