Efficacy of Hylenex in the Treatment of Pain Among Hospice Patients

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
HPC Healthcare, Inc.
ClinicalTrials.gov Identifier:
NCT00547664
First received: October 19, 2007
Last updated: February 27, 2014
Last verified: February 2014

October 19, 2007
February 27, 2014
January 2008
December 2009   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00547664 on ClinicalTrials.gov Archive Site
  • 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 ]
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 ]
Not Provided
Not Provided
 
Efficacy of Hylenex in the Treatment of Pain Among Hospice Patients
Not Provided

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Pain Management
  • 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.
  • Experimental: A
    Intervention: Drug: Hylenex recombinant , morphine, saline
  • Placebo Comparator: B
    Interventions:
    • Drug: Hylenex recombinant , morphine, saline
    • Other: Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
October 2010
December 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00547664
HPC200710
Yes
HPC Healthcare, Inc.
HPC Healthcare, Inc.
Baxter Healthcare Corporation
Study Director: Sehwan Kim, Ph.D HPC Healthcare, Inc.
HPC Healthcare, Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP