DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



INFUSE Morphine Study

Information source: Halozyme Therapeutics
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Hylenex (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Halozyme Therapeutics

Official(s) and/or principal investigator(s):
Jay Thomas, M.D., Principal Investigator, Affiliation: San Diego Hospice
Mark S Wallace, M.D., Principal Investigator, Affiliation: UCSD Thornton Hospital

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.

Clinical Details

Official title: INcreased Flow Utilizing Subcutaneously Enabled Morphine (INFUSE-Morphine) With and Without Human Recombinant Hyaluronidase (HYLENEX) and Intravenously

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Pharmacokinetics Study

Primary outcome: • Determine the Tmax and other pharmacokinetic parameters of morphine injected subcutaneously with HYLENEX compared to without HYLENEX and injected intravenously

Secondary outcome: Compare the safety and tolerability of these three methods of injections of morphine

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

San Diego Hospice and Palliative Care, San Diego, California 92103, United States

UCSD Thornton Hospital, San Diego, California 92037, United States

Additional Information

Starting date: January 2006
Ending date: October 2006
Last updated: January 11, 2008

Page last updated: June 20, 2008

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014