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Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study In Subjects With Osteoarthritic Pain Of The Knee

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
DeLand, Florida, 32720 United States
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
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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 Rheumatology Criteria. For radiographic criteria the Xray must have been
taken within the last 5 years. If none is available, one should be taken and the
diagnostic criteria confirmed prior to randomization.

- Willing and able to discontinue all current analgesic therapy, including OTC pain
medications and topical analgesics for OA pain, for period beginning with washout
phase (lasting 2 days or 5 half-lives of patient's current analgesic medication prior
to Day -6) and continuing for the entire duration of study. As an exception,
acetaminophen may be used for non-joint related pain at doses ≤1 g/day at the
discretion of a qualified member of the study team.

- If a subject has evidence or a history of clinically significant endocrine, pulmonary,
gastrointestinal, cardiovascular, hepatic, renal, psychiatric, or neurological
disease, the investigator must confirm that the disease is stable (at least 4 weeks)
and under control.

- QTc interval ≤450 msec and a PR interval ≤210 msec on Screening ECG.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Pregnant or lactating females, and females of childbearing potential.

- Arthroscopy performed on index knee within 1 year of screening.

- Active depression as defined by or meeting The Hospital Anxiety and Depression Scale
(HADS) of >10.

- Unwillingness to refrain from consumption of grapefruit or grapefruit juice from 7
days prior to the first dose of study medication until completion of the study.

- First degree or higher AV block, defined as PR interval >210 msecs, bundle branch
block, fascicular block or intraventricular conduction delay or clinically relevant
abnormality on screening ECG.

- Active malignancy of any type or history of a malignancy within 10 years (with the
exception of subjects with a history of treated basal cell carcinoma).

- Symptomatic OA of the hip ipsilateral to index knee which the patient considers more
painful than the knee.

- Use of prohibited medications as listed below, in the absence of appropriate washout
period. The following analgesic agents must be discontinued within 48 hours or 5 half
lives of the analgesic being washed out prior to the baseline period (Day -6 to Day
0);

- NSAIDs and selective COX-2 inhibitors;

- Acetaminophen ( as an exception acetaminophen may be used for non-joint related
pain at doses ?1g/day);

- Opioids.

- Oral or I/M corticosteroids within 4 weeks prior to screening. I/A steroids
within 12 weeks prior to baseline in study joint or any other joints within 4
weeks prior to baseline, or I/A hyaluronic acid within 24 weeks prior to
baseline;

- Use of concomitant medications that are CYP3A inhibitors or CYP3A inducers, or
that are P-glycoprotein substrates within 48 hours or 5 half lives prior to
baseline.

NCT00689273
Pfizer
Completed
Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study In Subjects With Osteoarthritic Pain Of The Knee

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[email protected]

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