Clinical Study of Depodur Efficacy in Decreasing Post Ope... | NCT00456638

Studies
Clinical Study of Depodur Efficacy in Decreasing Post Operative Pain After Off Pump Coronary Artery Bypass Grafting (OP-CABG)

NCT00456638

Sponsor

Drexel University College of Medicine

Status

Withdrawn

Last Update Posted

Aug 15, 2014Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Pain, Postoperative

Interventions

Depodur

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty aquiring investigational drug

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Apr 2008Actual

Completion Date

Apr 2008Actual

First Submitted Date

Apr 4, 2007

First Submission Date that Met QC Criteria

Apr 4, 2007

First Posted Date

Apr 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2014

Last Update Posted Date

Aug 15, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Depodur	Experimental	Depodur arm	Drug: Depodur
Traditional	Active Comparator	traditional management	Drug: Depodur

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Depodur	Drug	Depodur vs. traditional management	Depodur Traditional

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of pain (Visual Analog Scale), post-op morphine usage, and side effects between the two study groups

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or Female, 18-99 years old
All patients who will have surgery for OP-CABG

Exclusion Criteria:

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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jay Horrow, MD	Drexel University College of Medicine	Study Chair

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided