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A randomized crossover study comparing the efficacy and tolerability of a novel once-daily morphine preparation (MXL® capsules) with MST Continus® tablets in cancer patients with severe pain

Marymount Hospice, Cork

PG Mortimer

Napp Laboratories, Cambridge

CJ McDonald

Napp Laboratories, Cambridge

AJ Miller

Napp Laboratories, Cambridge

The efficacy, tolerability and 24-h duration of action of MXL® capsules, a novel once-daily morphine preparation, were compared with twice-daily morphine tablets (MST Continus® tablets) in patients with severe cancer pain. Eighty-five patients were recruited to this randomized, double-blind, double-dummy, crossover study. There was no significant difference between the two treatment groups in the number of occasions that escape medication was required, the pain scores at each of three time points throughout the day, and the number of nights woken due to pain. Both preparations were well tolerated with no significant difference in the number or severity of reported symptoms and side-effects. Sixteen patients withdrew from the study, of whom 13 withdrew for nontreatment-related reasons. There was no difference between the preparations in terms of expressed treatment preference. MXL capsules were shown to provide effective analgesia over the 24-h dosing interval which was comparable to that of MST Continus tablets administered twice daily.

Key Words: drug compounding • morphine • pain • palliative care • therapeutic equivalence

Palliative Medicine, Vol. 11, No. 6, 475-482 (1997)
DOI: 10.1177/026921639701100608


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