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NCT Number: NCT00380965

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

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.

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Key information

Conditions

Peripheral Neuropathy Antineoplastic Combined Chemotherapy Protocols Neoplasms Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

South Florida Medical Research, Aventura, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cesamet™ (nabilone)

Drug

Primary outcomes

  1. The Average Pain Score at target site.

Secondary outcomes

  1. The Worst Pain Score at target site.

  2. The Pain at Night Score at target site.

  3. Quality of Life measures.

  4. Patient satisfaction with treatment.

  5. Safety will be assessed through the collection of AEs and vital signs.

Sponsors and collaborators

Lead sponsor

NEMA Research, Inc.

Industry

Registry information

Official study title

A Multicenter Trial Evaluating the Safety and Efficacy of Cesamet™ for the Symptomatic Treatment of Chemotherapy-Induced Neuropathic Pain in Patients With Cancer

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Sep 27, 2006
Registry last updated
Feb 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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