Viewing Study NCT00478101



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Last Modification Date: 2024-10-26 @ 9:33 AM
Study NCT ID: NCT00478101
Status: COMPLETED
Last Update Posted: 2008-03-13
First Post: 2007-05-22

Brief Title: Opioid Rotation Versus Combination for Chronic Uncontrolled Cancer Pain
Sponsor: Gachon University Gil Medical Center
Organization: Gachon University Gil Medical Center

Study Overview

Official Title: None
Status: COMPLETED
Status Verified Date: 2008-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
Detailed Description: Patients with uncontrolled cancer pain despite treatment of oral morphine equivalent 100 mgd 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None