Pain, PostoperativeNCT00456638
Clinical Study of Depodur Efficacy in Decreasing Post Operative Pain After Off Pump Coronary Artery Bypass Grafting (OP-CABG)
A study testing Depodur in people with Pain, Postoperative, run by Drexel University College of Medicine.
Trial summary
The purpose of this study is to determine whether epidural Depodur alleviates the pain of OP-CABG surgery. This includes pain associated with sternotomy, retraction, dissection and other tissue insults, as well as the induced inflammatory system and effects from prolonged ventilation in the ICU setting. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Depodur
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Apr 2008
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female, 18-99 years old
- All patients who will have surgery for OP-CABG
Who cannot join
- Pregnant females
- Patients with allergy to morphine
- Patients nursing an infant
- Patients with migraine headaches
- Patients taking Coumadin within 7 days or demonstrating INR > 13
- Patients taking Heparin unless documented normal partial thromboplastin time
Show all 13Show fewer
- Patients taking Clopidogrel in previous 7 days
- Patients taking Ticlopidine in previous 14 days
- Patients taking Aspirin in previous 48 hours
- Patients receiving low molecular weight heparin therapy within 24 hours previous
- Patients with Narcolepsy and/or sleep apnea
- Patients on chronic opioid therapy
- Patients participating in another study
About this study
The purpose of this study is to determine whether epidural Depodur alleviates the pain of OP-CABG surgery. This includes pain associated with sternotomy, retraction, dissection and other tissue insults, as well as the induced inflammatory system and effects from prolonged ventilation in the ICU setting.
Read the detailed description
The purpose of this study is to determine whether epidural Depodur alleviates the pain of OP-CABG surgery. This includes pain associated with sternotomy, retraction, dissection and other tissue insults, as well as the induced inflammatory system and effects from prolonged ventilation in the ICU setting. It will be compared to placebo.
- Conditions
- Pain, Postoperative
- Being tested
- Depodur
- Keywords
- OP-CABG, Depodur traditional drug
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DepodurDrug
Also called Traditional
Depodur vs. traditional management
| Study group | Role | What they receive |
|---|---|---|
| Depodur | Experimental | Depodur arm Receives: Drug: Depodur |
| Traditional | Active comparator | traditional management Receives: Drug: Depodur |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of pain (Visual Analog Scale), post-op morphine usage, and side effects between the two study groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2007 (estimated)
- Study startApr 2008
- Primary completionApr 2008
- Study completionApr 2008
Why it stopped: Difficulty aquiring investigational drug
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jay Horrow, MD, Study chair, Drexel University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456638
- Sponsor's protocol ID
- 16402
- Status last verified
- Apr 2008
- First submitted
- 4 Apr 2007
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Depodur Efficacy in Decreasing Post Operative Pain After Off Pump Coronary Artery Bypass Grafting (OP-CABG)
- ClinicalTrials.gov ID
- NCT00456638
- Acronym / sponsor ID
- 16402
- Conditions
- Pain, Postoperative
- Keywords
- OP-CABG, Depodur traditional drug
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty aquiring investigational drug
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Drexel University College of MedicineUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 5 Apr 2007 (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 purpose of this study is to determine whether epidural Depodur alleviates the pain of OP-CABG surgery. This includes pain associated with sternotomy, retraction, dissection and other tissue insults, as well as the induced inflammatory system and effects from prolonged ventilation in the ICU setting.
Detailed description
The purpose of this study is to determine whether epidural Depodur alleviates the pain of OP-CABG surgery. This includes pain associated with sternotomy, retraction, dissection and other tissue insults, as well as the induced inflammatory system and effects from prolonged ventilation in the ICU setting. It will be compared to placebo.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depodur | Experimental | Drug: DepodurDepodur arm |
| Traditional | Active comparator | Drug: Depodurtraditional management |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or Female, 18-99 years old
- All patients who will have surgery for OP-CABG
Key exclusion criteria (13 listed)
- Pregnant females
- Patients with allergy to morphine
- Patients nursing an infant
- Patients with migraine headaches
- Patients taking Coumadin within 7 days or demonstrating INR > 13
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 |
|---|---|---|
| DepodurAlso: TraditionalDepodur vs. traditional management | Drug | Depodur, Traditional |
Primary outcome
Comparison of pain (Visual Analog Scale), post-op morphine usage, and side effects between the two study groups
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
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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.
Jay Horrow, MD study chair
Drexel University College of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Depodur in people with Pain, Postoperative, run by Drexel University College of Medicine.
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 2 inclusion and 13 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: withdrawn, as of the sponsor's last update on 15 Aug 2014. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Comparison of pain (Visual Analog Scale), post-op morphine usage, and side effects between the two study groups. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2014.