Ignite Creation Date:
2024-05-06 @ 9:51 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03096444
Status:
TERMINATED
Last Update Posted:
2019-07-02
First Post:
2017-03-16
Brief Title:
Antipruritic Effect of Topical Ketamine Amitriptyline and Lidocaine
Sponsor:
Gil Yosipovitch
Organization:
University of Miami
Study Overview
Official Title:
Antipruritic Effect of Topical Ketamine Amitriptyline and Lidocaine
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Efficacy was not seen after interim analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to examine the antipruritic efficacy of topical ketamine amitriptyline lidocaine and a tri-combination of ketamine amitriptyline and lidocaine hereafter referred to as KeAmLi using non-histaminergic itch provocations in healthy volunteers The primary outcome is itch reduction AUC between the vehicle and active treatment KeAmLi-combo Secondary outcomes include modality-specific analgesic properties of the topically applied ketamine amitriptyline lidocaine and KeAmLi-combo to controlled quantitative thermal and mechanical stimuli which can improve our understanding of the mechanism of action of these substances in the context of topical therapy
Detailed Description:
This is a double-blind vehicle-controlled study to evaluate the antipruritic efficacy of topical ketamine amitriptyline lidocaine and a tri-combination of ketamine amitriptyline and lidocaine hereafter referred to as KeAmLi using non-histaminergic itch provocations in healthy volunteers Each participant will be pre-treated with the vehicle and 4 active topical creams over two study visits 3 treatments on the 1st visit and 2 treatment on the 2nd visit Each treatment will be applied to the randomized forearm test area for 30 minute and then sensory testing will be performed Sensory testing includes thermal and mechanical stimuli and itch induction using the plant cowhage These tests will reveal mechanistic information and potential cellular and molecular targets for improved antipruritic and analgesic therapies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None