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Prialt (Ziconotide) In Severe Chronic Pain

NCT00047749 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2015-12-14

No results posted yet for this study

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

Interventions

DRUG

Prialt (ziconotide)

Sponsors & Collaborators

  • Elan Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-08-31
Completion
2003-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00047749 on ClinicalTrials.gov