NCT01374763

Brief Summary

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. The hypothesis is that the duration of opioid-induced bowel dysfunction and the need of laxatives will decrease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for phase_4 postoperative-pain

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 16, 2011

Completed
15 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 20, 2012

Status Verified

February 1, 2012

Enrollment Period

5 months

First QC Date

May 26, 2011

Last Update Submit

February 17, 2012

Conditions

Postoperative PainOpioid Related Disorders

Keywords

NaloxoneOxycodoneConstipationPain, postoperativePhysiological effects of drugsAnalgesics, Opioid

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Need of laxatives postoperatively

    Participants will be followed for the duration of hospital stay, an expected average of 5 days

Study Arms (2)

Oxycodone

ACTIVE COMPARATOR

Drug: prolonged-release oxycodone

Drug: Oxycodone

Oxycodone/naloxone

ACTIVE COMPARATOR

Prolonged-release oxycodone/naloxone

Drug: Prolonged-release oxycodone/naloxone

Interventions

OxycodoneDRUG

Prolonged-release oxycodone 10-30 mg twice daily

Oxycodone
Prolonged-release oxycodone/naloxoneDRUG

Prolonged-release oxycodone/naloxone 10-30 mg twice daily

Oxycodone/naloxone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult cardiac surgery patient

You may not qualify if:

  • Preoperative continuous use of laxatives
  • Known anatomic or functional gastrointestinal disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital Heart Center

Tampere, 33521, Finland

Location

MeSH Terms

Conditions

Pain, PostoperativeOpioid-Related DisordersConstipation

Interventions

OxycodoneNaloxone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Kati Järvelä, MD, PhD

    Tampere University Hospital Heart Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 26, 2011

First Posted

June 16, 2011

Study Start

July 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 20, 2012

Record last verified: 2012-02

Locations

FI(1)