INFUSE Morphine Study
Information source: Halozyme Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Hylenex (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Halozyme Therapeutics Official(s) and/or principal investigator(s):
Jay Thomas, M.D., Principal Investigator, Affiliation: San Diego Hospice
Mark S Wallace, M.D., Principal Investigator, Affiliation: UCSD Thornton Hospital
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.
Clinical Details
Official title: INcreased Flow Utilizing Subcutaneously Enabled Morphine (INFUSE-Morphine) With and Without Human Recombinant Hyaluronidase (HYLENEX) and Intravenously
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: • Determine the Tmax and other pharmacokinetic parameters of morphine injected subcutaneously with HYLENEX compared to without HYLENEX and injected intravenously
Secondary outcome: Compare the safety and tolerability of these three methods of injections of morphine
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. 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.
2. 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.
3. Vital signs (BP, HR, RR) within normal range.
4. Adequate venous access in both upper extremities.
5. A negative pregnancy test (if female of child-bearing potential) within 7 days prior
to first injection.
6. Life expectancy ≥ ten days.
7. Decision-making capacity.
8. Signed, written IRB-approved informed consent. -
Exclusion Criteria:
1. Known hypersensitivity or history of any toxicity to morphine.
2. 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.
3. Any contraindication to morphine.
4. Known hypersensitivity to naloxone.
5. Known allergy to hyaluronidase or any other ingredient in the formulation of HYLENEX.
6. Known allergy to bee or vespid venom.
7. Contraindication to IV heparin lock or known hypersensitivity to heparin.
8. Edema, infection, or any other lower extremity or pelvic disorder that might affect
subcutaneous absorption from the thigh.
9. Hemoglobin < 10 g/dL.
10. Presence of any other medical condition that would present an unacceptable safety
risk to the patient.
11. Participation in a study of any investigational drug or device within 30 days of
enrollment in this study.
Locations and Contacts
San Diego Hospice and Palliative Care, San Diego, California 92103, United States
UCSD Thornton Hospital, San Diego, California 92037, United States
Additional Information
Starting date: January 2006
Last updated: January 11, 2008
|
