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 . - ND
- Conditions
- MedDRA version: 8.1 Level: LLT Classification code 10039085 Term: Rhinitis allergicIntermittent Allergic Rhinitis
- Registration Number
- EUCTR2005-005449-20-IT
- Lead Sponsor
- SCHERING-PLOUGH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 547
Subjects 12 years of age or older, of either sex with at least a 2 year history consistent with allergic rhinitis who meet the criteria for IAR defined as symptoms of allergic rhinitis present less than four days per week or for less then four consecutive weeks per year .
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Subjects with a history of anaphylaxis and/or severe local reactions to skin test with allergens or with intolerable symptoms that would make partecipating in the study unbearable. Subjects who have had an upper respiratory tract or sinus infection that required antibiotic therapy, with asthma who require chronic use of inhaled or systemic corticosteroid or with clinically significant sinusitis.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to compare the efficacy and safety of desloratadine with placebo in the symptomatic treatment of subjects in 12 years and older with intermittent allergic rhinitis IAR ;Secondary Objective: The secondary objectives are to compare the effects of desloratadine to those of placebo on quality of life and impact on productivity and health care utilization.;Primary end point(s): Symptoms Severity Rating Scale Assessment severity scores for five T5SS individual allergic rhinitis signs/symptoms nasal congestion/stuffiness, sneezing, rhinorrhea/nasal discharge, nasal pruritus, and ocular pruritus. Symptom Severity Visual Analogue Scale VAS assessment. Subject s evaluation of therapeutic response to treatment. Rhinoconjuntivitis quality of life questionnaire. Interference with sleep and with activities of daily living. Pharmacoeconomic questionnaire. Adverse Events.
- Secondary Outcome Measures
Name Time Method