The Pain Pen for Breakthrough Cancer Pain
Primary Purpose
Neoplasms, Pain
Status
Terminated
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Subcutaneous hydromorphone delivered by pain pen
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasms
Eligibility 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
Sites / Locations
- Dept. Neurology, Erasmus MC
Outcomes
Primary Outcome Measures
Pain intensity difference (PID) at t=15 minutes
Secondary Outcome Measures
PID 5'
PID 30'
PID 45'
PID 60'
time to onset of meaningful pain relief
global efficacy rating at 60'
Full Information
NCT ID
NCT00125801
First Posted
August 1, 2005
Last Updated
October 13, 2008
Sponsor
Erasmus Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00125801
Brief Title
The Pain Pen for Breakthrough Cancer Pain
Official Title
Breakthrough Cancer Pain: A Randomized Trial Comparing Oral Morphine Immediate Release and Self-Administration of Subcutaneous Hydromorphone Using an Injection Pen
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Terminated
Why Stopped
Lack of patients
Study Start Date
August 2005 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Erasmus Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Subcutaneous hydromorphone delivered by pain pen
Intervention Description
Subcutaneous hydromorphone delivered by pain pen during breakthrough pain episodes, at max 4 daily. Dose established by opioid conversion from baseline opioids.
Primary Outcome Measure Information:
Title
Pain intensity difference (PID) at t=15 minutes
Time Frame
t=15 minutes
Secondary Outcome Measure Information:
Title
PID 5'
Time Frame
5 min
Title
PID 30'
Time Frame
30 min
Title
PID 45'
Time Frame
45 min
Title
PID 60'
Time Frame
60 minutes
Title
time to onset of meaningful pain relief
Time Frame
time to onset
Title
global efficacy rating at 60'
Time Frame
60 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joost L. Jongen, MD
Organizational Affiliation
Dept. Neurology, Erasmus MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. Neurology, Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
15733812
Citation
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. doi: 10.1016/j.jpainsymman.2004.05.010.
Results Reference
background
Links:
URL
http://www.erasmusmc.nl/neurologie/
Description
Related Info
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The Pain Pen for Breakthrough Cancer Pain
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