- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00380913
Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Diabetic Peripheral Neuropathy
February 14, 2008 updated by: NEMA Research, Inc.
A Multicenter Trial Evaluating the Efficacy of Cesamet™ for the Symptomatic Treatment of Pain in Patients With Diabetic Peripheral Neuropathy
This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain in subjects experiencing pain due to diabetic peripheral neuropathy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Anticipated)
23
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Aventura, Florida, United States, 33180
- South Florida Medical Research
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Hollywood, Florida, United States, 33021
- Sunrise Clinical Research, Inc.
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Naples, Florida, United States, 34108
- Naples Anesthesia and Pain Associates
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West Palm Beach, Florida, United States, 33407
- Lazlo Mate, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Hypersensitivity to compounds in study drug or similar drugs
- Pregnant or lactating females
- Drug or alcohol abuse
- Unstable medical condition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The Average Pain Score at target site.
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Secondary Outcome Measures
Outcome Measure |
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Patient satisfaction with treatment
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The Worst Pain Score at target site.
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The Pain at Night Score at target site.
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Safety will be assessed through the collection of AEs and vital signs.
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Quality of Life measures
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Charlotte Richmond, PhD, NEMA Research
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
September 25, 2006
First Submitted That Met QC Criteria
September 25, 2006
First Posted (Estimate)
September 27, 2006
Study Record Updates
Last Update Posted (Estimate)
February 15, 2008
Last Update Submitted That Met QC Criteria
February 14, 2008
Last Verified
February 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Endocrine System Diseases
- Diabetes Complications
- Diabetes Mellitus
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Diabetic Neuropathies
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Anti-Anxiety Agents
- Nabilone
Other Study ID Numbers
- CB1 Study 001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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