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

August 1, 2005
August 2, 2005
October 15, 2008
August 2005
May 2008   (Final data collection date for primary outcome measure)
Pain intensity difference (PID) at t=15 minutes [ Time Frame: t=15 minutes ]
Pain intensity difference (PID) at T=15 min
Complete list of historical versions of study NCT00125801 on Archive Site
  • 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 ]
  • PID 5'
  • PID 10'
  • PID 30'
  • PID 45'
  • PID 60'
  • time to onset of meaningful pain relief
  • global efficacy rating at 60'
Not Provided
Not Provided
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
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.

Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Neoplasms
  • Pain
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.
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2008
May 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
EMC 02-115
Not Provided
Not Provided
Dr. Joost L.M. Jongen, Erasmus MC
Erasmus Medical Center
Not Provided
Principal Investigator: Joost L. Jongen, MD Dept. Neurology, Erasmus MC
Erasmus Medical Center
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP