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Prialt (Ziconotide) In Severe Chronic Pain

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ClinicalTrials.gov Identifier: NCT00047749
Recruitment Status : Completed
First Posted : October 17, 2002
Last Update Posted : December 14, 2015
Information provided by:
Elan Pharmaceuticals

Brief Summary:

The purpose of this study is to understand the effects of intrathecal ziconotide (an experimental pain medication) when the dose is slowly increased over a 3-week period in patients with severe chronic pain. During the weaning phase, the study will also gather information about switching from other intrathecal or IT medication (slowly pumped directly into the space around the spine) to other systemic pain medication (by mouth or through the skin using a patch). After being weaned off current IT medication, patients will be placed on IT ziconotide or placebo (non-active substance) as well as being allowed a stable dose of systemic pain medications.

Patients who complete this study may be eligible for long-term ziconotide therapy via extension protocol ELN92045-352.

Condition or disease Intervention/treatment Phase
Pain Drug: Prialt (ziconotide) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Intrathecal Ziconotide in Adults With Severe Chronic Pain
Study Start Date : August 2002
Estimated Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
Drug Information available for: Ziconotide
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient is able to read, understand, and voluntarily sign the Institutional Review Board (IRB) approved, written informed consent document prior to the performance of any study-specific procedures;
  • Patient must be male or female at least 18 years of age;
  • Patient must have severe chronic pain for whom IT therapy is warranted;
  • Patient must be willing and able to comply with the protocol, and able to maintain the Patient Daily Diary for Opioid Consumption;
  • Patient must have an implanted programmable SynchroMed® Infusion System in place for the treatment of chronic pain;
  • Female patients of childbearing age agree to use adequate, appropriate contraceptive methods.

Males and their partner(s) of childbearing age must use adequate, appropriate contraceptive methods.

Exclusion Criteria:

  • Patient is pregnant or lactating;
  • Patient has been on an investigational drug other than ziconotide or device within 30 days prior to the initiation of the study drug;
  • Patients with a known hypersensitivity (allergy) to ziconotide or any of the excipients (other compounds) in the formulation;
  • Patient has a condition that would contraindicate the use of IT analgesia, including the presence of infection at the microinfusion injection site (where the needle is inserted in your abdomen to fill the pump with medication), uncontrolled bleeding diathesis (tendency for bleeding) and spinal canal obstruction that impairs circulation of Cerebral Spinal Fluid.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00047749

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Sponsors and Collaborators
Elan Pharmaceuticals

Additional Information:
ClinicalTrials.gov Identifier: NCT00047749     History of Changes
Other Study ID Numbers: ELN92045-301
First Posted: October 17, 2002    Key Record Dates
Last Update Posted: December 14, 2015
Last Verified: December 2015

Keywords provided by Elan Pharmaceuticals:

Additional relevant MeSH terms:
Chronic Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents