NCT00593281

INFUSE Morphine Study

INcreased Flow Utilizing Subcutaneously Enabled Morphine (INFUSE-Morphine) With and Without Human Recombinant Hyaluronidase (HYLENEX) and Intravenously

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Halozyme Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Hylenex	Add Hylenex to SC injection of Morphine

Timeline

• Start date: 2006-01-01
• Primary completion: 2006-10-01
• Completion: 2006-10-01
• First posted: 2008-01-14
• Last updated: 2008-01-14

Locations

2 sites across 1 country: United States