INFUSE Morphine Study

Completed · Phase 3

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT00593281

Run by

Halozyme Therapeutics

People needed

13

Starts

2006-01-01

Expected to finish

2006-10-01

Last updated by the study team

2008-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females at least 18 years of age who are patients of San Diego Hospice \& Palliative Care or recruited through San Diego Hospice \& Palliative Care or the UCSD Center for Pain and Palliative Medicine.
• During the treatment days of the study, on opioid therapy other than morphine that is equivalent to ≥ 60 mg oral morphine per day and without unacceptable toxicity.
• Vital signs (BP, HR, RR) within normal range.
• Adequate venous access in both upper extremities.
• A negative pregnancy test (if female of child-bearing potential) within 7 days prior to first injection.
• Life expectancy ≥ ten days.
• Decision-making capacity.
• Signed, written IRB-approved informed consent. -

You may not qualify if…

• Known hypersensitivity or history of any toxicity to morphine.
• Morphine within the 4 days prior to the first study medication injection or anticipated to be receiving morphine during any of the treatment days in this study.
• Any contraindication to morphine.
• Known hypersensitivity to naloxone.
• Known allergy to hyaluronidase or any other ingredient in the formulation of HYLENEX.
• Known allergy to bee or vespid venom.
• Contraindication to IV heparin lock or known hypersensitivity to heparin.
• Edema, infection, or any other lower extremity or pelvic disorder that might affect subcutaneous absorption from the thigh.
• Hemoglobin < 10 g/dL.
• Presence of any other medical condition that would present an unacceptable safety risk to the patient.
• Participation in a study of any investigational drug or device within 30 days of enrollment in this study.

Where it is running

• UCSD Thornton Hospital — San Diego, California, United States
• San Diego Hospice and Palliative Care — San Diego, California, United States

Full record on ClinicalTrials.gov

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