Opioid Rotation Versus Combination for Chronic Uncontrolled Cancer Pain

This study has been completed.
Sponsor:
Information provided by:
Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT00478101
First received: May 22, 2007
Last updated: March 12, 2008
Last verified: March 2008

May 22, 2007
March 12, 2008
February 2006
Not Provided
Change in pain score and treatment success
Same as current
Complete list of historical versions of study NCT00478101 on ClinicalTrials.gov Archive Site
Patient satisfaction
Same as current
Not Provided
Not Provided
 
Opioid Rotation Versus Combination for Chronic Uncontrolled Cancer Pain
Not Provided

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Advanced Solid Cancers
Drug: oxycodone fentanyl
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2006
April 2007
Not Provided

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00478101
GMO-SC-61
No
Not Provided
Gachon University Gil Medical Center
Not Provided
Principal Investigator: Se Hoon Park, MD Gachon University Gil Medical Center, Incheon, Korea
Gachon University Gil Medical Center
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP