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Phase II Study of Intrathecal Ziconotide for the Treatment of Neuropathic Pain in Patients With Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pain, Neuropathic Pain, Intractable Pain, Cancer

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Trial Information

Phase II Study of Intrathecal Ziconotide for the Treatment of Neuropathic Pain in Patients With Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (> 30% reduction in VASPI)

Outcome Time Frame:

48 hours after completion of titration phase

Safety Issue:

No

Principal Investigator

Arturo Cuomo, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

NCI Naples, Division of Pain Therapy

Authority:

Italy: Ethics Committee

Study ID:

ZIDON

NCT ID:

NCT00996983

Start Date:

September 2009

Completion Date:

May 2013

Related Keywords:

  • Pain
  • Neuropathic Pain
  • Intractable Pain
  • Cancer
  • Neuralgia
  • Pain, Intractable

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