The Pain Pen for Breakthrough Cancer Pain

This study has been terminated.
(Lack of patients)
Sponsor:
Information provided by:
Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT00125801
First received: August 1, 2005
Last updated: October 13, 2008
Last verified: October 2008
  Purpose

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 Intervention Phase
Neoplasms
Pain
Drug: Subcutaneous hydromorphone delivered by pain pen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • Pain intensity difference (PID) at t=15 minutes [ Time Frame: t=15 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PID 5' [ Time Frame: 5 min ] [ Designated as safety issue: No ]
  • PID 30' [ Time Frame: 30 min ] [ Designated as safety issue: No ]
  • PID 45' [ Time Frame: 45 min ] [ Designated as safety issue: No ]
  • PID 60' [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
  • time to onset of meaningful pain relief [ Time Frame: time to onset ] [ Designated as safety issue: No ]
  • global efficacy rating at 60' [ Time Frame: 60 min ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2005
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 chemotherapy or radiotherapy in as far as it would be effective in lowering breakthrough pain
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125801

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

Additional Information:
Publications:
Responsible Party: Dr. Joost L.M. Jongen, Erasmus MC
ClinicalTrials.gov Identifier: NCT00125801     History of Changes
Other Study ID Numbers: EMC 02-115
Study First Received: August 1, 2005
Last Updated: October 13, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Neoplasms
Hydromorphone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on July 28, 2014