Ziconotide Effectiveness and Safety Trial in Patients With Chronic Severe Pain

This study has been completed.
Sponsor:
Information provided by:
Elan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00076544
First received: January 26, 2004
Last updated: February 18, 2009
Last verified: February 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Long-Term, Multi-Center, Intrathecal Ziconotide (PRIALT) Effectiveness and Safety Trial (ZEST) in Patients With Chronic Severe Pain

Resource links provided by NLM:


Further study details as provided by Elan Pharmaceuticals:

Estimated Enrollment: 300
Study Start Date: February 2004
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
  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

No publications provided

ClinicalTrials.gov Identifier: NCT00076544     History of Changes
Other Study ID Numbers: ELN92045-501
Study First Received: January 26, 2004
Last Updated: February 18, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Elan Pharmaceuticals:
Intrathecal

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

ClinicalTrials.gov processed this record on April 16, 2014