Status:
COMPLETED
Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Chemotherapy-Induced Neuropathy
Lead Sponsor:
NEMA Research, Inc.
Conditions:
Peripheral Neuropathy
Antineoplastic Combined Chemotherapy Protocols
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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.
Detailed 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 progressi...
Eligibility Criteria
Inclusion
- 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
- Hypersensitivity to compounds in study drug or similar drugs
- Pregnant or lactating females
- Drug or alcohol abuse
- Unstable medical condition
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2007
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00380965
Start Date
October 1 2006
End Date
October 1 2007
Last Update
February 15 2008
Active Locations (2)
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1
South Florida Medical Research
Aventura, Florida, United States, 33180
2
Naples Anesthesia and Pain Associates
Naples, Florida, United States, 34108