NCT00369811

Brief Summary

To evaluate the analgesic efficacy of oxycodone and fentanyl in the treatment of postoperative pain after laparoscopic cholecystectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_4 pain

Timeline
Completed

Started Aug 2006

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

November 19, 2007

Status Verified

November 1, 2007

First QC Date

August 28, 2006

Last Update Submit

November 16, 2007

Conditions

Pain

Keywords

Cholecystectomy, postoperative

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

Interventions

Oxycodone, fentanylDRUG

Eligibility Criteria

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

You may qualify if:

  • Planned outpatient laparoscopic cholecystectomy
  • \>18 years

You may not qualify if:

  • Intolerance to study drugs
  • Treatment with MAO inhibitors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Pain

Interventions

OxycodoneFentanyl

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Lone Nikolajsen, MD, PhD

    Danish Pain Research Center, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 28, 2006

First Posted

August 29, 2006

Study Start

August 1, 2006

Study Completion

September 1, 2007

Last Updated

November 19, 2007

Record last verified: 2007-11

Locations

DK(1)