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

Condition(s) targeted: Postoperative Pain

Intervention: Fentanyl-ITS (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Janssen-Cilag G.m.b.H

Official(s) and/or principal investigator(s):
Janssen-Cilag G.m.b.H, Germany Clinical Trial, Study Director, Affiliation: Janssen-Cilag G.m.b.H

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.

Official title: Global Assessment of Treatment With IONSYS and Its Handling by Patients, Doctors and Nursing Staff in the Management of Acute Moderate to Severe Post-Surgery Pain in Hospitalised Patients

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

Primary outcome: Percentage of Participants With Global Assessment of Pain at Hour 24

Secondary outcome:

Number of Hours Per Day With Average Pain Intensity Less Than or Equal to 4

Change From Baseline in Pain Intensity Rating at Hour 24, 48 and 72

Time Spent Out of the Bed Per Day by the Participant

Time to Mobilization

Percentage of Participants With Global Assessment of Pain at Hour 48 and 72

Percentage of Participants With Physician Global Assessment of Pain

Percentage of Participants With Nursing Staff Global Assessment of Pain

Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization

Comprehensibility of the Information Material (IM): Physician Questionnaire Responses

Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses

Comprehensibility of the Information Material (IM): Participant Questionnaire Responses

Post-Operative Phase (PPP33) Quality of Life Questionnaire Score

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.

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

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.

Augsburg, Germany

Berlin, Germany

Bremen, Germany

Detmold, Germany

Dresden, Germany

Erfurt, Germany

Erlangen, Germany

Frankfurt, Germany

Halle, Germany

Jena, Germany

Kiel, Germany

Köln, Germany

Leipzig, Germany

Lünen, Germany

Mainz, Germany

Mannheim, Germany

Marburg, Germany

Münster, Germany

Ravensburg, Germany

Regensburg, Germany

Schwerin, Germany

Solingen, Germany

Starting date: March 2008
Last updated: August 2, 2013