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Sponsors and Collaborators: |
EKR Therapeutics, Inc Pacira Pharmaceuticals, Inc |
Information provided by: | EKR Therapeutics, Inc |
ClinicalTrials.gov Identifier: | NCT00728832 |
The primary purpose of this study is to evaluate the effects of lidocaine/epinephrine test dose administration on the PK profile of a single epidural dose of DepoDur (extended-release epidural morphine) in patients undergoing major upper abdominal surgery. A secondary objective was to evaluate the safety and efficacy profile.
Condition | Intervention | Phase |
Postoperative Pain |
Drug: DepoDur (extended-release epidural morphine) |
Phase I |
ChemIDplus related topics: | Fentanyl Citrate Fentanyl Lidocaine Epinephrine Epinephrine bitartrate |
Study Type: | Interventional |
Study Design: | Other, Randomized, Open Label, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Phase 1 Study to Evaluate the Effects of Lidocaine/Epinephrine Test Dose Administration on the Pharmacokinetic Profile of a Single Dose of Thoracic Extended-Release Epidural Morphine in Patients Undergoing Major Upper Abdominal Surgery |
Enrollment: | 39 |
Study Start Date: | May 2002 |
Primary Completion Date: | February 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
No test dose + DepoDur + flush with 1 mL normal saline
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Drug: DepoDur (extended-release epidural morphine)
DepoDur with on demand boluses of IV fentanyl PCA
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2: Experimental
Test dose + flush with 1 mL normal saline + 3-minute wait + DepoDur + flush with 1 mL normal saline
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Drug: DepoDur (extended-release epidural morphine)
DepoDur with on demand boluses of IV fentanyl PCA
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3: Experimental
Test dose + flush with 1 mL normal saline + 10-minute wait + DepoDur + flush with 1 mL normal saline
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Drug: DepoDur (extended-release epidural morphine)
DepoDur with on demand boluses of IV fentanyl PCA
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4: Experimental
Test dose + flush with 1 mL normal saline + 15-minute wait + DepoDur + flush with 1 mL normal saline
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Drug: DepoDur (extended-release epidural morphine)
DepoDur with on demand boluses of IV fentanyl PCA
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5: Experimental
Test dose + No flush + 3-minute wait + DepoDur + flush with 1 mL normal saline
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Drug: DepoDur (extended-release epidural morphine)
DepoDur with on demand boluses of IV fentanyl PCA
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Thomas Jefferson University ( Eugene R. Viscusi, MD ) |
Study ID Numbers: | SKY0401-016 |
First Received: | August 1, 2008 |
Last Updated: | August 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00728832 |
Health Authority: | United States: Food and Drug Administration |
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