Ignite Creation Date:
2024-05-06 @ 12:24 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01567345
Status:
COMPLETED
Last Update Posted:
2020-03-25
First Post:
2012-03-22
Brief Title:
Intrathecal Morphine Administration Using Implantable Pump With Continuous or Programmable Flow
Sponsor:
Institut Cancerologie de lOuest
Organization:
Institut Cancerologie de lOuest
Study Overview
Official Title:
Comparison of Two Types of Intrathecal Morphine Administration by Pump for Analgesia in Cancer Patients With Failure of Conventional Analgesic Therapy
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PITAC
Brief Summary:
The aim of this study is to compare intrathecal morphine administration using a pump with continuous or programmable flow
Detailed Description:
Cancer is frequently associated with pain In spite of recent improvements in cancer related pain treatment incidence of cancerous chronic pain did not decrease Indeed 15 to 20 of patients are still suffering from intractable pain despite an optimal symptom management
Treatment of cancer pain is generally based on the WHO analgesic ladder according to 3 steps Patients with advanced cancer are often treated at WHO step 3 analgesics ie morphine and its derivatives at high dosages But increasing the dosage of opioids also leads to accentuation of their adverse events and the corresponding risks
At this stage of the disease in patients with failure of conventional analgesic therapy intrathecal injection of analgesics can be decided in order to relieve pain 2 types of pumps allow intrathecal morphine administration continuous or programmable flow In this study we want to compare the quality of analgesia obtained through these 2 flows
Treatment of cancer pain is generally based on the WHO analgesic ladder according to 3 steps Patients with advanced cancer are often treated at WHO step 3 analgesics ie morphine and its derivatives at high dosages But increasing the dosage of opioids also leads to accentuation of their adverse events and the corresponding risks
At this stage of the disease in patients with failure of conventional analgesic therapy intrathecal injection of analgesics can be decided in order to relieve pain 2 types of pumps allow intrathecal morphine administration continuous or programmable flow In this study we want to compare the quality of analgesia obtained through these 2 flows
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2008-005087-14 | EUDRACT_NUMBER | None | None |