NCT00125801

The Pain Pen for Breakthrough Cancer Pain

Breakthrough Cancer Pain: A Randomized Trial Comparing Oral Morphine Immediate Release and Self-Administration of Subcutaneous Hydromorphone Using an Injection Pen

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Neoplasms
• Pain

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2005-08-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2005-08-02
• Last updated: 2008-10-15

Locations

1 site across 1 country: Netherlands