PMID- 17257473
OWN - NLM
STAT- MEDLINE
DCOM- 20070403
LR  - 20220317
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 23
IP  - 1
DP  - 2007 Jan
TI  - A 12-week, randomized, placebo-controlled trial assessing the safety and efficacy 
      of oxymorphone extended release for opioid-naive patients with chronic low back 
      pain.
PG  - 117-28
AB  - OBJECTIVE: Determine the efficacy and tolerability of oxymorphone extended 
      release (OPANA ER) in opioid-naive patients with moderate to severe chronic low 
      back pain (CLBP). DESIGN AND METHODS: Patients > or = 18 years of age were 
      titrated with oxymorphone ER (5- to 10-mg increments every 12 h, every 3-7 days) 
      to a well-tolerated, stabilized dose. Patients were then randomized to continue 
      their oxymorphone ER dose or receive placebo every 12 h for 12 weeks. Oxymorphone 
      immediate release was available every 4-6 h, as needed, for the first 4 days and 
      twice daily thereafter. RESULTS: Sixty-three percent of patients (205/325) were 
      titrated to a stabilized dose of oxymorphone ER, most (203/205) within 1 month. 
      During titration, 18% discontinued from adverse events (AEs) and 1% from lack of 
      efficacy. For patients completing titration, average pain intensity decreased 
      from 69.4 mm at screening to 22.7 mm (p < 0.0001). After randomization, 68% of 
      oxymorphone ER and 47% of placebo patients completed 12 weeks of double-blind 
      treatment. Approximately 8% of patients in each group discontinued because of 
      AEs. Placebo patients discontinued significantly sooner from lack of efficacy 
      than those receiving oxymorphone ER (p < 0.0001). Pain intensity increased 
      significantly more in the placebo group (least squares [LS] mean change 26.9 +/- 
      2.4 [median 28.0]) than in the oxymorphone ER group (LS mean change 10.0 +/- 2.4 
      [median 2.0]; p < 0.0001). Oxymorphone ER was generally well tolerated without 
      unexpected AEs. Although limitations of a randomized withdrawal study include the 
      potential for unblinding and opioid withdrawal in placebo patients, opioid 
      withdrawal was limited to two patients in the placebo group and one in the 
      oxymorphone ER group. CONCLUSIONS: Stabilized doses of oxymorphone ER were 
      generally safe and effective over a 12-week double-blind treatment period in 
      opioid-naive patients with CLBP.
FAU - Katz, Nathaniel
AU  - Katz N
AD  - Tufts University School of Medicine, Boston, MA, USA. NKatz@analgesicresearch.com
FAU - Rauck, Richard
AU  - Rauck R
FAU - Ahdieh, Harry
AU  - Ahdieh H
FAU - Ma, Tina
AU  - Ma T
FAU - Gerritsen van der Hoop, Roland
AU  - Gerritsen van der Hoop R
FAU - Kerwin, Rosemary
AU  - Kerwin R
FAU - Podolsky, Gilbert
AU  - Podolsky G
LA  - eng
SI  - ClinicalTrials.gov/NCT00225797
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Delayed-Action Preparations)
RN  - 9VXA968E0C (Oxymorphone)
SB  - IM
MH  - Analgesics, Opioid/administration & dosage/*therapeutic use
MH  - Analysis of Variance
MH  - Delayed-Action Preparations
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Low Back Pain/*drug therapy/etiology
MH  - Male
MH  - Middle Aged
MH  - Oxymorphone/administration & dosage/*therapeutic use
MH  - Pain Measurement
MH  - Statistics, Nonparametric
MH  - Treatment Outcome
MH  - United States
EDAT- 2007/01/30 09:00
MHDA- 2007/04/04 09:00
CRDT- 2007/01/30 09:00
PHST- 2007/01/30 09:00 [pubmed]
PHST- 2007/04/04 09:00 [medline]
PHST- 2007/01/30 09:00 [entrez]
AID - 10.1185/030079906x162692 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2007 Jan;23(1):117-28. doi: 10.1185/030079906x162692.