Opioid Rotation Versus Combination for Chronic Uncontrolled Cancer Pain

This study has been completed.

First Received: May 22, 2007 Last Updated: March 12, 2008 History of Changes

Sponsored by:	Gachon University Gil Medical Center
Information provided by:	Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:	NCT00478101

Purpose

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.

Condition	Intervention	Phase
Advanced Solid Cancers	Drug: oxycodone fentanyl	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Oxycodone Fentanyl

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:

Change in pain score and treatment success

Secondary Outcome Measures:

Patient satisfaction

Enrollment:	2006
Study Start Date:	February 2006
Study Completion Date:	April 2007

Detailed Description:

Patients with uncontrolled cancer pain despite treatment of oral morphine equivalent ≥100 mg/d will be randomly assigned to oral opioids to transdermal fentanyl (rotation group) or oral oxycodone plus fentanyl (combination group). Patients answer a questionnaire that included pain severity (0 to 10) and interference items at baseline and after one week. Primary outcomes are change in pain score and treatment success.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478101

Sponsors and Collaborators

Gachon University Gil Medical Center

Investigators

Principal Investigator:

Se Hoon Park, MD

Gachon University Gil Medical Center, Incheon, Korea

More Information

No publications provided

Study ID Numbers:	GMO-SC-61
Study First Received:	May 22, 2007
Last Updated:	March 12, 2008
ClinicalTrials.gov Identifier:	NCT00478101 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Gachon University Gil Medical Center:

Pain

Study placed in the following topic categories:

Fentanyl
Oxycodone
Pain

ClinicalTrials.gov processed this record on May 07, 2009