INFUSE Morphine Study

This study has been completed.
Sponsor:
Information provided by:
Halozyme Therapeutics
ClinicalTrials.gov Identifier:
NCT00593281
First received: January 2, 2008
Last updated: January 11, 2008
Last verified: January 2008
  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 3

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:


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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014