INFUSE Morphine Study
This study has been completed.
Sponsor:
Halozyme Therapeutics
Information provided by:
Halozyme Therapeutics
ClinicalTrials.gov Identifier:
NCT00593281
First received: January 2, 2008
Last updated: January 11, 2008
Last verified: January 2008
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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:
- 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.
- 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.
- Vital signs (BP, HR, RR) within normal range.
- Adequate venous access in both upper extremities.
- A negative pregnancy test (if female of child-bearing potential) within 7 days prior to first injection.
- Life expectancy ≥ ten days.
- Decision-making capacity.
- Signed, written IRB-approved informed consent. -
Exclusion Criteria:
- Known hypersensitivity or history of any toxicity to morphine.
- 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.
- Any contraindication to morphine.
- Known hypersensitivity to naloxone.
- Known allergy to hyaluronidase or any other ingredient in the formulation of HYLENEX.
- Known allergy to bee or vespid venom.
- Contraindication to IV heparin lock or known hypersensitivity to heparin.
- Edema, infection, or any other lower extremity or pelvic disorder that might affect subcutaneous absorption from the thigh.
- Hemoglobin < 10 g/dL.
- Presence of any other medical condition that would present an unacceptable safety risk to the patient.
- Participation in a study of any investigational drug or device within 30 days of enrollment in this study.
Contacts and Locations
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 Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotics |
ClinicalTrials.gov processed this record on June 17, 2013