Efficacy of Hylenex in the Treatment of Pain Among Hospice Patients

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 Overview

• Status: Completed
• Conditions: Pain Management
• Intervention / Treatment: Drug: Hylenex recombinant , morphine, saline; Other: Saline

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Lakeland, Florida, United States, 33815
      • Good Shepherd Hospice
    • Tampa, Florida, United States, 33609
      • LifePath Hospice, Inc.
    • Temple Terrace, Florida, United States, 33637
      • HPC Healthcare, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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 score 6+)
3. Ability to provide numerical report on pain level on pain scale
4. English-speaking
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 hydromorphone.

Exclusion Criteria:

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 inpatient facilities.

3. Patients who are actively dying identified by any of the following physical signs and symptoms:

   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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A	Drug: Hylenex recombinant , morphine, saline; Subcutaneous infusion of morphine and hydromorphone (Dilaudid) with or without the preceded co-injection of Hylenex. Hospice patients include both home-bound patients as well as those under intensive care in hospice houses.; Other Names: hyaluronidase human injection
Placebo Comparator: B	Drug: Hylenex recombinant , morphine, saline; Subcutaneous infusion of morphine and hydromorphone (Dilaudid) with or without the preceded co-injection of Hylenex. Hospice patients include both home-bound patients as well as those under intensive care in hospice houses.; Other Names: hyaluronidase human injection; Other: Saline; Subcutaneous infusion of morphine and hydromorphone (Dilaudid) with the preceded co-injection of saline.; Other Names: Saline is used to determine the placebo effect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	For a period of 8 hours from start to finish

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	For a period of 8 hours from start to finish
The mean number of bolus attempts made over the 8-hour period between experimental and control groups.	The bolus attempts will be observed for the 8-hour period from start to finish.

Collaborators and Investigators

• Sponsor: HPC Healthcare, Inc.
• Collaborators: Baxter Healthcare Corporation
• Investigators: Study Director: Sehwan Kim, Ph.D, HPC Healthcare, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: October 19, 2007
• First Submitted That Met QC Criteria: October 19, 2007
• First Posted (Estimate): October 22, 2007

Study Record Updates

• Last Update Posted (Estimate): February 28, 2014
• Last Update Submitted That Met QC Criteria: February 27, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Hylenex, time tagged pain pain reduction, hospice population
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: HPC200710