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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00380965
Recruitment Status : Completed
First Posted : September 27, 2006
Last Update Posted : February 15, 2008
Sponsor:
Information provided by:
NEMA Research, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Peripheral Neuropathy Antineoplastic Combined Chemotherapy Protocols Drug: Cesamet™ (nabilone) Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Nabilone

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. The Average Pain Score at target site.

Secondary Outcome Measures :
  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.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


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

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ClinicalTrials.gov Identifier: NCT00380965    
Other Study ID Numbers: CB1 Study 003
First Posted: September 27, 2006    Key Record Dates
Last Update Posted: February 15, 2008
Last Verified: February 2008
Keywords provided by NEMA Research, Inc.:
Chemotherapy-induced
neuropathy
cancer
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nabilone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Gastrointestinal Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs