Abstract | BACKGROUND: METHODS: A total of 202 patients with chronic pain (mainly non- cancer related, 2.5% of patients had cancer-related pain) under stable oral oxycodone therapy (40, 60 or 80 mg/day) were randomised to receive 10, 20, 40 mg/day naloxone or placebo. After a 4-week maintenance phase, patients received oxycodone only for 2 weeks. Pain intensity was evaluated using a numerical analogue scale and bowel function was assessed using the bowel function index. RESULTS: No loss of analgesic efficacy with naloxone was observed. Mean pain intensity scores on randomisation were comparable for placebo, 10mg, 20mg and 40 mg naloxone dose, and remained unchanged during treatment. Bowel function improved with increasing naloxone dose. Naloxone 20mg and 40 mg significantly improved bowel function at the end of the maintenance phase compared with placebo (p<0.05). Overall, the combination was well tolerated, with no unexpected adverse events. There was a trend towards an increased incidence of diarrhoea with higher doses of naloxone. The 2:1 oxycodone/ naloxone ratio was identified as the most suitable for further development. CONCLUSION:
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Authors | Winfried Meissner, Petra Leyendecker, Stefan Mueller-Lissner, Joachim Nadstawek, Michael Hopp, Christian Ruckes, Stefan Wirz, Wolfgang Fleischer, Karen Reimer |
Journal | European journal of pain (London, England)
(Eur J Pain)
Vol. 13
Issue 1
Pg. 56-64
(Jan 2009)
ISSN: 1532-2149 [Electronic] England |
PMID | 18762438
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Analgesics, Opioid
- Delayed-Action Preparations
- Narcotic Antagonists
- Naloxone
- Oxycodone
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Topics |
- Analgesics, Opioid
(administration & dosage, adverse effects, therapeutic use)
- Constipation
(chemically induced, prevention & control)
- Delayed-Action Preparations
- Double-Blind Method
- Female
- Humans
- Male
- Middle Aged
- Naloxone
(therapeutic use)
- Narcotic Antagonists
(therapeutic use)
- Oxycodone
(administration & dosage, adverse effects, therapeutic use)
- Pain
(drug therapy)
- Pain Measurement
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