Safety Study of Levocetirizine and Fexofenadine

NCT01586091 | Completed Phase 4 Results DMC

• 1 other identifier: 2010-022747-38
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Pruritus; Chronic Urticaria; Allergic Rhinitis

Outcome Measures

Primary Outcomes (3)

• Pruritus as Assessed by the VAS Score

  We measured drug concentrations and various aspects of skin provocation testing such as itch intensity and wheal size. Measurements made at each time point were as followed: Pruritus was assessed every 30 s for 10 min after SPT using a visual analogue scale (VAS) score with a "0" and "100" at the two ex- tremes of an unmarked 100 mm line with higher values indicating greater puritus. The mean VAS for each 10 min was calculated and used as a primary end Point.

  up to 10 minutes after skin prick test performed 24 hours after drug administration

• Flaire Diameter (mm)

  Flaire diameter was measured with a transparent ruler as the mean of the largest diameter and the diameter at right angles to this.

  24 hours per treatment

• Wheal Volume (cm3)

  Wheal volume was measured by a non-contact three dimensional measurement system (PRIMOS contact, GFM Messtechnik GmbH, Teltow, Germany).

  24 hours per treatment

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo per os at time 0 hours + placebo per os at 12 hours.

Drug: Placebo Oral Tablet

Levocetirizin

ACTIVE COMPARATOR

Levocetirizin 5mg at time 0 and placebo per os at 12 hours

Drug: Levocetirizine Oral Tablet; Drug: Placebo Oral Tablet

Fexofenadine

ACTIVE COMPARATOR

Fexofenadine 60mg per os at time 0 hours + fexofenadine 60mg per os at 12 hours

Drug: Fexofenadine 60 Mg Oral Tablet

Interventions

Levocetirizine Oral Tablet DRUG

Levocetirizin

Fexofenadine 60 Mg Oral Tablet DRUG

Also known as: Telfast

Fexofenadine

Placebo Oral Tablet DRUG

Also known as: Lichtenstein

Levocetirizin; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eighteen (18) healthy male volunteers, including at least 6 persons of Japanese origin, will be recruited for this study

You may not qualify if:

• None of the subjects will have taken oral antihistamines, antidepressants, antipsychotics or corticosteroids or applied topical antihistamines, corticosteroids or mast cell stabilizers to the skin for 2 weeks prior to testing.
• No subject shall perform physical exercise for 4 hours prior to the skin prick testing.

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

University of Berlin Charité, Department of Dermatology and Allergy

Berlin, 10117, Germany

Location

Related Publications (1)

• Schoepke N, Church MK, Maurer M. The inhibition by levocetirizine and fexofenadine of the histamine-induced wheal and flare response in healthy Caucasian and Japanese volunteers. Acta Derm Venereol. 2013 May;93(3):286-93. doi: 10.2340/00015555-1490.

  PMID: 23147964 DERIVED

MeSH Terms

Conditions

Pruritus; Chronic Urticaria; Rhinitis, Allergic

Interventions

levocetirizine; fexofenadine; Tablets

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urticaria; Skin Diseases, Vascular; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Professor Marcus Maurer
• Organization: University of Charité Berlin; Dpt. of Dermatology and Allergy

marcus.maurer@charite.de

+49 30 450 518 043

Study Officials

• Marcus Maurer, MD

  Charite Universitätsmedizin Berlin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: April 23, 2012
• First Posted: April 26, 2012
• Study Start: February 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: February 1, 2012
• Last Updated: October 4, 2019
• Results First Posted: October 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)