PMID- 25050592
OWN - NLM
STAT- MEDLINE
DCOM- 20150528
LR  - 20221222
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 30
IP  - 11
DP  - 2014 Nov
TI  - Clinical evaluation of the first oxycodone once daily prolonged release tablet in 
      moderate to severe chronic pain: a randomized, double-blind, multicenter, 
      cross-over, non-inferiority study to investigate efficacy and safety in 
      comparison with an established oxycodone twice daily prolonged release tablet.
PG  - 2365-75
LID - 10.1185/03007995.2014.946126 [doi]
AB  - OBJECTIVE: The first oxycodone once daily (OOD) has been developed and after 
      successful pharmacokinetic characterization, therapeutic efficacy and safety were 
      compared to an established oxycodone twice daily (OTD: Oxygesic/OxyContin, 
      Mundipharma). DESIGN AND METHODS: A randomized, double-blind, multicenter, 
      cross-over, non-inferiority study was conducted in patients (n = 68) with chronic 
      malignant or non-malignant pain. The new OOD was compared to OTD at identical 
      total daily doses (TDD: 40-120 mg/day) employing intensive, five times daily 
      current pain (0-100 mm visual analog scale, VAS) and twice daily 12 h recalled 
      pain assessments as well as safety parameters such as nausea and sedation (VAS) 
      over 5 days for each treatment (after a 5 day run-in phase). RESULTS: There was 
      no significant difference in analgesic potency detected between the two 
      treatments based on 95% CI for difference in the daily mean current pain 
      (-2.09 mm VAS) over 5 days, determined as -5.09 to 0.91 mm VAS. A difference 
      </=12 mm VAS indicated non-inferiority of OOD, i.e. lack of clinically relevant 
      difference in analgesia. Intake of rescue medication had no effect on study 
      results as evaluated by ANCOVA. The difference in adverse events (AEs) between 
      the two treatments did not reach significance, as 19.1% and 23.5% of patients 
      experienced treatment-related AEs while on OOD and OTD, respectively. Advantages 
      for OOD regarding consistency of analgesia (i.e. use of rescue medication, 
      current and recalled pain) and sedation did not reach statistical significance in 
      this limited study population. CONCLUSION: Despite the small number of patients 
      and short study duration, the results support the conclusion that new OOD is (at 
      least) equivalent to established OTD regarding safety and efficacy.
FAU - Lux, Eberhard Albert
AU  - Lux EA
AD  - Klinik fur Schmerz- und Palliativmedizin, Klinikum St.-Marienhospital GmbH , 
      Lunen , Germany.
FAU - Janecki, Marcin
AU  - Janecki M
FAU - Maritz, Martina Alice
AU  - Maritz MA
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140819
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  - 0 (Tablets)
RN  - CD35PMG570 (Oxycodone)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Analgesics, Opioid/*administration & dosage
MH  - Chronic Pain/*drug therapy
MH  - Cross-Over Studies
MH  - Delayed-Action Preparations
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Oxycodone/*administration & dosage
MH  - Pain Measurement
MH  - Prospective Studies
MH  - Tablets
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Chronic pain
OT  - New once daily prolonged release tablet formulation
OT  - Oxycodone
EDAT- 2014/07/23 06:00
MHDA- 2015/05/29 06:00
CRDT- 2014/07/23 06:00
PHST- 2014/07/23 06:00 [entrez]
PHST- 2014/07/23 06:00 [pubmed]
PHST- 2015/05/29 06:00 [medline]
AID - 10.1185/03007995.2014.946126 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2014 Nov;30(11):2365-75. doi: 10.1185/03007995.2014.946126. 
      Epub 2014 Aug 19.