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

NCT01804673 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2013-08-05

Study results available
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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

Interventions

DRUG

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.

Sponsors & Collaborators

  • Janssen-Cilag G.m.b.H

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01804673 on ClinicalTrials.gov