Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047749
Status:
COMPLETED
Last Update Posted:
2015-12-14
First Post:
2002-10-16
Brief Title:
Prialt Ziconotide In Severe Chronic Pain
Sponsor:
Elan Pharmaceuticals
Organization:
Elan Pharmaceuticals
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study of Intrathecal Ziconotide in Adults With Severe Chronic Pain
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to understand the effects of intrathecal ziconotide an experimental pain medication when the dose is slowly increased over a 3-week period in patients with severe chronic pain During the weaning phase the study will also gather information about switching from other intrathecal or IT medication slowly pumped directly into the space around the spine to other systemic pain medication by mouth or through the skin using a patch After being weaned off current IT medication patients will be placed on IT ziconotide or placebo non-active substance as well as being allowed a stable dose of systemic pain medications
Patients who complete this study may be eligible for long-term ziconotide therapy via extension protocol ELN92045-352
Patients who complete this study may be eligible for long-term ziconotide therapy via extension protocol ELN92045-352
Detailed Description:
None
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