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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00380913 |
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Date of registration:
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25/09/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Diabetic Peripheral Neuropathy
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Scientific title:
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A Multicenter Trial Evaluating the Efficacy of Cesamet™ for the Symptomatic Treatment of Pain in Patients With Diabetic Peripheral Neuropathy |
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Date of first enrolment:
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September 2006 |
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Target sample size:
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23 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00380913 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Joseph V Pergolizzi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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NEMA Research, Inc. |
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Name:
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Charlotte Richmond, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Nema Research |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetic Neuropathies
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Intervention(s)
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Drug: Cesamet™ (nabilone)
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Primary Outcome(s)
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The Average Pain Score at target site.
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Secondary Outcome(s)
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Safety will be assessed through the collection of AEs and vital signs.
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The Worst Pain Score at target site.
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Quality of Life measures
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The Pain at Night Score at target site.
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Patient satisfaction with treatment
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Secondary ID(s)
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CB1 Study 001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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