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Fexofenadine HCl 180 mg, Desloratadine 5 mg and Placebo in Suppression of Wheal and Flare Induced by Histamine | Clinical Trials | Clareo Health

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Fexofenadine HCl 180 mg, Desloratadine 5 mg and Placebo in Suppression of Wheal and Flare Induced by Histamine

A Comparison of Fexofenadine HCl 180 mg, Desloratadine 5 mg and Placebo in Suppression of Wheal and Flare Induced by Histamine

NCT00637585•Sanofi

View on ClinicalTrials.gov

Summary

To examine the relative potency, onset of action and duration of action of fexofenadine HCl 180 mg (ALLEGRA) and desloratadine 5 mg (CLARINEX) as compared to placebo on skin wheals and flares induced by histamine.

Eligibility

Age

12 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female subjects, 12 to 55 years of age, may participate
•Positive histamine skin prick tests (or duplicate histamine skin prick test) with a summation flare (ΣF) greater than or equal to 20 mm larger than diluent control, and summation wheal (ΣW) greater than or equal to 6 mm larger than diluent control at the screening visit 1
•All female subjects must have a negative urine pregnancy test at the screening visit
•Female subjects who are sexually active will be expected to use one of the following birth control methods throughout the study (see Section 4.4)
•Subjects must be within 15% of normal body weight for height or a BMI less than 29.9 (based on NHLBI guidelines)
•Subjects willing and able to adhere to visit schedules and all study requirements
•All female subjects must have a negative urine pregnancy test at each treatment visit (Visit 2, 4, and 6).

Exclusion Criteria

•Asthma that requires treatment with medication other than an inhaled, short-acting beta agonist
•Signs and symptoms of currently active allergic disease (seasonal allergic rhinitis, perennial allergic rhinitis, episodic allergic rhinitis)
•Upper respiratory tract infection, sinusitis, asthma or flu-like symptoms within 2 weeks prior to visit 1
•Subjects who have dermatographism or other skin conditions which might interfere with the interpretation of the skin test results
•Subjects who are receiving immunotherapy
•Any excessive amounts of alcohol (no more than two drinks/day on average)
•Any excessive use of caffeine (more than six cups of coffee per day or equivalent)
•Any use of tobacco/nicotine products within 90 days of visit 1
•Any disease state or surgery known to affect the gastrointestinal absorption of drugs
•Known hypersensitivity to the investigational product or to drugs with similar chemical properties
+14 more criteria

Locations (1)

Sanofi-Aventis

Bridgewater, New Jersey, United States

Key Dates

Start Date

December 1, 2002

Completion Date

July 1, 2003

Last Updated

January 11, 2011

Enrollment

ACTUAL participants

Conditions

Allergic Rhinitis

Interventions

Fexofenadine

DRUG

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Allergy, Sinus Disorders, Atopic Diseases, Asthma, Allergic Rhinitis, Atopic Dermatitis, EoE, Drug a

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 11, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Fexofenadine HCl 180 mg, Desloratadine 5 mg and Placebo in Suppression of Wheal and Flare Induced by Histamine

Inclusion Criteria

Exclusion Criteria

A Biorepository of Multiple Allergic Diseases (MADREP) With Longitudinal Follow-Up

Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"

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