The Pain Pen for Breakthrough Cancer Pain

Last updated: October 13, 2008
Sponsor: Erasmus Medical Center
Overall Status: Terminated

Phase

3

Condition

Neoplasms

Cancer Pain

Chronic Pain

Treatment

N/A

Clinical Study ID

NCT00125801
EMC 02-115
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 trialrequirements

  • Patients who have given written informed consent

Exclusion

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 inlowering breakthrough pain

Study Design

Total Participants: 50
Study Start date:
August 01, 2005
Estimated Completion Date:
May 31, 2008

Study 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.

Connect with a study center

  • Dept. Neurology, Erasmus MC

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

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