Neuragen® for the relief of neuropathic pain: a randomised, double-blind, placebo controlled clinical trial
| ISRCTN | ISRCTN13226601 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13226601 |
| Protocol serial number | N/A |
| Sponsor | Origin BioMed, Inc. (Canada) |
| Funder | Origin BioMed, Inc. (Canada) |
- 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 of protocol
Not provided at time of registration
Contact information
Dr Li Li
Scientific
Scientific
Department of Kinesiology
Louisiana State University
Baton Rouge
70803
United States of America
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double-blind, placebo controlled clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | Neuragen® 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. |
| Health condition(s) or problem(s) studied | Peripheral neuropathy |
| Intervention | Topical 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 type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Neuragen® |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Duration 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. |
| Completion date | 30/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 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 |
| Key exclusion criteria | 1. Pregnant 2. Have other types of pain 3. Skin condition 4. Central nerve impairment |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 30/04/2008 |
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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
