Status:
TERMINATED
The Pain Pen for Breakthrough Cancer Pain
Lead Sponsor:
Erasmus Medical Center
Conditions:
Neoplasms
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- Stable cancer pain requiring the equivalent of 60-1000 mg oral morphine/day
- 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
- Uncontrolled pain
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00125801
Start Date
August 1 2005
End Date
May 1 2008
Last Update
October 15 2008
Active Locations (1)
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1
Dept. Neurology, Erasmus MC
Rotterdam, Netherlands, 3015 GD