The Use of Controlled-Release Oxycodone for the Treatment of Chronic Cancer Pain

Abstract

To compare the effectiveness and safety of controlled-release (CR) oxycodone tablets with immediate-release (IR) oxycodone in patients with chronic cancer pain, a multicenter, randomized, double-blind, parallel-group study was performed in 111 patients with cancer pain. Patients were treated with 6 to 12 tablets or capsules of fixed-combination opioid/nonopioid analgesics per day at study entry. Patients received 30 mg of CR oxycodone tablets every 12 hr or 15 mg of IR oxycodone four times daily for 5 days. No titration or supplemental analgesic medications were permitted. The mean (+/- SE) baseline pain intensity (0 = none, 1 = slight, 2 = moderate, 3 = severe) was 1.5 +/- 0.1 for the CR oxycodone-treated group and 1.3 +/- 0.1 for the group given IR oxycodone (P > 0.05). The 5-day mean pain intensity was 1.4 +/- 0.1 and 1.1 +/- 0.1 for the CR and IR groups, respectively (P > 0.05). Discontinuation rates were equivalent (33%). There was no significant difference between treatment groups in the incidence of adverse events. This study demonstrates that cancer pain patients given 6 to 12 tablets or capsules of fixed-dose combination analgesics can be equally well treated with CR oxycodone administered every 12 hr or IR oxycodone four times daily at the same total daily dose. CR oxycodone offers the benefits of twice daily dosing.

Controlled clinical trials in cancer pain. How controlled should they be? A qualitative systematic review

“…Patients recently or currently receiving radiotherapy and/or chemotherapy were specifically excluded in 20 of 34 trials. In two of these trials (Kaplan et al, 1998;Parris et al, 1998), the protocol was subsequently changed to facilitate patient inclusion.…”

“…In two of these (Deschamps et al, 1992;Stambaugh et al, 2001), the description was restricted to the location of the pain. Five trials (Hays et al, 1994;Bruera et al, 1996Bruera et al, , 1998Bruera et al, , 2004Hagen and Babul, 1997) evaluated patients using the Edmonton staging system which classifies pain as visceral, Kaplan et al (1998) 180 (M) Parallel group 6 days 16 (9%) VRSpi 4 11 0/spontaneous report of nervousness, anxiety 20 Klepstad et al (2003) 40 (S) Parallel group p7 days 6 (15%) VASpi; VRSpi 5 11 'Loss of sleep'; HRQOL/HRQOL: ND; sleep data NR 21 Knudsen et al (1985) 18 (S) Crossover 14 days 2 (11%) VASpi 4 10 22 Lauretti et al (2003) 26 (S) Crossover X35 days 4 (11%) VASpi 4 10 23 Melzack et al (1979) 44 (S) Crossover 'About' 4 weeks 14 (32%) PPI 4 9 24 Mignault et al (1995) 19 (S) Crossover 10 days 8 (42%) VASpi; VASpr 4 7 25 Moriarty et al (1999) 100 ( Parris et al (1998) 111 (M) Parallel group 5 days 37 (33%) VRSpi 4 16 29 Portenoy et al (1989) 51 (S) Parallel group Max. 5 days 2 (4%) VRSpi 4 11 'Quality of sleep'/ND 30 Stambaugh et al (2001) 30 (S) Crossover Max.…”

Quantitative Contribution of Cyp2d6 and Cyp3a to Oxycodone Metabolism in Human Liver and Intestinal Microsomes

“…Oxycodone (4,5-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one; 14-dihydrohydroxycodeinone) is an opioid analgesic widely used for the treatment of postoperative pain (Nuutinen et al, 1986;Silvasti et al, 1998;Curtis et al, 1999) and pain associated with cancer (De Conno et al, 1991;Glare and Walsh, 1993;Parris et al, 1998). It has also been suggested for the management of nonmalignant chronic pain (Watson and Babul, 1998;Sindrup and Jensen, 1999).…”

Oxycodone and the Challenge of Neuropathic Cancer Pain: A Review

“…Six studies have a crossover design [7,8,9,10,11,12] and 4 have a parallel-group design [13,14,15,16]. The number of patients in the trials varies from 26 to 164 (total number of patients: n = 689).…”