NCT00593281

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_3 pain

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_3 pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 14, 2008

Completed
Last Updated

January 14, 2008

Status Verified

January 1, 2008

Enrollment Period

9 months

First QC Date

January 2, 2008

Last Update Submit

January 11, 2008

Conditions

Pain

Keywords

HyaluronidaseHylenexsubcutaneousmorphineabsorptionbioavailabilityPK study of morphine in patients with pain

Outcome Measures

Primary Outcomes (1)

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

    29 days

Secondary Outcomes (1)

  • Compare the safety and tolerability of these three methods of injections of morphine

    29 days

Study Arms (3)

1

NO INTERVENTION

IV Morphine

2

EXPERIMENTAL

SC Morphine with Hylenex

Drug: Hylenex

3

ACTIVE COMPARATOR

SC Morphine with Saline

Drug: Hylenex

Interventions

HylenexDRUG

Add Hylenex to SC injection of Morphine

23

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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. -

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCSD Thornton Hospital

San Diego, California, 92037, United States

Location

San Diego Hospice and Palliative Care

San Diego, California, 92103, United States

Location

Related Publications (1)

  • Thomas JR, Wallace MS, Yocum RC, Vaughn DE, Haller MF, Flament J. The INFUSE-Morphine study: use of recombinant human hyaluronidase (rHuPH20) to enhance the absorption of subcutaneously administered morphine in patients with advanced illness. J Pain Symptom Manage. 2009 Nov;38(5):663-72. doi: 10.1016/j.jpainsymman.2009.03.009. Epub 2009 Oct 12.

    PMID: 19819665DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jay Thomas, M.D.

    San Diego Hospice

    PRINCIPAL INVESTIGATOR

  • Mark S Wallace, M.D.

    UCSD Thornton Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 2, 2008

First Posted

January 14, 2008

Study Start

January 1, 2006

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

January 14, 2008

Record last verified: 2008-01

Locations

US(2)