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| Tracking Information | |
|---|---|
| First Received Date ICMJE | October 16, 2002 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | August 2002 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00047749 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Prialt (Ziconotide) In Severe Chronic Pain |
| Official Title ICMJE | A Randomized, Double-Blind, Placebo-Controlled Study of Intrathecal Ziconotide in Adults With Severe Chronic Pain |
| 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. |
| Detailed Description | |
| Study Phase | Phase III |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study |
| Condition ICMJE | Pain |
| Intervention ICMJE | Drug: Prialt (ziconotide) |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 220 |
| Completion Date | June 2003 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Males and their partner(s) of childbearing age must use adequate, appropriate contraceptive methods. Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00047749 |
| Responsible Party | |
| Study ID Numbers ICMJE | ELN92045-301 |
| Study Sponsor ICMJE | Elan Pharmaceuticals |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | Elan Pharmaceuticals |
| Verification Date | October 2003 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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