Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Chemotherapy-Induced Neuropathy
Phase 4
Completed
- Conditions
- Peripheral NeuropathyAntineoplastic Combined Chemotherapy Protocols
- Registration Number
- NCT00380965
- Lead Sponsor
- NEMA Research, Inc.
- 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 progressing to 2mg BID in subjects with chemotherapy-induced neuropathic pain. This study has two phases: A pretreatment phase and a treatment phase.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The Average Pain Score at target site.
- Secondary Outcome Measures
Name Time Method Quality of Life measures. The Pain at Night Score at target site. Patient satisfaction with treatment. Safety will be assessed through the collection of AEs and vital signs. The Worst Pain Score at target site.
Trial Locations
- Locations (2)
South Florida Medical Research
🇺🇸Aventura, Florida, United States
Naples Anesthesia and Pain Associates
🇺🇸Naples, Florida, United States