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A Study to Compare Patient-controlled Pain Medications Delivered Either Through the Skin or Intravenously

NCT00996177 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 657

Last updated 2014-01-29

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effectiveness and safety of a patient-controlled system to deliver fentanyl compared with a patient-controlled intravenous system to deliver morphine in the management of postoperative pain.

Conditions

  • Pain
  • Analgesia, Patient-Controlled
  • Pain, Postoperative

Interventions

DRUG

IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem

40 µg fentanyl on-demand (240µg/hr) or a maximum of 80 doses (3.2 mg) per day

DRUG

IV Morphine Patient-Controlled Analgesia (IV PCA)

20mg/2hr (240 mg during 24 hours)

Sponsors & Collaborators

  • Alza Corporation, DE, USA

    collaborator INDUSTRY

  • Janssen-Cilag International NV

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag International NV Clinical Trial · Janssen-Cilag International NV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2005-04-30
Completion
2005-04-30

Countries

  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • Ireland
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT00996177 on ClinicalTrials.gov