Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Chemotherapy-Induced Neuropathy
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|ClinicalTrials.gov Identifier: NCT00380965|
Recruitment Status : Completed
First Posted : September 27, 2006
Last Update Posted : February 15, 2008
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Neuropathy Antineoplastic Combined Chemotherapy Protocols||Drug: Cesamet™ (nabilone)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Trial Evaluating the Safety and Efficacy of Cesamet™ for the Symptomatic Treatment of Chemotherapy-Induced Neuropathic Pain in Patients With Cancer|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2007|
- The Average Pain Score at target site.
- The Worst Pain Score at target site.
- The Pain at Night Score at target site.
- Quality of Life measures.
- Patient satisfaction with treatment.
- Safety will be assessed through the collection of AEs and vital signs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00380965
|United States, Florida|
|South Florida Medical Research|
|Aventura, Florida, United States, 33180|
|Naples Anesthesia and Pain Associates|
|Naples, Florida, United States, 34108|
|Principal Investigator:||Joseph V Pergolizzi, MD||NEMA Research, Inc.|
|Study Director:||Charlotte A Richmond, PhD||NEMA Research, Inc.|