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ISRCTN
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ISRCTN08911796
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ClinicalTrials.gov identifier
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Public title
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Neuragen® for the relief of neuropathic pain part 2: a randomised, double-blind, placebo controlled clinical trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Neuragen® with a different amount of effective ingredients will reduce neuropathic pain more than the placebo whilst having different levels of effectiveness.
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Ethics approval
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Ethics approval received from the Institutional Review Board of Louisiana State University as an extension of IRB#2754, approved on 28th September 2007.
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Study design
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Randomised, double-blind, placebo controlled clinical trial
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Countries of recruitment
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United States of America
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Disease/condition/study domain
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Peripheral neuropathy
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Participants - inclusion criteria
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1. Male and female, over 21 years
2. Diagnosed neuropathic pain for more three months
3. Pain level between 3 - 8 on a 0 - 10 visual pain scale
4. Does not have mental and communication impairments
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Participants - exclusion criteria
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1. Pregnant
2. Have other types of pain
3. Skin condition
4. Central nerve impairment
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Anticipated start date
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19/05/2008
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Anticipated end date
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27/09/2008
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Status of trial
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Completed
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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60
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Interventions
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Topical application of Neuragen® with different amounts of effective ingredients versus a placebo. The medicine was sprayed onto the subjects feet at the sole and on top of the feet. One time application with an 8-hour follow-up.
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Primary outcome measure(s)
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Foot sole pain on 11-point numerical pain scale. 0 - 10 visual analog scale was use to document pain level at 30 minutes before and after the administration of the medication, with 8-hour follow up every hour on the hour.
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Secondary outcome measure(s)
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Duration of pain reduction. 0 - 10 visual analog scale was use to document pain level at 30 minutes before and after the administration of the medication, with 8-hour follow up every hour on the hour.
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Sources of funding
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Origin BioMed, Inc. (Canada)
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Trial website
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Publications
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Contact name
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Dr
Li
Li
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Address
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Department of Kinesiology
Louisiana State University
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City/town
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Baton Rouge
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Zip/Postcode
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70803
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Country
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United States of America
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Sponsor
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Origin BioMed, Inc. (Canada)
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Address
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5162 Duke St, Suite 300
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City/town
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Halifax
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Zip/Postcode
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B3J 1N7
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Country
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Canada
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Sponsor website:
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http://www.originbiomed.com/
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Date applied
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09/06/2008
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Last edited
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13/06/2008
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Date ISRCTN assigned
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13/06/2008
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