Ziconotide Effectiveness and Safety Trial in Patients With Chronic Severe Pain
This study has been completed.
Information provided by:
First received: January 26, 2004
Last updated: December 10, 2015
Last verified: December 2015
The purpose of this open-label study is to give chronic severe pain patients with existing intrathecal pump systems access to ziconotide.
Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
||An Open-Label, Long-Term, Multi-Center, Intrathecal Ziconotide (PRIALT) Effectiveness and Safety Trial (ZEST) in Patients With Chronic Severe Pain
| Estimated Enrollment:
| Study Start Date:
| Primary Completion Date:
||March 2005 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00076544
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 26, 2004
||December 10, 2015
||United States: Food and Drug Administration
Keywords provided by Elan Pharmaceuticals:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 28, 2016
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents