Preliminary experience with the use of a new once-daily prolonged-release oral morphine capsules* in cancer patients with pain

Background . In an open, clinical study, preliminary assessment of analgesic efficacy and adverse effects of prolonged-release morphine sulphate capsules administered once-daily was conducted in patients with cancer whose pain required strong opioid analgesics administration. Material and methods . Seventeen patients participated who were treated with capsules containing 20, 40 and 60 mg of the drug. The former treatment comprised morphine (8 patients): controlled-release (5), immediate-release (one), subcutaneous and the study drug (akin 1 patient), transdermal fentanyl (3), tramadol (2), non-opioid analgesics (3) and combination of transdermal buprenorphine with immediate-release morphine in one patient. Analgesia was assessed by NRS (Numerical Rating Scale: 0 — no pain, 10 — the most severe pain); the result 1–3 was assessed as good, 4–5 as satisfactory, over 5 as unsatisfactory. Adverse effects were assessed by verbal scale: 0 — none; 1 — mild; 2 — moderate; 3 — severe. Results . Treatment lasted 7–161 (mean 50.47 ± 40.51) days; the daily dose range was 20–180 mg. Eleven patients (65%) assessed analgesia as good, 5 patients (30%) as partial, one patient (5%) had unsatisfactory analgesic effect. Adverse effects observed were as follows: constipation in 9 patients, drowsiness in two patients, nausea and vomiting in 2 patients, nausea alone in one patient, dry mouth in one patient. Conclusions . This preliminary study demonstrated high analgesic efficacy of prolonged-release once-daily morphine capsules in the dose range 20–180 mg in cancer patients with pain requiring strong opioid analgesics administration. The treatment was well tolerated with no serious adverse effects observed. Adv. Pall. Med. 2011; 10, 1: 23–28