- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00478101
Opioid Rotation Versus Combination for Chronic Uncontrolled Cancer Pain
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Change in pain score and treatment success
|
Secondary Outcome Measures
Outcome Measure |
---|
Patient satisfaction
|
Collaborators and Investigators
Investigators
- Principal Investigator: Se Hoon Park, MD, Gachon University Gil Medical Center, Incheon, Korea
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GMO-SC-61
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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