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Sponsored by: |
Halozyme Therapeutics |
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Information provided by: | Halozyme Therapeutics |
ClinicalTrials.gov Identifier: | NCT00593281 |
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 |
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Pain |
Drug: Hylenex |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Pharmacokinetics Study |
Official Title: | INcreased Flow Utilizing Subcutaneously Enabled Morphine (INFUSE-Morphine) With and Without Human Recombinant Hyaluronidase (HYLENEX) and Intravenously |
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 |
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1: No Intervention
IV Morphine
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2: Experimental
SC Morphine with Hylenex
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Drug: Hylenex
Add Hylenex to SC injection of Morphine
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3: Active Comparator
SC Morphine with Saline
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Drug: Hylenex
Add Hylenex to SC injection of Morphine
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
San Diego Hospice and Palliative Care | |
San Diego, California, United States, 92103 | |
UCSD Thornton Hospital | |
San Diego, California, United States, 92037 |
Principal Investigator: | Jay Thomas, M.D. | San Diego Hospice |
Principal Investigator: | Mark S Wallace, M.D. | UCSD Thornton Hospital |
Responsible Party: | Halozyme Inc. ( Richard Yocum, M.D. ) |
Study ID Numbers: | HZ2-05-06, 05-015-MI (Hospice #) |
Study First Received: | January 2, 2008 |
Last Updated: | January 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00593281 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Hyaluronidase Hylenex subcutaneous morphine |
absorption bioavailability PK study of morphine in patients with pain |
Morphine Central Nervous System Depressants Narcotics Pain |
Peripheral Nervous System Agents Analgesics Analgesics, Opioid |
Morphine Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions Analgesics, Opioid |