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COMPLETEDPHASE3

Study for the Treatment of Intermittent Allergic Rhinitis With Desloratadine (Study P04683)

Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter/Multinational, Efficacy and Safety Study of Desloratadine 5 mg in the Treatment of Subjects With Allergic Rhinitis Who Meet the Criteria for Intermittent Allergic Rhinitis (IAR)

NCT00406783•Organon and Co

View on ClinicalTrials.gov

Summary

This study will investigate the effectiveness of desloratadine in treating subjects with allergic rhinitis (AR) who meet the criteria for intermittent allergic rhinitis.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The subject must meet ALL of the criteria listed below for entry:
•For this study, the diagnosis of IAR is not based solely on the current episode of AR. Subjects must have at least a 2 year history of AR consistent with IAR (defined as symptoms of allergic rhinitis present less than four days per week or for less than four consecutive weeks per year); the current episode can count as the second year.
•Subjects must be 12 years of age and older, of either sex and of any race.
•At the Run-In Visit, subjects must be sufficiently symptomatic, with a T5SS 12-hour AM-PRIOR (reflective) symptoms severity score of at least 6.
•In order for a subject to qualify at the Baseline Visit, the sum of the daily averages of the diary recordings of the 12-hour AM PRIOR + PM-PRIOR (reflective) T5SS collected during Days -4 to -1 and the AM PRIOR T5SS on the morning of the Baseline Visit (Day 1) must be \>= 30.
•Subjects must have a positive skin-prick test at screening to one or more allergens in the GA2LEN (or the usually used local) panel of seasonal and perennial allergens. Subjects must demonstrate an antigen-induced skin prick wheal at least 3 mm in diameter greater than diluent control. The positive tests must include the allergen(s) prevalent while this study is active.
•Subjects must be free of any clinically significant disease, other than IAR, which would interfere with the study evaluations.
•Subjects, or parents/legal guardians, must give written informed consent. Subjects must be able to adhere to dose and visit schedules and meet study requirements.
•In females of childbearing potential, the urine pregnancy test (hCG) must be negative at the Screening Visit.
•Nonsterile or premenopausal female subjects must be using a medically accepted method of birth control, that is, oral contraceptive, hormonal implant, medically prescribed intrauterine device (IUD), or depot injectable during the entire study. A female subject who is not currently sexually active must agree and consent to use one of the above-mentioned methods, if she becomes sexually active while participating in the study. A female subject who is not of childbearing potential must have a medical record of being surgically sterile (for example, hysterectomy and tubal ligation), or be at least 1 year postmenopausal.

Exclusion Criteria

•The subject will be excluded from entry if ANY of the criteria listed below are met:
•Subjects with a history of anaphylaxis and/or severe local reaction(s) to skin testing with allergens.
•Subjects with intolerable symptoms that would make participating in the study unbearable.
•Subjects who have had an upper respiratory tract or sinus infection that required antibiotic therapy, and have not had at least a 14-day washout prior to the run-in period, or who have had a viral upper respiratory infection within 7 days prior to screening.
•Subjects with asthma who require chronic use of inhaled or systemic corticosteroids.
•Subjects with current or a history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
•Subjects on immunotherapy (desensitization therapy) unless on a regular maintenance schedule prior to Visit 1 and staying on this schedule for the remainder of the study.
•Subjects who, in the opinion of the investigator, are dependent on nasal, oral or ocular decongestants, nasal topical antihistamines or nasal steroids.
•Subjects who have used any drug or device in an investigational protocol in the 30 days prior to Visit 1.
•Female subjects who are pregnant or nursing.
+8 more criteria

Key Dates

Start Date

August 1, 2006

Primary Completion Date

November 1, 2007

Completion Date

November 1, 2007

Last Updated

May 20, 2024

Enrollment

547

ACTUAL participants

Conditions

Rhinitis, Allergic, SeasonalRhinitis, Allergic, Perennial

Interventions

5-mg Desloratadine

DRUG

Placebo

DRUG

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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: May 20, 2024Data 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.

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Study for the Treatment of Intermittent Allergic Rhinitis With Desloratadine (Study P04683)

Inclusion Criteria

Exclusion Criteria

A Study of Mometasone Furoate Nasal Spray in Perennial Allergic Rhinitis (Study P03748)(COMPLETED)

An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)

Factors Predicting Efficacy of Allergen Injection Immunotherapy for Grass Pollen Hayfever

Methylprednisolone Injections Treating Birch Pollen Induced Allergic Rhinitis.

The Effects of Phenylephrine Compared With Those of Placebo and Pseudoephedrine on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis (SAR)(P04579)

Onset of Action of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray Compared With Placebo in Seasonal Allergic Rhinitis (C93-184)