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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Fentanyl ITS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fentanyl ITS<br>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. | Drug: Fentanyl ITS<br>* 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.<br>* Other names: IONSYS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | End of Study treatment (Hour 72) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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? | 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? | 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? | Hour 72 or early withdrawal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IONSYS, Fentanyl Iontophoretic Transdermal System, Postoperative pain