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The Pain Pen for Breakthrough Cancer Pain - Article


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Pain, Chest

 



Clinical Trial: The Pain Pen for Breakthrough Cancer Pain

This study is currently recruiting patients.
Verified by Erasmus Medical Center August 2005

Sponsored by: Erasmus Medical Center
Information provided by: Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT00125801

Purpose

The purpose of this study is to see whether injection of hydromorfone through a subcutaneous injection device is more effective in treating breakthrough cancer pain than oral morfine.
Condition Intervention Phase
Neoplasms
Pain
  Drug: Subcutaneous hydromorphone delivered by pain pen
 Phase III

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Pain

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study

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

Further Study Details: 
Primary Outcomes: Pain intensity difference (PID) at T=15 min
Secondary Outcomes: PID 5''''; PID 10''''; PID 30''''; PID 45''''; PID 60''''; time to onset of meaningful pain relief; global efficacy rating at 60''''
Expected Total Enrollment:  50

Study start: August 2005;  Expected completion: August 2007
Last follow-up: August 2005;  Data entry closure: August 2007

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

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 chemo or radiotherapy in as far as it would be effective in lowering breakthrough pain

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00125801


Netherlands
      Dept. Neurology, Erasmus MC, Rotterdam,  3015 GD,  Netherlands; Recruiting
Joost L. Jongen, MD  +31 (10) 4635754    j.jongen@erasmusmc.nl 
Joost L. Jongen, MD,  Principal Investigator

Study chairs or principal investigators

Joost L. Jongen, MD,  Principal Investigator,  Dept. Neurology, Erasmus MC   

More Information

Publications

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.

Study ID Numbers:  EMC 02-115
Last Updated:  August 1, 2005
Record first received:  August 1, 2005
ClinicalTrials.gov Identifier:  NCT00125801
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ClinicalTrials.gov processed this record on 2005-08-02


Source: ClinicalTrials.gov
Cache Date: August 3, 2005


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November 30, 2009


Page Updated: January 17, 2009
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