Neuragen® gel versus placebo in the relief of neuropathic foot pain
| ISRCTN | ISRCTN37736407 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37736407 |
| Secondary identifying numbers | 32438 |
- Submission date
- 01/11/2009
- Registration date
- 09/11/2009
- Last edited
- 09/11/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Li Li
Scientific
Scientific
Department of Kinesiology
Louisiana State University
112 Long Field House
Baton Rouge
70803
United States of America
| lli3@lsu.edu |
Study information
| Study design | Double-blind randomised placebo-controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details provided to request a patient information sheet |
| Scientific title | The effectiveness of Neuragen® gel versus placebo in the relief of neuropathic foot pain: a double-blind randomised placebo-controlled clinical trial |
| Study objectives | Neuragen® gel is more effective in relieving neuropathic foot pain than placebo. |
| Ethics approval(s) | Institutional Review Board of Louisiana State University approved on the 15th September 2009 (ref: 2754) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | Neuragen® gel |
| Primary outcome measure | 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 study start date | 09/11/2009 |
| Completion date | 31/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Key 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 |
| Key exclusion criteria | 1. Pregnant 2. Have other types of pain 3. Skin condition 4. Central nerve impairments |
| Date of first enrolment | 09/11/2009 |
| Date of final enrolment | 31/10/2010 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Department of Kinesiology
Baton Rouge
70803
United States of America
70803
United States of America
Sponsor information
Origin BioMed, Inc. (Canada)
Industry
Industry
5126 Duke Street
Suite 300
Halifax
B3J 1N7
Canada
| mclellan@originbiomed.com | |
| Website | http://www.originbiomed.com/canada-en/ |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
