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

Use our guide to learn which trials are right for you!

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
sites
Hershey, Pennsylvania 17033
337
mi
from 43215
Hershey, PA
Click here to add this to my saved trials
Bakersfield, California 93311
1980
mi
from 43215
Bakersfield, CA
Click here to add this to my saved trials
346
mi
from 43215
Baltimore, MD
Click here to add this to my saved trials
Billings, Montana 59101
1345
mi
from 43215
Billings, MT
Click here to add this to my saved trials
Boston, Massachusetts 02215
641
mi
from 43215
Boston, MA
Click here to add this to my saved trials
Charleston, South Carolina 29425
525
mi
from 43215
Charleston, SC
Click here to add this to my saved trials
Charleston, West Virginia 25301
134
mi
from 43215
Charleston, WV
Click here to add this to my saved trials
277
mi
from 43215
Chicago, IL
Click here to add this to my saved trials
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...
138
mi
from 43215
Cleveland, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80907
1162
mi
from 43215
Colorado Springs, CO
Click here to add this to my saved trials
Cudahy, Wisconsin 53110
324
mi
from 43215
Cudahy, WI
Click here to add this to my saved trials
Duarte, California 91010
1955
mi
from 43215
Duarte, CA
Click here to add this to my saved trials
Edina, Minnesota 55435
624
mi
from 43215
Edina, MN
Click here to add this to my saved trials
Eugene, Oregon 97401
2055
mi
from 43215
Eugene, OR
Click here to add this to my saved trials
698
mi
from 43215
Fort Smith, AR
Click here to add this to my saved trials
Hot Springs, Arkansas 71913
667
mi
from 43215
Hot Springs, AR
Click here to add this to my saved trials
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...
995
mi
from 43215
Houston, TX
Click here to add this to my saved trials
Huntington, New York 11743
508
mi
from 43215
Huntington, NY
Click here to add this to my saved trials
409
mi
from 43215
Huntsville, AL
Click here to add this to my saved trials
Kansas City, Missouri 64132
618
mi
from 43215
Kansas City, MO
Click here to add this to my saved trials
La Jolla, California 92037
1953
mi
from 43215
La Jolla, CA
Click here to add this to my saved trials
155
mi
from 43215
Lexington, KY
Click here to add this to my saved trials
Little Rock, Arkansas 72205
625
mi
from 43215
Little Rock, AR
Click here to add this to my saved trials
Los Gatos, California 95032
2095
mi
from 43215
Los Gatos, CA
Click here to add this to my saved trials
Lubbock, Texas 79430
1130
mi
from 43215
Lubbock, TX
Click here to add this to my saved trials
Marietta, Georgia 30060
423
mi
from 43215
Marietta, GA
Click here to add this to my saved trials
Memphis, Tennessee 38104
508
mi
from 43215
Memphis, TN
Click here to add this to my saved trials
Nashville, Tennessee 37203
333
mi
from 43215
Nashville, TN
Click here to add this to my saved trials
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...
480
mi
from 43215
New York, NY
Click here to add this to my saved trials
Northport, Alabama 35476
529
mi
from 43215
Northport, AL
Click here to add this to my saved trials
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...
162
mi
from 43215
Pittsburgh, PA
Click here to add this to my saved trials
Portland, Oregon 97232
2025
mi
from 43215
Portland, OR
Click here to add this to my saved trials
Providence, Rhode Island 02903
619
mi
from 43215
Providence, RI
Click here to add this to my saved trials
Salt Lake City, Utah 84107
1514
mi
from 43215
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas 78217
1129
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
San Francisco, California 94143
1982
mi
from 43215
San Francisco, CA
Click here to add this to my saved trials
2005
mi
from 43215
Seattle, WA
Click here to add this to my saved trials
Syracuse, New York 13210
414
mi
from 43215
Syracuse, NY
Click here to add this to my saved trials
830
mi
from 43215
Tampa, FL
Click here to add this to my saved trials
Temple, Pennsylvania 19560
375
mi
from 43215
Temple, PA
Click here to add this to my saved trials
Tucson, Arizona 85711
1637
mi
from 43215
Tucson, AZ
Click here to add this to my saved trials
Tulsa, Oklahoma 74137
752
mi
from 43215
Tulsa, OK
Click here to add this to my saved trials
Virginia Beach, Virginia 23454
433
mi
from 43215
Virginia Beach, VA
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
307
mi
from 43215
Winston-Salem, NC
Click here to add this to my saved trials