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


Phase 3
18 Years
N/A
Not Enrolling
Both
Neoplasms, Pain

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Pain intensity difference (PID) at t=15 minutes

Outcome Time Frame:

t=15 minutes

Safety Issue:

No

Principal Investigator

Joost L. Jongen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dept. Neurology, Erasmus MC

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

EMC 02-115

NCT ID:

NCT00125801

Start Date:

August 2005

Completion Date:

May 2008

Related Keywords:

  • Neoplasms
  • Pain
  • Neoplasms

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