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

NEMA Research

Status and phase: Completed; Phase 4

Conditions: Peripheral Neuropathy; Antineoplastic Combined Chemotherapy Protocols

Treatments: Drug: Cesamet™ (nabilone)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00380965

CB1 Study 003

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 23 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)