Prialt (Ziconotide) In Severe Chronic Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00047749|
Recruitment Status : Completed
First Posted : October 17, 2002
Last Update Posted : December 14, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Prialt (ziconotide)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Study of Intrathecal Ziconotide in Adults With Severe Chronic Pain|
|Study Start Date :||August 2002|
|Estimated Study Completion Date :||June 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00047749
Show 44 Study Locations