A double-blind, placebo-controlled, randomized, parallel-group multicenter study of Mometasone Furoate nasal spray on sleep disturbances and daytime somnolence in subjects with symptomatic seasonal allergic rhinitis. - ND

• Conditions: Symptomatic Seasonal Allergic Rhinitis; MedDRA version: 6.1Level: PTClassification code 10039085

• Registration Number: EUCTR2005-004464-24-IT
• Lead Sponsor: SCHERING-PLOUGH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 372

Inclusion Criteria

- Subject must be 18 years of age - Subject must be clinically symptomatic at the Screening Visit Day -7 to -4 Visit 2 , nasal stuffiness/congestion 8805; 2 rhinorrhea/nasal discharge 8805; 2 sneezing 8805; 1 nasal itching 8805; 1 TNSS 8805; 6 - Subject must be clinically symptomatic at the Baseline Visit Day 1 Visit 3 . Nasal stuffiness/congestion 8805; 14 Rhinorrhea/nasal discharge 8805; 14 Sneezing score 8805; 7 Nasal itching score 8805; 7 TNSS 8805; 42 5. At the Screening Visit Day -7 to -4 Visit 2 , subject must have complaints of sleep disturbance - At the Baseline Visit Day 1 Visit 3 , subject must have complaints of sleep disturbance and daytime somnolence - Subject must have a 2-year or longer history of seasonal allergic rhinitis occurring during the same season s as the current study. 8. Subject must have skin tests prick or intradermal positive for outdoor allergens common in subjects with seasonal allergic rhinitis
Are the trial subjects under 18? no
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

Exclusion Criteria

- Subject is a female who is pregnant, intends to become pregnant during the study, or is nursing. - Subject is currently taking medications prohibited during the study - Subject has used any investigational product within 30 days prior to enrollment or any antibodies for asthma or allergic rhinitis in the past 90 days. - Subject has evidence of nasal polyps, deviated septum, or other intranasal anatomical obstruction s that would interfere with nasal airflow. - Subject has acute or chronic sinusitis currently being treated with antibiotics and/or topical or oral nasal decongestants. - Subject has had an acute respiratory infection within 2 weeks of the Screening - Subject has been diagnosed with clinically relevant sleep problems unassociated with allergies eg, sleep apnea, narcolepsy, frequent nocturnal awakenings due to asthma .

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified