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

NCT01804673 | Terminated Phase 4 Results

• 3 other identifiers: CR005440FEN-PAI-30022005-004087-24
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 22

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.

Conditions

Postoperative Pain

Keywords

Postoperative Pain; Fentanyl Hydrochloride; IONSYS

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Global Assessment of Pain at Hour 24

  Participants were asked to rate their overall global assessment of pain therapy with study treatment on a 4-point verbal rating scale (poor, fair, good, excellent). Outcome of 'good' or 'excellent ' was recorded as Response while outcome of 'poor' or 'fair' was recorded as No response.

  Hour 24

Secondary Outcomes (12)

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

  Baseline to Hour 24, Hour 24 to Hour 48 and Hour 48 to Hour 72

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

  Baseline, Hour 24, 48 and 72

• Time Spent Out of the Bed Per Day by the Participant

  Baseline to Hour 24, Hour 24 to Hour 48 and Hour 48 to Hour 72

• Time to Mobilization

  Baseline, Hours 24, 48 and 72

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

  Hours 48 and 72

Study Arms (1)

Fentanyl-ITS

EXPERIMENTAL

Drug: Fentanyl-ITS

Interventions

Fentanyl-ITS 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.

Also known as: IONSYS, Fentanyl-ITS

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 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Janssen-Cilag G.m.b.H: lead

Study Sites (22)

Unknown Facility

Augsburg, Germany

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Bremen, Germany

Location

Unknown Facility

Cologne, Germany

Location

Unknown Facility

Detmold, Germany

Location

Unknown Facility

Dresden, Germany

Location

Unknown Facility

Erfurt, Germany

Location

Unknown Facility

Erlangen, Germany

Location

Unknown Facility

Frankfurt, Germany

Location

Unknown Facility

Halle, Germany

Location

Unknown Facility

Jena, Germany

Location

Unknown Facility

Kiel, Germany

Location

Unknown Facility

Leipzig, Germany

Location

Unknown Facility

Lünen, Germany

Location

Unknown Facility

Mainz, Germany

Location

Unknown Facility

Mannheim, Germany

Location

Unknown Facility

Marburg, Germany

Location

Unknown Facility

Münster, Germany

Location

Unknown Facility

Ravensburg, Germany

Location

Unknown Facility

Regensburg, Germany

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Unknown Facility

Schwerin, Germany

Location

Unknown Facility

Solingen, Germany

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

The study was prematurely discontinued after enrolling 184 of 200 planned participants because the study medication was no longer available.

Results Point of Contact

• Title: Head
• Organization: Clinic for Anaesthesiology, Intensive Care Unit and Pain Therapy at the Westfälische Wilhelms-Universität Münster, Albert-Schweitzer-Str. 33, 48149 Munster.

+49 251 / 83 - 4 72 52

Study Officials

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

  Janssen-Cilag G.m.b.H

  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: March 4, 2013
• First Posted: March 5, 2013
• Study Start: March 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: August 5, 2013
• Results First Posted: August 5, 2013

Record last verified: 2013-08

Locations

DE (22)