Phase 3 N=1,577 Randomized Double-blind Treatment

Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED)

Seasonal Allergic Rhinitis

Bottom Line

View on ClinicalTrials.gov: NCT00979901 ↗

Enrolled (actual)

1,577

Serious AEs

0.1%

Results posted

Jun 2010

Primary outcome: Primary: Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks — -0.24; -0.37; -0.47 Units on a Scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Comparator: montelukast (Drug); Comparator: loratadine (Drug); Comparator: placebo (Drug); Comparator: montelukast/loratadine (Drug)
Age: Pediatric, Adult, Older Adult · 15+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: May 2000

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks	-0.24; -0.37; -0.47	—
SECONDARY Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks	-0.14; -0.27; -0.23	—
SECONDARY Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks	-0.12; -0.26; -0.32	—
SECONDARY Patient's Global Evaluation of Allergic Rhinitis at Week 2	2.62; 2.20; 2.13	—
SECONDARY Physician's Global Evaluation of Allergic Rhinitis at Week 2	2.53; 2.23; 2.17	—
SECONDARY Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2	-0.65; -0.89; -0.99	—

Summary

This study will evaluate the ability of montelukast to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine and placebo.

Eligibility Criteria

Inclusion Criteria

Patient has a documented history of seasonal allergic rhinitis symptoms that flare up during the study season
Patient is a nonsmoker and has been a nonsmoker for at least 1 year
Patient is in good general health

Exclusion Criteria

Patient is hospitalized
Patient is a woman who is less than 8 weeks postpartum or is breast-feeding
Patient intends to move or vacation away during the study
Patient has had any major surgery within 4 weeks of study start
Patient is a current or past abuser of alcohol or illicit drugs
Patient has been treated in an emergency room for asthma in the past month
Patient had an upper respiratory infection with in 3 weeks prior to study start

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00979901). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.