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INFUSE Morphine Study

NCT00593281 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2008-01-14

No results posted yet for this study

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

Interventions

DRUG

Hylenex

Add Hylenex to SC injection of Morphine

Sponsors & Collaborators

  • Halozyme Therapeutics

    lead INDUSTRY

Principal Investigators

  • Jay Thomas, M.D. · San Diego Hospice

  • Mark S Wallace, M.D. · UCSD Thornton Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2006-10-31
Completion
2006-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00593281 on ClinicalTrials.gov