INFUSE Morphine Study - Full Text View

Sponsor:	Halozyme Therapeutics
Information provided by:	Halozyme Therapeutics
ClinicalTrials.gov Identifier:	NCT00593281

Purpose

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.

Condition	Intervention	Phase
Pain	Drug: Hylenex	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	INcreased Flow Utilizing Subcutaneously Enabled Morphine (INFUSE-Morphine) With and Without Human Recombinant Hyaluronidase (HYLENEX) and Intravenously

Resource links provided by NLM:

MedlinePlus related topics: Hospice Care

Drug Information available for: Hyaluronidase

U.S. FDA Resources

Further study details as provided by Halozyme Therapeutics:

Primary Outcome Measures:

• Determine the Tmax and other pharmacokinetic parameters of morphine injected subcutaneously with HYLENEX compared to without HYLENEX and injected intravenously [ Time Frame: 29 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare the safety and tolerability of these three methods of injections of morphine [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]

Enrollment:	13
Study Start Date:	January 2006
Study Completion Date:	October 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: 1 IV Morphine
Experimental: 2 SC Morphine with Hylenex	Drug: Hylenex Add Hylenex to SC injection of Morphine
Active Comparator: 3 SC Morphine with Saline	Drug: Hylenex Add Hylenex to SC injection of Morphine

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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. -

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593281

Locations

United States, California
San Diego Hospice and Palliative Care
San Diego, California, United States, 92103
UCSD Thornton Hospital
San Diego, California, United States, 92037

Sponsors and Collaborators

Halozyme Therapeutics

Investigators

Principal Investigator:	Jay Thomas, M.D.	San Diego Hospice
Principal Investigator:	Mark S Wallace, M.D.	UCSD Thornton Hospital

More Information

No publications provided by Halozyme Therapeutics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Thomas JR, Wallace MS, Yocum RC, Vaughn DE, Haller MF, Flament J. The INFUSE-Morphine study: use of recombinant human hyaluronidase (rHuPH20) to enhance the absorption of subcutaneously administered morphine in patients with advanced illness. J Pain Symptom Manage. 2009 Nov;38(5):663-72. Epub 2009 Oct 12.

Responsible Party:	Richard Yocum, M.D., Halozyme Inc.
ClinicalTrials.gov Identifier:	NCT00593281 History of Changes
Other Study ID Numbers:	HZ2-05-06, 05-015-MI (Hospice #)
Study First Received:	January 2, 2008
Last Updated:	January 11, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Halozyme Therapeutics:

Hyaluronidase
Hylenex
subcutaneous
morphine

absorption
bioavailability
PK study of morphine in patients with pain

Additional relevant MeSH terms:

Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on February 12, 2012