INFUSE Morphine Study (INFUSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00593281
Recruitment Status : Completed
First Posted : January 14, 2008
Last Update Posted : January 14, 2008
Information provided by:
Halozyme Therapeutics

Brief 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.

Condition or disease Intervention/treatment Phase
Pain Drug: Hylenex Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: INcreased Flow Utilizing Subcutaneously Enabled Morphine (INFUSE-Morphine) With and Without Human Recombinant Hyaluronidase (HYLENEX) and Intravenously
Study Start Date : January 2006
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. • Determine the Tmax and other pharmacokinetic parameters of morphine injected subcutaneously with HYLENEX compared to without HYLENEX and injected intravenously [ Time Frame: 29 days ]

Secondary Outcome Measures :
  1. Compare the safety and tolerability of these three methods of injections of morphine [ Time Frame: 29 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00593281

United States, California
UCSD Thornton Hospital
San Diego, California, United States, 92037
San Diego Hospice and Palliative Care
San Diego, California, United States, 92103
Sponsors and Collaborators
Halozyme Therapeutics
Principal Investigator: Jay Thomas, M.D. San Diego Hospice
Principal Investigator: Mark S Wallace, M.D. UCSD Thornton Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Richard Yocum, M.D., Halozyme Inc. Identifier: NCT00593281     History of Changes
Other Study ID Numbers: HZ2-05-06
05-015-MI (Hospice #)
First Posted: January 14, 2008    Key Record Dates
Last Update Posted: January 14, 2008
Last Verified: January 2008

Keywords provided by Halozyme Therapeutics:
PK study of morphine in patients with pain

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents