Osteoarthritis
Conditions
Brief summary
The primary aim is to assess if PF-00592379 is able to reduce pain in patients with osteoarthritis of the knee.
Interventions
DRUGOxycodone
Oxycodone: oral controlled release, 20 mg, twice a day for 2 weeks
DRUGPlacebo
Placebo: oral for 2 weeks.
DRUGPF-000592379
PF-00592379: oral, 30 mg, once a day for 2 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female of any race * Between the ages of 18 and 75 years * Knee Pain due to osteoarthritis
Exclusion criteria
* Pregnant * Participation in a clinical trial for an investigational drug and/or agent within 30 days prior to baseline * History of malignancy, convulsions, chronic infections, arthroscopy of the worst knee within the past year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the pain score averaged over the last week of treatment | 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain score - change from baseline to end of treatment | 2 weeks |
| Patient Global Impression of Change | 2 weeks |
| Patients Global Assessment of Osteoarthritis | 2 weeks |
| Pharmacokinetic trough levels | 2 weeks |
Countries
United States
Outcome results
None listed