A Study to Compare Patient-controlled Pain Medications Delivered Either Through the Skin or Intravenously (EuroTrans)

January 28, 2014 updated by: Janssen-Cilag International NV

Comparison of Transdermal Fentanyl PCA and IV Morphine PCA in the Management of Postoperative Pain Control

The purpose of this study is to evaluate the effectiveness and safety of a patient-controlled system to deliver fentanyl compared with a patient-controlled intravenous system to deliver morphine in the management of postoperative pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized (study drug assigned by chance), open-label (all people involved know the identity of the intervention) study to evaluate the clinical use, safety and ease of care of two patient-controlled analgesia (PCA) systems to deliver pain medication either through the skin or intravenously. The fentanyl hydrochloride PCA system, which delivers the medication through the skin, and morphine intravenous (IV)- PCA, which requires injection into a vein, are used for management of moderate to severe acute pain in postoperative patients who have undergone elective major abdominal or orthopedic surgery. These patients, who are expected to require postoperative pain relief with strong opioids for at least 24 hours, will control the delivery of medication for up to 3 days. Assessment of effectiveness include: patient's global assessment of pain control (poor, fair, good, excellent); Pain Intensity, measured on a visual numerical rating scale from 0 to 10, where 0 means no pain and 10 means the worst possible pain; Ease-of-Care questionnaires including Patient Ease-of-Care questionnaire, Nurse Ease-of-Care questionnaire, and Physical Therapist Ease-of-Care questionnaire; and, total number of doses delivered by patients in the fentanyl transdermal PCA or morphine IV PCA treatment groups. Safety evaluations include vital signs (pulse, blood pressure) and oxygen saturation, respiratory function, and the incidence of adverse events. The study hypothesis is that fentanyl transdermal PCA is not inferior to morphine IV PCA treatment in patient's global assessment of method of pain control during the first 24 hours after surgery. Transdermal PCA: 40 micrograms fentanyl per on-demand dose, each delivered over 10 minutes for a maximum of 6 doses/hr for 24 hours (maximum of 80 doses, 3.2milligrams). Morphine IV PCA: morphine doses with a maximum of 20 milligrams per 2 hours for 24 hours (maximum 12 doses, 240 milligrams).

Study Type

Interventional

Enrollment (Actual)

657

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria
  • Belgium
      • Brussel, Belgium
      • Gent, Belgium
      • Leuven, Belgium
  • Denmark
      • Aalborg, Denmark
      • Kÿbenhavn Nv N/A, Denmark
      • Kÿbenhavn Ÿ, Denmark
      • Odense C, Denmark
      • Ÿrhus C, Denmark
  • France
      • Boulogne Billancourt Cedex, France
      • Le Kremlin Bicetre, France
      • Lille Cedex, France
      • Montpellier Cedex 5, France
      • Nice, France
      • Paris, France
      • Rennes Cedex 2, France
      • Suresnes, France
  • Germany
      • Aachen, Germany
      • Bochum, Germany
      • Bonn, Germany
      • Frankfurt / Main, Germany
      • Halle, Germany
      • Hamburg N/A, Germany
      • Jena, Germany
      • Kiel, Germany
      • Kÿln, Germany
      • Mainz, Germany
      • Marburg, Germany
      • Ulm, Germany
  • Ireland
      • Cork, Ireland
  • Spain
      • Madrid, Spain
  • Sweden
      • Göteborg, Sweden
      • Huddinge N/A, Sweden
      • Linköpng N/A, Sweden
      • Stockholm, Sweden
      • Örebro, Sweden
  • Switzerland
      • Genève, Switzerland
      • Luzern, Switzerland
      • St Gallen, Switzerland
      • Zuerich, Switzerland
      • Zurich, Switzerland
  • United Kingdom
      • Edinburgh, United Kingdom
      • London, United Kingdom
      • N/a N/a, United Kingdom
      • Salford, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who meet the criteria of American Society of Anesthesiology (ASA) pre-operative physical status I, II, or III
  • Patients expected to have moderate or severe pain after a major abdominal or orthopedic procedure
  • Patients expected to remain hospitalized for at least 24 hours postoperatively

Exclusion Criteria:

  • Known allergy or hypersensitivity to fentanyl, morphine, or to skin adhesives
  • Known or suspected to be dependent on strong opioids or to have abused any drug substance or alcohol
  • Severe respiratory symptoms
  • Chronic pain disorder
  • Pregnant or nursing women, or those lacking adequate contraception

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IONSYS
IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem
Drug: IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem
40 µg fentanyl on-demand (240µg/hr) or a maximum of 80 doses (3.2 mg) per day
Active Comparator: Patient-Controlled Analgesia
IV Morphine Patient-Controlled Analgesia (IV PCA)
Drug: IV Morphine Patient-Controlled Analgesia (IV PCA)
20mg/2hr (240 mg during 24 hours)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient's global assessment of pain control (poor, fair, good, excellent) 24 hours after start of study treatment
Time Frame: 24 hours after randomization (24 hours after either the first transdermal iontorphoretic system was applied or 24 hours after the intravenous access for the morphine solution was applied).
24 hours after randomization (24 hours after either the first transdermal iontorphoretic system was applied or 24 hours after the intravenous access for the morphine solution was applied).

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of pain control by patient and doctor
Time Frame: At 24, 48, and 72 hours after randomization
At 24, 48, and 72 hours after randomization
Pain Intensity, vital signs, and oxygen level in the blood
Time Frame: Hourly through 8 hours and then every 4 hours after randomization
Hourly through 8 hours and then every 4 hours after randomization
Incidence of adverse events
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen-Cilag International NV

Collaborators

Alza Corporation, DE, USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

April 1, 2005

Study Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

September 28, 2009

First Submitted That Met QC Criteria

October 15, 2009

First Posted (Estimate)

October 16, 2009

Study Record Updates

Last Update Posted (Estimate)

January 29, 2014

Last Update Submitted That Met QC Criteria

January 28, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR003943
  • FEN-PPA-401 (Other Identifier: Janssen-Cilag International)
  • 2004-001201-10 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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