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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00125801

Enrollment

Registered

2005-08-02

Start date

2005-08-31

Completion date

2008-05-31

Last updated

2008-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms, Pain

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.

Interventions

DRUGSubcutaneous 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Pain intensity difference (PID) at t=15 minutes	t=15 minutes

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026