Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Diabetic Peripheral 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: NCT00380913|
Recruitment Status : Completed
First Posted : September 27, 2006
Last Update Posted : February 15, 2008
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|Condition or disease||Intervention/treatment||Phase|
|Diabetic Neuropathies||Drug: Cesamet™ (nabilone)||Phase 4|
The purpose of this study is to determine the safety and efficacy of Cesamet™ in the symptomatic treatment of pain due to diabetic peripheral neuropathy.
This is a phase IV, multi-center, open label outpatient clinical trial evaluating Cesamet™ treatment for control of pain due diabetic peripheral neuropathy. The study has two phases: a Pretreatment Phase and a Treatment Phase.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Trial Evaluating the Efficacy of Cesamet™ for the Symptomatic Treatment of Pain in Patients With Diabetic Peripheral Neuropathy|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2007|
- The Average Pain Score at target site.
- 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.
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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|
- Patients with diabetic peripheral 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 visual analog scale
- Hypersensitivity to compounds in study drug or similar drugs
- Pregnant or lactating females
- Drug or alcohol abuse
- Unstable medical condition
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): NCT00380913
|United States, Florida|
|South Florida Medical Research|
|Aventura, Florida, United States, 33180|
|Sunrise Clinical Research, Inc.|
|Hollywood, Florida, United States, 33021|
|Naples Anesthesia and Pain Associates|
|Naples, Florida, United States, 34108|
|Lazlo Mate, MD|
|West Palm Beach, Florida, United States, 33407|
|Principal Investigator:||Joseph V Pergolizzi, MD||NEMA Research, Inc.|
|Study Director:||Charlotte Richmond, PhD||Nema Research|
|Responsible Party:||Joseph Pergolizzi, MD, NEMA Research|
|Other Study ID Numbers:||
CB1 Study 001
|First Posted:||September 27, 2006 Key Record Dates|
|Last Update Posted:||February 15, 2008|
|Last Verified:||February 2008|
Peripheral Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants