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

NCT00779038 | Terminated Phase 4 Results

• 3 other identifiers: CR015121FENHYDPAI40142008-002074-35
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 3

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.

Conditions

Pain, Postoperative

Keywords

IONSYS; Fentanyl Iontophoretic Transdermal System; Postoperative pain

Outcome Measures

Primary Outcomes (3)

• 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.

  Hour 24

• 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.

  Hour 48

• 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.

  End of Study treatment (Hour 72)

Secondary Outcomes (3)

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

  Hour 72 or early withdrawal

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

  Hour 72 or early withdrawal

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

  Hour 72 or early withdrawal

Study Arms (1)

Fentanyl ITS

EXPERIMENTAL

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

Interventions

Fentanyl ITS DRUG

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.

Also known as: IONSYS

Fentanyl ITS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Cilag N.V./S.A.: lead

Study Sites (3)

Unknown Facility

Aalst, Belgium

Location

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Edegem, Belgium

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

No efficacy results were reported because the study was prematurely terminated, following the worldwide voluntary withdrawal of Fentanyl Iontophoretic Transdermal System (IONSYS) by Janssen-Cilag.

Results Point of Contact

• Title: Study Responsible Physician
• Organization: Janssen-Cilag Belgium

003214649584

Study Officials

• Janssen-Cilag N.V./S.A., Belgium Clinical Trial

  Janssen Cilag N.V./S.A.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: October 24, 2008
• Study Start: August 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: May 5, 2014
• Results First Posted: February 13, 2013

Record last verified: 2014-04

Locations

BE (3)