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Efficacy of Hylenex in the Treatment of Pain Among Hospice Patients

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by:
HPC Healthcare, Inc.
ClinicalTrials.gov Identifier:
NCT00547664
First received: October 19, 2007
Last updated: November 16, 2010
Last verified: June 2010
History of Changes
  Purpose

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.


Condition Intervention
Pain Management
 Drug: Hylenex recombinant , morphine, saline
Other: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Hospice Care
U.S. FDA Resources

Further study details as provided by HPC Healthcare, Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: For a period of 8 hours from start to finish ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: For a period of 8 hours from start to finish ] [ Designated as safety issue: Yes ]
  • The mean number of bolus attempts made over the 8-hour period between experimental and control groups. [ Time Frame: The bolus attempts will be observed for the 8-hour period from start to finish. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 88
Study Start Date: January 2008
Study Completion Date: October 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: hyaluronidase human injection
Other: Saline
Subcutaneous infusion of morphine and hydromorphone (Dilaudid) with the preceded co-injection of saline.
Other Name: Saline is used to determine the placebo effect.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547664

Locations
United States, Florida
Good Shepherd Hospice
Lakeland, Florida, United States, 33815
LifePath Hospice, Inc.
Tampa, Florida, United States, 33609
HPC Healthcare, Inc.
Temple Terrace, Florida, United States, 33637
Sponsors and Collaborators
HPC Healthcare, Inc.
Baxter Healthcare Corporation
Investigators
Study Director: Sehwan Kim, Ph.D HPC Healthcare, Inc.
  More Information

No publications provided

Responsible Party: Sehwan Kim/Director of Research, HPC Healthcare, Inc.
ClinicalTrials.gov Identifier: NCT00547664     History of Changes
Other Study ID Numbers: HPC200710
Study First Received: October 19, 2007
Last Updated: November 16, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by HPC Healthcare, Inc.:
Hylenex, time tagged pain pain reduction, hospice population

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 May 16, 2013