The Pain Pen for Breakthrough Cancer Pain

• Status: Terminated
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasmus Medical Center
• Treatments: Hydromorphone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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