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

• ClinicalTrials.gov Identifier: NCT00779038
• Recruitment Status: Terminated
• First Posted: October 24, 2008
• Results First Posted: February 13, 2013
• Last Update Posted: May 5, 2014
• Sponsor: Janssen Cilag N.V./S.A.
• Information provided by (Responsible Party): Janssen Cilag N.V./S.A.

Study Description

Brief 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 spine or orthopedic (related to bones) surgery.

Condition or disease	Intervention/treatment	Phase
Pain, Postoperative	Drug: Fentanyl ITS	Phase 4

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

• 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

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.

Secondary Outcome Measures :

1. 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?"
2. 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?"
3. 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?"

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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
• Other Study ID Numbers: CR015121; FENHYDPAI4014; 2008-002074-35
• First Posted: October 24, 2008
• Results First Posted: February 13, 2013
• Last Update Posted: May 5, 2014
• Last Verified: April 2014

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

IONSYS; Fentanyl Iontophoretic Transdermal System; Postoperative pain

Additional relevant MeSH terms:

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