CLINICAL-EVALUATION OF THE ANALGESIC EFFECT OF SUSTAINED-RELEASE MORPHINE-SULFATE MICROGRANULES IN PATIENTS WITH TERMINAL CANCER

Citation
Gz. Xu et al., CLINICAL-EVALUATION OF THE ANALGESIC EFFECT OF SUSTAINED-RELEASE MORPHINE-SULFATE MICROGRANULES IN PATIENTS WITH TERMINAL CANCER, Clinical drug investigation, 14, 1997, pp. 34-42
Citations number
2
Categorie Soggetti
Pharmacology & Pharmacy
Journal title
ISSN journal
11732563
Volume
14
Year of publication
1997
Supplement
1
Pages
34 - 42
Database
ISI
SICI code
1173-2563(1997)14:<34:COTAEO>2.0.ZU;2-0
Abstract
A randomised controlled clinical trial evaluating the analgesic effect of capsules containing sustained release (SR) morphine sulfate microg ranules (M-Eslon((R))) was conducted in 120 patients with terminal can cer and moderate or severe pain. SR morphine sulfate as a tablet formu lation (MS-Contin((R))) was used as the control drug. Both drugs were administered orally at dosages of 20mg (lower dosage) or 30mg (higher dosage) every 12 hours for 7 days. The parameters for pain assessment were pain intensity, evaluated on a 1 to 10 numerical rating scale, an d pain relief (PAR), evaluated on a 5-grade scale. The efficacy rates (the percentage of patients with PAR grades 2 to 4, 12 hours postdose on day 7) in groups given SR morphine sulfate microgranules or tablets at the lower dosage were 76.7% and 83.3%, respectively, on the last d ay of treatment. The respective rates for the higher dosage groups wer e 83.3% and 80.0%. There was no significant difference between the 2, drugs in analgesic efficacy. SR morphine sulfate microgranules or tabl ets did not significantly influence respiratory, cardiovascular, haema tological, hepatic or renal functions. The adverse effect profile for SR morphine sulfate microgranules was similar to that far the tablets, the most frequent events being drowsiness, dizziness, gastric discomf ort, nausea, vomiting, itching, difficulty urinating and constipation. The incidence of constipation tended to increase during the 7-day stu dy period in both drug groups.