The Pain Pen for Breakthrough Cancer Pain

Condition(s) targeted: Neoplasms; Pain

Intervention: Subcutaneous hydromorphone delivered by pain pen (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Erasmus Medical Center

Official(s) and/or principal investigator(s):
Joost L. Jongen, MD, Principal Investigator, Affiliation: Dept. Neurology, Erasmus MC

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.

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study

Primary outcome: Pain intensity difference (PID) at t=15 minutes

Secondary outcome:

PID 5'

PID 10'

PID 30'

PID 45'

PID 60'

time to onset of meaningful pain relief

global efficacy rating at 60'

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Dept. Neurology, Erasmus MC, Rotterdam 3015 GD, Netherlands; Recruiting
Joost L. Jongen, MD, Phone: +31 (10) 4635754, Email: j.jongen@erasmusmc.nl
Joost L. Jongen, MD, Principal Investigator

Related publications:

Enting RH, Mucchiano C, Oldenmenger WH, Fritzon M, Wallen A, Goslinga-van der Gaag S, Sillevis Smitt PA, Delhaas E. The "pain pen" for breakthrough cancer pain: a promising treatment. J Pain Symptom Manage. 2005 Feb;29(2):213-7.

Starting date: August 2005
Ending date: August 2008
Last updated: April 10, 2007