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
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.