Postoperative PainPhase 1NCT00728832
A Pharmacokinetic (PK) Study of Extended-Release Epidural Morphine in Upper Abdominal Surgery
A Phase 1 study testing DepoDur (extended-release epidural morphine) in people with Postoperative Pain, run by EKR Therapeutics, Inc.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- DepoDur (extended-release epidural morphine)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Feb 2003
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
About this 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
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.
- Conditions
- Postoperative Pain
- Being tested
- DepoDur (extended-release epidural morphine)
- Keywords
- extended release epidural morphine, morphine, thoracic epidural, pharmacokinetics, pharmacodynamics, postoperative pain, upper abdominal surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DepoDur (extended-release epidural morphine)Drug
DepoDur with on demand boluses of IV fentanyl PCA
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | No test dose + DepoDur + flush with 1 mL normal saline Receives: Drug: DepoDur (extended-release epidural morphine) |
| 2 | Experimental | Test dose + flush with 1 mL normal saline + 3-minute wait + DepoDur + flush with 1 mL normal saline Receives: Drug: DepoDur (extended-release epidural morphine) |
| 3 | Experimental | Test dose + flush with 1 mL normal saline + 10-minute wait + DepoDur + flush with 1 mL normal saline Receives: Drug: DepoDur (extended-release epidural morphine) |
| 4 | Experimental | Test dose + flush with 1 mL normal saline + 15-minute wait + DepoDur + flush with 1 mL normal saline Receives: Drug: DepoDur (extended-release epidural morphine) |
| 5 | Experimental | Test dose + No flush + 3-minute wait + DepoDur + flush with 1 mL normal saline Receives: Drug: DepoDur (extended-release epidural morphine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
efficacy and safety profiles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2008 (estimated)
- Study startMay 2002
- Primary completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- EKR Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pacira Pharmaceuticals, Inc
- Investigators
- Eugene R Viscusi, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728832
- Sponsor's protocol ID
- SKY0401-016
- Status last verified
- Aug 2008
- First submitted
- 1 Aug 2008
- Last updated
- 14 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Viscusi ER, Manvelian GZ. A randomized study of the serum pharmacokinetics of lower thoracic extended-release epidural morphine (DepoDur) after lidocaine-epinephrine test dose administration in patients undergoing upper abdominal surgery. Int J Clin Pharmacol Ther. 2009 Nov;47(11):659-70. doi: 10.5414/cpp47659.
PubMed 19840530
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00728832
- Acronym / sponsor ID
- SKY0401-016
- Conditions
- Postoperative Pain
- Keywords
- extended release epidural morphine, morphine, thoracic epidural, pharmacokinetics, pharmacodynamics, postoperative pain, upper abdominal surgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- EKR Therapeutics, IncIndustry (pharma, biotech, devices)
- Collaborators
- Pacira Pharmaceuticals, Inc
- Study start
- May 2002
- Primary completion
- Feb 2003 (actual)
- First posted
- 6 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: DepoDur (extended-release epidural morphine)No test dose + DepoDur + flush with 1 mL normal saline |
| 2 | Experimental | Drug: DepoDur (extended-release epidural morphine)Test dose + flush with 1 mL normal saline + 3-minute wait + DepoDur + flush with 1 mL normal saline |
| 3 | Experimental | Drug: DepoDur (extended-release epidural morphine)Test dose + flush with 1 mL normal saline + 10-minute wait + DepoDur + flush with 1 mL normal saline |
| 4 | Experimental | Drug: DepoDur (extended-release epidural morphine)Test dose + flush with 1 mL normal saline + 15-minute wait + DepoDur + flush with 1 mL normal saline |
| 5 | Experimental | Drug: DepoDur (extended-release epidural morphine)Test dose + No flush + 3-minute wait + DepoDur + flush with 1 mL normal saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DepoDur (extended-release epidural morphine)DepoDur with on demand boluses of IV fentanyl PCA | Drug | 1, 2, 3, 4, 5 |
Primary outcome
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
1 secondary outcome
efficacy and safety profiles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2008.
- Derived from this study: PubMed 19840530Viscusi ER, Manvelian GZ. A randomized study of the serum pharmacokinetics of lower thoracic extended-release epidural morphine (DepoDur) after lidocaine-epinephrine test dose administration in patients undergoing upper abdominal surgery. Int J Clin Pharmacol Ther. 2009 Nov;47(11):659-70. doi: 10.5414/cpp47659.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene R Viscusi, MD principal investigator
Thomas Jefferson University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DepoDur (extended-release epidural morphine) in people with Postoperative Pain, run by EKR Therapeutics, Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00728832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2008.