Prialt (Ziconotide) In Severe Chronic Pain



Status:Completed
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2002
End Date:June 2003

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

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.


Inclusion Criteria:

- Patient is able to read, understand, and voluntarily sign the Institutional Review
Board (IRB) approved, written informed consent document prior to the performance of
any study-specific procedures;

- Patient must be male or female at least 18 years of age;

- Patient must have severe chronic pain for whom IT therapy is warranted;

- Patient must be willing and able to comply with the protocol, and able to maintain
the Patient Daily Diary for Opioid Consumption;

- Patient must have an implanted programmable SynchroMed® Infusion System in place for
the treatment of chronic pain;

- Female patients of childbearing age agree to use adequate, appropriate contraceptive
methods.

Males and their partner(s) of childbearing age must use adequate, appropriate
contraceptive methods.

Exclusion Criteria:

- Patient is pregnant or lactating;

- Patient has been on an investigational drug other than ziconotide or device within 30
days prior to the initiation of the study drug;

- Patients with a known hypersensitivity (allergy) to ziconotide or any of the
excipients (other compounds) in the formulation;

- Patient has a condition that would contraindicate the use of IT analgesia, including
the presence of infection at the microinfusion injection site (where the needle is
inserted in your abdomen to fill the pump with medication), uncontrolled bleeding
diathesis (tendency for bleeding) and spinal canal obstruction that impairs
circulation of Cerebral Spinal Fluid.
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Bakersfield, California 93311
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Billings, Montana 59101
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Boston, Massachusetts 02215
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Charleston, South Carolina 29425
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Charleston, West Virginia 25301
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2049 E 100th St
Cleveland, Ohio 44106
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Colorado Springs, Colorado 80907
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Cudahy, Wisconsin 53110
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Edina, Minnesota 55435
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Eugene, Oregon 97401
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Hershey, Pennsylvania 17033
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Hot Springs, Arkansas 71913
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1515 Holcombe Blvd
Houston, Texas 77030
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Huntington, New York 11743
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Nashville, Tennessee 37203
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445 E 69th St
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320 E North Ave
Pittsburgh, Pennsylvania 15212
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Portland, Oregon 97232
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