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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

Primary Purpose

Pain, Postoperative

Status
Terminated
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Fentanyl ITS
Sponsored by
Janssen Cilag N.V./S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring IONSYS, Fentanyl Iontophoretic Transdermal System, Postoperative pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fentanyl ITS

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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?"
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?"
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?"

Full Information

First Posted
October 23, 2008
Last Updated
April 22, 2014
Sponsor
Janssen Cilag N.V./S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT00779038
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
Stopped prematurely in 2008 due to IONSYS withdrawal off the market globally
Study Start Date
August 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Cilag N.V./S.A.

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
IONSYS, Fentanyl Iontophoretic Transdermal System, Postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fentanyl ITS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fentanyl ITS
Other Intervention Name(s)
IONSYS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Intravenous Administration During Treatment With Fentanyl Iontophoretic Transdermal System (ITS) at Hour 24
Description
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.
Time Frame
Hour 24
Title
Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at Hour 48
Description
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.
Time Frame
Hour 48
Title
Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at End of Study Treatment
Description
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.
Time Frame
End of Study treatment (Hour 72)
Secondary Outcome Measure Information:
Title
Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control
Description
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?"
Time Frame
Hour 72 or early withdrawal
Title
Number of Participants With Nurse Global Assessment of Method of Pain Control
Description
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?"
Time Frame
Hour 72 or early withdrawal
Title
Number of Participants With Physician Global Assessment of Method of Pain Control
Description
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?"
Time Frame
Hour 72 or early withdrawal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen-Cilag N.V./S.A., Belgium Clinical Trial
Organizational Affiliation
Janssen Cilag N.V./S.A.
Official's Role
Study Director
Facility Information:
City
Aalst
Country
Belgium
City
Brussel
Country
Belgium
City
Edegem
Country
Belgium

12. IPD Sharing Statement

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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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