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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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. | For a period of 8 hours from start to finish |
| Measure | Description | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Sehwan Kim, Ph.D | HPC Healthcare, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Good Shepherd Hospice | Lakeland | Florida | 33815 | United States | ||
| LifePath Hospice, Inc. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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|
| Saline | Other | Subcutaneous infusion of morphine and hydromorphone (Dilaudid) with the preceded co-injection of saline. |
|
|
| The bolus attempts will be observed for the 8-hour period from start to finish. |
| Tampa |
| Florida |
| 33609 |
| United States |
| HPC Healthcare, Inc. | Temple Terrace | Florida | 33637 | United States |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |