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A Multicenter Trial Evaluating the Safety and Efficacy of Cesamet™ for the Symptomatic Treatment of Chemotherapy-Induced Neuropathic Pain in Patients With Cancer


Phase 4
18 Years
75 Years
Not Enrolling
Both
Peripheral Neuropathy, Antineoplastic Combined Chemotherapy Protocols

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Trial Information

A Multicenter Trial Evaluating the Safety and Efficacy of Cesamet™ for the Symptomatic Treatment of Chemotherapy-Induced Neuropathic Pain in Patients With Cancer


To determine the safety and efficacy of Cesamet™ in the symptomatic treatment of
chemotherapy-induced neuropathic pain.

This is a phase IV, multicenter, open label of Cesamet™ at 1 mg daily progressing to 2mg BID
in subjects with chemotherapy-induced neuropathic pain. This study has two phases: A
pretreatment phase and a treatment phase.


Inclusion Criteria:



- Patients diagnosed with chemotherapy-induced neuropathic pain.

- Chronic daily pain present for at least 2 months.

- On stable analgesic regimen for one month.

- Baseline pain score greater than 40mm on a VAS.

Exclusion Criteria:

- Hypersensitivity to compounds in study drug or similar drugs

- Pregnant or lactating females

- Drug or alcohol abuse

- Unstable medical condition

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:

The Average Pain Score at target site.

Principal Investigator

Joseph V Pergolizzi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NEMA Research, Inc.

Authority:

United States: Institutional Review Board

Study ID:

CB1 Study 003

NCT ID:

NCT00380965

Start Date:

October 2006

Completion Date:

October 2007

Related Keywords:

  • Peripheral Neuropathy
  • Antineoplastic Combined Chemotherapy Protocols
  • Chemotherapy-induced
  • neuropathy
  • cancer
  • Peripheral Nervous System Diseases

Name

Location

South Florida Medical ResearchAventura, Florida  33180
Naples Anesthesia and Pain AssociatesNaples, Florida  34108