A Pharmacokinetic (PK) Study of Extended-Release Epidural Morphine in Upper Abdominal Surgery

August 12, 2008 updated by: EKR Therapeutics, Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 1

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females ≥ 18 years of age at Screening
  • Negative pregnancy test in females of childbearing potential
  • Scheduled for major upper abdominal surgery via an upper midline incision under general anesthesia
  • American Society of Anesthesiology (ASA) Physical Class 1, 2, or 3
  • Willing and able to use a PCA pump
  • Willing to receive only IV fentanyl for 72 hours post-dose to control post-operative pain
  • Capable of providing written informed consent and responses to pain assessment scales and neurological assessment questionnaires

Exclusion Criteria:

  • Morbid obesity, defined as a body mass index (BMI) ≥ 40
  • Scheduled to undergo surgery under regional anesthesia
  • Usage of analgesic medications containing morphine or codeine within three days prior to study drug administration
  • Chronic opioid medication usage (defined as daily opioids for more than 7 days prior to enrollment)
  • Suspected or documented history of sleep apnea, narcolepsy, or excessive daytime sleepiness
  • Female who was pregnant or lactating
  • History of hypersensitivity or idiosyncratic reaction to opioid medications, local anesthetics, or epinephrine
  • Any contraindication for the epidural administration of study drug (e.g., coagulopathy, local infection)
  • Administration of an investigational drug within 30 days prior to Screening
  • Suspected or documented history of substance abuse and/or alcoholism
  • Any contraindication to frequent blood PK sampling (such as significant anemia) or other barrier to obtaining timely PK samples

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

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
No test dose + DepoDur + flush with 1 mL normal saline
Drug: DepoDur (extended-release epidural morphine)
DepoDur with on demand boluses of IV fentanyl PCA
EXPERIMENTAL: 2
Test dose + flush with 1 mL normal saline + 3-minute wait + DepoDur + flush with 1 mL normal saline
Drug: DepoDur (extended-release epidural morphine)
DepoDur with on demand boluses of IV fentanyl PCA
EXPERIMENTAL: 3
Test dose + flush with 1 mL normal saline + 10-minute wait + DepoDur + flush with 1 mL normal saline
Drug: DepoDur (extended-release epidural morphine)
DepoDur with on demand boluses of IV fentanyl PCA
EXPERIMENTAL: 4
Test dose + flush with 1 mL normal saline + 15-minute wait + DepoDur + flush with 1 mL normal saline
Drug: DepoDur (extended-release epidural morphine)
DepoDur with on demand boluses of IV fentanyl PCA
EXPERIMENTAL: 5
Test dose + No flush + 3-minute wait + DepoDur + flush with 1 mL normal saline
Drug: DepoDur (extended-release epidural morphine)
DepoDur with on demand boluses of IV fentanyl PCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Evaluate the serum pharmacokinetic profile of a single 15-mg dose of DepoDur administered at the lower thoracic epidural space with or without a prior lidocaine-epinephrine test dose

Secondary Outcome Measures

Outcome Measure
efficacy and safety profiles

Collaborators and Investigators

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

Sponsor

EKR Therapeutics, Inc

Collaborators

Pacira Pharmaceuticals, Inc

Investigators

  • Principal Investigator: Eugene R Viscusi, MD, Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2002

Primary Completion (ACTUAL)

February 1, 2003

Study Registration Dates

First Submitted

August 1, 2008

First Submitted That Met QC Criteria

August 5, 2008

First Posted (ESTIMATE)

August 6, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 14, 2008

Last Update Submitted That Met QC Criteria

August 12, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKY0401-016

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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