19 Years
N/A
Both
Advanced Solid Cancers
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Change in pain score and treatment success
Principal Investigator
Se Hoon Park, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Gachon University Gil Medical Center, Incheon, Korea
Authority:
Korea: Food and Drug Administration
Study ID:
GMO-SC-61
NCT ID:
NCT00478101
Start Date:
February 2006
Completion Date:
April 2007
Related Keywords:
- Advanced Solid Cancers
- Pain
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