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Safety and Efficacy Study of Fentanyl Iontophoretic Transdermal System (ITS) for Management of Moderate to Severe Acute Pain in Participants Who Have Undergone Elective Spine or Orthopedic Surgery

NCT00779038 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2014-05-05

Study results available
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Summary

The purpose of this study is to evaluate in daily clinical practice the safety and efficacy of fentanyl Iontophoretic Transdermal (through the skin) System (ITS) for management of moderate (medium level of seriousness) to severe (very serious) acute (a quick and severe) pain in participants who have undergone elective spine or orthopedic (related to bones) surgery.

Conditions

  • Pain, Postoperative

Interventions

DRUG

Fentanyl ITS

40 mcg per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an ITS. Total duration of treatment will be 72 hours.

Sponsors & Collaborators

  • Janssen Cilag N.V./S.A.

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag N.V./S.A., Belgium Clinical Trial · Janssen Cilag N.V./S.A.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • Belgium

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 NCT00779038 on ClinicalTrials.gov