Ignite Creation Date:
2024-05-06 @ 12:29 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01586091
Status:
COMPLETED
Last Update Posted:
2019-10-04
First Post:
2012-04-23
Brief Title:
Safety Study of Levocetirizine and Fexofenadine
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
Comparison of Efficacy and Consistency of Action of Levocetirizine 5 mg Once Daily With Fexofenadine 60 mg Twice Daily in the Histamine Induced Wheal Flare and Itch Response
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LAWAF
Brief Summary:
This Study is to comparison of Efficacy and Consistency of Action of Levocetirizine 5 mg once daily with Fexofenadine 60 mg twice daily in the histamine induced wheal flare and itch Response
Detailed Description:
This will be a randomized double-blind placebo-controlled study with intra-individual comparison of the histamine induced wheal and flare reaction In September 2009 Fexofenadine was approved as an antihistamine against allergies in Japan and it is currently used widely It has been approved in 120 countries including the US UK France and Germany 11 In Europe and the United States fexofenadine is marketed at 120 mg once daily for allergic rhinitis and 180mg once daily for urticaria In Japan fexofenadine is marketed at 60 mg twice daily for both conditions But is this dosage regimen as effective as levocetirizine 5 mg once daily The above described study from Takahashi et al comparing 60 mg twice daily versus cetirizine 10 mg once daily suggests that it is not 4 The aim of the study is to compare the efficacy and consistency of action of levocetirizine 5 mg once daily with fexofenadine 60 mg twice daily over a 24 hour period in the histamine induced wheal flare and itch response Furthermore we would like to investigate whether a different between Japanese and Caucasian exists or not Each volunteer will receive the study medication at time point 0 and 12 hour later Skin Prick Test SPT will be performed in each volunteer using histamine 10 mgml 15 minutes before drug admission baseline and at 05 1 2 3 4 6 8 10 12 and 24 hours afterwards Volumetric optical scanning system and infrared camera will be used for objective evaluation of the wheal- and flare reduction Additionally measurement of the erythema diameter with a transparent ruler will be performed The subjective intensity of itching will be assessed using a Visual Analogue Scale VAS To relate the pharmacokinetics of the drugs to their pharmacodynamics blood samples for assay of drug concentrations will be taken at baseline and at 05 1 2 3 4 6 8 10 12 and 24 hours later Subjects will undergo the same procedure on three separate occasions to receive each treatment option The options are placebo at time 0 hours placebo at 12 hours Levocetirizine 5mg at time 0 hours placebo at 12 hours or fexofenadine 60mg at time 0 hours fexofenadine 60mg at 12 hours There will be a washout period of at least 6 days between the treatments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None