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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols
  • Peripheral Nervous System Diseases
  • Peripheral Neuropathy

NCT number NCT00380965
Study type Interventional
Source NEMA Research, Inc.
Contact
Status Completed
Phase Phase 4
Start date October 2006
Completion date October 2007

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