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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase IV

Supportive care

Completed

18 to 75

Other

CB1 Study 003
NCT00380965

Trial Description

Summary

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.

Further Study Information

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.

Eligibility Criteria

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 Contact Information

Trial Lead Organizations/Sponsors

Nema Research, Incorporated

Joseph V Pergolizzi, MD

Principal Investigator

Charlotte A Richmond, PhD

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00380965
Information obtained from ClinicalTrials.gov on July 16, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.