Long-Term Safety Of PF-00345439 (Oxycodone) In Patients With Moderate To Severe Chronic Low Back Pain Or Osteoarthritis
This study will evaluate: (a) the long-term safety of PTI-821 during a 12-month period; and (b) the long-term efficacy of PTI-821 by assessing pain intensity (PI), the quality of analgesia, and the global assessment of study medication.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
823
5-80 mg twice-a-day for 12 months
Number and Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 12 months
Percent change from baseline Pain Intensity Scale
Time frame: baseline 1, 3, 6, 9 and 12 months
Quality of Analgesia - patient reported outcome of analgesia quality using ratings of excellent, very good, good, fair, or poor.
Time frame: 1, 3, 6, 9 and 12 months
Global Assessment of Study Medication - patient reported outcome using ratings of excellent, very good, good, fair, or poor.
Time frame: 1, 3, 6, 9 and 12 months
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