PainPhase 4EuroTransNCT00996177
A Study to Compare Patient-controlled Pain Medications Delivered Either Through the Skin or Intravenously
A Phase 4 study testing IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem in people with Pain and Analgesia, Patient-Controlled, run by Janssen-Cilag International NV at 44 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Analgesia, Patient-Controlled, Pain, Postoperative
- What is being tested?
- IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 657 participants
- Where
- 44 sitesin 10 countries
- Study dates
- Jun 2004to Apr 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
44 sites in 10 countries.
44 sites in 10 countries
Germany12 sites
Study site
Aachen
Study site
Bochum
Study site
Bonn
Study site
Frankfurt am Main
Study site
Halle
Study site
Hamburg
Study site
Jena
Study site
Kiel
Study site
Kÿln
Study site
Mainz
Study site
Marburg
Study site
Ulm
France8 sites
Study site
Boulogne-Billancourt
Study site
Le Kremlin-Bicêtre
Study site
Lille
Study site
Montpellier
Study site
Nice
Study site
Paris
Study site
Rennes
Study site
Suresnes
Denmark5 sites
Study site
Aalborg
Study site
Kÿbenhavn Nv N/A
Study site
Kÿbenhavn Ÿ
Study site
Odense C
Study site
Ÿrhus C
Sweden5 sites
Study site
Gothenburg
Study site
Huddinge
Study site
Linköpng N/A
Study site
Örebro
Study site
Stockholm
Switzerland4 sites
Study site
Geneva
Study site
Lucerne
Study site
Sankt Gallen
Study site
Zurich
United Kingdom4 sites
Study site
Edinburgh
Study site
London
Study site
N/a N/a
Study site
Salford
About this study
Official title: 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.
Read the 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).
- Conditions
- Pain, Analgesia, Patient-Controlled, Pain, Postoperative
- Being tested
- IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem, IV Morphine Patient-Controlled Analgesia (IV PCA)
- Keywords
- Pain, Patient-controlled analgesia, Postoperative pain, Transdermal fentanyl, Surgical pain, Opioid analgesics
- Medical subject headings
- Pain, Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IONSYS (fentanyl HCl) Iontophoretic TransdermalSystemDrug
40 µg fentanyl on-demand (240µg/hr) or a maximum of 80 doses (3.2 mg) per day
IV Morphine Patient-Controlled Analgesia (IV PCA)Drug
20mg/2hr (240 mg during 24 hours)
| Study group | Role | What they receive |
|---|---|---|
| IONSYS | Experimental | IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem Receives: Drug: IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem |
| Patient-Controlled Analgesia | Active comparator | IV Morphine Patient-Controlled Analgesia (IV PCA) Receives: Drug: IV Morphine Patient-Controlled Analgesia (IV PCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's global assessment of pain control (poor, fair, good, excellent) 24 hours after start of study treatment
Measured: 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
Measured: At 24, 48, and 72 hours after randomization
Pain Intensity, vital signs, and oxygen level in the blood
Measured: Hourly through 8 hours and then every 4 hours after randomization
Incidence of adverse events
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startJun 2004
- Primary completionApr 2005
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 657 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag International NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alza Corporation, DE, USA
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag International NV Clinical Trial, Study director, Janssen-Cilag International NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996177
- Sponsor's protocol ID
- CR003943
- Other IDs
- FEN-PPA-401, 2004-001201-10, 2004
- Acronym
- EuroTrans
- Status last verified
- Jan 2014
- First submitted
- 28 Sep 2009
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17519263
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Transdermal Fentanyl PCA and IV Morphine PCA in the Management of Postoperative Pain Control
- ClinicalTrials.gov ID
- NCT00996177
- Acronym / sponsor ID
- EuroTrans / CR003943
- Conditions
- Pain, Analgesia, Patient-Controlled, Pain, Postoperative
- Keywords
- Pain, Patient-controlled analgesia, Postoperative pain, Transdermal fentanyl, Surgical pain, Opioid analgesics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 657 participants (actual)
- Lead sponsor
- Janssen-Cilag International NVIndustry (pharma, biotech, devices)
- Collaborators
- Alza Corporation, DE, USA
- Study start
- Jun 2004
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 16 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IONSYS | Experimental | Drug: IONSYS (fentanyl HCl) Iontophoretic TransdermalSystemIONSYS (fentanyl HCl) Iontophoretic TransdermalSystem |
| Patient-Controlled Analgesia | Active comparator | Drug: IV Morphine Patient-Controlled Analgesia (IV PCA)IV Morphine Patient-Controlled Analgesia (IV PCA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem40 µg fentanyl on-demand (240µg/hr) or a maximum of 80 doses (3.2 mg) per day | Drug | IONSYS |
| IV Morphine Patient-Controlled Analgesia (IV PCA)20mg/2hr (240 mg during 24 hours) | Drug | Patient-Controlled Analgesia |
Primary outcome
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).
3 secondary outcomes
Assessment of pain control by patient and doctor
Time frame: 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
Incidence of adverse events
Time frame: Throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
- Results publication: PubMed 17519263Grond 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag International NV Clinical Trial study director
Janssen-Cilag International NV
44 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem in people with Pain and Analgesia, Patient-Controlled, run by Janssen-Cilag International NV at 44 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in Germany, France, Denmark, Sweden, Switzerland and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00996177, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2014.