Condition category
Nervous System Diseases
Date applied
09/06/2008
Date assigned
13/06/2008
Last edited
13/06/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Li Li

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Neuragen® with a different amount of effective ingredients will reduce neuropathic pain more than the placebo whilst having different levels of effectiveness.

Ethics approval

Ethics approval received from the Institutional Review Board of Louisiana State University as an extension of IRB#2754, approved on 28th September 2007.

Study design

Randomised, double-blind, placebo controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Peripheral neuropathy

Intervention

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.

Intervention type

Drug

Phase

Not Specified

Drug names

Neuragen®

Primary outcome measures

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.

Secondary outcome measures

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.

Overall trial start date

19/05/2008

Overall trial end date

27/09/2008

Reason abandoned

Eligibility

Participant 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

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 impairment

Recruitment start date

19/05/2008

Recruitment end date

27/09/2008

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

5162 Duke St
Suite 300
Halifax
B3J 1N7
Canada

Sponsor type

Industry

Website

http://www.originbiomed.com/

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

Publication citations

Additional files

Editorial Notes