Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125801
Status:
TERMINATED
Last Update Posted:
2008-10-15
First Post:
2005-08-01
Brief Title:
The Pain Pen for Breakthrough Cancer Pain
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Breakthrough Cancer Pain A Randomized Trial Comparing Oral Morphine Immediate Release and Self-Administration of Subcutaneous Hydromorphone Using an Injection Pen
Status:
TERMINATED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None