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

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

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.

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