Neuragen® for the relief of neuropathic pain: a randomised, double-blind, placebo controlled clinical trial

ISRCTN ISRCTN13226601
DOI https://doi.org/10.1186/ISRCTN13226601
Secondary identifying numbers N/A
Submission date
09/06/2008
Registration date
13/06/2008
Last edited
25/05/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Li Li
Scientific

Department of Kinesiology
Louisiana State University
Baton Rouge
70803
United States of America

Study information

Study designRandomised, double-blind, placebo controlled clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study hypothesisNeuragen® reduces neuropathic pain more and longer than placebo.
Ethics approval(s)Ethics approval received from the Institutional Review Board of Louisiana State University as an extension of IRB#2754, approved on 28th September 2007.
ConditionPeripheral neuropathy
InterventionTopical application of Neuragen® versus 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.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Neuragen®
Primary outcome measureFoot 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.
Secondary outcome measuresDuration of pain reduction. 0 - 10 visual analogue 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.
Overall study start date01/01/2008
Overall study end date30/04/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants60
Participant inclusion criteria1. 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
Participant exclusion criteria1. Pregnant
2. Have other types of pain
3. Skin condition
4. Central nerve impairment
Recruitment start date01/01/2008
Recruitment end date30/04/2008

Locations

Countries of recruitment

  • United States of America

Study participating centre

Department of Kinesiology
Baton Rouge
70803
United States of America

Sponsor information

Origin BioMed, Inc. (Canada)
Industry

5162 Duke St, Suite 300
Halifax
B3J 1N7
Canada

Website http://originbiomed.com
ROR logo "ROR" https://ror.org/008mcnd42

Funders

Funder type

Industry

Origin BioMed, Inc. (Canada)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 20/05/2010 Yes No