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Breakthrough Cancer Pain: A Randomized Trial Comparing Oral Morphine Immediate Release and Self-Administration of Subcutaneous Hydromorphone Using an Injection Pen
The purpose of this study is to see whether injection of hydromorphone through a subcutaneous injection device is more effective in treating breakthrough cancer pain than oral morphine.
Breakthrough pain is an exacerbation of severe pain that occurs on a background of otherwise controlled pain. Breakthrough pain is common in patients with advanced cancer. Current medications to treat breakthrough pain include oral immediate release opioid formulations and more recently oral transmucosal fentanyl citrate. The pain pen study is a randomized controlled double blind cross-over study comparing the efficacy of oral immediate release morphine with that of subcutaneous hydromorphone, injected through a so called pain pen, on breakthrough pain in cancer patients. Preliminary experience with the pain pen suggests that it has a more rapid time of onset of pain relief than oral formulations.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Dept. Neurology, Erasmus MC
Rotterdam, Netherlands
Start Date
August 1, 2005
Primary Completion Date
May 1, 2008
Completion Date
May 1, 2008
Last Updated
October 15, 2008
50
ESTIMATED participants
Subcutaneous hydromorphone delivered by pain pen
DRUG
Lead Sponsor
Erasmus Medical Center
NCT06346132
NCT00026884
Data Source & Attribution
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