NCT00047749

Prialt (Ziconotide) In Severe Chronic Pain

A Randomized, Double-Blind, Placebo-Controlled Study of Intrathecal Ziconotide in Adults With Severe Chronic Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (planned)
• Sponsor: Elan Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Prialt (ziconotide)

Timeline

• Start date: 2002-08-01
• Completion: 2003-06-01
• First posted: 2002-10-17
• Last updated: 2015-12-14

Locations

44 sites across 1 country: United States