Efficacy of Hylenex in the Treatment of Pain Among Hospice Patients
Information source: HPC Healthcare, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain Management
Intervention: Hylenex recombinant , morphine, saline (Drug); Saline (Other)
Sponsored by: HPC Healthcare, Inc.
Official(s) and/or principal investigator(s):
Sehwan Kim, Ph.D, Study Director, Affiliation: HPC Healthcare, Inc.
The overall aim of this study is to find out whether Hylenex recombinant (for short,
Hylenex) in subcutaneous (SC) injection improves the speed and effectiveness of SC opioids
in hospice patients. Specifically, this study proposes to compare the level of self-reported
pain in hospice patients started on SC infusions of morphine and hydromorphone (Dilaudid)
over the initial 8 hours of opioid infusion with and without the preceded co-injection of
Hylenex. Hospice patients include both home-bound patients as well as those under intensive
care in hospice houses.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The primary outcome measure will be the sum of 7 pain intensity differences (SPID) computed from 8 observations of pain during the 8-hour period.
The secondary outcome measure will be the sum of distress level differences (SDLD), sum of relief level differences (SRLD), and sum of bolus attempts (SBAM) made during the same 8-hour period.
The mean number of bolus attempts made over the 8-hour period between experimental and control groups.
As of January 2009, 58 patients were recruited to the study as study subjects. Target goals
for the study is to recruit 88 subjects with full and accurate information with about 44
patients in the Hylenex group and another group of subjects in the control group.
Minimum age: 18 Years.
Maximum age: N/A.
1. Non-pregnant, non-lactating adults 18+ years enrolled in inpatient facilities at
LifePath or Good Shepherd Hospice
2. Ability to provide informed consent; Patient has decision-making capacity (SPMSQ
3. Ability to provide numerical report on pain level on pain scale
5. Pain not satisfactorily controlled with current meds - oral, topical, or rectal; Pain
level greater than 3 at admission on a 0-10 scale
6. Able to self-administer bolus dose or ask someone to hit bolus button
7. Estimated life expectancy of 3 days or more
8. Patients appropriate for continuous SC infusion with either morphine or
1. History of allergy or hypersensitivity to Hylenex or any components of product
2. Patients on infusion therapy for pain management up to 14 days prior to entering
3. Patients who are actively dying identified by any of the following physical signs and
1. non-communicative or unresponsiveness; b) confusion/disorientation about time,
place, and people; c) significant chest congestion with gurgling sounds; d)
restless and repetitive motions; e) little or no food or fluid intake; f)
minimal urine output and g) different breathing pattern, i. e., shallow rapid
breaths with period of no breathing.
Locations and Contacts
Good Shepherd Hospice, Lakeland, Florida 33815, United States
LifePath Hospice, Inc., Tampa, Florida 33609, United States
HPC Healthcare, Inc., Temple Terrace, Florida 33637, United States
Starting date: January 2008
Last updated: February 27, 2014