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Ziconotide Effectiveness and Safety Trial in Patients With Chronic Severe Pain
This study has been completed.
Study NCT00076544   Information provided by Elan Pharmaceuticals
First Received: January 26, 2004   Last Updated: February 18, 2009   History of Changes

January 26, 2004
February 18, 2009
February 2004
March 2005   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00076544 on ClinicalTrials.gov Archive Site
 
 
 
Ziconotide Effectiveness and Safety Trial in Patients With Chronic Severe Pain
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.

 
Phase III
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Safety Study
Pain
Drug: Ziconotide
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
300
 
March 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00076544
 
ELN92045-501
Elan Pharmaceuticals
 
 
Elan Pharmaceuticals
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP