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| Sponsor: | Elan Pharmaceuticals |
|---|---|
| Information provided by: | Elan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00047749 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: Prialt (ziconotide) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study of Intrathecal Ziconotide in Adults With Severe Chronic Pain |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Males and their partner(s) of childbearing age must use adequate, appropriate contraceptive methods.
Exclusion Criteria:
Contacts and Locations
Show 44 Study Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00047749 History of Changes |
| Other Study ID Numbers: | ELN92045-301 |
| Study First Received: | October 16, 2002 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
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pain ziconotide Prialt intrathecal Synchromed |
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Ziconotide Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Neuroprotective Agents |
Protective Agents Physiological Effects of Drugs Central Nervous System Agents Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |