Phase 3
N=829
A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED)
Seasonal Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT00960141 ↗Enrolled (actual)
829
Serious AEs
0.1%
Results posted
Jun 2010
Primary outcome: Primary: Mean Change From Baseline in Daytime Nasal Symptoms Score — -0.32; -0.38; -0.47 Units 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
- Oct 2000
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Daytime Nasal Symptoms Score |
-0.32; -0.38; -0.47 | — |
| SECONDARY Mean Change From Baseline in Nighttime Symptoms Score |
-0.18; -0.28; -0.26 | — |
| SECONDARY Mean Change From Baseline in Daytime Eye Symptoms Score |
-0.23; -0.29; -0.35 | — |
| SECONDARY Patient's Global Evaluation of Allergic Rhinitis |
2.62; 2.43; 2.27 | — |
| SECONDARY Physician's Global Evaluation of Allergic Rhinitis |
2.53; 2.35; 2.26 | — |
| SECONDARY Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score |
-0.75; -0.85; -0.97 | — |
Summary
A study of the ability of montelukast to improve signs and symptoms of seasonal allergic rhinitis compared with placebo. Loratadine is included in the study as an active control.
Eligibility Criteria
Inclusion Criteria
- Patient has a documented clinical history of seasonal allergic rhinitis symptoms that become worse during the study season
- Patient is a non-smoker
- Patient is in good mental and physical health
Exclusion Criteria
- Patient is hospitalized
- Patient is a woman who is <8 weeks postpartum or is breast feeding
- Patient intends to move or vacation away during the study
- Patient is a current or past abuser of alcohol or illicit drugs
Data sourced from ClinicalTrials.gov (NCT00960141). 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.