Efficacy of Hylenex in the Treatment of Pain Among Hospice Patients

NCT00547664 | Completed DMC

• 1 other identifier: HPC200710
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Pain Management

Keywords

Hylenex, time tagged pain pain reduction, hospice population

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

Study Arms (2)

A

EXPERIMENTAL

Drug: Hylenex recombinant , morphine, saline

B

PLACEBO COMPARATOR

Drug: Hylenex recombinant , morphine, saline; Other: Saline

Interventions

Hylenex recombinant , morphine, saline DRUG

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.

Also known as: hyaluronidase human injection

A; B

Saline OTHER

Subcutaneous infusion of morphine and hydromorphone (Dilaudid) with the preceded co-injection of saline.

Also known as: Saline is used to determine the placebo effect.

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• HPC Healthcare, Inc.: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (3)

Good Shepherd Hospice

Lakeland, Florida, 33815, United States

Location

LifePath Hospice, Inc.

Tampa, Florida, 33609, United States

Location

HPC Healthcare, Inc.

Temple Terrace, Florida, 33637, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Morphine; Sodium Chloride

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Sehwan Kim, Ph.D

  HPC Healthcare, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2007
• First Posted: October 22, 2007
• Study Start: January 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: October 1, 2010
• Last Updated: February 28, 2014

Record last verified: 2014-02

Locations

US (3)