Safety and Activity Study of Intrathecally Administered Ziconotide for Neuropathic Pain in Patients With Cancer
NCT00996983 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2023-03-24
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 a drug that is used to treat neuropathic pain in patients who have had inadequate pain control with prior combination of medicines.
Conditions
Interventions
- DRUG
-
ziconotide
intrathecal ziconotide starting at 2.4 micrograms/day, with titration daily to achieve adequate pain control up to maximum dose of 21.6 micrograms/day
Sponsors & Collaborators
-
National Cancer Institute, Naples
lead OTHER
Principal Investigators
-
Arturo Cuomo, M.D. · NCI Naples, Division of Pain Therapy
-
Gennaro Russo, M.D. · NCI Naples, Division of Pain Therapy
-
Alessandro Morabito, M.D. · NCI Naples, Clinical Trials Unit
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-09-30
- Primary Completion
- 2024-12-31
- Completion
- 2024-12-31
Countries
- Italy
Study Locations
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