PMID- 16750450
OWN - NLM
STAT- MEDLINE
DCOM- 20060707
LR  - 20131121
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 28
IP  - 3
DP  - 2006 Mar
TI  - A 2-week, multicenter, randomized, double-blind, placebo-controlled, 
      dose-ranging, phase III trial comparing the efficacy of oxymorphone extended 
      release and placebo in adults with pain associated with osteoarthritis of the hip 
      or knee.
PG  - 352-64
AB  - BACKGROUND: Oxymorphone extended release (ER) is a tablet formulation of the 
      mu-opioid agonist oxymorphone designed to achieve a low peak-to-trough 
      fluctuation in plasma concentrations over a 12-hour dosing period. OBJECTIVE: 
      This study compared the analgesic efficacy, dose response, and tolerability of 3 
      doses of oxymorphone ER given every 12 hours with those of placebo in patients 
      with pain related to osteoarthritis (OA) of the hip or knee. METHODS: This was a 
      2-week, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, 
      Phase III trial. Patients with OA of the hip or knee who were receiving an opioid 
      medication for chronic, moderate to severe pain or who were judged by the 
      investigator to have received suboptimal analgesia with nonopioid analgesics 
      entered a 2- to 7-day washout of analgesic medication. When pain in the index 
      joint was >40 mm on a 100-mm visual analog scale (VAS), patients were randomized 
      to receive 1 of 4 regimens: oxymorphone ER 10 mg q12h during weeks 1 and 2; 
      oxymorphone ER 20 mg q12h in week 1 and 40 mg q12h in week 2; oxymorphone ER 20 
      mg q12h in week 1 and 50 mg q12h in week 2; or placebo q12h during weeks 1 and 2. 
      The primary end point was the change in VAS score for arthritis pain intensity. 
      Other assessments included the Western Ontario and McMaster Universities (WOMAC) 
      OA Index subscales for pain, stiffness, and physical function and the composite 
      index; the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) 
      physical health component summary (PCS) score; the Chronic Pain Sleep Inventory 
      (CPSI) score; vital signs; clinical laboratory parameters; and adverse events 
      (AEs). AEs were recorded at each clinic visit. RESULTS: Three hundred seventy 
      patients were randomized to treatment (95 oxymorphone ER 10 mg, 93 oxymorphone ER 
      40 mg, 91 oxymorphone ER 50 mg, and 91 placebo), and 198 completed the study. 
      Least squares mean changes from baseline in the VAS arthritis pain intensity 
      score were -21, -28, -29, and -17 mm in the oxymorphone ER 10, 40, and 50 mg and 
      placebo groups, respectively (P = 0.002, modified Tukey linear trend test). 
      Oxymorphone ER 40 and 50 mg produced significant improvements from baseline 
      compared with placebo in the WOMAC subscale scores for pain (least squares mean 
      change: -85.1, -108.0, and -42.5, respectively; P < or = 0.025 for 40 mg, P < or 
      = 0.001 for 50 mg), stiffness (-40.5, -48.1, and -17.0; both, P < or = 0.001), 
      and physical function (-256.8, -310.8, and -116.5; P < or = 0.01 and P < or = 
      0.001, respectively); the SF-36 PCS score (4.6, 3.6, and -0.1; P < 0.001); and 
      the CPSI score (-21.2, -22.2, and -10.7; P < 0.05). The 10-mg dose also was 
      associated with significant improvements compared with placebo in the WOMAC pain 
      (-83.6; P < or = 0.025) and physical function subscales (-232.9; P < or = 0.025) 
      and the SF-36 PCS score (3.9; P < 0.001). The most frequently reported AEs (> or 
      =5% of patients) in the oxymorphone ER groups were nausea (39.4%), vomiting 
      (23.7%), dizziness (22.6%), constipation (22.2%), somnolence (17.6%), pruritus 
      (16.5%), and headache (15.0%). The majority of AEs with oxymorphone ER were mild 
      or moderate in intensity. Three serious AEs (urinary retention, central nervous 
      system depression, and pancreatitis) were considered possibly or probably related 
      to study medication. CONCLUSION: In these patients with chronic, moderate to 
      severe pain related to OA of the hip or knee, oxymorphone ER administered twice 
      daily for 2 weeks produced dose-related reductions in arthritis pain intensity 
      and improvements in physical function.
FAU - Kivitz, Alan
AU  - Kivitz A
AD  - Altoona Center for Clinical Research, Duncansville, Pennsylvania, USA.
FAU - Ma, Carl
AU  - Ma C
FAU - Ahdieh, Harry
AU  - Ahdieh H
FAU - Galer, Bradley S
AU  - Galer BS
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Delayed-Action Preparations)
RN  - 9VXA968E0C (Oxymorphone)
SB  - IM
MH  - Analgesics, Opioid/*therapeutic use
MH  - Delayed-Action Preparations
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Osteoarthritis, Hip/*drug therapy
MH  - Osteoarthritis, Knee/*drug therapy
MH  - Oxymorphone/*therapeutic use
MH  - Pain Measurement
MH  - Sleep/drug effects
MH  - Treatment Outcome
EDAT- 2006/06/06 09:00
MHDA- 2006/07/11 09:00
CRDT- 2006/06/06 09:00
PHST- 2006/01/23 00:00 [accepted]
PHST- 2006/06/06 09:00 [pubmed]
PHST- 2006/07/11 09:00 [medline]
PHST- 2006/06/06 09:00 [entrez]
AID - S0149-2918(06)00073-7 [pii]
AID - 10.1016/j.clinthera.2006.03.008 [doi]
PST - ppublish
SO  - Clin Ther. 2006 Mar;28(3):352-64. doi: 10.1016/j.clinthera.2006.03.008.