NCT00478101

Brief Summary

For cancer patients with inadequate pain relief, a switch to an alternative opioid is the preferred option for symptomatic improvement. However, multiple opioids are often simultaneously administered for anecdotal reasons. The present study isdesigned to assess the analgesic profiles of two different strategies in chronic cancer pain: the opioid rotation from oxycodone to transdermal fentanyl and the combination of oral oxycodone and transdermal fentanyl.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,006

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_2

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

February 1, 2006

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2007

Completed
Last Updated

March 13, 2008

Status Verified

March 1, 2008

First QC Date

May 22, 2007

Last Update Submit

March 12, 2008

Conditions

Advanced Solid Cancers

Keywords

Pain

Outcome Measures

Primary Outcomes (1)

  • Change in pain score and treatment success

Secondary Outcomes (1)

  • Patient satisfaction

Interventions

oxycodone fentanylDRUG

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic Uncontrolled Pain That Required Stronger Opioid Therapy Than They Have Been Taking
  • Histologically Confirmed Solid Cancer
  • Aged Over 18 Years
  • Admitted in a Palliative Cancer Care Unit

You may not qualify if:

  • Uspected to Have Narcotic Abuse, Clinically Relevant CO2 Retention or Had an Active Skin Disease
  • Inability to swallow oral medication, and impaired sensory or cognitive function
  • Patients who had an active infection, uncontrolled central nervous system involvement, or on antitumor therapy of any kind

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kim HJ, Kim YS, Park SH. Opioid rotation versus combination for cancer patients with chronic uncontrolled pain: a randomized study. BMC Palliat Care. 2015 Sep 16;14:41. doi: 10.1186/s12904-015-0038-7.

    PMID: 26377913DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Se Hoon Park, MD

    Gachon University Gil Medical Center, Incheon, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 22, 2007

First Posted

May 24, 2007

Study Start

February 1, 2006

Study Completion

April 1, 2007

Last Updated

March 13, 2008

Record last verified: 2008-03