The Pain Pen for Breakthrough Cancer Pain

Phase 3

Terminated

• Conditions: Neoplasms; Pain

• Registration Number: NCT00125801
• Lead Sponsor: Erasmus Medical Center

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 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.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-08-01
• Study First Submitted QC: 2005-08-01
• Study First Posted: 2005-08-02
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-13
• Last Update Posted: 2008-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Pain intensity difference (PID) at t=15 minutes	t=15 minutes

Secondary Outcome Measures

Name	Time	Method
PID 45'	45 min
PID 5'	5 min
PID 30'	30 min
PID 60'	60 minutes
time to onset of meaningful pain relief	time to onset
global efficacy rating at 60'	60 min

Trial Locations

Locations (1)

Dept. Neurology, Erasmus MC; 🇳🇱 Rotterdam, Netherlands