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

Phase 1

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: DepoDur (extended-release epidural morphine)

• Registration Number: NCT00728832
• Lead Sponsor: EKR Therapeutics, Inc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05
• Primary Completion: 2003-02
• Status Verified: 2008-08
• Study First Submitted: 2008-08-01
• Study First Submitted QC: 2008-08-05
• Study First Posted: 2008-08-06
• Last Update Submitted: 2008-08-12
• Last Update Posted: 2008-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	DepoDur (extended-release epidural morphine)	Test dose + flush with 1 mL normal saline + 3-minute wait + DepoDur + flush with 1 mL normal saline
1	DepoDur (extended-release epidural morphine)	No test dose + DepoDur + flush with 1 mL normal saline
4	DepoDur (extended-release epidural morphine)	Test dose + flush with 1 mL normal saline + 15-minute wait + DepoDur + flush with 1 mL normal saline
3	DepoDur (extended-release epidural morphine)	Test dose + flush with 1 mL normal saline + 10-minute wait + DepoDur + flush with 1 mL normal saline
5	DepoDur (extended-release epidural morphine)	Test dose + No flush + 3-minute wait + DepoDur + flush with 1 mL normal saline

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
efficacy and safety profiles