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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Pain, Postoperative	Drug: Fentanyl ITS	Phase 4


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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)

Resource links provided by NLM:

Drug Information available for: Fentanyl Fentanyl citrate

U.S. FDA Resources

Further study details as provided by Janssen Cilag N.V./S.A.:

Primary Outcome Measures:

Number of Participants With Intravenous Administration During Treatment With Fentanyl Iontophoretic Transdermal System (ITS) at Hour 24 [ Time Frame: Hour 24 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control [ Time Frame: Hour 72 or early withdrawal ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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?"


Enrollment:	13
Study Start Date:	August 2008
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00779038

Locations


Belgium

Aalst, Belgium

Brussel, Belgium

Edegem, Belgium

Sponsors and Collaborators

Janssen Cilag N.V./S.A.

Investigators


Study Director:	Janssen-Cilag N.V./S.A., Belgium Clinical Trial	Janssen Cilag N.V./S.A.

More Information


Responsible Party:	Janssen Cilag N.V./S.A.
ClinicalTrials.gov Identifier:	NCT00779038 History of Changes
Other Study ID Numbers:	CR015121 FENHYDPAI4014 2008-002074-35
Study First Received:	October 23, 2008
Results First Received:	January 10, 2013
Last Updated:	April 22, 2014
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Janssen Cilag N.V./S.A.:


IONSYS Fentanyl Iontophoretic Transdermal System Postoperative pain

Additional relevant MeSH terms:


Pain, Postoperative Pain Neurologic Manifestations Nervous System Diseases Postoperative Complications Pathologic Processes Signs and Symptoms 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

ClinicalTrials.gov processed this record on September 23, 2016