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An Open-Label, Long-Term, Multi-Center, Intrathecal Ziconotide (PRIALT) Effectiveness and Safety Trial (ZEST) in Patients With Chronic Severe Pain


Phase 3
18 Years
N/A
Not Enrolling
Both
Pain

Thank you

Trial Information

An Open-Label, Long-Term, Multi-Center, Intrathecal Ziconotide (PRIALT) Effectiveness and Safety Trial (ZEST) in Patients With Chronic Severe Pain


Inclusion Criteria:



- 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.

Exclusion Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

ELN92045-501

NCT ID:

NCT00076544

Start Date:

February 2004

Completion Date:

Related Keywords:

  • Pain
  • Intrathecal

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Lehigh Valley HospitalAllentown, Pennsylvania  18103
University of KentuckyLexington, Kentucky  40536-0098
Outcomes Research InternationalTucson, Arizona  85711
Innovative Spine CareLittle Rock, Arkansas  72205
Advanced Pain InstituteDuarte, California  91010
Pain Care SpecialistsColorado Springs, Colorado  80907
Pain Consultants of OregonEugene, Oregon  97401
Clinical Pharmacology ServicesTampa, Florida  
Alabama Pain CenterHuntsville, Alabama  35801
Center for Pain ManagementHuntsville, Alabama  35801
Otto Uhrik, MDSun City West, Arizona  85373
The RC Goodman Pain InstituteFort Smith, Arkansas  72901
Shreenath Clinical ServicesBeverly Hills, California  90211
Bay Area Pain CenterLos Gatos, California  95032
Northridge Surgery & Pain Management CenterNorthridge, California  91324
Pacific Pain Medicine ConsultantsOceanside, California  92056
Pacific Pain Treatment CentersSan Francisco, California  94109
Galileo Surgery CenterSan Luis Obispo, California  93405
Pain Relief Center of ColoradoArvada, Colorado  80002
Rocky Mountain Clinical ResearchGolden, Colorado  80401
Comprehensive Pain and Headache Treatment Centers, LLCDerby, Connecticut  06418
Florida Institute of Medical ResearchJacksonville, Florida  32207
Space Coast Pain InstituteMerritt Island, Florida  32953
West Gables Rehabilitation HospitalMiami, Florida  33155
Sarasota Pain AssociatesSarasota, Florida  34243
Shepherd Center, Inc.Atlanta, Georgia  30309
Comprehensive Pain Care, PCMarietta, Georgia  30060
The University of Chicago, Dept. of Surgery, Section of NeurosurgeryChicago, Illinois  60637
Indianapolis Neurosurgical GroupIndianapolis, Indiana  46202
University of Iowa Health CareIowa City, Iowa  52242
Des Moines Orthopedic SurgeonsWest Des Moines, Iowa  50266
Pain Control Network, PSC/PCN Surgical Suites, LLCLouisville, Kentucky  40205
Wayne State University - School of MedicineDetroit, Michigan  48201
Medical Advanced Pain Specialists (MAPS)Minneapolis, Minnesota  55433
The Center for Pain MedicineHattiesburg, Mississippi  39402
Pain Management Associates, Clinical ResearchIndependence, Missouri  64055
St. John's Regional HealthcareSpringfield, Missouri  65804
Pain Management - AnesthesiologyLas Vegas, Nevada  89117
Dr. O'Connell's Pain Care Centers, Inc.Somersworth, New Hampshire  03878
All Island Pain ConsultantsBay Shore, New York  11706
Cohn Pain Management CenterBethpage, New York  11714
New York Presbyterian Hospital/Cornell Medical CenterNew York, New York  10021
NYU Pain Management CenterNew York, New York  10016
Medical Pain Management of Central New YorkSyracuse, New York  13210
Duke Medical Center Pain ClinicDurham, North Carolina  27705
The Center for Clinical ResearchWinston-Salem, North Carolina  27103
Cincinnati Centers for Pain Relief, Inc.Hamilton, Ohio  45011
PETC Research Group, Inc.Tulsa, Oklahoma  74137
Pain Management Consultants, PCPortland, Oregon  97225
Magee RehabilitationPhiladelphia, Pennsylvania  19102
Carolinas Center for Advanced Management of PainSpartanburg, South Carolina  29302
Avera St. Luke's HospitalAberdeen, South Dakota  57401
Dallas Spine Care P.A.Dallas, Texas  75235
Advanced Pain MedicineDallas, Texas  75237
The University of Texas Medical BranchGalveston, Texas  77555
International Pain InstituteLubbock, Texas  79413
American Pain & Wellness, PAPlano, Texas  75093
Consultants in Pain Research, PASan Antonio, Texas  78217
Lifetree Clinical ResearchSalt Lake City, Utah  84106
University of Utah Pain Management CenterSalt Lake City, Utah  84108
Pain Management Center, University of VirginiaCharlottesville, Virginia  22903
The Center for Pain ReliefCharleston, West Virginia  25301