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

Sponsored by:	NEMA Research, Inc.
Information provided by:	NEMA Research, Inc.
ClinicalTrials.gov Identifier:	NCT00380965

Purpose

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.

Condition	Intervention	Phase
Peripheral Neuropathy Antineoplastic Combined Chemotherapy Protocols	Drug: Cesamet™ (nabilone)	Phase IV

MedlinePlus related topics: Cancer Peripheral Nerve Disorders

Drug Information available for: Nabilone 3-(1,1-Dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6,6-dimethyl-9H-dibenzo(b,d)pyran-9-one

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by NEMA Research, Inc.:

Primary Outcome Measures:

The Average Pain Score at target site.

Secondary Outcome Measures:

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.

Estimated Enrollment:	23
Study Start Date:	October 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00380965

Locations

United States, Florida
South Florida Medical Research
Aventura, Florida, United States, 33180
Naples Anesthesia and Pain Associates
Naples, Florida, United States, 34108

Sponsors and Collaborators

NEMA Research, Inc.

Investigators

Principal Investigator:	Joseph V Pergolizzi, MD	NEMA Research, Inc.
Study Director:	Charlotte A Richmond, PhD	NEMA Research, Inc.

More Information

Nema Research website This link exits the ClinicalTrials.gov site

Study ID Numbers:	CB1 Study 003
Study First Received:	September 25, 2006
Last Updated:	February 14, 2008
ClinicalTrials.gov Identifier:	NCT00380965
Health Authority:	United States: Institutional Review Board

Keywords provided by NEMA Research, Inc.:

Chemotherapy-induced
neuropathy
cancer

Study placed in the following topic categories:

Neuromuscular Diseases
Peripheral Nervous System Diseases
Pain
Nabilone

Additional relevant MeSH terms:

Tranquilizing Agents
Nervous System Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants

Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009