Current partner codePEPTIDESDE
NCT00076544·Phase 3·INTERVENTIONAL

Ziconotide Effectiveness and Safety Trial in Patients With Chronic Severe Pain

Status

Completed

Phase

Phase 3

Enrollment

300

Locations

65

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Interventions

Treatment arms and agents.

DRUG

Ziconotide

Timeline

From registration to results.

  1. First posted

    Feb 4, 2004

  2. Study start

    Feb 2004

  3. Primary completion

    Mar 2005

  4. Study completion

    Not reported

  5. Results posted

    Not reported

  6. Registry updated

    Dec 14, 2015

Outcomes

What the study measures.

Primary outcomes

Not reported in the indexed record.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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.

Study locations

65 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Alabama Pain Center

Huntsville, Alabama, United States

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

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Ziconotide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.