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.
We found this trial at
44
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Charleston, West Virginia 25301
880
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Charleston, WV
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Bakersfield, California 93311
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Baltimore, MD
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Billings, Montana 59101
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Billings, MT
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Boston, Massachusetts 02215
1442
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Boston, MA
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Charleston, South Carolina 29425
1064
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Charleston, SC
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608
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Chicago, IL
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
898
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Cleveland, OH
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Colorado Springs, Colorado 80907
386
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Cudahy, Wisconsin 53110
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Duarte, California 91010
1152
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Duarte, CA
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Edina, Minnesota 55435
544
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Edina, MN
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Eugene, Oregon 97401
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Eugene, OR
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250
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Fort Smith, AR
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Hershey, Pennsylvania 17033
1147
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Hershey, PA
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Hot Springs, Arkansas 71913
347
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Hot Springs, AR
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
572
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Houston, TX
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Huntington, New York 11743
1317
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661
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Huntsville, AL
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Kansas City, Missouri 64132
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La Jolla, California 92037
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725
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Lexington, KY
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Little Rock, Arkansas 72205
368
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Los Gatos, California 95032
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Lubbock, Texas 79430
367
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Marietta, Georgia 30060
787
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Marietta, GA
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Memphis, Tennessee 38104
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Memphis, TN
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Nashville, Tennessee 37203
618
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Nashville, TN
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445 E 69th St
New York, New York 10021
(212) 746-1067
Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
1289
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Northport, Alabama 35476
654
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Northport, AL
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
971
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Portland, Oregon 97232
1382
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Providence, Rhode Island 02903
1424
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Salt Lake City, Utah 84107
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Salt Lake City, UT
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San Antonio, Texas 78217
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San Francisco, California 94143
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1410
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Syracuse, New York 13210
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Tampa, FL
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Temple, Pennsylvania 19560
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Tucson, Arizona 85711
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Tulsa, Oklahoma 74137
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Virginia Beach, Virginia 23454
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Winston-Salem, North Carolina 27103
973
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Winston-Salem, NC
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