PMID- 21046930
OWN - NLM
STAT- MEDLINE
DCOM- 20101116
LR  - 20191111
IS  - 1551-7489 (Print)
IS  - 1551-7489 (Linking)
VI  - 6
IP  - 5
DP  - 2010 Sep-Oct
TI  - A double-blind, placebo-controlled study of dual-opioid treatment with the 
      combination of morphine plus oxycodone in patients with acute postoperative pain.
PG  - 329-40
AB  - OBJECTIVE: animal and human studies suggest that coadministration of two opioids 
      with different receptor binding properties may result in enhanced analgesia and 
      fewer opioid-related adverse events (AEs). Q8003 (MoxDuo), an oral dual-opioid 
      formulation with a fixed ratio (3:2) of morphine and oxycodone, was evaluated for 
      analgesic effects and safety in the management of acute moderate to severe pain. 
      DESIGN: randomized, double-blind, placebo-controlled, ascending-dose cohort, 
      dose-response study with flexible dosing. SETTING: private clinic. PATIENTS: 
      adults undergoing unilateral bunionectomy surgery. Following surgery, patients 
      were required to have moderate or severe intensity pain on a 4-point Likert scale 
      and >or= 4 on an 11-point Numerical Pain Rating Scale to continue in the study. 
      INTERVENTIONS: Q8003 was administered in four ascending-dose cohorts of 3/2, 6/4, 
      12/8, and 18/12 mg during the 48-hour period following surgery. MAIN OUTCOME 
      MEASURES: sum of the pain intensity differences from baseline over 48 hours 
      (SPID48), percentage of responders, and use of ibuprofen. RESULTS: Of 263 
      patients, 256 were randomly assigned to treatment. In patients treated with 
      Q8003, 12 to 18 percent withdrew before study completion versus 30 percent on 
      placebo. The mean dose of morphine/oxycodone per 6-hour period and the mean 
      interdose interval (hours) was 6/4 mg (2.9), 9.8/6.5 mg (4.1), 11/7.5 mg (6.8), 
      and 15/10 mg (6.6) for the 3/2-, 6/4-, 12/8-, and 18/12-mg groups, respectively. 
      The mean SPID48 was significantly greater with each Q8003 dose when compared with 
      placebo (p - 0.0017 for all doses versus placebo). The 12/8-mg group (11/7.5 mg/6 
      h) had the greatest percentage of patient responders (76 percent; p < 0.001 
      versus placebo) and required the fewest daily doses of ibuprofen. AEs were 
      typical of those associated with opioid use, with the highest occurrence for 
      nausea (38-65 percent) and low rates of somnolence (2-8 percent). Minimal or no 
      changes in respiration and blood oxygenation were observed and euphoria was not 
      reported. CONCLUSIONS: the 12/8 mg dose of Q8003, an immediate-release 
      formulation, provided the optimal combination of analgesic efficacy and 
      tolerability, with the 3/2 and the 6/4 mg doses being an effective alternative 
      for treatment.
FAU - Webster, Lynn
AU  - Webster L
AD  - Lifetree Clinical Research, Salt Lake City, Utah, USA.
FAU - Richards, Patricia
AU  - Richards P
FAU - Stern, Warren
AU  - Stern W
FAU - Kelen, Robin
AU  - Kelen R
CN  - MoxDuo Study Group
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Opioid Manag
JT  - Journal of opioid management
JID - 101234523
RN  - 0 (Drug Combinations)
RN  - 0 (MoxDuo)
RN  - 76I7G6D29C (Morphine)
RN  - CD35PMG570 (Oxycodone)
SB  - IM
MH  - Acute Disease
MH  - Adult
MH  - Aged
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Morphine/*administration & dosage/adverse effects
MH  - Oxycodone/*administration & dosage/adverse effects
MH  - Pain, Postoperative/*drug therapy
FIR - Gottlieb, I
IR  - Gottlieb I
FIR - Raymond, G
IR  - Raymond G
FIR - Riff, D
IR  - Riff D
FIR - Robson, M
IR  - Robson M
FIR - Soulier, S
IR  - Soulier S
FIR - Webster, L
IR  - Webster L
EDAT- 2010/11/05 06:00
MHDA- 2010/11/17 06:00
CRDT- 2010/11/05 06:00
PHST- 2010/11/05 06:00 [entrez]
PHST- 2010/11/05 06:00 [pubmed]
PHST- 2010/11/17 06:00 [medline]
AID - 10.5055/jom.2010.0030 [doi]
PST - ppublish
SO  - J Opioid Manag. 2010 Sep-Oct;6(5):329-40. doi: 10.5055/jom.2010.0030.