Efficacy of Hylenex in the Treatment of Pain Among Hospice Patients - Full Text View

Sponsors and Collaborators:	HPC Healthcare, Inc. Baxter Healthcare Corporation
Information provided by:	HPC Healthcare, Inc.
ClinicalTrials.gov Identifier:	NCT00547664

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

MedlinePlus related topics: Hospice Care

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

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
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	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.
B: Placebo Comparator	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: Saline Subcutaneous infusion of morphine and hydromorphone (Dilaudid) with the preceded co-injection of 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.

Eligibility

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

Criteria

Inclusion Criteria:

Non-pregnant, non-lactating adults 18+ years enrolled in inpatient facilities at LifePath or Good Shepherd Hospice
Ability to provide informed consent; Patient has decision-making capacity (SPMSQ score 6+)
Ability to provide numerical report on pain level on pain scale
English-speaking
Pain not satisfactorily controlled with current meds -oral, topical, or rectal; Pain level greater than 3 at admission on a 0-10 scale
Able to self-administer bolus dose or ask someone to hit bolus button
Estimated life expectancy of 3 days or more
Patients appropriate for continuous SC infusion with either morphine or hydromorphone.

Exclusion Criteria:

History of allergy or hypersensitivity to Hylenex or any components of product
Patients on infusion therapy for pain management up to 14 days prior to entering inpatient facilities.
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

Contacts

Contact: Sehwan Kim, Ph.D

(813) 877-2200

kims@hpchealthcare.org

Locations

United States, Florida
HPC Healthcare, Inc.	Recruiting
Temple Terrace, Florida, United States, 33637
Contact: Sehwan Kim, Ph.D 813-357-5667 kims@hpchealthcare.org
Principal Investigator: Michelle Salvat, M.D.
Good Shepherd Hospice	Recruiting
Lakeland, Florida, United States, 33815
Contact: Teresa Kirkland, BS, RN 813-877-2200 kirklandt@hpchealthcare.org
LifePath Hospice, Inc.	Recruiting
Tampa, Florida, United States, 33609
Contact: Teresa Kirkland, BS, RN 813-877-2200 kirklandt@hpchealthcare.org

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:	HPC Healthcare, Inc. ( Sehwan Kim/Director of Research )
Study ID Numbers:	HPC200710
Study First Received:	October 19, 2007
Last Updated:	January 28, 2009
ClinicalTrials.gov Identifier:	NCT00547664 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by HPC Healthcare, Inc.:

Hylenex, time tagged pain pain reduction, hospice population

Study placed in the following topic categories:

Hydromorphone
Morphine
Central Nervous System Depressants
Narcotics

Pain
Peripheral Nervous System Agents
Analgesics
Analgesics, Opioid

Additional relevant MeSH terms:

Morphine
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 07, 2009