NCT00665522

Brief Summary

The purpose of the study is to document the use of fentanyl HCl 40 mcg system under routine conditions and obtain a more comprehensive understanding of the safety of the system and complications that may not be spontaneously reported.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
218

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2007

Shorter than P25 for all trials

Geographic Reach
4 countries

26 active sites

Status
terminated

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

December 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

9 months

First QC Date

April 22, 2008

Last Update Submit

April 9, 2015

Conditions

Pain

Keywords

PainPostoperative AnalgesiaPatient-Controlled Opioids

Outcome Measures

Primary Outcomes (1)

  • The purpose of the study is to document the use of fentanyl HCl 40 mcg system under routine conditions and obtain a more comprehensive understanding of the safety of the system and complications that may not be spontaneously reported.

    Patients will receive treatment and care according to the standard practices at the study center, including: treatment choice, pain management set-up, and operation.

Study Arms (2)

001

fentanyl iontophoretic transdermal system (40mcg) No Placebo 40 mcg per dose maximum of 6 doses/hourtotal maximum 80 doses/24 hours

Drug: fentanyl iontophoretic transdermal system (40mcg) No Placebo

002

IV PCA with standard of care opioid analgesia per 24 hour period

Drug: IV PCA with standard of care opioid analgesia

Interventions

fentanyl iontophoretic transdermal system (40mcg) No PlaceboDRUG

40 mcg per dose, maximum of 6 doses/hour

001
IV PCA with standard of care opioid analgesiaDRUG

total maximum 80 doses/24 hours

002

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Approximately 3,000 patients who have scheduled surgery and need treatment of acute moderate to severe post-operative pain and are treated with fentanyl HCl 40 mcg system in the hospital setting will be evaluated. In addition, a group of approximately 1,500 patients treated with opioid intravenous patient-controlled analgesia (IV PCA) will be matched to fentanyl HCl 40 mcg system patients with respect to (1) country (match will first be sought within the same research center, and extended to patients in the same country if no match is found), (2) pre-surgical physical condition and (3) surgery risk (high risk versus low risk). Patients at multiple research centers in multiple countries will be included.

You may qualify if:

  • Adult patients
  • Planned surgery
  • Planned use of fentanyl HCl 40 mcg system or IV Patient-Controlled Analgesia opioid treatment for postoperative pain

You may not qualify if:

  • \- Pain resulting from emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Unknown Facility

Feldkirch, Austria

Location

Unknown Facility

Graz, Austria

Location

Unknown Facility

Klagenfurt, Austria

Location

Unknown Facility

Linz, Austria

Location

Unknown Facility

Salzburg, Austria

Location

Unknown Facility

Vienna, Austria

Location

Unknown Facility

Wels, Austria

Location

Unknown Facility

Wiener Neustadt, Austria

Location

Unknown Facility

Helsinki, Finland

Location

Unknown Facility

Kuopio, Finland

Location

Unknown Facility

Aachen, Germany

Location

Unknown Facility

Bad Dürkheim, Germany

Location

Unknown Facility

Bergisch Gladbach, Germany

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Bonn, Germany

Location

Unknown Facility

Cologne, Germany

Location

Unknown Facility

Hamburg, Germany

Location

Unknown Facility

Hanover, Germany

Location

Unknown Facility

Kaiserslautern, Germany

Location

Unknown Facility

Koblenz, Germany

Location

Unknown Facility

München, Germany

Location

Unknown Facility

Neubrandenburg, Germany

Location

Unknown Facility

Sinsheim, Germany

Location

Unknown Facility

Speyer, Germany

Location

Unknown Facility

Wÿrzburg, Germany

Location

Unknown Facility

Sneek, Netherlands

Location

Related Links

MeSH Terms

Conditions

Pain

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Study Officials

  • Alza Corporation Clinical Trial

    ALZA

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2008

First Posted

April 24, 2008

Study Start

December 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations

FI(2)NL(1)AU(8)DE(15)