A Comparison of PR Oxycodone/Naloxone and PR Oxycodone Af... | NCT01374763

Studies
A Comparison of PR Oxycodone/Naloxone and PR Oxycodone After Cardiac Surgery

NCT01374763

Sponsor

Kati Järvelä

Status

Completed

Last Update Posted

Feb 20, 2012Estimated

Enrollment

165Actual

Phase

Phase 4

Conditions

Postoperative Pain
Opioid Related Disorders

Interventions

Oxycodone
Prolonged-release oxycodone/naloxone

Countries

Finland

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

ID	Type	Description	Link
2010-023025-37	EudraCT Number

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

May 26, 2011

First Submission Date that Met QC Criteria

Jun 15, 2011

First Posted Date

Jun 16, 2011Estimated

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

Feb 17, 2012

Last Update Posted Date

Feb 20, 2012Estimated

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

Detailed Description

Opioid-induced bowel dysfunction is common in cardiac surgery patients postoperatively. Opioids are needed to treat severe postoperative pain, but they have troublesome side-effects such as nausea, vomiting and bowel dysfunction. These symptoms also limit the use of gastrointestinal tract for nutrition and medication. Combined prolonged-releases oxycodone and naloxone has been shown to provide as effective analgesia as PR oxycodone. Oxycodone/naloxone has also been suggested to improve bowel function without compromising analgesic efficacy.

The aim of the study is to describe the effects of oxycodone/naloxone combination in comparison to oxycodone for the treatment of postoperative pain in patients undergoing cardiac surgery. During the first three months of the study, all cardiac surgery patients will be treated with PR oxycodone. During the second part of the study (3 months), all cardiac surgery patients will be treated with PR oxycodone/naloxone. The primary end point is the duration of opioid-induced bowel dysfunction. Need of laxatives will be recorded.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

165Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oxycodone	Active Comparator	Drug: prolonged-release oxycodone	Drug: Oxycodone
Oxycodone/naloxone	Active Comparator	Prolonged-release oxycodone/naloxone	Drug: Prolonged-release oxycodone/naloxone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxycodone	Drug	Prolonged-release oxycodone 10-30 mg twice daily	Oxycodone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Duration of opioid-induced bowel dysfunction postoperatively		Participants will be followed for the duration of hospital stay, an expected average of 5 days

Secondary Outcomes

Measure	Description	Time Frame
Need of laxatives postoperatively		Participants will be followed for the duration of hospital stay, an expected average of 5 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult cardiac surgery patient

Exclusion Criteria:

Preoperative continuous use of laxatives
Known anatomic or functional gastrointestinal disorder

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kati Järvelä, MD, PhD	Tampere University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tampere University Hospital Heart Center		Tampere		33521	Finland

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D009293	Opioid-Related Disorders
D003248	Constipation

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

Intervention Browse Module

MeSH Terms

ID	Term
D010098	Oxycodone
D009270	Naloxone

Ancestor Terms

ID	Term
D003061	Codeine
D009022	Morphine Derivatives
D009019	Morphinans
D053610	Opiate Alkaloids

Browse Leaves

Not provided

Browse Branches

Not provided