Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
50 participants
INTERVENTIONAL
2005-08-31
2008-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Interventions
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Subcutaneous hydromorphone delivered by pain pen
Subcutaneous hydromorphone delivered by pain pen during breakthrough pain episodes, at max 4 daily. Dose established by opioid conversion from baseline opioids.
Eligibility Criteria
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Inclusion Criteria
* 1-4 breakthrough pain episodes/day
* Patients must be able, in the opinion of the investigator, to fully comply with trial requirements
* Patients who have given written informed consent
Exclusion Criteria
* Women who are pregnant, lactating or intend to become pregnant
* Cardiopulmonary disease that would increase the risk of opioids
* Neurologic or psychiatric disease that would compromise data collection
* Recently started chemotherapy or radiotherapy in as far as it would be effective in lowering breakthrough pain
18 Years
ALL
No
Sponsors
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Erasmus Medical Center
OTHER
Responsible Party
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Erasmus MC
Principal Investigators
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Joost L. Jongen, MD
Role: PRINCIPAL_INVESTIGATOR
Dept. Neurology, Erasmus MC
Locations
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Dept. Neurology, Erasmus MC
Rotterdam, , Netherlands
Countries
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References
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Enting RH, Mucchiano C, Oldenmenger WH, Fritzon M, Wallen A, Goslinga-van der Gaag S, Sillevis Smitt PA, Delhaas E. The "pain pen" for breakthrough cancer pain: a promising treatment. J Pain Symptom Manage. 2005 Feb;29(2):213-7. doi: 10.1016/j.jpainsymman.2004.05.010.
Related Links
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Related Info
Other Identifiers
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EMC 02-115
Identifier Type: -
Identifier Source: org_study_id