Contact information
Type
Scientific
Primary contact
Dr Li Li
ORCID ID
Contact details
Department of Kinesiology
Louisiana State University
112 Long Field House
Baton Rouge
70803
United States of America
lli3@lsu.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
32438
Study information
Scientific title
The effectiveness of Neuragen® gel versus placebo in the relief of neuropathic foot pain: a double-blind randomised placebo-controlled clinical trial
Acronym
Study hypothesis
Neuragen® gel is more effective in relieving neuropathic foot pain than placebo.
Ethics approval
Institutional Review Board of Louisiana State University approved on the 15th September 2009 (ref: 2754)
Study design
Double-blind randomised placebo-controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details provided to request a patient information sheet
Condition
Peripheral neuropathy
Intervention
This is a double blind randomised clinical trial. The company pre-packages the treatments in two identical containers labeled A and B; each contains one application of the topical Neuragen® gel and placebo. A or B will be applied to the foot sole of the participants only once each, at least seven days apart between the two applications. Foot pain will be recorded 30 minutes before, 30 minutes after and every hour on the hour for up to 8 hours.
Intervention type
Drug
Phase
Phase II/III
Drug names
Neuragen® gel
Primary outcome measures
Level of pain on a 0 - 10 visual pain scale, measured 30 minutes before and after the application of of the treatment, and every hour thereafter for 8 hours.
Secondary outcome measures
Duration of pain reduction, measured on a 0 - 10 visual pain scale which will be used every hour on the hour for up to 8 hours.
Overall trial start date
09/11/2009
Overall trial end date
31/10/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male and female aged over 21 years
2. Diagnosed with neuropathic pain more 3 months
3. Pain level between 5 - 9 on a 0 - 10 visual pain scale
4. Does not have mental and communication impairments
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Pregnant
2. Have other types of pain
3. Skin condition
4. Central nerve impairments
Recruitment start date
09/11/2009
Recruitment end date
31/10/2010
Locations
Countries of recruitment
United States of America
Trial participating centre
Department of Kinesiology
Baton Rouge
70803
United States of America
Sponsor information
Organisation
Origin BioMed, Inc. (Canada)
Sponsor details
5126 Duke Street
Suite 300
Halifax
B3J 1N7
Canada
mclellan@originbiomed.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Origin BioMed, Inc. (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary