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

Condition(s) targeted: Pain, Postoperative

Intervention: Fentanyl ITS (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Janssen Cilag N.V./S.A.

Official(s) and/or principal investigator(s):
Janssen-Cilag N.V./S.A., Belgium Clinical Trial, Study Director, Affiliation: Janssen Cilag N.V./S.A.

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.

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 design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Number of Participants With Intravenous Administration During Treatment With Fentanyl Iontophoretic Transdermal System (ITS) at Hour 24

Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at Hour 48

Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at End of Study Treatment

Secondary outcome:

Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control

Number of Participants With Nurse Global Assessment of Method of Pain Control

Number of Participants With Physician Global Assessment of Method of Pain Control

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Aalst, Belgium

Brussel, Belgium

Edegem, Belgium

Starting date: August 2008
Last updated: April 22, 2014