Patient Registry of Intrathecal Ziconotide Management(PRIZM)

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Jazz Pharmaceuticals

Status

Completed

Conditions

Patients With Severe Chronic Pain

Treatments

Drug: Ziconotide

Study type

Observational

Funder types

Industry

Identifiers

NCT01888120
13-001

Details and patient eligibility

About

The objectives of this study are to evaluate the effectiveness, long-term safety, tolerability, satisfaction with treatment, and health-related quality of life (HRQoL) associated with Intrathecal PRIALT use for severe chronic pain of varying etiologies.

Enrollment

93 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient is at least 18 years of age at the time of study entry.
  • Patient who has severe chronic pain, whom IT therapy is warranted, and who is intolerant of, or refractory to other treatments, such as systemic analgesics, adjunctive therapies, and/or IT morphine.
  • Patient is planned to be initiated on IT PRIALT as the sole agent in the pump at a participated site.
  • Patient has not received PRIALT treatment administered continuously via Medtronic SynchroMed® II pump within the past 30 days.
  • Patient has a life expectancy >6 months as determined by the physician.
  • Patient is able to read, understand, and voluntarily sign the IRB-approved informed consent document prior to the performance of any study-specific procedures.
  • Patient is able to understand and complete required assessments.

Exclusion criteria

  • Patient has a known hypersensitivity to PRIALT or any of its formulation components.
  • Patient has a pre-existing history of psychosis.
  • Patient has infection at the microinjection site, uncontrolled bleeding diathesis, or known spinal canal obstruction that impairs circulation of cerebrospinal fluid.
  • Patient is being initiated with PRIALT in conjunction with other IT agents.
  • Patients with any other concomitant treatment or medical condition that, in the opinion of the clinician, would render IT administration hazardous.

Trial design

93 participants in 1 patient group

Severe Chronic Pain
Treatment:
Drug: Ziconotide

Trial contacts and locations

43

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Data sourced from clinicaltrials.gov

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