Phase 3
Completed N=829
A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED)
Source: ClinicalTrials.gov NCT00960141 ↗Enrolled (actual)
829
Serious AEs
0.1%
Results posted
Jun 2010
Primary outcomePrimary: Mean Change From Baseline in Daytime Nasal Symptoms Score — -0.32; -0.38; -0.47 Units on a Scale
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.
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 | — |
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. Informational only — not medical advice.