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Ziconotide Effectiveness and Safety Trial in Patients With Chronic Severe Pain
This study is ongoing, but not recruiting participants.
Sponsored by: Elan Pharmaceuticals
Information provided by: Elan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00076544
  Purpose

The purpose of this open-label study is to give chronic severe pain patients with existing intrathecal pump systems access to ziconotide.


Condition Intervention Phase
Pain
Drug: Ziconotide
Phase III

Drug Information available for: SNX 111
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Safety Study
Official Title: An Open-Label, Long-Term, Multi-Center, Intrathecal Ziconotide (PRIALT) Effectiveness and Safety Trial (ZEST) in Patients With Chronic Severe Pain

Further study details as provided by Elan Pharmaceuticals:

Estimated Enrollment: 300
Study Start Date: February 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00076544

  Show 65 Study Locations
Sponsors and Collaborators
Elan Pharmaceuticals
  More Information

Study ID Numbers: ELN92045-501
Study First Received: January 26, 2004
Last Updated: February 2, 2007
ClinicalTrials.gov Identifier: NCT00076544  
Health Authority: United States: Food and Drug Administration

Keywords provided by Elan Pharmaceuticals:
Intrathecal

Study placed in the following topic categories:
Calcium, Dietary
Ziconotide
Pain

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Calcium Channel Blockers
Cardiovascular Agents
Neuroprotective Agents
Protective Agents
Pharmacologic Actions
Membrane Transport Modulators
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009