Status:
UNKNOWN
Safety and Activity Study of Intrathecally Administered Ziconotide for Neuropathic Pain in Patients With Cancer
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
Pain
Neuropathic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Neuropathic pain is difficult to control because it is only partially sensitive to opioid analgesics, and requires the addition of other therapies such as antidepressants and epileptics. Ziconotide is...
Detailed Description
The purpose of this study is to evaluate the effects and the tolerability of intrathecal ziconotide in cancer patients suffering from severe neuropathic pain not controlled by previous therapies.
Eligibility Criteria
Inclusion
- Diagnosis of neoplasm
- Neuropathic pain level VASPI \> or = 6 (0-10 scale)
- Inadequate pain relief with opioid analgesics and adjuvants
- Age \> or = 18 years
- Performance status ECOG 0-2
- Life expectancy at least one month
- Adequate contraception in women of child-bearing potential
- Signed Informed Consent
Exclusion
- Use of experimental drugs within previous 30 days
- Pregnancy or lactation
- Contraindication to the use of intrathecal analgesics, including active infection or conditions that could alter the circulation of cerebrospinal fluid
- Presence of cerebral metastasis
- INR \> 2
- Contraindication to the use of ziconotide
- Unable or unwilling to provide informed consent
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00996983
Start Date
September 1 2009
End Date
December 1 2024
Last Update
March 24 2023
Active Locations (1)
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1
Istituto Nazionale dei Tumori , Unita Terapia Antalgica
Napoli, Italy