Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Chemotherapy-Induced Neuropathy

NEMA Research, Inc.23 enrolled

Overview

This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain in subjects experiencing pain due to 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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral Neuropathy Antineoplastic Combined Chemotherapy Protocols

Interventions

Cesamet™ (nabilone)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

South Florida Medical Research

Aventura, Florida, United States

Naples Anesthesia and Pain Associates

Naples, Florida, United States

Outcomes

Primary Outcomes

The Average Pain Score at target site.

Secondary Outcomes

The Worst Pain Score at target site.

The Pain at Night Score at target site.

Quality of Life measures.

Patient satisfaction with treatment.

Safety will be assessed through the collection of AEs and vital signs.

Data from ClinicalTrials.gov

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