Back to Search
Start Over
Efficacy and safety of tapentadol prolonged release for chronic osteoarthritis pain and low back pain
- Source :
- Advances in therapy. 27(6)
- Publication Year :
- 2010
-
Abstract
- This pooled analysis of data from three phase 3 studies in patients with chronic osteoarthritis knee or low back pain evaluated the efficacy and tolerability of tapentadol prolonged release (PR; 100–250 mg twice daily) compared with placebo and oxycodone hydrochloride (HCl) controlled release (CR; 20–50 mg twice daily). Patients in each study were randomized to receive twice-daily doses of placebo, tapentadol PR (100–250 mg), or oxycodone HCl CR (20–50 mg) for a 12-week maintenance period, preceded by a 3-week titration period. Primary endpoints were change from baseline in average pain intensity (11-point numeric rating scale) at week 12 of the maintenance period and for the overall maintenance period using last observation carried forward for imputation of values missing after treatment discontinuation. A total of 2968 patients were evaluated for efficacy; 2974 patients were evaluated for safety. Compared with placebo, treatment with tapentadol PR or oxycodone CR resulted in significantly greater reductions in pain intensity from baseline at week 12 and for the overall maintenance period (all P
- Subjects :
- Male
Osteoarthritis
Kaplan-Meier Estimate
Placebo
Severity of Illness Index
Double-Blind Method
Phenols
medicine
Oxycodone hydrochloride
Humans
Pharmacology (medical)
Least-Squares Analysis
Aged
Pain Measurement
Randomized Controlled Trials as Topic
Analysis of Variance
business.industry
Chronic pain
General Medicine
Middle Aged
Osteoarthritis, Knee
medicine.disease
Tapentadol
Low back pain
Analgesics, Opioid
Treatment Outcome
Tolerability
Clinical Trials, Phase III as Topic
Anesthesia
Delayed-Action Preparations
Chronic Disease
Quality of Life
Female
medicine.symptom
Safety
business
Oxycodone
Low Back Pain
medicine.drug
Subjects
Details
- ISSN :
- 18658652
- Volume :
- 27
- Issue :
- 6
- Database :
- OpenAIRE
- Journal :
- Advances in therapy
- Accession number :
- edsair.doi.dedup.....8cf4182ee03ca66690d6c14b482b28de