INFUSE Morphine Study

Launched by HALOZYME THERAPEUTICS · Jan 11, 2008

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility 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.