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
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ClinicalTrials.gov Identifier: NCT00779038 |
Recruitment Status :
Terminated
(Stopped prematurely in 2008 due to IONSYS withdrawal off the market globally)
First Posted : October 24, 2008
Results First Posted : February 13, 2013
Last Update Posted : May 5, 2014
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Condition or disease | Intervention/treatment | Phase |
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Pain, Postoperative | Drug: Fentanyl ITS | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 13 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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) |
Study Start Date : | August 2008 |
Actual Primary Completion Date : | September 2008 |
Actual Study Completion Date : | September 2008 |

Arm | Intervention/treatment |
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Experimental: Fentanyl ITS
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.
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Drug: Fentanyl ITS
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.
Other Name: IONSYS |
- 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.
- Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control [ Time Frame: Hour 72 or early withdrawal ]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?"
- Number of Participants With Nurse Global Assessment of Method of Pain Control [ Time Frame: Hour 72 or early withdrawal ]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?"
- Number of Participants With Physician Global Assessment of Method of Pain Control [ Time Frame: Hour 72 or early withdrawal ]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?"

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00779038
Belgium | |
Aalst, Belgium | |
Brussel, Belgium | |
Edegem, Belgium |
Study Director: | Janssen-Cilag N.V./S.A., Belgium Clinical Trial | Janssen Cilag N.V./S.A. |
Responsible Party: | Janssen Cilag N.V./S.A. |
ClinicalTrials.gov Identifier: | NCT00779038 |
Other Study ID Numbers: |
CR015121 FENHYDPAI4014 2008-002074-35 |
First Posted: | October 24, 2008 Key Record Dates |
Results First Posted: | February 13, 2013 |
Last Update Posted: | May 5, 2014 |
Last Verified: | April 2014 |
IONSYS Fentanyl Iontophoretic Transdermal System Postoperative pain |
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Fentanyl Analgesics, Opioid Narcotics Central Nervous System Depressants |
Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Anesthetics |