Ziconotide Effectiveness and Safety Trial in Patients With Chronic Severe Pain

Completed · Phase 3

Conditions studied: Pain

In brief

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

Key facts

Study ID

NCT00076544

Run by

Elan Pharmaceuticals

People needed

300

Starts

2004-02-01

Last updated by the study team

2015-12-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Center for Pain Management — Huntsville, Alabama, United States
• Otto Uhrik, MD — Sun City West, Arizona, United States
• Outcomes Research International — Tucson, Arizona, United States
• The RC Goodman Pain Institute — Fort Smith, Arkansas, United States
• Innovative Spine Care — Little Rock, Arkansas, United States
• Shreenath Clinical Services — Beverly Hills, California, United States
• Advanced Pain Institute — Duarte, California, United States
• Shreenath Clinical Services — Lake Forest, California, United States
• Shreenath Clinical Services — Long Beach, California, United States
• Bay Area Pain Center — Los Gatos, California, United States
• Northridge Surgery & Pain Management Center — Northridge, California, United States
• Pacific Pain Medicine Consultants — Oceanside, California, United States
• Pacific Pain Treatment Centers — San Francisco, California, United States
• Galileo Surgery Center — San Luis Obispo, California, United States
• Pain Relief Center of Colorado — Arvada, Colorado, United States
• Pain Care Specialists — Colorado Springs, Colorado, United States
• Rocky Mountain Clinical Research — Golden, Colorado, United States
• Comprehensive Pain and Headache Treatment Centers, LLC — Derby, Connecticut, United States
• Florida Institute of Medical Research — Jacksonville, Florida, United States
• Space Coast Pain Institute — Merritt Island, Florida, United States
• West Gables Rehabilitation Hospital — Miami, Florida, United States
• Sarasota Pain Associates — Sarasota, Florida, United States
• Clinical Pharmacology Services — Tampa, Florida, United States
• Shepherd Center, Inc. — Atlanta, Georgia, United States
• Alabama Pain Center — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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