The Pain Pen for Breakthrough Cancer Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00125801
• Other study ID #: EMC 02-115
• Status: Terminated
• Phase: Phase 3
• First received: August 1, 2005
• Last updated: October 13, 2008
• Start date: August 2005
• Est. completion date: May 2008

Study information

• Verified date: October 2008
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms
• Pain

Intervention

Drug:
• Subcutaneous 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.

Locations

Country	Name	City	State
Netherlands	Dept. Neurology, Erasmus MC	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity difference (PID) at t=15 minutes		t=15 minutes	No
Secondary	PID 5'		5 min	No
Secondary	PID 30'		30 min	No
Secondary	PID 45'		45 min	No
Secondary	PID 60'		60 minutes	No
Secondary	time to onset of meaningful pain relief		time to onset	No
Secondary	global efficacy rating at 60'		60 min	No

External Links

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