PainPhase 3NCT00076544
Ziconotide Effectiveness and Safety Trial in Patients With Chronic Severe Pain
A Phase 3 study testing Ziconotide in people with Pain, run by Elan Pharmaceuticals at 65 sites in United States.
Trial summary
The purpose of this open-label study is to give chronic severe pain patients with existing intrathecal pump systems access to ziconotide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Ziconotide
- How many people
- 300 participants
- Where
- 65 sitesUnited States
- Study dates
- Feb 2004to Mar 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Each patient must have chronic severe pain of malignant or nonmalignant etiology with inadequate pain relief from or intolerance to conventional therapy.
- Each patient must have a predicted life expectancy of greater than or equal to 6 weeks relative to baseline.
- Each patient must be able to respond to the Visual Analog Scale of Pain Intensity (VASPI).
- Each patient must have an implanted programmable SynchroMed infusion device or a CADD-Micro external programmable infusion device and spinal catheter (hereafter "IT pump and spinal catheter") prior to enrollment into this trial. (If a patient has an external pump, the Investigator must ensure that the patient is at a low risk for infection and that the patient is capable of maintaining good personal hygiene. The Investigator must have demonstrated the ability to successfully manage patients with external pumps prior to enrolling a patient in this trial.)
- Each patient must be at least 18 years of age.
- Each patient must be competent to give written informed consent and has given written informed consent prior to performance of any study-related procedures. Reasonable accommodation of visually impaired patients will be allowed.
- Each patient is willing and able to comply with the protocol requirements.
- Each female patient of childbearing potential must agree to use adequate contraceptive methods while on PRIALT as determined by the Investigator.
Who cannot join
- Presence of pregnancy or lactation.
- Participation in another investigational drug or device trial within the preceding 30 days.
- Presence of known hypersensitivity to PRIALT or any of its components.
- Presence of any contraindication to continued IT therapy (for example, infection at the pump or catheter externalization site, uncontrolled bleeding diathesis, spinal canal obstruction that impairs cerebrospinal fluid [CSF] circulation, or patient and caregiver inability to manage and protect the IT pump and spinal catheter system and return for clinic follow up visits).
- Presence of any condition (for example, psychosis, severe depression or suicidal ideation, homicidality, somatization disorder, active substance abuse, cognitive deficits, dementia or other serious medical or psychiatric condition) that in the Investigator's opinion precludes the patient's ability to participate in this study.
Trial locations and contacts
65 sites in 1 country.
65 sites in 1 country
United States65 sites
Avera St. Luke's Hospital
Aberdeen, South Dakota, 57401
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
Pain Relief Center of Colorado
Arvada, Colorado, 80002
Shepherd Center, Inc.
Atlanta, Georgia, 30309
All Island Pain Consultants
Bay Shore, New York, 11706
Cohn Pain Management Center
Bethpage, New York, 11714
Shreenath Clinical Services
Beverly Hills, California, 90211
Roswell Park Cancer Institute
Buffalo, New York, 14263
The Center for Pain Relief
Charleston, West Virginia, 25301
Pain Management Center, University of Virginia
Charlottesville, Virginia, 22903
The University of Chicago, Dept. of Surgery, Section of Neurosurgery
Chicago, Illinois, 60637
Pain Care Specialists
Colorado Springs, Colorado, 80907
Dallas Spine Care P.A.
Dallas, Texas, 75235
Advanced Pain Medicine
Dallas, Texas, 75237
Comprehensive Pain and Headache Treatment Centers, LLC
Derby, Connecticut, 06418
Wayne State University - School of Medicine
Detroit, Michigan, 48201
Advanced Pain Institute
Duarte, California, 91010
Duke Medical Center Pain Clinic
Durham, North Carolina, 27705
Pain Consultants of Oregon
Eugene, Oregon, 97401
The RC Goodman Pain Institute
Fort Smith, Arkansas, 72901
The University of Texas Medical Branch
Galveston, Texas, 77555
Rocky Mountain Clinical Research
Golden, Colorado, 80401
Cincinnati Centers for Pain Relief, Inc.
Hamilton, Ohio, 45011
The Center for Pain Medicine
Hattiesburg, Mississippi, 39402
Alabama Pain Center
Huntsville, Alabama, 35801
Center for Pain Management
Huntsville, Alabama, 35801
Pain Management Associates, Clinical Research
Independence, Missouri, 64055
Indianapolis Neurosurgical Group
Indianapolis, Indiana, 46202
University of Iowa Health Care
Iowa City, Iowa, 52242
Florida Institute of Medical Research
Jacksonville, Florida, 32207
Shreenath Clinical Services
Lake Forest, California, 92630
Pain Management - Anesthesiology
Las Vegas, Nevada, 89117
University of Kentucky
Lexington, Kentucky, 40536
Innovative Spine Care
Little Rock, Arkansas, 72205
Shreenath Clinical Services
Long Beach, California, 90807
Bay Area Pain Center
Los Gatos, California, 95032
Pain Control Network, PSC/PCN Surgical Suites, LLC
Louisville, Kentucky, 40205
International Pain Institute
Lubbock, Texas, 79413
Comprehensive Pain Care, PC
Marietta, Georgia, 30060
Space Coast Pain Institute
Merritt Island, Florida, 32953
West Gables Rehabilitation Hospital
Miami, Florida, 33155
Medical Advanced Pain Specialists (MAPS)
Minneapolis, Minnesota, 55433
NYU Pain Management Center
New York, New York, 10016
New York Presbyterian Hospital/Cornell Medical Center
New York, New York, 10021
Northridge Surgery & Pain Management Center
Northridge, California, 91324
Pacific Pain Medicine Consultants
Oceanside, California, 92056
Magee Rehabilitation
Philadelphia, Pennsylvania, 19102
American Pain & Wellness, PA
Plano, Texas, 75093
Pain Management Consultants, PC
Portland, Oregon, 97225
Lifetree Clinical Research
Salt Lake City, Utah, 84106
University of Utah Pain Management Center
Salt Lake City, Utah, 84108
Consultants in Pain Research, PA
San Antonio, Texas, 78217
Pacific Pain Treatment Centers
San Francisco, California, 94109
Galileo Surgery Center
San Luis Obispo, California, 93405
Sarasota Pain Associates
Sarasota, Florida, 34243
Dr. O'Connell's Pain Care Centers, Inc.
Somersworth, New Hampshire, 03878
Carolinas Center for Advanced Management of Pain
Spartanburg, South Carolina, 29302
St. John's Regional Healthcare
Springfield, Missouri, 65804
Otto Uhrik, MD
Sun City West, Arizona, 85373
Medical Pain Management of Central New York
Syracuse, New York, 13210
Clinical Pharmacology Services
Tampa, Florida, 33617
Outcomes Research International
Tucson, Arizona, 85712
PETC Research Group, Inc.
Tulsa, Oklahoma, 74137
Des Moines Orthopedic Surgeons
West Des Moines, Iowa, 50266
The Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: An Open-Label, Long-Term, Multi-Center, Intrathecal Ziconotide (PRIALT) Effectiveness and Safety Trial (ZEST) in Patients With Chronic Severe Pain
The purpose of this open-label study is to give chronic severe pain patients with existing intrathecal pump systems access to ziconotide.
- Conditions
- Pain
- Being tested
- Ziconotide
- Keywords
- Intrathecal
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZiconotideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2004 (estimated)
- Study startFeb 2004
- Primary completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Elan Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00076544
- Sponsor's protocol ID
- ELN92045-501
- Status last verified
- Dec 2015
- First submitted
- 26 Jan 2004
- Last updated
- 14 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Long-Term, Multi-Center, Intrathecal Ziconotide (PRIALT) Effectiveness and Safety Trial (ZEST) in Patients With Chronic Severe Pain
- ClinicalTrials.gov ID
- NCT00076544
- Acronym / sponsor ID
- ELN92045-501
- Conditions
- Pain
- Keywords
- Intrathecal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Elan PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Mar 2005 (actual)
- First posted
- 4 Feb 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this open-label study is to give chronic severe pain patients with existing intrathecal pump systems access to ziconotide.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Each patient must have chronic severe pain of malignant or nonmalignant etiology with inadequate pain relief from or intolerance to conventional therapy.
- Each patient must have a predicted life expectancy of greater than or equal to 6 weeks relative to baseline.
- Each patient must be able to respond to the Visual Analog Scale of Pain Intensity (VASPI).
- Each patient must have an implanted programmable SynchroMed infusion device or a CADD-Micro external programmable infusion device and spinal catheter (hereafter "IT pump and spinal catheter") prior to enrollment into this trial. (If a patient has an external pump, the Investigator must ensure that the patient is at a low risk for infection and that the patient is capable of maintaining good personal hygiene. The Investigator must have demonstrated the ability to successfully manage patients with external pumps prior to enrolling a patient in this trial.)
- Each patient must be at least 18 years of age.
Key exclusion criteria (5 listed)
- Presence of pregnancy or lactation.
- Participation in another investigational drug or device trial within the preceding 30 days.
- Presence of known hypersensitivity to PRIALT or any of its components.
- Presence of any contraindication to continued IT therapy (for example, infection at the pump or catheter externalization site, uncontrolled bleeding diathesis, spinal canal obstruction that impairs cerebrospinal fluid [CSF] circulation, or patient and caregiver inability to manage and protect the IT pump and spinal catheter system and return for clinic follow up visits).
- Presence of any condition (for example, psychosis, severe depression or suicidal ideation, homicidality, somatization disorder, active substance abuse, cognitive deficits, dementia or other serious medical or psychiatric condition) that in the Investigator's opinion precludes the patient's ability to participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ziconotide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
65 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ziconotide in people with Pain, run by Elan Pharmaceuticals at 65 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.