The Pain Pen for Breakthrough Cancer Pain

Phase 3TerminatedNCT00125801

Erasmus Medical Center50 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Neoplasms Pain

Interventions

Subcutaneous hydromorphone delivered by pain penDRUG

Subcutaneous hydromorphone delivered by pain pen during breakthrough pain episodes, at max 4 daily. Dose established by opioid conversion from baseline opioids.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Dept. Neurology, Erasmus MC

Rotterdam, Netherlands

Outcomes

Primary Outcomes

Pain intensity difference (PID) at t=15 minutes

Time frame: t=15 minutes

Secondary Outcomes

PID 5'

Time frame: 5 min

PID 30'

Time frame: 30 min

PID 45'

Time frame: 45 min

PID 60'

Time frame: 60 minutes

time to onset of meaningful pain relief

Time frame: time to onset

global efficacy rating at 60'

Time frame: 60 min

Data from ClinicalTrials.gov

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