Back to resultsEvaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Chemotherapy-Induced Neuropathy
Primary Purpose
Peripheral Neuropathy, Antineoplastic Combined Chemotherapy Protocols
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cesamet™ (nabilone)
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Neuropathy focused on measuring Chemotherapy-induced, neuropathy, cancer
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
Sites / Locations
- South Florida Medical Research
- Naples Anesthesia and Pain Associates
Outcomes
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.
Full Information
NCT ID
NCT00380965
First Posted
September 25, 2006
Last Updated
February 14, 2008
Sponsor
NEMA Research, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00380965
Brief Title
Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Chemotherapy-Induced Neuropathy
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 Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
NEMA Research, Inc.
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy, Antineoplastic Combined Chemotherapy Protocols
Keywords
Chemotherapy-induced, neuropathy, cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cesamet™ (nabilone)
Primary Outcome Measure Information:
Title
The Average Pain Score at target site.
Secondary Outcome Measure Information:
Title
The Worst Pain Score at target site.
Title
The Pain at Night Score at target site.
Title
Quality of Life measures.
Title
Patient satisfaction with treatment.
Title
Safety will be assessed through the collection of AEs and vital signs.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph V Pergolizzi, MD
Organizational Affiliation
NEMA Research, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charlotte A Richmond, PhD
Organizational Affiliation
NEMA Research, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Naples Anesthesia and Pain Associates
City
Naples
State/Province
Florida
ZIP/Postal Code
34108
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.nema.net
Description
Nema Research website
Learn more about this trial
Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Chemotherapy-Induced Neuropathy
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