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Prialt (Ziconotide) In Severe Chronic Pain

Primary Purpose

Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Prialt (ziconotide)
Sponsored by
Elan Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring pain, ziconotide, Prialt, intrathecal, Synchromed

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tennesee Valley Pain Consultants - Center For Pain Management
  • The Pain Center
  • Outcomes Research International
  • The RC Goodman Pain Institute: Clinical Research
  • Hot Springs Mercy Pain Clinic
  • Innovative Spine Care
  • Advanced Pain Medicine
  • Advanced Pain Institute
  • UCSD Medical Center, Thornton Hospital
  • Abaci and Massey Pain Center
  • UCSF Pain Management Center
  • Pain Care Specialists
  • Clinical Pharmacology Services, Inc.
  • Georgia Medical Research Institute
  • Rush Presbyterian - St. Luke's Medical Center
  • University of Kentucky, Dept Anesthesiology
  • Johns Hopkins Hospital, Division of Pain Management
  • Arnold Pain Management
  • Edina Medical Pain Center
  • Research Medical Center - Pain Institute
  • Yellowstone Medical Center East
  • Huntington Center for Pain Treatment
  • Weill Medical College of Cornell University
  • Medical Pain Management of Central NY
  • Center For Clinical Research
  • The Cleveland Clinic Foundation
  • Pain Institute of Tulsa
  • Pain Consultants of Oregon
  • Legacy Holladay Park Medical Center
  • Penn State University Hospital
  • Allegheny General Hospital
  • Advanced Clinical Concepts
  • Neurosurgery Foundation
  • MUSC, Neurological Surgery
  • Methodist Comprehensive Pain Institute
  • Clinical Research Associates, Inc.
  • University of Texas M.D. Anderson Cancer Center
  • Texas Tech University HSC
  • Consultants in Pain Research
  • Alpine Pain and Addiction Medicine
  • Advanced Pain Management and Rehabilitation
  • University of Washington Medical Center - Pain Center
  • Center for Pain Relief
  • Cardinal Clinical Research Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 16, 2002
Last Updated
December 10, 2015
Sponsor
Elan Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00047749
Brief Title
Prialt (Ziconotide) In Severe Chronic Pain
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study of Intrathecal Ziconotide in Adults With Severe Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Elan Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
pain, ziconotide, Prialt, intrathecal, Synchromed

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
220 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Prialt (ziconotide)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Tennesee Valley Pain Consultants - Center For Pain Management
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
The Pain Center
City
Northport
State/Province
Alabama
ZIP/Postal Code
35476
Country
United States
Facility Name
Outcomes Research International
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
The RC Goodman Pain Institute: Clinical Research
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72901
Country
United States
Facility Name
Hot Springs Mercy Pain Clinic
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Innovative Spine Care
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Advanced Pain Medicine
City
Bakersfield
State/Province
California
ZIP/Postal Code
93311
Country
United States
Facility Name
Advanced Pain Institute
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
UCSD Medical Center, Thornton Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Abaci and Massey Pain Center
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
UCSF Pain Management Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-1654
Country
United States
Facility Name
Pain Care Specialists
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Clinical Pharmacology Services, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33617
Country
United States
Facility Name
Georgia Medical Research Institute
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Rush Presbyterian - St. Luke's Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Kentucky, Dept Anesthesiology
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Johns Hopkins Hospital, Division of Pain Management
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Arnold Pain Management
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Edina Medical Pain Center
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Research Medical Center - Pain Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Yellowstone Medical Center East
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Huntington Center for Pain Treatment
City
Huntington
State/Province
New York
ZIP/Postal Code
11743
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Medical Pain Management of Central NY
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Center For Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Pain Institute of Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74137
Country
United States
Facility Name
Pain Consultants of Oregon
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Legacy Holladay Park Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97232
Country
United States
Facility Name
Penn State University Hospital
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Advanced Clinical Concepts
City
Temple
State/Province
Pennsylvania
ZIP/Postal Code
19560
Country
United States
Facility Name
Neurosurgery Foundation
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
MUSC, Neurological Surgery
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Methodist Comprehensive Pain Institute
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Clinical Research Associates, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
University of Texas M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Tech University HSC
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
Facility Name
Consultants in Pain Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Alpine Pain and Addiction Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Advanced Pain Management and Rehabilitation
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
University of Washington Medical Center - Pain Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Center for Pain Relief
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25301
Country
United States
Facility Name
Cardinal Clinical Research Center
City
Cudahy
State/Province
Wisconsin
ZIP/Postal Code
53110
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.centerwatch.com
Description
Ziconotide in severe chronic pain (search using ziconotide)

Learn more about this trial

Prialt (Ziconotide) In Severe Chronic Pain

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