Efficacy of Hylenex in the Treatment of Pain Among Hospice Patients

February 27, 2014 updated by: HPC Healthcare, Inc.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Lakeland, Florida, United States, 33815
        • Good Shepherd Hospice
      • Tampa, Florida, United States, 33609
        • LifePath Hospice, Inc.
      • Temple Terrace, Florida, United States, 33637
        • HPC Healthcare, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • hyaluronidase human injection
Other: Saline
Subcutaneous infusion of morphine and hydromorphone (Dilaudid) with the preceded co-injection of saline.
Other Names:
  • Saline is used to determine the placebo effect.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
For a period of 8 hours from start to finish

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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.
Time Frame: The bolus attempts will be observed for the 8-hour period from start to finish.
The bolus attempts will be observed for the 8-hour period from start to finish.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HPC Healthcare, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Baxter Healthcare Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sehwan Kim, Ph.D, HPC Healthcare, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HPC200710

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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