Efficacy of Hylenex in the Treatment of Pain Among Hospice Patients

Pain Management Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00547664
• Other study ID #: HPC200710
• Status: Completed
• Phase: N/A
• First received: October 19, 2007
• Last updated: February 27, 2014
• Start date: January 2008
• Est. completion date: October 2010

Study information

• Verified date: February 2014
• Source: HPC Healthcare, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: October 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Pain Management

Intervention

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.

Locations

Country	Name	City	State
United States	Good Shepherd Hospice	Lakeland	Florida
United States	LifePath Hospice, Inc.	Tampa	Florida
United States	HPC Healthcare, Inc.	Temple Terrace	Florida

Sponsors (2)

Lead Sponsor	Collaborator
HPC Healthcare, Inc.	Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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.	Yes