The Pain Pen for Breakthrough Cancer Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00125801
Recruitment Status : Terminated (Lack of patients)
First Posted : August 2, 2005
Last Update Posted : October 15, 2008
Information provided by:
Erasmus Medical Center

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.

Condition or disease Intervention/treatment Phase
Neoplasms Pain Drug: Subcutaneous hydromorphone delivered by pain pen Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Breakthrough Cancer Pain: A Randomized Trial Comparing Oral Morphine Immediate Release and Self-Administration of Subcutaneous Hydromorphone Using an Injection Pen
Study Start Date : August 2005
Primary Completion Date : May 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    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.

Primary Outcome Measures :
  1. Pain intensity difference (PID) at t=15 minutes [ Time Frame: t=15 minutes ]

Secondary Outcome Measures :
  1. PID 5' [ Time Frame: 5 min ]
  2. PID 30' [ Time Frame: 30 min ]
  3. PID 45' [ Time Frame: 45 min ]
  4. PID 60' [ Time Frame: 60 minutes ]
  5. time to onset of meaningful pain relief [ Time Frame: time to onset ]
  6. global efficacy rating at 60' [ Time Frame: 60 min ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00125801

Dept. Neurology, Erasmus MC
Rotterdam, Netherlands, 3015 GD
Sponsors and Collaborators
Erasmus Medical Center
Principal Investigator: Joost L. Jongen, MD Dept. Neurology, Erasmus MC

Additional Information:
Responsible Party: Dr. Joost L.M. Jongen, Erasmus MC Identifier: NCT00125801     History of Changes
Other Study ID Numbers: EMC 02-115
First Posted: August 2, 2005    Key Record Dates
Last Update Posted: October 15, 2008
Last Verified: October 2008

Additional relevant MeSH terms:
Cancer Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents