PMID- 21481168
OWN - NLM
STAT- MEDLINE
DCOM- 20110902
LR  - 20220331
IS  - 1526-4637 (Electronic)
IS  - 1526-2375 (Linking)
VI  - 12
IP  - 5
DP  - 2011 May
TI  - Long-term safety of Remoxy(R) (extended-release oxycodone) in patients with 
      moderate to severe chronic osteoarthritis or low back pain.
PG  - 755-60
LID - 10.1111/j.1526-4637.2011.01100.x [doi]
AB  - OBJECTIVE: Evaluate the long-term safety, tolerability, and efficacy of Remoxy(R) 
      (extended-release oxycodone) in patients with chronic pain related to 
      osteoarthritis of the hip and/or knee or chronic low back pain. DESIGN: 
      Open-label, 12-month, phase 3 trial. SETTING: Fifty-nine US sites. PATIENTS: Men 
      and women with moderate to severe hip and/or knee pain caused by osteoarthritis 
      or persistent moderate to severe low back pain. INTERVENTION: Remoxy 5 mg twice 
      daily, which could be increased in fixed increments up to 80 mg twice daily. 
      OUTCOME MEASURES: Safety and tolerability assessments included adverse events 
      (AEs), laboratory tests, vital signs, physical examinations, and 
      electrocardiograms. Efficacy was assessed through ratings of pain intensity, 
      quality of analgesia, and global assessment of study drug. RESULTS: Of the 828 
      patients enrolled, 823 received >/=1 dose of Remoxy, with 469 exposed for >/=180 days 
      and 381 for >/=358 days. At least one AE was experienced by 678 patients (82%), the 
      most common of which were opioid related, including constipation, nausea, and 
      somnolence; 173 patients (21%) discontinued treatment because of AEs. No 
      clinically relevant changes were seen in other safety assessments. Mean pain 
      intensity scores decreased significantly from baseline at all time points (P < 
      0.001). At month 12, quality of analgesia and global assessment of study drug 
      were rated positively (good, very good, or excellent) by 64% and 61% of patients 
      (last observation carried forward), respectively. CONCLUSIONS: Long-term 
      treatment with Remoxy was safe, well tolerated, and efficacious in patients with 
      chronic pain related to osteoarthritis of the hip and/or knee or chronic low back 
      pain.
CI  - Wiley Periodicals, Inc.
FAU - Friedmann, Nadav
AU  - Friedmann N
AD  - Pain Therapeutics, Inc., San Mateo, California 94404, USA. 
      nfriedmann@paintrials.com
FAU - Klutzaritz, Vicki
AU  - Klutzaritz V
FAU - Webster, Lynn
AU  - Webster L
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20110411
PL  - England
TA  - Pain Med
JT  - Pain medicine (Malden, Mass.)
JID - 100894201
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Delayed-Action Preparations)
RN  - CD35PMG570 (Oxycodone)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - *Analgesics, Opioid/administration & dosage/adverse effects/therapeutic use
MH  - Arthralgia/drug therapy
MH  - Chronic Disease
MH  - *Delayed-Action Preparations/administration & dosage/adverse effects/therapeutic 
      use
MH  - Female
MH  - Humans
MH  - Low Back Pain/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Osteoarthritis/*drug therapy
MH  - *Oxycodone/administration & dosage/adverse effects/therapeutic use
MH  - Pain Measurement
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2011/04/13 06:00
MHDA- 2011/09/03 06:00
CRDT- 2011/04/13 06:00
PHST- 2011/04/13 06:00 [entrez]
PHST- 2011/04/13 06:00 [pubmed]
PHST- 2011/09/03 06:00 [medline]
AID - 10.1111/j.1526-4637.2011.01100.x [doi]
PST - ppublish
SO  - Pain Med. 2011 May;12(5):755-60. doi: 10.1111/j.1526-4637.2011.01100.x. Epub 2011 
      Apr 11.