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

Janssen (J&J Innovative Medicine)

Status and phase

Terminated

Phase 4

Conditions

Postoperative Pain

Treatments

Drug: Fentanyl-ITS

Study type

Interventional

Funder types

Industry

Identifiers

NCT01804673

FEN-PAI-3002

CR005440

2005-004087-24 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

This is an open label (all people know the identity of the intervention), single arm, and multi-center (when more than one hospital or medical school team work on a medical research study) study to evaluate safety and efficacy of the fentanyl-ITS for management of acute moderate to severe pain in post-operative participants' who have undergone elective surgery (surgery which could be postponed or not done at all without danger to the participant). The study will consists of 2 phases: screening phase (which comprises of pre-operative and post-operative stages) and an open label treatment phase. The participants will be treated with 40 microgram (mcg) of fentanyl transdermally per on-demand dose; each delivered over 10 minutes for a maximum of 6 doses (240 mcg) per hour for 24 hours and a maximum of 80 doses (3.2 milligram [mg]). Each system will inactivate at 80 doses or 24 hour, whichever occurs first. A new system will be applied every 24 hours unless the participant has used 80 doses in less than 24 hours. Maximum treatment duration of 72 hours is allowed. Participants will be expected to require parenteral (administration by injection) opioids (morphine like medications) for at least 24 hours post-operatively. This study will evaluate participant's, nurse's and physician's assessment of fentanyl-ITS under routine conditions. Participants' safety will be monitored throughout the study.

Enrollment

174 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.