Double-blind study comparing the pharmacokinetics, safety and tolerability of morphine
administered subcutaneously (SC) with and without human recombinant hyaluronidase (HYLENEX)
and intravenously conducted in patients in a hospice care setting or through a palliative
care medicine setting. In this within-patient controlled study, each eligible study patient
receives a single injection by each of the three methods of morphine administration,
sequentially on three consecutive days, according to the order specified by a randomization
schedule.
Each of the three injections consists of 5 mg of morphine (1.0 mL of 5 mg/mL solution). The
HYLENEX injection will be 1 mL of 150 units. Although the IV administration will not be
blinded, the two SC injections will be double-blinded, using the same volume of normal saline
(0.9% sodium chloride) placebo (1.0 mL) as HYLENEX.