Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
HPC Healthcare, Inc. Baxter Healthcare Corporation |
---|---|
Information provided by: | HPC Healthcare, Inc. |
ClinicalTrials.gov Identifier: | NCT00547664 |
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.
Condition | Intervention |
---|---|
Pain Management |
Drug: Hylenex recombinant , morphine, saline Other: Saline |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Estimated Enrollment: | 88 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
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.
|
B: Placebo Comparator |
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.
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients who are actively dying identified by any of the following physical signs and symptoms:
Contact: Sehwan Kim, Ph.D | (813) 877-2200 | kims@hpchealthcare.org |
United States, Florida | |
HPC Healthcare, Inc. | Recruiting |
Temple Terrace, Florida, United States, 33637 | |
Contact: Sehwan Kim, Ph.D 813-357-5667 kims@hpchealthcare.org | |
Principal Investigator: Michelle Salvat, M.D. | |
Good Shepherd Hospice | Recruiting |
Lakeland, Florida, United States, 33815 | |
Contact: Teresa Kirkland, BS, RN 813-877-2200 kirklandt@hpchealthcare.org | |
LifePath Hospice, Inc. | Recruiting |
Tampa, Florida, United States, 33609 | |
Contact: Teresa Kirkland, BS, RN 813-877-2200 kirklandt@hpchealthcare.org |
Study Director: | Sehwan Kim, Ph.D | HPC Healthcare, Inc. |
Responsible Party: | HPC Healthcare, Inc. ( Sehwan Kim/Director of Research ) |
Study ID Numbers: | HPC200710 |
Study First Received: | October 19, 2007 |
Last Updated: | January 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00547664 History of Changes |
Health Authority: | United States: Institutional Review Board |
Hylenex, time tagged pain pain reduction, hospice population |
Hydromorphone Morphine Central Nervous System Depressants Narcotics |
Pain Peripheral Nervous System Agents Analgesics Analgesics, Opioid |
Morphine Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions Analgesics, Opioid |