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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06312254
Other study ID # N-20230071
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2024
Est. completion date August 2025

Study information

Verified date March 2024
Source Aalborg University
Contact Trine Andresen, Post.Doc
Phone 004528908551
Email trinea@hst.aau.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The present project is a human experimental study. The aim is to assess the pharmacologically modulated excitability of peripheral sensory nerves with a human experimental model. The study measures the excitability of peripheral sensory nerves before and after application of different topical drugs (lidocaine (5%), phenytoin (10%),mepyramine (2%) and placebo).


Description:

Design and method Study design The study is a randomized, double-blinded, placebo-controlled study. To minimize the risk of bias and achieve balance in the allocation of participants and application of creams, block randomization is used. To ensure double blinding, 1-2 colleagues from Center for Neuroplasticity and Pain (CNAP), who is not otherwise involved in the project, will keep the randomization list in a secure room. Study procedure and experimental test The PTT model will be used to measure the excitability of peripheral sensory afferents. PTT will be measured before and after topical drug application at four distinct areas - two at each side of the volar site of the forearms. In total four topical creams will be used in the study. One cream containing placebo, one with lidocaine (5%), one with phenytoin (10%) and one with mepyramine (2%). The study consists of one session lasting 3-4 hrs. The study will include 20 healthy volunteers.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date August 2025
Est. primary completion date February 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Men and Women age > 18 years - Understand and speak Danish - No medication besides contraceptives Exclusion Criteria: - Pregnancy or lactating women - Drug addiction (use of cannabis, opioids, or other drugs) - Use of pain killers, alcohol, or nicotine within the last 24 hours before study start - Any other medical treatment (e.g., antidepressants, anticonvulsants) - History of peripheral or chronic pain conditions / neuropathy - Skin diseases - Scars and/or tattoos at the volar site of the forearm - Previous traumatic experience of an electrical accident - Application of moisturizing lotion of the volar site of the forearms (24 hours before study start) - Participation in any other research projects/studies 7 days before study start - Known allergy/intolerance to lidocaine/phenytoin/mepyramine - Lack of ability to cooperate

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Topical lidocaine 5%
Drug is used to pharmacologically modulate peripheral sensory afferents
Topical Phenytoin 10%
Drug is used to pharmacologically modulate peripheral sensory afferents
Topical Mepyramine 2%
Drug is used to pharmacologically modulate peripheral sensory afferents
Other:
Topical Placebo
Drug is used as control

Locations

Country Name City State
Denmark Center for Neuroplasticity and Pain Aalborg

Sponsors (1)

Lead Sponsor Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in PTT-value Primary outcome measures are changes in the PTT-value (registered as mA) before and after application with topical pharmaceutical drugs. 1 hour after application of cream
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