A Study to Evaluate the Safety and Tolerability of Fentanyl Iontophoretic Transdermal System (Fentanyl-ITS) in the Management of Post-Surgery Pain

• Status: Terminated
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and tolerability of the fentanyl iontophoretic transdermal (through the skin) system (fentanyl-ITS) in daily clinical practice for management of acute (a quick and severe form of illness in its early stage) moderate to severe post-operative pain (pain after surgery) including the comprehensibility and usefulness of the accompanying information material.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag G.m.b.H
• Treatments: Fentanyl

Criteria

Inclusion Criteria:

• Participants with American Society of Anesthesiology (specialty concerned with the study of anesthetics [drug that is used to produce loss of pain sensation] and anesthesia [loss of sensation or feeling]) pre-operative physical status 1, 2 or 3

• Participants who are expected to remain hospitalized for at least 24 hours post-operatively (after the surgery)

• Participants, after an elective major surgical procedure (surgery which could be postponed or not done at all without danger to the participant), who are expected to have moderate or severe pain requiring parenteral (administration by injection) opioids (morphine like medications) for at least 24 hours after surgery

• Participants who are capable of understanding and cooperating with the requirements of the study and operating a transdermal (through the skin) Patients-Controlled Analgesia (PCA; methods of pain relief that may be used with or in place of analgesics [drug used to control pain])

• Participants with a pain score less than or equal to 4 (moderate pain) out of 10 on a Numerical Rating Scale (NRS), whereas 0 corresponds to no pain and 10 to the strongest imaginable pain at movement of the operated limb or body region, after titration (slow increase in drug dosage, guided by participant's responses) to comfort according to current postoperative procedures

Exclusion Criteria:

• Participants allergic or hypersensitive (very sensitive) to fentanyl or cetylpyridinium chloride or to skin adhesives

• Participants who are known or suspected to be strong opioid dependent, or who have a very high a need for strong opioids before entering the study

• Participants with a history of psychological opioid dependence before the start of the study

• Participants who are known or suspected to have abused any drug substance or alcohol in the opinion of the investigator

• Women who are pregnant, breast feeding, or planning to breast feed within 24 hrs of the last dose of study drug.