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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Keywords provided by Gachon University Gil Medical Center:
Pain

Additional relevant MeSH terms:
Fentanyl
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on August 18, 2014