Pain ManagementNCT00547664
Efficacy of Hylenex in the Treatment of Pain Among Hospice Patients
A study testing Hylenex recombinant , morphine, saline and Saline in people with Pain Management, run by HPC Healthcare, Inc. at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Management
- What is being tested?
- Hylenex recombinant , morphine, saline and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2008to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Good Shepherd Hospice
Lakeland, Florida, 33815
LifePath Hospice, Inc.
Tampa, Florida, 33609
HPC Healthcare, Inc.
Temple Terrace, Florida, 33637
About this study
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.
Read the 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.
- Conditions
- Pain Management
- Being tested
- Hylenex recombinant , morphine, saline, Saline
- Keywords
- Hylenex, time tagged pain pain reduction, hospice population
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hylenex recombinant , morphine, salineDrug
Also called hyaluronidase human injection
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.
SalineOther
Also called Saline is used to determine the placebo effect.
Subcutaneous infusion of morphine and hydromorphone (Dilaudid) with the preceded co-injection of saline.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Hylenex recombinant , morphine, saline |
| B | Placebo comparator | Not described Receives: Drug: Hylenex recombinant , morphine, saline; Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: The bolus attempts will be observed for the 8-hour period from start to finish.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2007 (estimated)
- Study startJan 2008
- Primary completionDec 2009
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- HPC Healthcare, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Sehwan Kim, Ph.D, Study director, HPC Healthcare, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547664
- Sponsor's protocol ID
- HPC200710
- Status last verified
- Feb 2014
- First submitted
- 19 Oct 2007
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hylenex in the Treatment of Pain Among Hospice Patients
- ClinicalTrials.gov ID
- NCT00547664
- Acronym / sponsor ID
- HPC200710
- Conditions
- Pain Management
- Keywords
- Hylenex, time tagged pain pain reduction, hospice population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- HPC Healthcare, Inc.University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Jan 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 22 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Hylenex recombinant , morphine, saline |
| B | Placebo comparator | Drug: Hylenex recombinant , morphine, saline, Other: Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hylenex recombinant , morphine, salineAlso: hyaluronidase human injectionSubcutaneous 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. | Drug | A, B |
| SalineAlso: Saline is used to determine the placebo effect.Subcutaneous infusion of morphine and hydromorphone (Dilaudid) with the preceded co-injection of saline. | Other | B |
Primary outcome
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
2 secondary outcomes
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sehwan Kim, Ph.D study director
HPC Healthcare, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hylenex recombinant , morphine, saline and Saline in people with Pain Management, run by HPC Healthcare, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2014.