Pain, PostoperativePhase 4NCT00779038
Safety and Efficacy Study of Fentanyl Iontophoretic Transdermal System (ITS) for Management of Moderate to Severe Acute Pain in Participants Who Have Undergone Elective Spine or Orthopedic Surgery
A Phase 4 study testing Fentanyl ITS in people with Pain, Postoperative, run by Janssen Cilag N.V./S.A. at 3 sites in Belgium.
Trial summary
The purpose of this study is to evaluate in daily clinical practice the safety and efficacy of fentanyl Iontophoretic Transdermal (through the skin) System (ITS) for management of moderate (medium level of seriousness) to severe (very serious) acute (a quick and severe) pain in participants who have undergone elective… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Fentanyl ITS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesBelgium
- Study dates
- Aug 2008to Sep 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participants who will undergo elective spine or orthopedic (related to bones) surgery
- Participants who are expected to have moderate (medium level of seriousness) or severe (very serious) pain requiring parenteral (given by injection) opioids (morphine like medications) for at least 48 hours after surgery
- Participants who have been admitted to the Post Anesthesia Care Unit (PACU) after general anesthesia, spinal anesthetic of less than 4 hours duration of action or epidural (outside the spinal cord) anesthesia
- Participants who are alert and breathing spontaneously for at least 30 minutes in the PACU
- Participants with a pain score less than or equal to 4 out of 10 on a Numerical Rating Scale (NRS) at movement of the operated limb or body region, after titration to comfort according to current postoperative procedures
Who cannot join
- Participants with active systemic skin disease or active local skin disease that prohibit fentanyl Iontophoretic Transdermal (through the skin) System (ITS) application
- Participants with a history of allergy or hypersensitivity to fentanyl and/or an allergy/hypersensitivity to skin adhesives and/or cetylpyridinium chloride
- Participants who received regular treatment with transdermal strong opioids within 14 days prior to surgery
- Participants who are known or suspected to have abused any drug substance or alcohol
- Participants who will probably require additional surgical procedures within 72 hours
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: Clinical Outcome Study in Postoperative Pain Management to Demonstrate the Efficacy and Safety of IONSYS (Fentanyl ITS Iontophoretic Transdermal System) in Daily Clinical Practice and to Assess Its Convenience (IPAC)
The purpose of this study is to evaluate in daily clinical practice the safety and efficacy of fentanyl Iontophoretic Transdermal (through the skin) System (ITS) for management of moderate (medium level of seriousness) to severe (very serious) acute (a quick and severe) pain in participants who have undergone elective spine or orthopedic (related to bones) surgery.
Read the detailed description
This is an open-label (participants and physicians are told which treatment the participants are receiving), multi-center (when more than one hospital or medical school team work on a medical research study), single-arm study of fentanyl ITS. The study will consist of 2 phases: screening phase and an open-label treatment phase. The duration of participation in the study for an individual participant will be 72 hours. All eligible participants (who require pain treatment with strong opioids [morphine like medications] for at least 48 hours after an elective spine or elective orthopedic surgery) will be treated with fentanyl ITS, delivering 40 microgram (mcg) fentanyl per on-demand dose, each deliver over 10 minutes for a maximum of 6 doses per hour (240 mcg per hour) for 24 hours or a maximum of 80 doses (3.2 milligram). Participants will be analyzed for the use of intravenous (giving a medicine directly into a vein) access during postoperative pain treatment with fentanyl ITS. Participant's safety will be monitored.
- Conditions
- Pain, Postoperative
- Being tested
- Fentanyl ITS
- Keywords
- IONSYS, Fentanyl Iontophoretic Transdermal System, Postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl ITSDrug
Also called IONSYS
40 mcg per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an ITS. Total duration of treatment will be 72 hours.
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl ITS | Experimental | 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS). Total duration of treatment will be 72 hours. Receives: Drug: Fentanyl ITS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Intravenous Administration During Treatment With Fentanyl Iontophoretic Transdermal System (ITS) at Hour 24
Total number of participants who required intravenous administration (when medicine is given directly into a vein) postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.
Measured: Hour 24
Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at Hour 48
Total number of participants who required intravenous administration postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.
Measured: Hour 48
Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at End of Study Treatment
Total number of participants who required intravenous administration postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.
Measured: End of Study treatment (Hour 72)
Secondary outcomes (3)
Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control
The PGA was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the participants: "Overall, would you rate this method of pain control as being poor, fair, good, or excellent?"
Measured: Hour 72 or early withdrawal
Number of Participants With Nurse Global Assessment of Method of Pain Control
The nurse global assessment was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the nurses: "Overall, would you rate this method of pain control as being poor, fair, good, or excellent?"
Measured: Hour 72 or early withdrawal
Number of Participants With Physician Global Assessment of Method of Pain Control
The physician global assessment was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the Physicians: "Overall, would you rate this method of pain control as being poor, fair, good, or excellent?"
Measured: Hour 72 or early withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startAug 2008
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: Stopped prematurely in 2008 due to IONSYS withdrawal off the market globally
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, PostoperativeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Cilag N.V./S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag N.V./S.A., Belgium Clinical Trial, Study director, Janssen Cilag N.V./S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779038
- Sponsor's protocol ID
- CR015121
- Other IDs
- FENHYDPAI4014, 2008-002074-35, 2008
- Status last verified
- Apr 2014
- First submitted
- 23 Oct 2008
- Last updated
- 5 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome Study in Postoperative Pain Management to Demonstrate the Efficacy and Safety of IONSYS (Fentanyl ITS Iontophoretic Transdermal System) in Daily Clinical Practice and to Assess Its Convenience (IPAC)
- ClinicalTrials.gov ID
- NCT00779038
- Acronym / sponsor ID
- CR015121
- Conditions
- Pain, Postoperative
- Keywords
- IONSYS, Fentanyl Iontophoretic Transdermal System, Postoperative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped prematurely in 2008 due to IONSYS withdrawal off the market globally
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Janssen Cilag N.V./S.A.Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 24 Oct 2008 (estimated)
- Results
- Posted 13 Feb 2013
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 in daily clinical practice the safety and efficacy of fentanyl Iontophoretic Transdermal (through the skin) System (ITS) for management of moderate (medium level of seriousness) to severe (very serious) acute (a quick and severe) pain in participants who have undergone elective spine or orthopedic (related to bones) surgery.
Detailed description
This is an open-label (participants and physicians are told which treatment the participants are receiving), multi-center (when more than one hospital or medical school team work on a medical research study), single-arm study of fentanyl ITS. The study will consist of 2 phases: screening phase and an open-label treatment phase. The duration of participation in the study for an individual participant will be 72 hours. All eligible participants (who require pain treatment with strong opioids [morphine like medications] for at least 48 hours after an elective spine or elective orthopedic surgery) will be treated with fentanyl ITS, delivering 40 microgram (mcg) fentanyl per on-demand dose, each deliver over 10 minutes for a maximum of 6 doses per hour (240 mcg per hour) for 24 hours or a maximum of 80 doses (3.2 milligram). Participants will be analyzed for the use of intravenous (giving a medicine directly into a vein) access during postoperative pain treatment with fentanyl ITS. Participant's safety will be monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fentanyl ITS | Experimental | Drug: Fentanyl ITS40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS). Total duration of treatment will be 72 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants who will undergo elective spine or orthopedic (related to bones) surgery
- Participants who are expected to have moderate (medium level of seriousness) or severe (very serious) pain requiring parenteral (given by injection) opioids (morphine like medications) for at least 48 hours after surgery
- Participants who have been admitted to the Post Anesthesia Care Unit (PACU) after general anesthesia, spinal anesthetic of less than 4 hours duration of action or epidural (outside the spinal cord) anesthesia
- Participants who are alert and breathing spontaneously for at least 30 minutes in the PACU
- Participants with a pain score less than or equal to 4 out of 10 on a Numerical Rating Scale (NRS) at movement of the operated limb or body region, after titration to comfort according to current postoperative procedures
Key exclusion criteria (5 listed)
- Participants with active systemic skin disease or active local skin disease that prohibit fentanyl Iontophoretic Transdermal (through the skin) System (ITS) application
- Participants with a history of allergy or hypersensitivity to fentanyl and/or an allergy/hypersensitivity to skin adhesives and/or cetylpyridinium chloride
- Participants who received regular treatment with transdermal strong opioids within 14 days prior to surgery
- Participants who are known or suspected to have abused any drug substance or alcohol
- Participants who will probably require additional surgical procedures within 72 hours
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 |
|---|---|---|
| Fentanyl ITSAlso: IONSYS40 mcg per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an ITS. Total duration of treatment will be 72 hours. | Drug | Fentanyl ITS |
Primary outcome
Number of Participants With Intravenous Administration During Treatment With Fentanyl Iontophoretic Transdermal System (ITS) at Hour 24
Time frame: Hour 24
Total number of participants who required intravenous administration (when medicine is given directly into a vein) postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.
Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at Hour 48
Time frame: Hour 48
Total number of participants who required intravenous administration postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.
Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at End of Study Treatment
Time frame: End of Study treatment (Hour 72)
Total number of participants who required intravenous administration postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.
3 secondary outcomes
Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control
Time frame: Hour 72 or early withdrawal
Number of Participants With Nurse Global Assessment of Method of Pain Control
Time frame: Hour 72 or early withdrawal
Number of Participants With Physician Global Assessment of Method of Pain Control
Time frame: Hour 72 or early withdrawal
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 N.V./S.A., Belgium Clinical Trial study director
Janssen Cilag N.V./S.A.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl ITS in people with Pain, Postoperative, run by Janssen Cilag N.V./S.A. at 3 sites in Belgium.
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 5 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: stopped early, as of the sponsor's last update on 5 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. 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?
Yes. Results are posted in the registry (first posted 13 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Intravenous Administration During Treatment With Fentanyl Iontophoretic Transdermal System (ITS) at Hour 24 (time frame: Hour 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2014.