Phase 3 N=1,079 Randomized Double-blind Treatment

Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240)

Seasonal Allergic Rhinitis

Bottom Line

View on ClinicalTrials.gov: NCT00963469 ↗

Enrolled (actual)

1,079

Serious AEs

0.2%

Results posted

Jun 2010

Primary outcome: Primary: Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period — -0.23; -0.33; -0.45 Scores on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: montelukast sodium (Drug); Comparator: loratadine (Drug); Comparator: placebo (Drug)
Age: Pediatric, Adult, Older Adult · 15+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Nov 2001

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period	-0.23; -0.33; -0.45	—
SECONDARY Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period	-0.18; -0.28; -0.25	—
SECONDARY Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period	-0.21; -0.30; -0.36	—
SECONDARY Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period	-0.18; -0.28; -0.33	—
SECONDARY Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment	2.73; 2.43; 2.30	—
SECONDARY Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment	2.75; 2.36; 2.38	—
SECONDARY Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period	-0.55; -0.85; -0.85	—

Summary

This is a study to evaluate the treatment effect of montelukast 10 mg taken in the morning, versus placebo, in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active control.

Eligibility Criteria

Inclusion Criteria

Patient has a history of seasonal allergic rhinitis that worsens during the study season
Patient is a nonsmoker
Patient is in good health physical and mental health

Exclusion Criteria

Patient is hospitalized
Patient is a woman who is < 8 weeks postpartum or is breastfeeding
Patient plans to move or vacation away during the study
Patient has had any major surgery with in past 4 weeks
Patient is a current or past abuser of alcohol or illicit drugs

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00963469). 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.