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

No results posted yet for this study

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00996983 on ClinicalTrials.gov