Safety and Activity Study of Intrathecally Administered Ziconotide for Neuropathic Pain in Patients With Cancer
This trial is active, not recruiting.
|Conditions||pain, neuropathic pain, intractable pain, cancer|
|Sponsor||National Cancer Institute, Naples|
|Start date||September 2009|
|End date||July 2016|
|Trial size||16 participants|
|Trial identifier||NCT00996983, EudraCT number: 2008-005307-26, ZIDON|
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 a drug that is used to treat neuropathic pain in patients who have had inadequate pain control with prior combination of medicines.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Response rate (> 30% reduction in VASPI)
time frame: 48 hours after completion of titration phase
time frame: daily during drug titration, weekly thereafter
duration of analgesic response
time frame: weekly
Male or female participants at least 18 years old.
Inclusion Criteria: - 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 Criteria: - 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
|Official title||Phase II Study of Intrathecal Ziconotide for the Treatment of Neuropathic Pain in Patients With Cancer|
|Principal investigator||Arturo Cuomo, M.D.|
|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.|
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