Condition category
Nervous System Diseases
Date applied
01/11/2009
Date assigned
09/11/2009
Last edited
09/11/2009
Prospective/Retrospective
Prospectively 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
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

http://www.originbiomed.com/canada-en/

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