A Study to Compare Patient-controlled Pain Medications Delivered Either Through the Skin or Intravenously
EuroTrans
Comparison of Transdermal Fentanyl PCA and IV Morphine PCA in the Management of Postoperative Pain Control
3 other identifiers
interventional
657
10 countries
44
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 pain
Started Jun 2004
44 active sites
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
June 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 28, 2009
CompletedFirst Posted
Study publicly available on registry
October 16, 2009
CompletedJanuary 29, 2014
January 1, 2014
10 months
September 28, 2009
January 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient's global assessment of pain control (poor, fair, good, excellent) 24 hours after start of study treatment
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 Outcomes (3)
Assessment of pain control by patient and doctor
At 24, 48, and 72 hours after randomization
Pain Intensity, vital signs, and oxygen level in the blood
Hourly through 8 hours and then every 4 hours after randomization
Incidence of adverse events
Throughout study
Study Arms (2)
IONSYS
EXPERIMENTALIONSYS (fentanyl HCl) Iontophoretic TransdermalSystem
Patient-Controlled Analgesia
ACTIVE COMPARATORIV Morphine Patient-Controlled Analgesia (IV PCA)
Interventions
40 µg fentanyl on-demand (240µg/hr) or a maximum of 80 doses (3.2 mg) per day
20mg/2hr (240 mg during 24 hours)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen-Cilag International NVlead
- Alza Corporation, DE, USAcollaborator
Study Sites (44)
Unknown Facility
Vienna, Austria
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Brussels, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Aalborg, Denmark
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Kÿbenhavn Nv N/A, Denmark
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Kÿbenhavn Ÿ, Denmark
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Odense C, Denmark
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Ÿrhus C, Denmark
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Boulogne-Billancourt, France
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Le Kremlin-Bicêtre, France
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Lille, France
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Montpellier, France
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Nice, France
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Paris, France
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Rennes, France
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Suresnes, France
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Aachen, Germany
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Bochum, Germany
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Bonn, Germany
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Frankfurt am Main, Germany
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Halle, Germany
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Hamburg, Germany
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Jena, Germany
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Kiel, Germany
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Kÿln, Germany
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Mainz, Germany
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Marburg, Germany
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Ulm, Germany
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Cork, Ireland
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Madrid, Spain
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Gothenburg, Sweden
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Huddinge, Sweden
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Linköpng N/A, Sweden
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Örebro, Sweden
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Stockholm, Sweden
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Geneva, Switzerland
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Lucerne, Switzerland
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Sankt Gallen, Switzerland
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Zurich, Switzerland
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Edinburgh, United Kingdom
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London, United Kingdom
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N/a N/a, United Kingdom
Unknown Facility
Salford, United Kingdom
Related Publications (1)
Grond S, Hall J, Spacek A, Hoppenbrouwers M, Richarz U, Bonnet F. Iontophoretic transdermal system using fentanyl compared with patient-controlled intravenous analgesia using morphine for postoperative pain management. Br J Anaesth. 2007 Jun;98(6):806-15. doi: 10.1093/bja/aem102.
PMID: 17519263RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen-Cilag International NV Clinical Trial
Janssen-Cilag International NV
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2009
First Posted
October 16, 2009
Study Start
June 1, 2004
Primary Completion
April 1, 2005
Study Completion
April 1, 2005
Last Updated
January 29, 2014
Record last verified: 2014-01