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Safety and Activity Study of Intrathecally Administered Ziconotide for Neuropathic Pain in Patients With Cancer (ZIDON)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00996983
First Posted: October 16, 2009
Last Update Posted: March 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute, Naples
September 30, 2009
October 16, 2009
March 29, 2017
September 2009
September 2017   (Final data collection date for primary outcome measure)
Response rate (> 30% reduction in VASPI) [ Time Frame: 48 hours after completion of titration phase ]
Same as current
Complete list of historical versions of study NCT00996983 on ClinicalTrials.gov Archive Site
  • toxicity [ Time Frame: daily during drug titration, weekly thereafter ]
  • duration of analgesic response [ Time Frame: weekly ]
Same as current
Not Provided
Not Provided
 
Safety and Activity Study of Intrathecally Administered Ziconotide for Neuropathic Pain in Patients With Cancer
Phase II Study of Intrathecal Ziconotide for the Treatment of Neuropathic Pain in Patients With Cancer
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.
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.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Pain
  • Neuropathic Pain
  • Intractable Pain
  • Cancer
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
Experimental: A
Intervention: Drug: ziconotide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
16
July 2018
September 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00996983
ZIDON
EudraCT number: 2008-005307-26
No
Not Provided
Not Provided
National Cancer Institute, Naples
National Cancer Institute, Naples
Not Provided
Principal Investigator: Arturo Cuomo, M.D. NCI Naples, Division of Pain Therapy
Principal Investigator: Gennaro Russo, M.D. NCI Naples, Division of Pain Therapy
Principal Investigator: Alessandro Morabito, M.D. NCI Naples, Clinical Trials Unit
National Cancer Institute, Naples
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP