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

NCT ID: NCT01804673

Last Updated: 2013-08-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2008-09-30

Brief 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.

Detailed 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.

Conditions

Postoperative Pain

Keywords

Postoperative Pain; Fentanyl Hydrochloride; IONSYS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fentanyl-ITS

Group Type: EXPERIMENTAL

Fentanyl-ITS

Intervention Type: DRUG

Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) will release fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment will be 72 hours.

Interventions

Fentanyl-ITS

Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) will release fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment will be 72 hours.

Intervention Type: DRUG

Other Intervention Names

IONSYS, Fentanyl-ITS

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag G.m.b.H

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag G.m.b.H, Germany Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag G.m.b.H

Locations

Augsburg, , Germany

Berlin, , Germany

Bremen, , Germany

Cologne, , Germany

Detmold, , Germany

Dresden, , Germany

Erfurt, , Germany

Erlangen, , Germany

Frankfurt, , Germany

Halle, , Germany

Jena, , Germany

Kiel, , Germany

Leipzig, , Germany

Lünen, , Germany

Mainz, , Germany

Mannheim, , Germany

Marburg, , Germany

Münster, , Germany

Ravensburg, , Germany

Regensburg, , Germany

Schwerin, , Germany

Solingen, , Germany

Countries

Germany

Other Identifiers

FEN-PAI-3002

Identifier Type: -

Identifier Source: secondary_id

2005-004087-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR005440

Identifier Type: -

Identifier Source: org_study_id