Clinical trial NCT00779038: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: IONSYS
Fentanyl Iontophoretic Transdermal System
Postoperative pain
Lead sponsor: Janssen Cilag N.V./S.A.
Sponsor class: INDUSTRY
First posted: 2008-10-24
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Intravenous Administration During Treatment With Fentanyl Iontophoretic Transdermal System (ITS) at Hour 24
timeFrame: Hour 24
measure: Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at Hour 48
timeFrame: Hour 48
measure: Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at End of Study Treatment
timeFrame: End of Study treatment (Hour 72)
Secondary outcomes:
measure: Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control
timeFrame: Hour 72 or early withdrawal
measure: Number of Participants With Nurse Global Assessment of Method of Pain Control
timeFrame: Hour 72 or early withdrawal
measure: Number of Participants With Physician Global Assessment of Method of Pain Control
timeFrame: Hour 72 or early withdrawal
Other outcomes:
Locations:
city: Aalst
country: Belgium
city: Brussel
country: Belgium
city: Edegem
country: Belgium
Study officials:
affiliation: Janssen Cilag N.V./S.A.
name: Janssen-Cilag N.V./S.A., Belgium Clinical Trial
role: STUDY_DIRECTOR
References: