NCT00576017

Brief Summary

To show, using the analgesic WHO scale, that fentanyl-TTS may be directly used for treating moderate to severe cancer pain in patients treated with NSAIDs, acetaminophen, or metamizole (first step drugs) avoiding the second step, and may be at least as effective and safe as currently used second step drugs, minor opioids.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_4 pain

Timeline
Completed

Started Oct 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 18, 2007

Completed
Last Updated

May 19, 2011

Status Verified

April 1, 2010

First QC Date

December 14, 2007

Last Update Submit

May 18, 2011

Conditions

Pain

Keywords

Cancer pain treatmentFentanyl TTSDihydrocodeineTramadolCancer painDurogesicUltram

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint was the control of pain during treatment. Pain was assessed by the visual analogue scale. Pain severity was assessed at each follow-up visit.

Secondary Outcomes (1)

  • The secondary endpoint was to assess the advantages of using fentanyl-TTS after the first step of the WHO analgesic ladder as compared to minor opioids.

Interventions

Fentanyl-TTSDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with moderate to severe chronic pain due to the oncological condition, defined as VAS =\> 5, treated with first step drugs, either NSAIDs or acetaminophen or metamizole (the dose of first step drugs requiring a switch in treatment is left to the physician's discretion)
  • Patients with a documented histological diagnosis of cancer.

You may not qualify if:

  • Patients whose pain has some neuropathic component
  • Patients who have been treated with opioids during the 2 months prior to study entry
  • Patients with dermatological disease, a history of allergy or hypersensitivity to fentanyl or to adhesive components preventing use of patches
  • Patients with a history of cardiac, CNS, or respiratory disease that prevents their participation in the study in the investigator's judgment
  • Patients with kidney or liver failure contraindicating use of opioids based on medical criterion
  • Pregnant women or women of childbearing age who do not use an effective contraceptive method throughout the study
  • Patients in whom surgery is planned during the study
  • Patients who are participating at the same time in another trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

PainCancer Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial

    Janssen-Cilag, S.A.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 14, 2007

First Posted

December 18, 2007

Study Start

October 1, 2003

Study Completion

March 1, 2005

Last Updated

May 19, 2011

Record last verified: 2010-04