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Search / Trial NCT00380965

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

Launched by NEMA RESEARCH, INC. · Sep 25, 2006

Trial Information

Current as of May 19, 2025

Completed

Keywords

Chemotherapy Induced Neuropathy Cancer

ClinConnect Summary

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.

Gender

ALL

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

About Nema Research, Inc.

Nema Research, Inc. is a leading clinical trial sponsor dedicated to advancing medical innovation through rigorous research and development. With a focus on therapeutic areas including oncology, neurology, and rare diseases, the company is committed to conducting high-quality clinical trials that adhere to regulatory standards and ethical guidelines. Nema Research leverages a robust network of experienced investigators and cutting-edge technology to accelerate the drug development process, ensuring the delivery of safe and effective treatment options to patients in need. Through collaboration and a patient-centered approach, Nema Research aims to contribute significantly to the future of healthcare.

Locations

Aventura, Florida, United States

Naples, Florida, United States

Patients applied

0 patients applied

Trial Officials

Joseph V Pergolizzi, MD

Principal Investigator

NEMA Research, Inc.

Charlotte A Richmond, PhD

Study Director

NEMA Research, Inc.

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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